{{Short description|SSRI antidepressant}} {{Distinguish|Fluoxetine}} {{CS1 config|name-list-style=vanc|display-authors=3}} {{Use dmy dates|date=December 2023}} {{Infobox drug | Verifiedfields = changed | Watchedfields = changed | verifiedrevid = 443824781 | image = Fluvoxamine.svg | image_class = skin-invert-image | width = | alt = | caption = | image2 = Fluvoxamine 3D 4ENH.png | image_class2 = bg-transparent | width2 = | alt2 =
<!-- Clinical data --> | pronounce = {{respell|floo|VAHK|sə|meen}} <br /> UK: {{IPAc-en|f|l|uː|ˈ|v|ɒ|k|s|ə|m|iː|n}} US: {{IPAc-en|f|l|uː|ˈ|v|ɑː|k|s|ə|ˌ|m|iː|n}} | tradename = Luvox, others | Drugs.com = {{drugs.com|monograph|fluvoxamine-maleate}} | MedlinePlus = a695004 | DailyMedID = Fluvoxamine | pregnancy_AU = C | pregnancy_AU_comment = <ref name= "Drugs.com pregnancy">{{drugs.com|pregnancy|fluvoxamine}}, ''drugs.com''</ref> | pregnancy_category = | routes_of_administration = By mouth | class = Selective serotonin reuptake inhibitor (SSRI) | ATC_prefix = N06 | ATC_suffix = AB08 | ATC_supplemental = <!-- Legal status --> | legal_AU = S4 | legal_AU_comment = | legal_BR = C1 | legal_BR_comment = <ref name= "Anvisa-2023">{{cite web | vauthors = Anvisa | title = RDC Nº 784 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial | date = 31 March 2023 | trans-title = Collegiate Board Resolution No. 784 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control | url = https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-784-de-31-de-marco-de-2023-474904992 | url-status = live | archive-url = https://web.archive.org/web/20230803143925/https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-784-de-31-de-marco-de-2023-474904992 | archive-date = 3 August 2023 | access-date = 16 August 2023 | publisher = Diário Oficial da União | language = pt-BR | publication-date = 4 April 2023 }}</ref> | legal_CA = Rx-only | legal_CA_comment = | legal_DE = <!--Anlage I, II, III, or Unscheduled--> | legal_DE_comment = | legal_NZ = <!--Class A, B, C--> | legal_NZ_comment = | legal_UK = POM | legal_UK_comment = | legal_US = Rx-only | legal_US_comment = | legal_UN = <!--N I, II, III, IV / P I, II, III, IV--> | legal_UN_comment = | legal_status = <!--For countries not listed above-->
<!-- Pharmacokinetic data -->| bioavailability = 53% (90% confidence interval: 44–62%)<ref name="LUVOX" /> | protein_bound = 77–80%<ref name= "LUVOX" /><ref name= "vanHarten1993">{{cite journal | vauthors = van Harten J | title = Clinical pharmacokinetics of selective serotonin reuptake inhibitors | journal = Clinical Pharmacokinetics | volume = 24 | issue = 3 | pages = 203–220 | date = March 1993 | pmid = 8384945 | doi = 10.2165/00003088-199324030-00003 | s2cid = 84636672 }}</ref> | metabolism = Liver (primarily O-demethylation)<ref name="AltamuraCaldiroliBuoli2015" /><br />Major: CYP2D6 or CYP1A2<ref name="AltamuraCaldiroliBuoli2015" /><ref name="Wyska2019" /><ref name="LUVOX" /><br />Minor: CYP3A4, CYP2C19, and/or CYP1A2<ref name="Wyska2019" /><ref name="LUVOX" /> | metabolites = | onset = | elimination_half-life = 12–13 hours (single dose), 22 hours (repeated dosing)<ref name="LUVOX" /> | duration_of_action = | excretion = Kidney (98%; 94% as metabolites, 4% as unchanged drug)<ref name="LUVOX" />
<!-- Identifiers -->| CAS_number_Ref = {{cascite|correct|??}} | CAS_number = 54739-18-3 | CAS_supplemental = | PubChem = 5324346 | IUPHAR_ligand = 7189 | DrugBank_Ref = {{drugbankcite|changed|drugbank}} | DrugBank = DB00176 | ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}} | ChemSpiderID = 4481878 | UNII_Ref = {{fdacite|correct|FDA}} | UNII = O4L1XPO44W | KEGG_Ref = {{keggcite|correct|kegg}} | KEGG = D07984 | ChEBI_Ref = {{ebicite|correct|EBI}} | ChEBI = 5138 | ChEMBL_Ref = {{ebicite|correct|EBI}} | ChEMBL = 814 | NIAID_ChemDB = | PDB_ligand = | synonyms = <!-- Chemical and physical data --> | IUPAC_name = 2-<nowiki/>{[(''E'')-<nowiki/>{5-Methoxy-1-[4-(trifluoromethyl)phenyl] pentylidene}amino]oxy}ethanamine<ref name= "ChemSpider-2013">{{cite web | title = Luvox | work = ChemSpider | publisher = Royal Society of Chemistry | access-date = 21 October 2013 | url = http://www.chemspider.com/Chemical-Structure.4481878 | archive-url = https://web.archive.org/web/20131115055836/http://www.chemspider.com/Chemical-Structure.4481878 | archive-date = 15 November 2013 }}</ref> | C = 15 | H = 21 | F = 3 | N = 2 | O = 2 | SMILES = FC(F)(F)c1ccc(\C(=N\OCCN)CCCCOC)cc1 | StdInChI_Ref = {{stdinchicite|correct|chemspider}} | StdInChI = 1S/C15H21F3N2O2/c1-21-10-3-2-4-14(20-22-11-9-19)12-5-7-13(8-6-12)15(16,17)18/h5-8H,2-4,9-11,19H2,1H3/b20-14+ | StdInChI_comment = | StdInChIKey_Ref = {{stdinchicite|correct|chemspider}} | StdInChIKey = CJOFXWAVKWHTFT-XSFVSMFZSA-N | density = | density_notes = | melting_point = | melting_high = | melting_notes = | boiling_point = | boiling_notes = | solubility = | sol_units = | specific_rotation = }}
'''Fluvoxamine''', sold under the brand name '''Luvox''' among others, is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class.<ref name="U.S. Food and Drug Administration (FDA)-2015">{{cite web | title = Fluvoxamine Maleate Information | date = 15 July 2015 | website = FDA.gov| publisher= US Food and Drug Administration | url = https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fluvoxamine-maleate-information | archive-url = https://web.archive.org/web/20191129061058/https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fluvoxamine-maleate-information | archive-date = 29 November 2019 | access-date = 28 November 2019 }}</ref> It is primarily used to treat major depressive disorder and, perhaps more-especially, obsessive–compulsive disorder (OCD),<ref name= "pmid20140100">{{cite journal | vauthors = McCain JA | title = Antidepressants and suicide in adolescents and adults: a public health experiment with unintended consequences? | journal = P & T: A Peer-Reviewed Journal for Formulary Management | volume = 34 | issue = 7 | pages = 355–378 | date = July 2009 | pmid = 20140100 | pmc = 2799109 }}</ref> but is also used to treat anxiety disorders<ref name= "pmid11323729">{{cite journal | vauthors = | title = Fluvoxamine for the treatment of anxiety disorders in children and adolescents. The Research Unit on Pediatric Psychopharmacology Anxiety Study Group | journal = The New England Journal of Medicine | volume = 344 | issue = 17 | pages = 1279–1285 | date = April 2001 | pmid = 11323729 | doi = 10.1056/NEJM200104263441703 | doi-access = free }}</ref> such as panic disorder, social anxiety disorder, and post-traumatic stress disorder.<ref name= "pmid11085201">{{cite journal | vauthors = Figgitt DP, McClellan KJ | title = Fluvoxamine. An updated review of its use in the management of adults with anxiety disorders | journal = Drugs | volume = 60 | issue = 4 | pages = 925–954 | date = October 2000 | pmid = 11085201 | doi = 10.2165/00003495-200060040-00006 | s2cid = 265712201 }}</ref><ref name="pmid18568110"/><ref name= "pmid11472786">{{cite journal | vauthors = Asnis GM, Hameedi FA, Goddard AW, Potkin SG, Black D, Jameel M, Desagani K, Woods SW | title = Fluvoxamine in the treatment of panic disorder: a multi-center, double-blind, placebo-controlled study in outpatients | journal = Psychiatry Research | volume = 103 | issue = 1 | pages = 1–14 | date = August 2001 | pmid = 11472786 | doi = 10.1016/S0165-1781(01)00265-7 | s2cid = 40412606 }}</ref>
Fluvoxamine's side-effect profile is similar to that of other SSRIs. Common adverse effects include constipation, gastrointestinal problems, headache, anxiety, irritation, sexual problems, dry mouth, sleep problems, and an increased risk of suicide at the start of treatment. These effects appear to be significantly weaker than with other SSRIs, with the exception of gastrointestinal side-effects.<ref name= "Vezmar-2009">{{cite journal | vauthors = Vezmar S, Miljkovic B, Vucicevic K, Timotijevic I, Prostran M, Todorovic Z, Pokrajac M | title = Pharmacokinetics and efficacy of fluvoxamine and amitriptyline in depression | journal = Journal of Pharmacological Sciences | volume = 110 | issue = 1 | pages = 98–104 | date = May 2009 | pmid = 19444001 | doi = 10.1254/jphs.09013fp }}</ref> In some patients, sexual dysfunction may persist even after the drug is discontinued, a condition known as post-SSRI sexual dysfunction; regulatory agencies including the European Medicines Agency and Health Canada have recommended that fluvoxamine's product labeling warn of this risk.<ref name="Healy2022" /><ref name="PRAC2019" />
