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{{Short description|SSRI antidepressant}}{{Redirect|Prozac}}{{Distinguish|Fluvoxamine}}{{cs1 config |name-list-style=vanc |display-authors=6}}{{Use dmy dates|date=January 2024}}

factoids

{{respellOKSteen}}| tradename = Prozac, Sarafem, othersmonograph|fluoxetine-hydrochloride}}| MedlinePlus = a689006| DailyMedID = Fluoxetine| pregnancy_AU = C| pregnancy_AU_comment =| pregnancy_category =| dependency_liability =DATE=2001 ISBN=978-0-8247-4497-7 URL=HTTPS://BOOKS.GOOGLE.COM/BOOKS?ID=MY1KFYK98MQC&PG=PA26, Oral administration>By mouth| class = Selective serotonin reuptake inhibitor (SSRI)| ATC_prefix = N06| ATC_suffix = AB03N06|AB03}}| legal_AU = S4 DATE=21 JUNE 2022 ACCESS-DATE=30 MARCH 2024, | legal_BR = C1DATE=31 MARCH 2023 TRANS-TITLE=COLLEGIATE BOARD RESOLUTION NO. 784 - LISTS OF NARCOTIC, PSYCHOTROPIC, PRECURSOR, AND OTHER SUBSTANCES UNDER SPECIAL CONTROLURL-STATUS=LIVE ARCHIVE-DATE=3 AUGUST 2023 PUBLISHER=DIáRIO OFICIAL DA UNIãO PUBLICATION-DATE=4 APRIL 2023, | legal_CA = Rx-onlyHEALTH CANADA > DATE=9 MAY 2018 ACCESS-DATE=13 APRIL 2024, | legal_DE = | legal_DE_comment =| legal_NZ = | legal_NZ_comment =| legal_UK = POM| legal_UK_comment =| legal_US = Rx-only| legal_US_comment = | legal_EU = Rx-only| legal_EU_comment =| legal_UN = | legal_UN_comment =| legal_status = | bioavailability = 60–80%| protein_bound = 94–95%| metabolism = Liver (mostly CYP2D6-mediated)| metabolites = Norfluoxetine, desmethylfluoxetine| onset =| elimination_half-life = 1–3 days (acute)4–6 days (chronic)| duration_of_action =PUBLISHER=ELI LILLY AUSTRALIA PTY. LIMITEDACCESS-DATE=23 NOVEMBER 2013FORMAT=PDFARCHIVE-URL=HTTPS://WEB.ARCHIVE.ORG/WEB/20170425231029/HTTPS://WWW.EBS.TGA.GOV.AU/EBS/PICMI/PICMIREPOSITORY.NSF/PDF?OPENAGENT&ID=CP-2010-PI-04098-3 JOURNAL = CLINICAL PHARMACOKINETICS ISSUE = 3 DATE = MARCH 1994 DOI = 10.2165/00003088-199426030-00004, 1406955, | index2_label = as HClcorrect|CAS}}| CAS_number = 54910-89-3correct|CAS}}| CAS_number2 = 56296-78-7| CAS_supplemental =| PubChem = 3386| PubChem2 = 62857| IUPHAR_ligand = 203correct|drugbank}}| DrugBank = DB00472correct|drugbank}}| DrugBank2 = DBSALT000087correct|chemspider}}| ChemSpiderID = 3269correct|chemspider}}| ChemSpiderID2 = 56589correct|FDA}}| UNII = 01K63SUP8Dcorrect|FDA}}| UNII2 = I9W7N6B1KJcorrect|kegg}}| KEGG = D00326correct|kegg}}| KEGG2 = D00823correct|EBI}}| ChEBI = 5118correct|EBI}}| ChEBI2 = 5119correct|EBI}}| ChEMBL = 41correct|EBI}}| ChEMBL2 = 1201082| NIAID_ChemDB =| PDB_ligand =| synonyms =| IUPAC_name = N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine H = 18 N = 1| O = 1| SMILES = CNCCC(c1ccccc1)Oc2ccc(cc2)C(F)(F)Fcorrect|chemspider}}| StdInChI = 1S/C17H18F3NO/c1-21-12-11-16(13-5-3-2-4-6-13)22-15-9-7-14(8-10-15)17(18,19)20/h2-10,16,21H,11-12H2,1H3| StdInChI_comment =correct|chemspider}}| StdInChIKey = RTHCYVBBDHJXIQ-UHFFFAOYSA-N| density =| density_notes =| melting_point = 179| melting_high = 182| melting_notes =| boiling_point = 395| boiling_notes =| solubility = 14| sol_units =| specific_rotation =}}Fluoxetine, sold under the brand name Prozac, among others, is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class.WEB, Fluoxetine Hydrochloride,www.drugs.com/monograph/fluoxetine-hydrochloride.html, The American Society of Health-System Pharmacists, 2 December 2015, live,www.drugs.com/monograph/fluoxetine-hydrochloride.html," title="web.archive.org/web/20151208193110www.drugs.com/monograph/fluoxetine-hydrochloride.html,">web.archive.org/web/20151208193110www.drugs.com/monograph/fluoxetine-hydrochloride.html, 8 December 2015, It is used for the treatment of major depressive disorder, obsessive–compulsive disorder (OCD), anxiety, bulimia nervosa, panic disorder, and premenstrual dysphoric disorder. It is also approved for treatment of major depressive disorder in adolescents and children 8 years of age and over.WEB, Depressive Disorders in Children and Adolescents – Pediatrics,www.merckmanuals.com/professional/pediatrics/mental-disorders-in-children-and-adolescents/depressive-disorders-in-children-and-adolescents, 25 December 2020, Merck Manuals Professional Edition, It has also been used to treat premature ejaculation. Fluoxetine is taken by mouth.Common side effects include indigestion, trouble sleeping, sexual dysfunction, loss of appetite, nausea, diarrhea, dry mouth, and rash. Serious side effects include serotonin syndrome, mania, seizures, an increased risk of suicidal behavior in people under 25 years old, and an increased risk of bleeding. Antidepressant discontinuation syndrome is less likely to occur with fluoxetine than with other antidepressants, but it still happens in many cases. Fluoxetine taken during pregnancy is associated with significant increase in congenital heart defects in the newborns. It has been suggested that fluoxetine therapy may be continued during breastfeeding if it was used during pregnancy or if other antidepressants were ineffective.WEB, Fluoxetine Pregnancy and Breastfeeding Warnings,www.drugs.com/pregnancy/fluoxetine.html, 2 December 2015, live,web.archive.org/web/20170831221820/https://www.drugs.com/pregnancy/fluoxetine.html, 31 August 2017, Fluoxetine was invented by Eli Lilly and Company in 1972, and entered medical use in 1986.BOOK, Myers RL, The 100 most important chemical compounds: a reference guide, 2007, Greenwood Press, Westport, CN, 978-0-313-33758-1, 128, 1st,archive.org/details/100mostimportant0000myer, registration, It is on the World Health Organization’s List of Essential Medicines.BOOK, ((World Health Organization)), World Health Organization model list of essential medicines: 22nd list (2021), 2021, 10665/345533, World Health Organization, World Health Organization, Geneva, WHO/MHP/HPS/EML/2021.02, free, It is available as a generic medication. In 2021, it was the 25th most commonly prescribed medication in the United States, with more than 22{{nbsp}}million prescriptions.WEB, The Top 300 of 2021,clincalc.com/DrugStats/Top300Drugs.aspx, ClinCalc, 14 January 2024, 15 January 2024,web.archive.org/web/20240115223848/https://clincalc.com/DrugStats/Top300Drugs.aspx, live, WEB, Fluoxetine – Drug Usage Statistics, ClinCalc,clincalc.com/DrugStats/Drugs/Fluoxetine, 14 January 2024, Lilly also markets fluoxetine in a fixed-dose combination with olanzapine as olanzapine/fluoxetine (Symbyax).WEB, Symbyax- olanzapine and fluoxetine hydrochloride capsule, DailyMed, 23 December 2021,dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6b28c424-0b7e-4b75-b090-f116b113554e, 8 October 2022, PRESS RELEASE,investor.lilly.com/news-releases/news-release-details/fda-approves-symbyaxr-first-medication-treatment-resistant, FDA Approves Symbyax as First Medication for Treatment-Resistant Depression, Eli Lilly, 17 March 2021,