Fluvoxamine appears to be more tolerable than other SSRIs, particularly with respect to cardiovascular complications.<ref name = "Westenberg_2006">{{cite journal | vauthors = Westenberg HG, Sandner C | title = Tolerability and safety of fluvoxamine and other antidepressants | journal = International Journal of Clinical Practice | volume = 60 | issue = 4 | pages = 482–491 | date = April 2006 | pmid = 16620364 | pmc = 1448696 | doi = 10.1111/j.1368-5031.2006.00865.x }}</ref>
It is on the World Health Organization's List of Essential Medicines.<ref name="WHO23rd">{{cite book | title = The selection and use of essential medicines: web annex A: World Health Organization model list of essential medicines: 23rd list | year = 2023 | hdl = 10665/371090 | publisher = World Health Organization | location = Geneva | id = WHO/MHP/HPS/EML/2023.02 | hdl-access = free | vauthors = Organization WH }}</ref>
==Medical uses==
In many countries (e.g., Australia,<ref name = AMH/><ref name="NPS-MedicineWise-2018">{{cite web | title = Luvox Tablets | url = https://www.nps.org.au/medical-info/medicine-finder/luvox-tablets | website = NPS MedicineWise | access-date = 22 October 2018 | archive-date = 22 October 2018 | archive-url = https://web.archive.org/web/20181022153450/https://www.nps.org.au/medical-info/medicine-finder/luvox-tablets | url-status = live }}</ref> the United Kingdom,<ref name = BNF/> and Russia<ref name="Drug Registry of Russia (RLS) Drug Compendium">{{cite web | title = Summary of Full Prescribing Information: Fluvoxamine | url = http://www.rlsnet.ru/mnn_index_id_307.htm | website = Drug Registry of Russia (RLS) Drug Compendium | access-date = 21 March 2015 | language = ru | archive-date = 2 April 2015 | archive-url = https://web.archive.org/web/20150402162017/http://www.rlsnet.ru/mnn_index_id_307.htm | url-status = live }}</ref>) it is commonly used for major depressive disorder. Fluvoxamine is also approved in the United States for obsessive–compulsive disorder (OCD),<ref name = DailyMed/><ref name="pmid20140100" /> and social anxiety disorder.<ref name="Luvox CR approved for OCD and SAD">{{cite web | title = Luvox CR approved for OCD and SAD | date = 29 February 2008 | url = https://www.empr.com/home/news/luvox-cr-approved-for-ocd-and-sad/ | website = MPR | access-date = 2 March 2019 | archive-date = 28 August 2021 | archive-url = https://web.archive.org/web/20210828090440/https://www.empr.com/home/news/luvox-cr-approved-for-ocd-and-sad/ | url-status = live }}</ref> In Japan, it is also approved to treat OCD, social anxiety disorder, and major depressive disorder.<ref name="Astellas-Pharma-2018">{{cite web | title = 2005 News Releases | url = https://www.astellas.com/en/corporate/news/detail/luvox-receives-approval-for-so.html | website = Astellas Pharma | access-date = 16 September 2018 | archive-date = 16 September 2018 | archive-url = https://web.archive.org/web/20180916235231/https://www.astellas.com/en/corporate/news/detail/luvox-receives-approval-for-so.html }}</ref><ref name="www.medscape.com-2018">{{cite web | title = International Approvals: Ebixa, Depromel/Luvox, M-Vax | url = https://www.medscape.com/viewarticle/514804 | website = www.medscape.com | access-date = 16 September 2018 | archive-date = 29 October 2020 | archive-url = https://web.archive.org/web/20201029173810/https://www.medscape.com/viewarticle/514804 | url-status = live }}</ref> Fluvoxamine is indicated for children and adolescents with OCD.<ref name="Jazz Pharmaceuticals, Inc.-2005">{{cite web | title = Fluvoxamine Product Insert | date = March 2005 | url = https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022235lbl.pdf | work = Jazz Pharmaceuticals, Inc. | publisher = U.S. Food and Drug Administration | access-date = 4 November 2022 | archive-date = 4 November 2022 | archive-url = https://web.archive.org/web/20221104055928/https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022235lbl.pdf }}</ref> The NICE guidelines in the United Kingdom have, as of 2005, authorized its use for OCD in adults and adolescents of any age and children over the age of 7.{{medical citation needed|date=April 2024}}
There is evidence that fluvoxamine is effective for generalised social anxiety in adults, although, as with other SSRIs, some of the results may be compromised by having been funded by pharmaceutical companies.<ref name="pmid29048739">{{cite journal | vauthors = Williams T, Hattingh CJ, Kariuki CM, Tromp SA, van Balkom AJ, Ipser JC, Stein DJ | title = Pharmacotherapy for social anxiety disorder (SAnD) | journal = The Cochrane Database of Systematic Reviews | volume = 10 | issue = 10 | article-number = CD001206 | date = October 2017 | pmid = 29048739 | pmc = 6360927 | doi = 10.1002/14651858.CD001206.pub3 }}</ref><ref name="pmid29995828">{{cite journal | vauthors = Liu X, Li X, Zhang C, Sun M, Sun Z, Xu Y, Tian X | title = Efficacy and tolerability of fluvoxamine in adults with social anxiety disorder: A meta-analysis | journal = Medicine | volume = 97 | issue = 28 | article-number = e11547 | date = July 2018 | pmid = 29995828 | pmc = 6076099 | doi = 10.1097/MD.0000000000011547}}</ref> Of the SSRIs, however, fluvoxamine, paroxetine, and sertraline do appear consistent as viable treatments for generalised social anxiety.<ref name="Williams-2020">Williams, T., McCaul, M., Schwarzer, G., Cipriani, A., Stein, D. J., & Ipser, J. (2020). Pharmacological treatments for social anxiety disorder in adults: a systematic review and network meta-analysis. Acta neuropsychiatrica, 32(4), 169–176. https://doi.org/10.1017/neu.2020.6 {{Webarchive|url=https://web.archive.org/web/20240907193632/https://www.cambridge.org/core/journals/acta-neuropsychiatrica/article/abs/pharmacological-treatments-for-social-anxiety-disorder-in-adults-a-systematic-review-and-network-metaanalysis/38FA011F8B7B205A8714F57528DF59A4 |date=7 September 2024 }}</ref><ref name="Davidson-2003">Davidson J. R. (2003). Pharmacotherapy of social phobia. Acta psychiatrica Scandinavica. Supplementum, (417), 65–71. https://doi.org/10.1034/j.1600-0447.108.s417.7.x {{Webarchive|url=https://web.archive.org/web/20240907193630/https://onlinelibrary.wiley.com/doi/10.1034/j.1600-0447.108.s417.7.x |date=7 September 2024 }}</ref>
Fluvoxamine is also effective for treating a range of anxiety disorders in children and adolescents, including generalized anxiety disorder, social anxiety disorder, panic disorder, and separation anxiety disorder.<ref name="NIHR-Evidence-2022">{{cite journal | title = Antidepressants for children and teenagers: what works for anxiety and depression? | journal = NIHR Evidence | date = 3 November 2022 | doi = 10.3310/nihrevidence_53342 | url = https://evidence.nihr.ac.uk/collection/antidepressants-for-children-and-teenagers-what-works-anxiety-depression/ | type = Plain English summary | publisher = National Institute for Health and Care Research | s2cid = 253347210 | url-access = subscription | access-date = 7 November 2022 | archive-date = 5 November 2022 | archive-url = https://web.archive.org/web/20221105153958/https://evidence.nihr.ac.uk/collection/antidepressants-for-children-and-teenagers-what-works-anxiety-depression/ | url-status = live }}</ref><ref name="pmid32982805">{{cite journal | vauthors = Boaden K, Tomlinson A, Cortese S, Cipriani A | title = Antidepressants in Children and Adolescents: Meta-Review of Efficacy, Tolerability and Suicidality in Acute Treatment | journal = Frontiers in Psychiatry | volume = 11 | article-number = 717 | date = 2 September 2020 | pmid = 32982805 | pmc = 7493620 | doi = 10.3389/fpsyt.2020.00717 | doi-access = free }}</ref><ref name="pmid34002501">{{cite journal | vauthors = Correll CU, Cortese S, Croatto G, Monaco F, Krinitski D, Arrondo G, Ostinelli EG, Zangani C, Fornaro M, Estradé A, Fusar-Poli P, Carvalho AF, Solmi M | title = Efficacy and acceptability of pharmacological, psychosocial, and brain stimulation interventions in children and adolescents with mental disorders: an umbrella review | journal = World Psychiatry | volume = 20 | issue = 2 | pages = 244–275 | date = June 2021 | pmid = 34002501 | pmc = 8129843 | doi = 10.1002/wps.20881 }}</ref>
The drug works long-term, and retains its therapeutic efficacy for at least one year.<ref name="pmid7507038">{{cite journal | vauthors = Wilde MI, Plosker GL, Benfield P | title = Fluvoxamine. An updated review of its pharmacology, and therapeutic use in depressive illness | journal = Drugs | volume = 46 | issue = 5 | pages = 895–924 | date = November 1993 | pmid = 7507038 | doi = 10.2165/00003495-199346050-00008 | s2cid = 195691900 }}</ref>
The average therapeutic dose for fluvoxamine is 100 to 300 mg/day, with 300 mg being the upper daily limit normally recommended. OCD, however, often requires higher doses; doses of up to 450 mg/day may be prescribed in this case.<ref name="Seibell-2015">Seibell PJ, Hamblin RJ, Hollander E.
Obsessive-compulsive disorder: Overview and standard treatment strategies. Psychiatric Annals. 2015 Jun 1;45(6):297-302.</ref><ref name="Rivas-1997">Rivas-Vazquez, R.A., and Blais, M.A., 1997. Selective serotonin reuptake inhibitors and atypical antidepressants: A review and update for psychologists. Professional Psychology: Research and Practice, 28(6), p.526.</ref><ref name="Middleton-2019">Middleton, R., Wheaton, M.G., Kayser, R., and Simpson, H.B., 2019. Treatment resistance in obsessive-compulsive disorder. Treatment resistance in psychiatry: risk factors, biology, and management, pp.165-177.</ref> The (off-label) upper daily limits for other serotonin-reuptake inhibitors used in the treatment of OCD, by analogy, are 400 mg for sertraline,<ref name="pmid16426083">Ninan PT, Koran LM, Kiev A, Davidson JR, Rasmussen SA, Zajecka JM, Robinson DG, Crits-Christoph P, Mandel FS, Austin C. High-dose sertraline strategy for nonresponders to acute treatment for obsessive-compulsive disorder: a multicenter double-blind trial. J Clin Psychiatry. 2006 Jan;67(1):15-22. doi: 10.4088/jcp.v67n0103. PMID 16426083.</ref> 100 mg for paroxetine, 120 mg for both fluoxetine and citalopram, 60 mg for escitalopram and 300 mg for clomipramine.<ref>{{Cite web | title = Psychopharmacology Institute | url = https://psychopharmacologyinstitute.com/section/adequate-treatment-trials-in-ocd-fda-approvals-and-maximal-dosing-2523-4887 | website = psychopharmacologyinstitute.com }}</ref><ref name="pmid17849776">Koran LM, Hanna GL, Hollander E, Nestadt G, Simpson HB; American Psychiatric Association. Practice guideline for the treatment of patients with obsessive-compulsive disorder. Am J Psychiatry. 2007 Jul;164(7 Suppl):5-53. PMID 17849776.</ref>
In any case with fluvoxamine, treatment is generally begun at 50 mg and increased in 50 mg increments every 4 to 7 days until a therapeutic optimum is reached.<ref name="Figgitt-2000">Figgitt, D.P., and McClellan, K.J., 2000. Fluvoxamine: an updated review of its use in the management of adults with anxiety disorders. Drugs, 60, pp.925-954.</ref>
==Adverse effects== Fluvoxamine's side-effect profile is very similar to other SSRIs. Gastrointestinal side effects are characteristic of those receiving treatment with fluvoxamine.<ref name=LUVOX>{{cite web | title = Product Information Luvox | date = 15 January 2013 | work = TGA eBusiness Services | publisher = Abbott Australasia Pty Ltd | access-date = 21 October 2013 | url = https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-07140-3 | archive-date = 9 October 2017 | archive-url = https://web.archive.org/web/20171009014348/https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-07140-3 | url-status = live }}</ref><ref name=DailyMed>{{cite web | title = Fluvoxamine Maleate tablet, coated prescribing information | date = 14 December 2018 | work = DailyMed | publisher = U.S. National Library of Medicine | url = https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7ecd83ec-88f5-4f85-9cc2-9068375d8820 | access-date = 28 November 2019 | archive-date = 19 October 2020 | archive-url = https://web.archive.org/web/20201019235438/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7ecd83ec-88f5-4f85-9cc2-9068375d8820 | url-status = live }}</ref><ref name="AMH">{{cite book | veditors = Rossi S | title = Australian Medicines Handbook | year = 2013 | isbn = 978-0-9805790-9-3 | place = Adelaide | publisher = The Australian Medicines Handbook Unit Trust | edition = 2013 }}</ref><ref name="BNF">{{cite book | title = British National Formulary (BNF) | year = 2013 | isbn = 978-0-85711-084-8 | publisher = Pharmaceutical Press | location = London, UK | edition = 65th | url-access = registration | url = https://archive.org/details/bnf65britishnati0000unse }}</ref><ref name="Maudsley">{{cite book | vauthors = Taylor D, Paton C, Shitij K | title = The Maudsley prescribing guidelines in psychiatry | year = 2012 | isbn = 978-0-470-97948-8 | publisher = Wiley-Blackwell | location = West Sussex }}</ref><ref name="electronic Medicines Compendium-2013">{{cite web | title = Faverin 100 mg film-coated tablets – Summary of Product Characteristics (SPC) | date = 14 May 2013 | work = electronic Medicines Compendium | publisher = Abbott Healthcare Products Limited | access-date = 21 October 2013 | url-status = live | url = http://www.medicines.org.uk/emc/medicine/22124/SPC/Faverin+100+mg+film-coated+tablets/ | archive-date = 21 October 2013 | archive-url = https://web.archive.org/web/20131021042737/http://www.medicines.org.uk/emc/medicine/22124/SPC/Faverin+100+mg+film-coated+tablets/ }}</ref> However, compared to escitalopram and sertraline, fluvoxamine's gastrointestinal profile may be less intense,<ref name="Oliva Lippi Paci Del Fabro 2021 p. 110266">{{cite journal | vauthors = Oliva V, Lippi M, Paci R, Del Fabro L, Delvecchio G, Brambilla P, De Ronchi D, Fanelli G, Serretti A | title = Gastrointestinal side effects associated with antidepressant treatments in patients with major depressive disorder: A systematic review and meta-analysis | journal = Progress in Neuro-psychopharmacology & Biological Psychiatry | volume = 109 | article-number = 110266 | date = July 2021 | pmid = 33549697 | doi = 10.1016/j.pnpbp.2021.110266 | publisher = Elsevier BV | s2cid = 231809760 | hdl = 11390/1329975 | hdl-access = free }}</ref> often being limited to nausea.<ref name="pmid18568110">{{cite journal | vauthors = Irons J | title = Fluvoxamine in the treatment of anxiety disorders | journal = Neuropsychiatric Disease and Treatment | volume = 1 | issue = 4 | pages = 289–299 | date = December 2005 | pmid = 18568110 | pmc = 2424117}}</ref> Mosapride has demonstrated efficacy in treating fluvoxamine-induced nausea.<ref name="Ueda Yoshimura Shinkai Terao 2001 pp. 259–264">{{cite journal | vauthors = Ueda N, Yoshimura R, Shinkai K, Terao T, Nakamura J | title = Characteristics of fluvoxamine-induced nausea | journal = Psychiatry Research | volume = 104 | issue = 3 | pages = 259–264 | date = November 2001 | pmid = 11728615 | doi = 10.1016/s0165-1781(01)00320-1 | publisher = Elsevier BV | s2cid = 38761139 }}</ref> It is also advised practice to divide total daily doses of fluvoxamine greater than 100 mg, with the higher fraction being taken in the evening (e.g., 50 mg at the beginning of the waking day and 200 mg at bedtime). In any case, high starting daily doses of fluvoxamine rather than the recommended gradual titration (starting at 50 mg and gradually titrating, up to 300 mg if necessary) may increase the likelihood of nausea.<ref name="Ware 1997 pp. 15–23">{{cite journal | vauthors = Ware MR | title = Fluvoxamine: A Review of the Controlled Trials in Depression | journal = The Journal of Clinical Psychiatry | volume = 58 | issue = suppl 5 | pages = 15–23 | date = 1 March 1997 | pmid = 9184623 | publisher = Physicians Postgraduate Press, Inc. | issn = 0160-6689 | url = https://www.psychiatrist.com/read-pdf/7342/ | access-date = 1 December 2023 | archive-date = 6 December 2022 | archive-url = https://web.archive.org/web/20221206050356/https://www.psychiatrist.com/read-pdf/7342/ | url-status = live }}</ref>
In comparison to other SSRIs, fluvoxamine has the second highest rate of causing discontinuation syndrome, as a result of the low half-life of fluvoxamine.<ref>{{Cite journal | vauthors = Hosenbocus S, Chahal R | title = SSRIs and SNRIs: A review of the Discontinuation Syndrome in Children and Adolescents | journal = Journal of the Canadian Academy of Child and Adolescent Psychiatry | volume = 20 | issue = 1 | pages = 60–67 | date = February 2011 | pmid = 21286371 | pmc = 3024727 | issn = 2293-6122 }}</ref>
===Common===
Common side effects occurring with 1–10% incidence:
{{div col |colwidth=20em}} * Abdominal pain * Agitation * Anxiety * Asthenia (weakness) * Constipation * Diarrhea * Dizziness * Dyspepsia (indigestion) * Headache * Hyperhidrosis (excess sweating) * Insomnia * Loss of appetite * Malaise * Nausea * Nervousness * Palpitations * Restlessness * Sexual dysfunction (including delayed ejaculation, erectile dysfunction, decreased libido, etc.) * Somnolence (drowsiness) * Tachycardia (high heart rate) * Tremor * Vomiting * Weight loss * Xerostomia (dry mouth) * Yawning
{{div col end}}
===Uncommon===
Uncommon side effects occurring with 0.1–1% incidence:
{{div col |colwidth=30em}} * Arthralgia * Confusional state * Cutaneous hypersensitivity reactions (e.g. oedema [buildup of fluid in the tissues], rash, pruritus) * Extrapyramidal side effects (e.g. dystonia, parkinsonism, tremor, etc.) * Hallucination * Orthostatic hypotension {{div col end}}
===Rare===
Rare side effects occurring with 0.01–0.1% incidence:
{{div col |colwidth=32em}} * Abnormal hepatic (liver) function * Galactorrhoea (expulsion of breast milk unrelated to pregnancy or breastfeeding) * Mania * Photosensitivity (being abnormally sensitive to light) * Seizures
{{div col end}}
===Unknown frequency=== {{div col |colwidth=30em}} * Akathisia{{snd}} a sense of inner restlessness that presents itself with the inability to stay still * Bed-wetting * Bone fractures * Dysgeusia * Ecchymoses * Glaucoma * Haemorrhage * Hyperprolactinaemia (elevated plasma prolactin levels leading to galactorrhoea, amenorrhoea [cessation of menstrual cycles], etc.) * Hyponatraemia * Mydriasis * Neuroleptic malignant syndrome – practically identical presentation to serotonin syndrome except with a more prolonged onset * Paraesthesia * Serotonin syndrome – a potentially fatal condition characterised by abrupt onset muscle rigidity, hyperthermia (elevated body temperature), rhabdomyolysis, mental status changes (e.g. coma, hallucinations, agitation), etc. * Suicidal ideation and behaviour * Syndrome of inappropriate antidiuretic hormone secretion * Urinary incontinence * Urinary retention * Violence toward others<ref name = LUVOXTIME>{{cite magazine | vauthors = Szalavitz M | title = Top Ten Legal Drugs Linked to Violence | date = 7 January 2011 | magazine = Time | access-date = 10 September 2014 | url = https://healthland.time.com/2011/01/07/top-ten-legal-drugs-linked-to-violence/ | archive-date = 21 September 2014 | archive-url = https://web.archive.org/web/20140921052039/http://healthland.time.com/2011/01/07/top-ten-legal-drugs-linked-to-violence/ | url-status = live }}</ref> * Weight changes * Withdrawal symptoms
{{div col end}}