Medical uses

File:Fluoxetine 20mg with Packet.jpg|thumb|Fluoxetine blister packblister pack(File:10mgBlueProzacPills.jpg|thumb|Fluoxetine 10 mg tablets)Fluoxetine is frequently used to treat major depressive disorder, obsessive–compulsive disorder (OCD), post-traumatic stress disorder (PTSD), bulimia nervosa, panic disorder, premenstrual dysphoric disorder, and trichotillomania.REPORT,effectivehealthcare.ahrq.gov/topics/ptsd-adult-treatment-update/research-2018, Forman-Hoffman V, Middleton JC, Feltner C, Gaynes BN, Weber RP, Bann C, Viswanathan M, Lohr KN, Baker C, Green J, Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder: A Systematic Review Update, 17 May 2018, Rockville (MD), Agency for Healthcare Research and Quality (AHRQ), Comparative Effectiveness Review, 235, 10.23970/ahrqepccer207, 11 March 2024, 12 February 2024, 10 July 2018,web.archive.org/web/20180710011511/https://effectivehealthcare.ahrq.gov/topics/ptsd-adult-treatment-update/research-2018, dead, BOOK, Hagerman RJ, Angelman Syndrome and Prader-Willi Syndrome, Neurodevelopmental Disorders: Diagnosis and Treatment, 16 September 1999,books.google.com/books?id=9DvXxi_ugUUC&pg=PA273, Oxford University Press, 978-0-19-512314-2, Dech and Budow (1991) were among the first to report the anecdotal use of fluoxetine in a case of PWS to control behavior problems, appetite, and trichotillomania., Truven Health Analytics, Inc. DrugPoint® System (Internet) [cited 2013 Oct 4]. Greenwood Village, CO: Thomsen Healthcare; 2013.Australian Medicines Handbook 2013. The Australian Medicines Handbook Unit Trust; 2013.British National Formulary (BNF) 65. Pharmaceutical Pr; 2013.JOURNAL, Husted DS, Shapira NA, Murphy TK, Mann GD, Ward HE, Goodman WK, Effect of comorbid tics on a clinically meaningful response to 8-week open-label trial of fluoxetine in obsessive compulsive disorder, Journal of Psychiatric Research, 41, 3–4, 332–337, 2007, 16860338, 10.1016/j.jpsychires.2006.05.007, It has also been used for cataplexy, obesity, and alcohol dependence,WEB, Fluoxetine Hydrochloride,www.drugs.com/monograph/fluoxetine-hydrochloride.html, The American Society of Health-System Pharmacists, 3 April 2011, live,www.drugs.com/monograph/fluoxetine-hydrochloride.html," title="web.archive.org/web/20110411215533www.drugs.com/monograph/fluoxetine-hydrochloride.html,">web.archive.org/web/20110411215533www.drugs.com/monograph/fluoxetine-hydrochloride.html, 