=== Post-SSRI sexual dysfunction === {{Main|Post-SSRI sexual dysfunction}}
Post-SSRI sexual dysfunction (PSSD) is an iatrogenic condition in which sexual side effects persist after discontinuation of serotonin reuptake inhibiting antidepressants, including fluvoxamine.<ref name="Bala2018">{{cite journal | vauthors = Bala A, Tue Nguyen HM, Hellstrom WJ | title = Post-SSRI Sexual Dysfunction: A Literature Review | journal = Sexual Medicine Reviews | volume = 6 | issue = 1 | pages = 29–34 | date = January 2018 | pmid = 28778697 | doi = 10.1016/j.sxmr.2017.07.002 }}</ref><ref name="Healy2022">{{cite journal | vauthors = Healy D, Bahrick A, Bak M, Barbato A, Calabro RS, Chubak BM | title = Diagnostic criteria for enduring sexual dysfunction after treatment with antidepressants, finasteride and isotretinoin | journal = International Journal of Risk & Safety in Medicine | volume = 33 | issue = 1 | pages = 65–76 | date = 2022 | pmid = 34719438 | pmc = 8925105 | doi = 10.3233/JRS-210023 }}</ref> Characteristic symptoms include genital numbness, pleasureless or weak orgasm, loss of libido, and erectile dysfunction; non-sexual symptoms such as emotional blunting and cognitive impairment may also occur.<ref name="Healy2022" /> The condition can arise after even brief exposure to a serotonin reuptake inhibitor and may persist indefinitely; there is currently no established treatment.<ref name="Healy2018">{{cite journal | vauthors = Healy D, Le Noury J, Mangin D | title = Enduring sexual dysfunction after treatment with antidepressants, 5-alpha-reductase inhibitors and isotretinoin: 300 cases | journal = International Journal of Risk & Safety in Medicine | volume = 29 | issue = 3–4 | pages = 125–134 | date = 2018 | pmid = 29733030 | doi = 10.3233/JRS-180744 | pmc = 6004900 }}</ref> The DSM-5 noted in 2013 that serotonin reuptake inhibitor-induced sexual dysfunction may persist after the agent is discontinued.<ref name="Healy2024barriers">{{cite journal | vauthors = Healy D, Mangin D | title = Post-SSRI sexual dysfunction: barriers to quantifying incidence and prevalence | journal = Epidemiology and Psychiatric Sciences | volume = 33 | article-number = e52 | date = 2024 | pmid = 39363727 | pmc = 11450419 | doi = 10.1017/S2045796024000532 | doi-access = free }}</ref>
A 2023 retrospective cohort study of over 12,000 males estimated the risk of irreversible sexual dysfunction at approximately 0.46% of patients treated with serotonergic antidepressants, including SSRIs, though the actual prevalence remains uncertain and the condition is likely underreported.<ref name="BenSheetrit2023">{{cite journal | vauthors = Ben-Sheetrit J, Aizenberg D, Csoka AB, Weizman A, Hermesh H | title = Estimating the risk of irreversible post-SSRI sexual dysfunction (PSSD) due to serotonergic antidepressants | journal = Annals of General Psychiatry | volume = 22 | issue = 1 | article-number = 15 | date = April 2023 | pmid = 37076856 | pmc = 10122283 | doi = 10.1186/s12991-023-00447-0 | doi-access = free }}</ref> A 2023 systematic review noted that while data on fluvoxamine is more limited than for some other SSRIs, it was included in the EMA's class-wide signal assessment and cases have been reported with SNRIs, SRI tricyclic antidepressants, and other serotonin reuptake inhibiting drugs in addition to SSRIs.<ref name="Tarchi2023">{{cite journal | vauthors = Tarchi L, Merola GP, Ferrara M, Ferraro E, Ferrando L, Castellini G, Ricca V | title = Selective serotonin reuptake inhibitors, post-treatment sexual dysfunction and persistent genital arousal disorder: A systematic review | journal = Pharmacoepidemiology and Drug Safety | volume = 32 | issue = 10 | pages = 1041–1055 | date = October 2023 | pmid = 37345683 | doi = 10.1002/pds.5653 | hdl = 2158/1317239 | hdl-access = free }}</ref> A citizen petition submitted to regulators in 2018 suggested that SNRIs and other serotonin reuptake inhibiting drugs, including fluvoxamine, may be less likely to induce PSSD than SSRIs, though this remains unconfirmed.<ref name="Healy2024barriers" />
In 2019, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) reviewed evidence on fluvoxamine as part of its class-wide signal assessment and recommended that product labels for all SSRIs and SNRIs be updated to state that sexual dysfunction may be long-lasting even after treatment is stopped.<ref name="PRAC2019">{{cite web | title = PRAC recommendations on signals adopted at the 13-16 May 2019 PRAC meeting | publisher = European Medicines Agency | date = 11 June 2019 | url = https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-13-16-may-2019-prac-meeting_en.pdf | access-date = 8 April 2026 }}</ref> Health Canada followed with similar label updates in 2021.<ref name="Healy2024barriers" /> In 2024, Australia's Therapeutic Goods Administration aligned all SSRI and SNRI product information to reflect this risk; fluvoxamine was among the products requiring updated warnings.<ref name="TGA2024">{{cite web | title = Updated warnings about persistent sexual dysfunction for antidepressants | publisher = Therapeutic Goods Administration | date = 23 May 2024 | url = https://www.tga.gov.au/news/safety-updates/updated-warnings-about-persistent-sexual-dysfunction-antidepressants | access-date = 8 April 2026 }}</ref>
== Interactions == thumb|Luvox (fluvoxamine) 100 mg film-coated scored tablets
Fluvoxamine inhibits the following cytochrome P450 enzymes:<ref name=Pharm>{{cite book | vauthors = Ciraulo DA, Shader RI | veditors = Ciraulo DA, Shader RI | title = Pharmacotherapy of Depression | year = 2011 | doi = 10.1007/978-1-60327-435-7 | publisher = Springer | isbn = 978-1-60327-435-7 | page = 49 | edition = 2nd }}</ref><ref name="GG">{{cite book | vauthors = Brunton L, Chabner B, Knollman B | title = Goodman and Gilman's The Pharmacological Basis of Therapeutics | year = 2010 | isbn = 978-0-07-162442-8 | edition = 12th | publisher = McGraw-Hill Professional | location = New York | title-link = Goodman and Gilman's The Pharmacological Basis of Therapeutics }}</ref><ref name="pmid8968657">{{cite journal | vauthors = Baumann P | title = Pharmacokinetic-pharmacodynamic relationship of the selective serotonin reuptake inhibitors | journal = Clinical Pharmacokinetics | volume = 31 | issue = 6 | pages = 444–469 | date = December 1996 | pmid = 8968657 | doi = 10.2165/00003088-199631060-00004 | s2cid = 31923953 }}</ref><ref name="pmid9184622">{{cite journal | vauthors = DeVane CL, Gill HS | title = Clinical pharmacokinetics of fluvoxamine: applications to dosage regimen design | journal = The Journal of Clinical Psychiatry | volume = 58 | issue = Suppl 5 | pages = 7–14 | year = 1997 | pmid = 9184622 }}</ref><ref name="pmid9809216">{{cite journal | vauthors = DeVane CL | title = Translational pharmacokinetics: current issues with newer antidepressants | journal = Depression and Anxiety | volume = 8 | issue = Suppl 1 | pages = 64–70 | year = 1998 | pmid = 9809216 | doi = 10.1002/(SICI)1520-6394(1998)8:1+<64::AID-DA10>3.0.CO;2-S | s2cid = 22297498 | doi-access = free }}</ref><ref name="pmid17278909">{{cite journal | vauthors = Bondy B, Spellmann I | title = Pharmacogenetics of antipsychotics: useful for the clinician? | journal = Current Opinion in Psychiatry | volume = 20 | issue = 2 | pages = 126–130 | date = March 2007 | pmid = 17278909 | doi = 10.1097/YCO.0b013e328017f69f | s2cid = 23859992 }}</ref><ref name="pmid17823102">{{cite journal | vauthors = Kroon LA | title = Drug interactions with smoking | journal = American Journal of Health-System Pharmacy | volume = 64 | issue = 18 | pages = 1917–1921 | date = September 2007 | pmid = 17823102 | doi = 10.2146/ajhp060414 }}</ref><ref name="Waknine-2007">{{cite web | vauthors = Waknine Y | title = Prescribers Warned of Tizanidine Drug Interactions | date = 13 April 2007 | work = Medscape News | publisher = Medscape | url = http://www.medscape.com/viewarticle/555194_print | access-date = 1 February 2008 | archive-date = 21 February 2013 | archive-url = https://web.archive.org/web/20130221020721/http://www.medscape.com/viewarticle/555194_print | url-status = live }}</ref><ref name="Mayo-Clinic-2018">{{cite web | title = Fluvoxamine (Oral Route) Precautions | url = https://www.mayoclinic.org/drugs-supplements/fluvoxamine-oral-route/precautions/drg-20066874?p=1 | website = Mayo Clinic | access-date = 2 November 2018 | archive-date = 6 March 2019 | archive-url = https://web.archive.org/web/20190306043631/https://www.mayoclinic.org/drugs-supplements/fluvoxamine-oral-route/precautions/drg-20066874?p=1 | url-status = live }}</ref>{{Excessive citations inline|date=April 2024}}<!--there should be citations near the relevant enzymes/substances rather than the whole list of citations with unknown relevance--> * CYP1A2 (strongly) which metabolizes agomelatine, amitriptyline, caffeine, clomipramine, clozapine, duloxetine, haloperidol, imipramine, phenacetin, tacrine, tamoxifen, theophylline, olanzapine, etc. * CYP3A4 (moderately) which metabolizes alprazolam, aripiprazole, clozapine, haloperidol, quetiapine, pimozide, ziprasidone, etc.<ref name="pmid11876575">{{cite journal | vauthors = Hemeryck A, Belpaire FM | title = Selective serotonin reuptake inhibitors and cytochrome P-450 mediated drug-drug interactions: an update | journal = Current Drug Metabolism | volume = 3 | issue = 1 | pages = 13–37 | date = February 2002 | pmid = 11876575 | doi = 10.2174/1389200023338017 }}</ref> * CYP2D6 (weakly) which metabolizes aripiprazole, chlorpromazine, clozapine, codeine, fluoxetine, haloperidol, olanzapine, oxycodone, paroxetine, perphenazine, pethidine, risperidone, sertraline, thioridazine, zuclopenthixol, etc.<ref name="FDA_drug_development">{{cite journal | title = Drug Development and Drug Interactions: Table of Substrates, Inhibitors and Inducers | journal = FDA | date = 26 May 2021 | url = https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers | access-date = 25 December 2020 | archive-date = 4 November 2020 | archive-url = https://web.archive.org/web/20201104173036/https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers }}</ref> * CYP2C9 (moderately) which metabolizes nonsteroidal anti-inflammatory drugs, phenytoin, sulfonylureas, etc. * CYP2C19 (strongly) which metabolizes clonazepam, diazepam, phenytoin, etc. * CYP2B6 (weakly) which metabolizes bupropion, cyclophosphamide, sertraline, tamoxifen, valproate, etc.