11 April 2011, as well as binge eating disorder.WEB, NIMH•Eating Disorders, The National Institute of Mental Health, National Institute of Health, 2011, 25 November 2013,www.nimh.nih.gov/health/publications/eating-disorders/binge-eating-disorder.shtml, live,www.nimh.nih.gov/health/publications/eating-disorders/binge-eating-disorder.shtml," title="web.archive.org/web/20110819010403www.nimh.nih.gov/health/publications/eating-disorders/binge-eating-disorder.shtml,">web.archive.org/web/20110819010403www.nimh.nih.gov/health/publications/eating-disorders/binge-eating-disorder.shtml, 19 August 2011, Fluoxetine seems to be ineffective for social anxiety disorder.WEB,www.health.harvard.edu/newsletter_article/treating-social-anxiety-disorder, Treating social anxiety disorder, Harvard Health Publishing, 15 May 2019, 23 September 2020,web.archive.org/web/20200923013349/https://www.health.harvard.edu/newsletter_article/treating-social-anxiety-disorder, dead, Studies do not support a benefit in children with autism, though there is tentative evidence for its benefit in adult autism.JOURNAL, Williams K, Brignell A, Randall M, Silove N, Hazell P, Selective serotonin reuptake inhibitors (SSRIs) for autism spectrum disorders (ASD), The Cochrane Database of Systematic Reviews, 8, 8, CD004677, August 2013, 23959778, 10.1002/14651858.CD004677.pub3, JOURNAL, Myers SM, The status of pharmacotherapy for autism spectrum disorders, Expert Opinion on Pharmacotherapy, 8, 11, 1579–1603, August 2007, 17685878, 10.1517/14656566.8.11.1579, 24674542, JOURNAL, Doyle CA, McDougle CJ, Pharmacotherapy to control behavioral symptoms in children with autism, Expert Opinion on Pharmacotherapy, 13, 11, 1615–1629, August 2012, 22550944, 10.1517/14656566.2012.674110, 32144885, JOURNAL, Benvenuto A, Battan B, Porfirio MC, Curatolo P, Pharmacotherapy of autism spectrum disorders, Brain & Development, 35, 2, 119–127, February 2013, 22541665, 10.1016/j.braindev.2012.03.015, 19614718, Fluoxetine together with fluvoxamine has shown some initial promise as a potential treatment for reducing COVID-19 severity if given early.JOURNAL, Mahdi M, Hermán L, Réthelyi JM, Bálint BL, Potential Role of the Antidepressants Fluoxetine and Fluvoxamine in the Treatment of COVID-19, International Journal of Molecular Sciences, 23, 7, 3812, March 2022, 35409171, 8998734, 10.3390/ijms23073812, free,

Depression

Fluoxetine is approved for the treatment of major depression in children and adults. Meta-analysis of trials in adults conclude that fluoxetine modestly outperforms placebo.JOURNAL, Cipriani A, Furukawa TA, Salanti G, Chaimani A, Atkinson LZ, Ogawa Y, Leucht S, Ruhe HG, Turner EH, Higgins JP, Egger M, Takeshima N, Hayasaka Y, Imai H, Shinohara K, Tajika A, Ioannidis JP, Geddes JR, April 2018, Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder: a systematic review and network meta-analysis, Lancet, 391, 10128, 1357–1366, 10.1016/S0140-6736(17)32802-7, 5889788, 29477251, Fluoxetine may be less effective than other antidepressants, but has high acceptability.JOURNAL, Magni LR, Purgato M, Gastaldon C, Papola D, Furukawa TA, Cipriani A, Barbui C, Fluoxetine versus other types of pharmacotherapy for depression, The Cochrane Database of Systematic Reviews, 2013, 7, CD004185, July 2013, 24353997, 10.1002/14651858.CD004185.pub3, For children and adolescents with moderate-to-severe depressive disorder, fluoxetine seems to be the best treatment (either with or without cognitive behavioural therapy, although fluoxetine alone does not appear to be superior to CBT alone) but more research is needed to be certain, as effect sizes are small and the existing evidence is of dubious quality.JOURNAL, 12 October 2020, Prozac may be the best treatment for young people with depression – but more research is needed,evidence.nihr.ac.uk/alert/prozac-may-be-the-best-treatment-for-young-people-with-depression-but-more-research-is-needed/, NIHR Evidence, Plain English summary, National Institute for Health and Care Research, 10.3310/alert_41917, 242952585, JOURNAL, Zhou X, Teng T, Zhang Y, Del Giovane C, Furukawa TA, Weisz JR, Li X, Cuijpers P, Coghill D, Xiang Y, Hetrick SE, Leucht S, Qin M, Barth J, Ravindran AV, Yang L, Curry J, Fan L, Silva SG, Cipriani A, Xie P, Comparative efficacy and acceptability of antidepressants, psychotherapies, and their combination for acute treatment of children and adolescents with depressive disorder: a systematic review and network meta-analysis, The Lancet. Psychiatry, 7, 7, 581–601, July 2020, 32563306, 7303954, 10.1016/S2215-0366(20)30137-1, JOURNAL, Boaden K, Tomlinson A, Cortese S, Cipriani A, Antidepressants in Children and Adolescents: Meta-Review of Efficacy, Tolerability and Suicidality in Acute Treatment, Frontiers in Psychiatry, 11, 717, 2 September 2020, 32982805, 7493620, 10.3389/fpsyt.2020.00717, free, JOURNAL, Hetrick SE, McKenzie JE, Bailey AP, Sharma V, Moller CI, Badcock PB, Cox GR, Merry SN, Meader N, New generation antidepressants for depression in children and adolescents: a network meta-analysis, The Cochrane Database of Systematic Reviews, 2021, 5, CD013674, May 2021, 34029378, 8143444, 10.1002/14651858.CD013674.pub2, Cochrane Common Mental Disorders Group, A 2022 systematic review and trial restoration of the two original blinded-control trials used to approve the use of fluoxetine in children and adolescents with depression found that both of the trials were severely flawed, and therefore did not demonstrate the safety or efficacy of the medication.JOURNAL, Gøtzsche PC, Healy D, Restoring the two pivotal fluoxetine trials in children and adolescents with depression, The International Journal of Risk & Safety in Medicine, 33, 385–408, November 2022, 4, 35786661, 10.3233/JRS-210034, 250241461, Systematic review,

Obsessive–compulsive disorder

Fluoxetine is effective in the treatment of obsessive–compulsive disorder (OCD) for adults.JOURNAL, Etain B, Bonnet-Perrin E, [Value of fluoxetine in obsessive-compulsive disorder in the adult: review of the literature], L’Encephale, 27, 3, 280–289, May–Jun 2001, 11488259,pubmed.ncbi.nlm.nih.gov/11488259, It is also effective for treating OCD in children and adolescents.JOURNAL, 3 November 2022, Antidepressants for children and teenagers: what works for anxiety and depression?,evidence.nihr.ac.uk/collection/antidepressants-for-children-and-teenagers-what-works-anxiety-depression/, NIHR Evidence, Plain English summary, National Institute for Health and Care Research, 10.3310/nihrevidence_53342, 253347210, JOURNAL, 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, Efficacy and acceptability of pharmacological, psychosocial, and brain stimulation interventions in children and adolescents with mental disorders: an umbrella review, World Psychiatry, 20, 2, 244–275, June 2021, 34002501, 8129843, 10.1002/wps.20881, The American Academy of Child and Adolescent Psychiatry state that SSRIs, including fluoxetine, should be used as first-line therapy in children, along with cognitive behavioral therapy (CBT), for the treatment of moderate to severe OCD.JOURNAL, Geller DA, March J, The AACAP Committee on Quality Issues (CQI), Practice parameter for the assessment and treatment of children and adolescents with obsessive-compulsive disorder, Journal of the American Academy of Child and Adolescent Psychiatry, 51, 1, 98–113, January 2012, 22176943, 10.1016/j.jaac.2011.09.019, free,