By so doing, fluvoxamine can increase serum concentration of the substrates of these enzymes.<ref name = Pharm/>
Fluvoxamine may also elevate plasma levels of olanzapine by approximately two times.<ref name="pmid17214606">{{cite journal | vauthors = Spina E, de Leon J | title = Metabolic drug interactions with newer antipsychotics: a comparative review | journal = Basic & Clinical Pharmacology & Toxicology | volume = 100 | issue = 1 | pages = 4–22 | date = January 2007 | pmid = 17214606 | doi = 10.1111/j.1742-7843.2007.00017.x | doi-access = free }}</ref> Combined olanzapine and fluvoxamine, which may cause increased sedation,<ref name="pmid11063782">{{cite journal | vauthors = Bogetto F, Bellino S, Vaschetto P, Ziero S | title = Olanzapine augmentation of fluvoxamine-refractory obsessive-compulsive disorder (OCD): a 12-week open trial | journal = Psychiatry Research | volume = 96 | issue = 2 | pages = 91–98 | date = October 2000 | pmid = 11063782 | doi = 10.1016/s0165-1781(00)00203-1 | s2cid = 43395897 }}</ref> should be used cautiously and controlled clinically and by therapeutic drug monitoring to avoid olanzapine induced adverse effects and/or intoxication.<ref name="pmid12352274">{{cite journal | vauthors = Hiemke C, Peled A, Jabarin M, Hadjez J, Weigmann H, Härtter S, Modai I, Ritsner M, Silver H | title = Fluvoxamine augmentation of olanzapine in chronic schizophrenia: pharmacokinetic interactions and clinical effects | journal = Journal of Clinical Psychopharmacology | volume = 22 | issue = 5 | pages = 502–506 | date = October 2002 | pmid = 12352274 | doi = 10.1097/00004714-200210000-00010 | s2cid = 38073367 }}</ref><ref name="NPS MedicineWise-2020">{{cite web | title = Movox | date = 23 November 2020 | url = https://www.nps.org.au/medicine-finder/movox-tablets | access-date = 4 November 2022 | website = NPS MedicineWise | archive-date = 4 November 2022 | archive-url = https://web.archive.org/web/20221104034758/https://www.nps.org.au/medicine-finder/movox-tablets | url-status = live }}</ref>
The plasma levels of oxidatively metabolized benzodiazepines (e.g., triazolam, midazolam, alprazolam, and diazepam) are likely to be increased when co-administered with fluvoxamine. However, the clearance of benzodiazepines metabolized by glucuronidation (e.g., lorazepam; oxazepam, which is coincidentally a metabolite of diazepam;<ref name="pmid28903606">{{cite journal | vauthors = Dinis-Oliveira RJ | title = Metabolic profile of oxazepam and related benzodiazepines: clinical and forensic aspects | journal = Drug Metabolism Reviews | volume = 49 | issue = 4 | pages = 451–463 | date = November 2017 | pmid = 28903606 | doi = 10.1080/03602532.2017.1377223 | s2cid = 4528255 }}</ref> temazepam)<ref name="Raouf-2016">{{cite web | vauthors = Raouf M | veditors = Fudin J | title = Benzodiazepine Metabolism and Pharmacokinetics | date = 2016 | url = http://paindr.com/wp-content/uploads/2015/10/Revised-BZD_-9-30.pdf | access-date = 16 September 2018 | archive-date = 12 July 2018 | archive-url = https://web.archive.org/web/20180712232038/http://paindr.com/wp-content/uploads/2015/10/Revised-BZD_-9-30.pdf | url-status = live }}</ref><ref name="pmid8700792">{{cite journal | vauthors = Peppers MP | title = Benzodiazepines for alcohol withdrawal in the elderly and in patients with liver disease | journal = Pharmacotherapy | volume = 16 | issue = 1 | pages = 49–57 | date = 1996 | pmid = 8700792 | doi = 10.1002/j.1875-9114.1996.tb02915.x | s2cid = 1389910 }}</ref> are not affected by fluvoxamine and may be safely taken alongside fluvoxamine should concurrent treatment with a benzodiazepine be necessary.<ref name="fluvoxamine maleate-2016">{{cite web | title = fluvoxamine maleate: PRODUCT MONOGRAPH | date = 2016 | url = http://www.mylan.ca/-/media/mylanca/documents/english/product%20pdf/pdfs%20dec%202015/luvox-pm-2016.01.08.pdf | access-date = 16 September 2018 | archive-date = 16 September 2018 | archive-url = https://web.archive.org/web/20180916130322/http://www.mylan.ca/-/media/mylanca/documents/english/product%20pdf/pdfs%20dec%202015/luvox-pm-2016.01.08.pdf | url-status = live }}</ref> Additionally, it appears that benzodiazepines metabolized by nitro-reduction (clonazepam, nitrazepam) may also, in a somewhat similar vein, be unlikely to be affected by fluvoxamine.<ref name="Medsafe, New Zealand-2017">{{cite web | title = Luvox Data Sheet | date = 2017 | url = http://www.medsafe.govt.nz/profs/datasheet/l/luvoxtab.pdf | publisher = Medsafe, New Zealand | access-date = 16 September 2018 | archive-date = 29 March 2018 | archive-url = https://web.archive.org/web/20180329045516/http://www.medsafe.govt.nz/profs/datasheet/l/luvoxtab.pdf }}</ref><ref name="NPS MedicineWise-2022">{{cite web | title = Faverin Tablets | date = July 2022 | url = https://www.nps.org.au/medicine-finder/faverin-tablets | access-date = 4 November 2022 | website = NPS MedicineWise | archive-date = 4 November 2022 | archive-url = https://web.archive.org/web/20221104201934/https://www.nps.org.au/medicine-finder/faverin-tablets | url-status = live }}</ref>
Using fluvoxamine and alprazolam together can increase alprazolam plasma concentrations.<ref name="pmid12698310">{{cite journal | vauthors = Suzuki Y, Shioiri T, Muratake T, Kawashima Y, Sato S, Hagiwara M, Inoue Y, Shimoda K, Someya T | title = Effects of concomitant fluvoxamine on the metabolism of alprazolam in Japanese psychiatric patients: interaction with CYP2C19 mutated alleles | journal = European Journal of Clinical Pharmacology | volume = 58 | issue = 12 | pages = 829–833 | date = April 2003 | pmid = 12698310 | doi = 10.1007/s00228-003-0563-9 | s2cid = 32559753 }}</ref> If alprazolam is coadministered with fluvoxamine, the initial alprazolam dose should be reduced to the lowest effective dose.<ref name="Gerlach-2014">{{cite book | vauthors = Gerlach M, Warnke A, Greenhill L | title = Psychiatric Drugs in Children and Adolescents: Basic Pharmacology and Practical Applications | page = 131 | year = 2014 | url = https://books.google.com/books?id=AmQlBAAAQBAJ&pg=PA131 | publisher = Springer-Verlag Wien | isbn = 978-3-7091-1500-8 | access-date = 21 May 2020 | archive-date = 10 January 2023 | archive-url = https://web.archive.org/web/20230110041817/https://books.google.com/books?id=AmQlBAAAQBAJ&pg=PA131 | url-status = live }}</ref><ref name="pmid8005185">{{cite journal | vauthors = Fleishaker JC, Hulst LK | title = A pharmacokinetic and pharmacodynamic evaluation of the combined administration of alprazolam and fluvoxamine | journal = European Journal of Clinical Pharmacology | volume = 46 | issue = 1 | pages = 35–39 | date = 1994 | pmid = 8005185 | doi = 10.1007/bf00195913 | s2cid = 2161450 }}</ref>
As with all SSRI medications, using fluvoxamine with NSAIDs like ibuprofen may increase the risk of bleeding, particularly in the GI tract.<ref>{{cite journal | vauthors = Alam SM, Qasswal M, Ahsan MJ, Walters RW, Chandra S | title = Selective serotonin reuptake inhibitors increase risk of upper gastrointestinal bleeding when used with NSAIDs: a systemic review and meta-analysis | journal = Scientific Reports | volume = 12 | issue = 1 | article-number = 14452 | date = August 2022 | pmid = 36002638 | doi = 10.1038/s41598-022-18654-2 | pmc = 9402708 | bibcode = 2022NatSR..1214452A }}</ref>
Fluvoxamine is contraindicated with other medications that increase serotonin (dextromethorphan, ondansetron, amphetamine, sumatriptan, Tramadol, ''Hypericum perforatum'', etc.).<ref>{{cite journal | vauthors = Scotton WJ, Hill LJ, Williams AC, Barnes NM | title = Serotonin Syndrome: Pathophysiology, Clinical Features, Management, and Potential Future Directions | journal = International Journal of Tryptophan Research | volume = 12 | article-number = 1178646919873925 | date = 2019 | pmid = 31523132 | pmc = 6734608 | doi = 10.1177/1178646919873925 }}</ref> Combining these medications may rarely lead to a life-threatening complication known as serotonin syndrome.