Panic disorder

The efficacy of fluoxetine in the treatment of panic disorder was demonstrated in two 12-week randomized multicenter phase III clinical trials that enrolled patients diagnosed with panic disorder, with or without agoraphobia. In the first trial, 42% of subjects in the fluoxetine-treated arm were free of panic attacks at the end of the study, vs. 28% in the placebo arm. In the second trial, 62% of fluoxetine treated patients were free of panic attacks at the end of the study, vs. 44% in the placebo arm.WEB, Prozac- fluoxetine hydrochloride capsule, DailyMed, 23 December 2021,dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c88f33ed-6dfb-4c5e-bc01-d8e36dd97299, 11 March 2023,

Bulimia nervosa

A 2011 systematic review discussed seven trials which compared fluoxetine to a placebo in the treatment of bulimia nervosa, six of which found a statistically significant reduction in symptoms such as vomiting and binge eating.JOURNAL, Aigner M, Treasure J, Kaye W, Kasper S, World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the pharmacological treatment of eating disorders, The World Journal of Biological Psychiatry, 12, 6, 400–43, September 2011, 21961502, 10.3109/15622975.2011.602720,www.wfsbp.org/fileadmin/user_upload/Treatment_Guidelines/Aigner_WFSBP_guidelines_eating_disorder_World_J_Biol_Psychia_11.pdf, live, 16733060,www.wfsbp.org/fileadmin/user_upload/Treatment_Guidelines/Aigner_WFSBP_guidelines_eating_disorder_World_J_Biol_Psychia_11.pdf," title="web.archive.org/web/20140801032832www.wfsbp.org/fileadmin/user_upload/Treatment_Guidelines/Aigner_WFSBP_guidelines_eating_disorder_World_J_Biol_Psychia_11.pdf,">web.archive.org/web/20140801032832www.wfsbp.org/fileadmin/user_upload/Treatment_Guidelines/Aigner_WFSBP_guidelines_eating_disorder_World_J_Biol_Psychia_11.pdf, 1 August 2014, However, no difference was observed between treatment arms when fluoxetine and psychotherapy were compared to psychotherapy alone.

Premenstrual dysphoric disorder

Fluoxetine is used to treat premenstrual dysphoric disorder, a condition where individuals have affective and somatic symptoms monthly during the luteal phase of menstruation.WEB, Sarafem (fluoxetine hydrochloride tablets ) for oral use Initial U.S. Approval: 1987, DailyMed,dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=600145, 12 March 2023, JOURNAL, Rapkin AJ, Lewis EI, Treatment of premenstrual dysphoric disorder, Women’s Health, 9, 6, 537–56, November 2013, 24161307, 10.2217/whe.13.62, free, Taking fluoxetine 20 mg/d can be effective in treating PMDD,JOURNAL, Carr RR, Ensom MH, Fluoxetine in the treatment of premenstrual dysphoric disorder, The Annals of Pharmacotherapy, 36, 4, 713–7, April 2002, 11918525, 10.1345/aph.1A265, 37088388, JOURNAL, Romano S, Judge R, Dillon J, Shuler C, Sundell K, The role of fluoxetine in the treatment of premenstrual dysphoric disorder, Clinical Therapeutics, 21, 4, 615–33; discussion 613, April 1999, 10363729, 10.1016/S0149-2918(00)88315-0, though doses of 10 mg/d have also been prescribed effectively.JOURNAL, Pearlstein T, Yonkers KA, Review of fluoxetine and its clinical applications in premenstrual dysphoric disorder, Expert Opinion on Pharmacotherapy, 3, 7, 979–91, July 2002, 12083997, 10.1517/14656566.3.7.979, 9455962, JOURNAL, Cohen LS, Miner C, Brown EW, Freeman E, Halbreich U, Sundell K, McCray S, Premenstrual daily fluoxetine for premenstrual dysphoric disorder: a placebo-controlled, clinical trial using computerized diaries, Obstetrics and Gynecology, 100, 3, 435–44, September 2002, 12220761, 10.1016/S0029-7844(02)02166-X, 753100,

Impulsive aggression

Fluoxetine is considered a first-line medication for the treatment of impulsive aggression of low intensity.BOOK, Felthous A, Stanford M, The Wiley International Handbook on Psychopathic Disorders and the Law, 34.The Pharmacotherapy of Impulsive Aggression in Psychopathic Disorders, 2nd, Felthous A, Sass H, Wiley, 2021, 810–13, 978-1-119-15932-2, Fluoxetine reduced low intensity aggressive behavior in patients in intermittent aggressive disorder and borderline personality disorder.JOURNAL, Coccaro EF, Lee RJ, Kavoussi RJ, A double-blind, randomized, placebo-controlled trial of fluoxetine in patients with intermittent explosive disorder, The Journal of Clinical Psychiatry, 70, 5, 653–62, April 2009, 19389333, 10.4088/JCP.08m04150, JOURNAL, Coccaro EF, Kavoussi RJ, Fluoxetine and impulsive aggressive behavior in personality-disordered subjects, Archives of General Psychiatry, 54, 12, 1081–8, December 1997, 9400343, 10.1001/archpsyc.1997.01830240035005, Fluoxetine also reduced acts of domestic violence in alcoholics with a history of such behavior.JOURNAL, George DT, Phillips MJ, Lifshitz M, Lionetti TA, Spero DE, Ghassemzedeh N, Doty L, Umhau JC, Rawlings RR, Fluoxetine treatment of alcoholic perpetrators of domestic violence: a 12-week, double-blind, randomized, placebo-controlled intervention study, The Journal of Clinical Psychiatry, 72, 1, 60–5, January 2011, 20673556, 3026856, 10.4088/JCP.09m05256gry,

Obesity and overweight adults

In 2019 a systematic review compared the effects on weight of various doses of fluoxetine (60 mg/d, 40 mg/d, 20 mg/d, 10 mg/d) in obese and overweight adults.JOURNAL, Serralde-Zúñiga AE, Gonzalez Garay AG, Rodríguez-Carmona Y, Melendez G, Fluoxetine for adults who are overweight or obese, The Cochrane Database of Systematic Reviews, 10, 10, CD011688, October 2019, 31613390, 6792438, 10.1002/14651858.CD011688.pub2, Cochrane Metabolic and Endocrine Disorders Group, When compared to placebo, all dosages of fluoxetine appeared to contribute to weight loss but lead to increased risk of experiencing side effects, such as dizziness, drowsiness, fatigue, insomnia and nausea, during period of treatment. However, these conclusions were from low certainty evidence. When comparing, in the same review, the effects of fluoxetine on weight of obese and overweight adults, to other anti-obesity agents, omega-3 gel capsule and not receiving a treatment, the authors could not reach conclusive results due to poor quality of evidence.