Fluvoxamine and ramelteon coadministration is not indicated.<ref name="pmid20478852">{{cite journal | vauthors = Obach RS, Ryder TF | title = Metabolism of ramelteon in human liver microsomes and correlation with the effect of fluvoxamine on ramelteon pharmacokinetics | journal = Drug Metabolism and Disposition: The Biological Fate of Chemicals | volume = 38 | issue = 8 | pages = 1381–1391 | date = August 2010 | pmid = 20478852 | doi = 10.1124/dmd.110.034009 | s2cid = 8421997 }}</ref><ref name="pmid23861638">{{cite journal | vauthors = Pandi-Perumal SR, Spence DW, Verster JC, Srinivasan V, Brown GM, Cardinali DP, Hardeland R | title = Pharmacotherapy of insomnia with ramelteon: safety, efficacy and clinical applications | journal = Journal of Central Nervous System Disease | volume = 3 | pages = 51–65 | date = 12 April 2011 | pmid = 23861638 | pmc = 3663615 | doi = 10.4137/JCNSD.S1611 }}</ref>
Fluvoxamine has been observed to increase serum concentrations of mirtazapine, which is mainly metabolized by CYP1A2, CYP2D6, and CYP3A4, by three- to four-fold in humans.<ref name="AnttilaRasanen2001">{{cite journal | vauthors = Anttila AK, Rasanen L, Leinonen EV | title = Fluvoxamine augmentation increases serum mirtazapine concentrations three- to fourfold | journal = The Annals of Pharmacotherapy | volume = 35 | issue = 10 | pages = 1221–1223 | date = October 2001 | pmid = 11675851 | doi = 10.1345/aph.1A014 | s2cid = 44807359 }}</ref> Caution and adjustment of dosage as necessary are warranted when combining fluvoxamine and mirtazapine.<ref name="AnttilaRasanen2001" />
Fluvoxamine seriously affects the pharmacokinetics of tizanidine and increases the intensity and duration of its effects. Because of the potentially hazardous consequences, the concomitant use of tizanidine with fluvoxamine, or other potent inhibitors of CYP1A2, should be avoided.<ref name="pmid15060511">{{cite journal | vauthors = Granfors MT, Backman JT, Neuvonen M, Ahonen J, Neuvonen PJ | title = Fluvoxamine drastically increases concentrations and effects of tizanidine: a potentially hazardous interaction | journal = Clinical Pharmacology and Therapeutics | volume = 75 | issue = 4 | pages = 331–341 | date = April 2004 | pmid = 15060511 | doi = 10.1016/j.clpt.2003.12.005 | s2cid = 25781307 }}</ref>
When a beta-blocker is required, atenolol,<ref name="pmid7988100">{{cite journal | vauthors = Perucca E, Gatti G, Spina E | title = Clinical pharmacokinetics of fluvoxamine | journal = Clinical Pharmacokinetics | volume = 27 | issue = 3 | pages = 175–190 | date = September 1994 | pmid = 7988100 | doi = 10.2165/00003088-199427030-00002 | s2cid = 22472247 }}</ref> pindolol<ref name="pmid11543734">{{cite journal | vauthors = Zanardi R, Serretti A, Rossini D, Franchini L, Cusin C, Lattuada E, Dotoli D, Smeraldi E | title = Factors affecting fluvoxamine antidepressant activity: influence of pindolol and 5-HTTLPR in delusional and nondelusional depression | journal = Biological Psychiatry | volume = 50 | issue = 5 | pages = 323–330 | date = September 2001 | pmid = 11543734 | doi = 10.1016/s0006-3223(01)01118-0 | s2cid = 22692759 }}</ref><ref name="Sluzewska-1996">{{cite journal | vauthors = Sluzewska A, Szczawinska K | title = The effects of pindolol addition to fluvoxamine and buspirone in chronic mild stress model of depression. | journal = Behavioural Pharmacology | volume = 7 | page = 105 | date = May 1996 }}</ref><ref name="pmid9817627">{{cite journal | vauthors = Mundo E, Guglielmo E, Bellodi L | title = Effect of adjuvant pindolol on the antiobsessional response to fluvoxamine: a double-blind, placebo-controlled study | journal = International Clinical Psychopharmacology | volume = 13 | issue = 5 | pages = 219–224 | date = September 1998 | pmid = 9817627 | doi = 10.1097/00004850-199809000-00005 | s2cid = 23946424 }}</ref> and, possibly, metoprolol<ref name="pmid9681670">{{cite journal | vauthors = Belpaire FM, Wijnant P, Temmerman A, Rasmussen BB, Brøsen K | title = The oxidative metabolism of metoprolol in human liver microsomes: inhibition by the selective serotonin reuptake inhibitors | journal = European Journal of Clinical Pharmacology | volume = 54 | issue = 3 | pages = 261–264 | date = May 1998 | pmid = 9681670 | doi = 10.1007/s002280050456 | s2cid = 28105445 | url = https://portal.findresearcher.sdu.dk/da/publications/84c508b1-ad9c-42bf-8457-b55a30835810 }}</ref><ref name="pmid8904628">{{cite journal | vauthors = Xu ZH, Xie HG, Zhou HH | title = In vivo inhibition of CYP2C19 but not CYP2D6 by fluvoxamine | journal = British Journal of Clinical Pharmacology | volume = 42 | issue = 4 | pages = 518–521 | date = October 1996 | pmid = 8904628 | pmc = 2042705 | doi = 10.1046/j.1365-2125.1996.45319.x | doi-broken-date = 17 July 2025 }}</ref><ref name="pmid11876575"/><ref name="Belpaire-1997">{{cite journal | vauthors = Belpaire FM, Wijnant P, Tammerman A, Bogaert M, Rasmussen B, Brosen K | title = Inhibition of the oxidative metabolism of metoprolol by selective serotonin reuptake inhibitors in human liver microsomes. | journal = Fundamental and Clinical Pharmacology | volume = 2 | issue = 11 | page = 147 | date = 1997 }}</ref> may be safer choices than propranolol, as the latter's metabolism is seriously, potentially dangerously, inhibited by fluvoxamine.<ref name="pmid8846617">{{cite journal | vauthors = van Harten J | title = Overview of the pharmacokinetics of fluvoxamine | journal = Clinical Pharmacokinetics | volume = 29 | issue = Suppl 1 | pages = 1–9 | date = 1995 | pmid = 8846617 | doi = 10.2165/00003088-199500291-00003 | s2cid = 71812133 }}</ref> Indeed, fluvoxamine may increase propranolol blood-levels by five-fold.<ref name="pmid22311403">{{cite journal | vauthors = Muscatello MR, Spina E, Bandelow B, Baldwin DS | title = Clinically relevant drug interactions in anxiety disorders | journal = Human Psychopharmacology | volume = 27 | issue = 3 | pages = 239–253 | date = May 2012 | pmid = 22311403 | doi = 10.1002/hup.2217 | s2cid = 11592004 }}</ref>
Clomipramine increases fluvoxamine levels and, conversely-likewise, fluvoxamine increases clomipramine levels (thereby its serotonergic potential) and inhibits its metabolism to its strongly-noradrenergic metabolite, norclomipramine.<ref name="pmid8666564">{{cite journal | vauthors = Szegedi A, Wetzel H, Leal M, Härtter S, Hiemke C | title = Combination treatment with clomipramine and fluvoxamine: drug monitoring, safety, and tolerability data | journal = The Journal of Clinical Psychiatry | volume = 57 | issue = 6 | pages = 257–264 | date = June 1996 | pmid = 8666564}}</ref><ref name="pmid34777510">{{cite journal | vauthors = Hardy NE, Walkup JT | title = Clomipramine in Combination with Fluvoxamine: A Potent Medication Combination for Severe or Refractory Pediatric OCD | journal = Journal of the Canadian Academy of Child and Adolescent Psychiatry | volume = 30 | issue = 4 | pages = 273–277 | date = November 2021 | pmid = 34777510 | pmc = 8561855}}</ref>
==Pharmacology==
===Pharmacodynamics===
{| class="wikitable sortable floatright"
|+Receptor affinity profile<ref name="pmid17662961">{{cite journal | vauthors = Ishikawa M, Ishiwata K, Ishii K, Kimura Y, Sakata M, Naganawa M, Oda K, Miyatake R, Fujisaki M, Shimizu E, Shirayama Y, Iyo M, Hashimoto K | title = High occupancy of sigma-1 receptors in the human brain after single oral administration of fluvoxamine: a positron emission tomography study using [11C]SA4503 | journal = Biological Psychiatry | volume = 62 | issue = 8 | pages = 878–883 | date = October 2007 | pmid = 17662961 | doi = 10.1016/j.biopsych.2007.04.001 | s2cid = 728565 }}</ref><ref name="Schatzberg-2009">{{cite book | vauthors = Schatzberg AF, Nemeroff CB | title = The American Psychiatric Publishing textbook of psychopharmacology | page = 354 | year = 2009 | publisher = American Psychiatric Pub. | isbn = 978-1-58562-386-0 | edition = 4th | location = Arlington, VA | oclc = 320111564 }}</ref><ref name="pmid28501470">{{cite journal | vauthors = Yahata M, Chiba K, Watanabe T, Sugiyama Y | title = Possibility of Predicting Serotonin Transporter Occupancy From the In Vitro Inhibition Constant for Serotonin Transporter, the Clinically Relevant Plasma Concentration of Unbound Drugs, and Their Profiles for Substrates of Transporters | journal = Journal of Pharmaceutical Sciences | volume = 106 | issue = 9 | pages = 2345–2356 | date = September 2017 | pmid = 28501470 | doi = 10.1016/j.xphs.2017.05.007 | bibcode = 2017JPhmS.106.2345Y | doi-access = free }}</ref> |-
! Site !! K<sub>i</sub> (nM)
|- | {{abbrlink|SERT|Serotonin transporter}} || 2.5 |- | {{abbrlink|NET|Norepinephrine transporter}} || 1427 |- | 5-HT<sub>2C</sub> || 5786 |- | α<sub>1</sub>-adrenergic || 1288 |- | σ<sub>1</sub> || 36 |}
Fluvoxamine is a potent selective serotonin reuptake inhibitor with around 100-fold affinity for the serotonin transporter over the norepinephrine transporter.<ref name = GG/> It has negligible affinity for the dopamine transporter or any other site, with the sole exception of the σ<sub>1</sub> receptor.<ref name = sig>{{cite journal | vauthors = Hashimoto K | title = Sigma-1 receptors and selective serotonin reuptake inhibitors: clinical implications of their relationship | journal = Central Nervous System Agents in Medicinal Chemistry | volume = 9 | issue = 3 | pages = 197–204 | date = September 2009 | pmid = 20021354 | doi = 10.2174/1871524910909030197 }}</ref><ref name = "Westenberg_2006" /> It behaves as a potent agonist at this receptor and has the highest affinity (36 nM) of any SSRI for doing so.<ref name = sig/> This may contribute to its antidepressant and anxiolytic effects and may also afford it some efficacy in treating the cognitive symptoms of depression.<ref name = cog>{{cite journal | vauthors = Hindmarch I, Hashimoto K | title = Cognition and depression: the effects of fluvoxamine, a sigma-1 receptor agonist, reconsidered | journal = Human Psychopharmacology | volume = 25 | issue = 3 | pages = 193–200 | date = April 2010 | pmid = 20373470 | doi = 10.1002/hup.1106 | s2cid = 26491662 }}</ref> It increases concentrations of the neurosteroid allopregnanolone, which may also contribute to its anxiolytic effects.<ref name="pmid9501247">{{cite journal | vauthors = Uzunova V, Sheline Y, Davis JM, Rasmusson A, Uzunov DP, Costa E, Guidotti A | title = Increase in the cerebrospinal fluid content of neurosteroids in patients with unipolar major depression who are receiving fluoxetine or fluvoxamine | journal = Proceedings of the National Academy of Sciences of the United States of America | volume = 95 | issue = 6 | pages = 3239–3244 | date = March 1998 | pmid = 9501247 | pmc = 19726 | doi = 10.1073/pnas.95.6.3239 | doi-access = free | bibcode = 1998PNAS...95.3239U }}</ref> Unlike some other SSRIs, fluvoxamine's metabolites are pharmacologically neutral.<ref name="pmid1931931">{{cite journal | vauthors = Hrdina PD | title = Pharmacology of serotonin uptake inhibitors: focus on fluvoxamine | journal = Journal of Psychiatry & Neuroscience | volume = 16 | issue = 2 Suppl 1 | pages = 10–18 | date = July 1991 | pmid = 1931931 | pmc = 1188307 }}</ref>
===Pharmacokinetics=== Literature reviews have stated that fluvoxamine is metabolized primarily by CYP2D6 and to a minor extent by CYP1A2.<ref name="AltamuraCaldiroliBuoli2015">{{cite journal | vauthors = Altamura AC, Caldiroli A, Buoli M | title = Pharmacokinetic evaluation of fluvoxamine for the treatment of anxiety disorders | journal = Expert Opinion on Drug Metabolism & Toxicology | volume = 11 | issue = 4 | pages = 649–660 | date = April 2015 | pmid = 25728382 | doi = 10.1517/17425255.2015.1021331}}</ref><ref name="Wyska2019">{{cite journal | vauthors = Wyska E | title = Pharmacokinetic considerations for current state-of-the-art antidepressants | journal = Expert Opinion on Drug Metabolism & Toxicology | volume = 15 | issue = 10 | pages = 831–847 | date = October 2019 | pmid = 31526279 | doi = 10.1080/17425255.2019.1669560 | url = https://ruj.uj.edu.pl/xmlui/handle/item/256191 }}</ref> However, CYP2D6 poor metabolizers do not have considerably higher fluvoxamine levels than extensive metabolizers.<ref name="AltamuraCaldiroliBuoli2015" /> Fluvoxamine inhibits oxidative drug metabolising enzymes (particularly CYP1A2, and less potently CYP3A4 and CYP2D6)<ref>{{Cite journal | vauthors = van Harten J | title = Overview of the pharmacokinetics of fluvoxamine | journal = Clinical Pharmacokinetics | volume = 29 Suppl 1 | pages = 1–9 | date = 1995 | pmid = 8846617 | doi = 10.2165/00003088-199500291-00003 | issn = 0312-5963 }}</ref> The mean plasma half-life of fluvoxamine after multiple oral doses of 100 mg/day in healthy, young volunteers was 13.6-15.6 hours. In the elderly, however the half life ranged from 17.4 to 25.9.<ref name=":0">{{Cite web | title = FDA prescribing information | url = https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022235lbl.pdf | archive-url = https://web.archive.org/web/20131019125207/http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022235lbl.pdf | archive-date = 19 October 2013 }}</ref> Steady-state plasma fluvoxamine concentrations were 2-3 fold higher in children than in adolescents.
==History==
Fluvoxamine was developed by Kali-Duphar,<ref name="Sittig"/> part of Solvay Pharmaceuticals, Belgium, now Abbott Laboratories, and introduced as Floxyfral in Switzerland in 1983.<ref name=Sittig>{{cite book | title = Sittig's Pharmaceutical Manufacturing Encyclopedia | year = 2008 | publisher = William Andrew | isbn = 978-0-8155-1526-5 | page = 1699 | url = http://www.armchairpatriot.com/Encyclopedias/Encyclopedia-Pharmaceutical%20Manufacturing%20%283rd%20edition%29/15265_v02_04.pdf | edition = 3rd | access-date = 17 October 2013 | archive-date = 14 October 2013 | archive-url = https://web.archive.org/web/20131014042521/http://www.armchairpatriot.com/Encyclopedias/Encyclopedia-Pharmaceutical%20Manufacturing%20%283rd%20edition%29/15265_v02_04.pdf }}</ref> It was approved by the U.S. Food and Drug Administration (FDA) in 1994, and introduced as Luvox in the US.<ref name="pmid15995053">{{cite journal | vauthors = Leslie LK, Newman TB, Chesney PJ, Perrin JM | title = The Food and Drug Administration's deliberations on antidepressant use in pediatric patients | journal = Pediatrics | volume = 116 | issue = 1 | pages = 195–204 | date = July 2005 | pmid = 15995053 | pmc = 1550709 | doi = 10.1542/peds.2005-0074 }}</ref> In India, it is available, among several other brands, as Uvox by Abbott.<ref name=India>{{cite web | title = Brand Index―Fluvoxamine India | url = http://www.drugsupdate.com/brand/showavailablebrands/184 | access-date = 18 October 2013 | archive-url = https://web.archive.org/web/20131019151123/http://www.drugsupdate.com/brand/showavailablebrands/184 | archive-date = 19 October 2013 }}</ref> It was one of the first SSRI antidepressants to be launched, and is prescribed in many countries to patients with major depression.<ref name="Cochrane 2010/2013">{{cite journal | vauthors = Omori IM, Watanabe N, Nakagawa A, Cipriani A, Barbui C, McGuire H, Churchill R, Furukawa TA | title = Fluvoxamine versus other anti-depressive agents for depression | journal = The Cochrane Database of Systematic Reviews | volume = 2013 | issue = 3 | article-number = CD006114 | date = March 2010 | pmid = 20238342 | pmc = 4171125 | doi = 10.1002/14651858.CD006114.pub2 }}</ref> It was the first SSRI, a non-TCA drug, approved by the U.S. FDA specifically for the treatment of OCD.<ref name="OCD Medication">{{cite web | title = OCD Medication | date = 24 February 2010 | url = http://www.brainphysics.com/medications.php | access-date = 17 October 2013 | archive-url = https://web.archive.org/web/20131014072454/http://www.brainphysics.com/medications.php | archive-date = 14 October 2013 }}</ref> At the end of 1995, more than ten million patients worldwide had been treated with fluvoxamine.<ref name="Fluvoxamine Product Monograph-1999">{{cite web | title = Fluvoxamine Product Monograph | year = 1999 | url = https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021519s003lbl.pdf | access-date = 15 September 2018 | archive-date = 27 October 2020 | archive-url = https://web.archive.org/web/20201027214646/https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021519s003lbl.pdf }}</ref>{{failed verification|reason=no discussion of ten million patients|date=November 2019}} Fluvoxamine was the first SSRI to be registered for the treatment of obsessive compulsive disorder in children by the FDA in 1997.<ref name="Luvox Approved For Obsessive Compulsive Disorder in Children and Teens-2009">{{cite web | title = Luvox Approved For Obsessive Compulsive Disorder in Children and Teens | url = http://www.pslgroup.com/dg/2261a.htm | access-date = 8 February 2014 | archive-url = https://web.archive.org/web/20090116004424/http://www.pslgroup.com/dg/2261a.htm | archive-date = 16 January 2009 }}</ref> In Japan, fluvoxamine was the first SSRI to be approved for the treatment of depression in 1999<ref name="pmid19300537">{{cite journal | vauthors = Higuchi T, Briley M | title = Japanese experience with milnacipran, the first serotonin and norepinephrine reuptake inhibitor in Japan | journal = Neuropsychiatric Disease and Treatment | volume = 3 | issue = 1 | pages = 41–58 | date = February 2007 | pmid = 19300537 | pmc = 2654524 | doi = 10.2147/nedt.2007.3.1.41 | doi-access = free }}</ref><ref name="Wishart">{{cite HMDB | title = Showing metabocard for Fluvoxamine (HMDB0014322) | author1-link = David S. Wishart | url = http://www.hmdb.ca/metabolites/HMDB0014322 }}</ref> and was later in 2005 the first drug to be approved for the treatment of social anxiety disorder.<ref name="Solvay-2018">{{cite web | title = Solvay's Fluvoxamine maleate is first drug approved for the treatment of social anxiety disorder in Japan | url = https://www.fdanews.com/articles/81585-solvay-s-fluvoxamine-maleate-is-first-drug-approved-for-treatment-of-social-anxiety-disorder-in-japan | access-date = 15 September 2018 | archive-date = 15 September 2018 | archive-url = https://web.archive.org/web/20180915122310/https://www.fdanews.com/articles/81585-solvay-s-fluvoxamine-maleate-is-first-drug-approved-for-treatment-of-social-anxiety-disorder-in-japan | url-status = live }}</ref> Fluvoxamine was the first SSRI approved for clinical use in the United Kingdom.<ref name="Churchill Livingstone Elsevier-2007">{{cite book | veditors = Walker R, Whittlesea C | title = Clinical Pharmacy and Therapeutics | year = 2007 | isbn = 978-0-7020-4293-5 | orig-date = 1994 | publisher = Churchill Livingstone Elsevier | location = Edinburgh | edition = 4th }}</ref> Manufacturers include BayPharma, Synthon, and Teva, among others.<ref name="www.drugbank.ca-2019">{{cite web | title = Fluvoxamine | url = https://www.drugbank.ca/drugs/DB00176 | website = www.drugbank.ca | access-date = 22 October 2019 | archive-date = 4 November 2019 | archive-url = https://web.archive.org/web/20191104161742/https://www.drugbank.ca/drugs/DB00176 | url-status = live }}</ref>
== Research directions ==
A 2022 review concluded that according to low-certainty evidence, fluvoxamine may slightly decrease all-cause mortality by day 28 and potentially reduce the risk of hospitalization or death in outpatients with mild COVID-19.<ref name="pmid36103313">{{cite journal | vauthors = Nyirenda JL, Sofroniou M, Toews I, Mikolajewska A, Lehane C, Monsef I, Abu-Taha A, Maun A, Stegemann M, Schmucker C | title = Fluvoxamine for the treatment of COVID-19 | journal = The Cochrane Database of Systematic Reviews | volume = 2022 | issue = 9 | article-number = CD015391 | date = September 2022 | pmid = 36103313 | pmc = 9473347 | doi = 10.1002/14651858.CD015391 | type = Systematic review }}</ref> While early studies have suggested potential benefits for fluvoxamine as an anti-inflammatory agent and a possible impact on reducing cytokine storms, further studies did not confirm this expected benefit on COVID-19 patients.<ref name="pmid35383578">{{cite journal | vauthors = Bhuta S, Khokher W, Kesireddy N, Iftikhar S, Beran A, Mhanna M, Patel NJ, Patel M, Burmeister C, Assaly R | title = Fluvoxamine in Nonhospitalized Patients With Acute COVID-19 Infection and the Lack of Efficacy in Reducing Rates of Hospitalization, Mechanical Ventilation, and Mortality in Placebo-Controlled Trials: A Systematic Review and Meta-Analysis | journal = American Journal of Therapeutics | volume = 29 | issue = 3 | pages = e298–e304 | date = 2022 | pmid = 35383578 | doi = 10.1097/MJT.0000000000001496 | s2cid = 247978477 | doi-access = free }}</ref><ref name="pmid36532776">{{cite journal | vauthors = Asadi Anar M, Foroughi E, Sohrabi E, Peiravi S, Tavakoli Y, Kameli Khouzani M, Behshood P, Shamshiri M, Faridzadeh A, Keylani K, Langari SF, Ansari A, Khalaji A, Garousi S, Mottahedi M, Honari S, Deravi N | title = Selective serotonin reuptake inhibitors: New hope in the fight against COVID-19 | journal = Frontiers in Pharmacology | volume = 13 | issue = | article-number = 1036093 | date = 2022 | pmid = 36532776 | pmc = 9748354 | doi = 10.3389/fphar.2022.1036093 | doi-access = free }}</ref> A cytokine storm refers to an excessive immune response characterized by a release of large amounts of pro-inflammatory cytokines.<ref name="pmid32592501">{{cite journal | vauthors = Hu B, Huang S, Yin L | title = The cytokine storm and COVID-19 | journal = Journal of Medical Virology | volume = 93 | issue = 1 | pages = 250–256 | date = January 2021 | pmid = 32592501 | pmc = 7361342 | doi = 10.1002/jmv.26232 }}</ref>
In May 2022, based on a review of available scientific evidence, the U.S. Food and Drug Administration (FDA) did not issue an emergency use authorization covering the use of fluvoxamine to treat COVID-19, saying that, at the time, the data was not sufficient to conclude that fluvoxamine may be effective in treating non-hospitalized people with COVID-19 to prevent serious illness or hospitalization. The agency stated that study results suggest that further clinical trials may be warranted.<ref name="Reuters-2022">{{cite news | title = FDA declines to authorize common antidepressant as COVID treatment | date = 16 May 2022 | url = https://www.reuters.com/business/healthcare-pharmaceuticals/fda-declines-authorize-common-antidepressant-covid-treatment-2022-05-16/ | access-date = 18 May 2022 | work = Reuters | archive-date = 17 May 2022 | archive-url = https://web.archive.org/web/20220517202625/https://www.reuters.com/business/healthcare-pharmaceuticals/fda-declines-authorize-common-antidepressant-covid-treatment-2022-05-16/ | url-status = live }}</ref><ref name="Food and Drug Administration-2022">{{cite tech report | title = Memorandum Explaining Basis for Declining Request for Emergency Use Authorization of Fluvoxamine Maleate | date = 16 May 2022 | type = Memorandum | id = 4975580 | institution = Food and Drug Administration | url = https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/EUA%20110%20Fluvoxamine%20Decisional%20Memo_Redacted.pdf | archive-url = https://web.archive.org/web/20220517001646/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/EUA%20110%20Fluvoxamine%20Decisional%20Memo_Redacted.pdf | archive-date = 17 May 2022 | url-status = live }} {{Source-attribution}}</ref>
Reviews published in 2024 indicate that clinical trials have shown fluvoxamine to be more effective than a placebo in reducing clinical deterioration and hospitalization in COVID-19 patients, particularly those taking 200 mg or more daily.<ref name="pmid38148036">{{cite journal | vauthors = Deng J, Moskalyk M, Zuo QK, Garcia C, Abbas U, Ramaraju HB, Rayner D, Park YJ, Heybati K, Zhou F, Lohit S | title = Evaluating fluvoxamine for the outpatient treatment of COVID-19: A systematic review and meta-analysis | journal = Reviews in Medical Virology | volume = 34 | issue = 1 | article-number = e2501 | date = January 2024 | pmid = 38148036 | doi = 10.1002/rmv.2501 | doi-access = free }}</ref><ref name="pmid38862591">{{cite journal | vauthors = Prasanth MI, Wannigama DL, Reiersen AM, Thitilertdecha P, Prasansuklab A, Tencomnao T, Brimson S, Brimson JM | title = A systematic review and meta-analysis, investigating dose and time of fluvoxamine treatment efficacy for COVID-19 clinical deterioration, death, and Long-COVID complications | journal = Scientific Reports | volume = 14 | issue = 1 | article-number = 13462 | date = June 2024 | pmid = 38862591 | pmc = 11166997 | doi = 10.1038/s41598-024-64260-9 | bibcode = 2024NatSR..1413462P}}</ref><ref name="pmid38753761">{{cite journal | vauthors = Zhou Q, Zhao G, Pan Y, Zhang Y, Ni Y | title = The efficacy and safety of fluvoxamine in patients with COVID-19: A systematic review and meta-analysis from randomized controlled trials | journal = PLOS ONE | volume = 19 | issue = 5 | article-number = e0300512 | date = 2024 | pmid = 38753761 | pmc = 11098472 | doi = 10.1371/journal.pone.0300512 | doi-access = free | bibcode = 2024PLoSO..1900512Z}}</ref>
==Environment==
Fluvoxamine is a common finding in waters near human settlement.<ref name="Runoff" /> Christensen ''et al.'' 2007 finds it is "very toxic to aquatic organisms" by European Union standards.<ref name="Runoff">
{{Unbulleted list citebundle
|{{*}} {{cite journal | vauthors = Chia MA, Lorenzi AS, Ameh I, Dauda S, Cordeiro-Araújo MK, Agee JT, Okpanachi IY, Adesalu AT | title = Susceptibility of phytoplankton to the increasing presence of active pharmaceutical ingredients (APIs) in the aquatic environment: A review | journal = Aquatic Toxicology (Amsterdam, Netherlands) | volume = 234 | article-number = 105809 | date = May 2021 | pmid = 33780670 | doi = 10.1016/j.aquatox.2021.105809 | publisher = Elsevier | bibcode = 2021AqTox.23405809C | s2cid = 232419482 }} |{{*}} {{cite journal | vauthors = Christensen AM, Faaborg-Andersen S, Ingerslev F, Baun A | title = Mixture and single-substance toxicity of selective serotonin reuptake inhibitors toward algae and crustaceans | journal = Environmental Toxicology and Chemistry | volume = 26 | issue = 1 | pages = 85–91 | date = January 2007 | pmid = 17269464 | doi = 10.1897/06-219R.1 | publisher = John Wiley & Sons, Inc. (Society of Environmental Toxicology and Chemistry (SETAC)) | s2cid = 6562531 | doi-access = free | bibcode = 2007EnvTC..26...85C }}
}}
</ref>
== References == {{Reflist}}
{{Antidepressants}} {{Anxiolytics}} {{OCD pharmacotherapies}} {{Monoamine reuptake inhibitors}} {{Sigma receptor modulators}} {{Portal bar | Medicine}}
Category:4-(Trifluoromethyl)phenyl compounds Category:Amines Category:Antidepressants Category:CYP1A1 inhibitors Category:CYP1A2 inhibitors Category:CYP2B6 inhibitors Category:CYP2C19 inhibitors Category:CYP2C9 inhibitors Category:CYP2D6 inhibitors Category:CYP3A4 inhibitors Category:Drugs developed by AbbVie Category:Ketoxime ethers Category:Methoxy compounds Category:Selective serotonin reuptake inhibitors Category:Sigma agonists