Special populations

In children and adolescents, fluoxetine is the antidepressant of choice due to tentative evidence favoring its efficacy and tolerability.JOURNAL, Taurines R, Gerlach M, Warnke A, Thome J, Wewetzer C, Pharmacotherapy in depressed children and adolescents, The World Journal of Biological Psychiatry, 12, Suppl 1, 11–5, September 2011, 21905988, 10.3109/15622975.2011.600295, 18186328, JOURNAL, Cohen D, Should the use of selective serotonin reuptake inhibitors in child and adolescent depression be banned?, Psychotherapy and Psychosomatics, 76, 1, 5–14, 2007, 17170559, 10.1159/000096360, 1112192, Evidence supporting an increased risk of major fetal malformations resulting from fluoxetine exposure is limited, although the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has warned prescribers and patients of the potential for fluoxetine exposure in the first trimester (during organogenesis, formation of the fetal organs) to cause a slight increase in the risk of congenital cardiac malformations in the newborn.JOURNAL, Morrison JL, Riggs KW, Rurak DW, Fluoxetine during pregnancy: impact on fetal development, Reproduction, Fertility, and Development, 17, 6, 641–50, March 2005, 16263070, 10.1071/RD05030, BOOK, Fluoxetine Hydrochloride, Martindale: The Complete Drug Reference, Pharmaceutical Press, Brayfield A, London, UK, 13 August 2013, 24 November 2013,www.medicinescomplete.com/mc/martindale/current/12763-x.htm, {{subscription required}}WEB, Fluoxetine in pregnancy: slight risk of heart defects in unborn child, MHRA, Medicines and Healthcare products Regulatory Agency, 10 September 2011, 23 November 2013,www.mhra.gov.uk/home/groups/pl-p/documents/websiteresources/con129100.pdf, dead,www.mhra.gov.uk/home/groups/pl-p/documents/websiteresources/con129100.pdf," title="web.archive.org/web/20131202231255www.mhra.gov.uk/home/groups/pl-p/documents/websiteresources/con129100.pdf,">web.archive.org/web/20131202231255www.mhra.gov.uk/home/groups/pl-p/documents/websiteresources/con129100.pdf, 2 December 2013, Furthermore, an association between fluoxetine use during the first trimester and an increased risk of minor fetal malformations was observed in one study.However, a systematic review and meta-analysis of 21 studies – published in the Journal of Obstetrics and Gynaecology Canada – concluded, “the apparent increased risk of fetal cardiac malformations associated with maternal use of fluoxetine has recently been shown also in depressed women who deferred SSRI therapy in pregnancy, and therefore most probably reflects an ascertainment bias. Overall, women who are treated with fluoxetine during the first trimester of pregnancy do not appear to have an increased risk of major fetal malformations.“JOURNAL, Rowe T, Drugs in Pregnancy, Journal of Obstetrics and Gynaecology Canada, 37, 6, 489–92, June 2015, 26334601, 10.1016/S1701-2163(15)30222-X, free, Per the FDA, infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn. Limited data support this risk, but the FDA recommends physicians consider tapering SSRIs such as fluoxetine during the third trimester. A 2009 review recommended against fluoxetine as a first-line SSRI during lactation, stating, “Fluoxetine should be viewed as a less-preferred SSRI for breastfeeding mothers, particularly with newborn infants, and in those mothers who consumed fluoxetine during gestation.“JOURNAL, Kendall-Tackett K, Hale TW, The use of antidepressants in pregnant and breastfeeding women: a review of recent studies, Journal of Human Lactation, 26, 2, 187–95, May 2010, 19652194, 10.1177/0890334409342071, 29112093, Sertraline is often the preferred SSRI during pregnancy due to the relatively minimal fetal exposure observed and its safety profile while breastfeeding.BOOK, 978-0-470-97948-8, The Maudsley prescribing guidelines in psychiatry, Taylor D, Paton C, Shitij K, 2012, Wiley-Blackwell, West Sussex,

Adverse effects

Side effects observed in fluoxetine-treated persons in clinical trials with an incidence >5% and at least twice as common in fluoxetine-treated persons compared to those who received a placebo pill include abnormal dreams, abnormal ejaculation, anorexia, anxiety, asthenia, diarrhea, dizziness, dry mouth, dyspepsia, fatigue, flu syndrome, impotence, insomnia, decreased libido, nausea, nervousness, pharyngitis, rash, sinusitis, somnolence, sweating, tremor, vasodilation, and yawning.JOURNAL, Bland RD, Clarke TL, Harden LB, Rapid infusion of sodium bicarbonate and albumin into high-risk premature infants soon after birth: a controlled, prospective trial, American Journal of Obstetrics and Gynecology, 124, 3, 263–7, February 1976, 2013, 10.1016/0002-9378(76)90154-x, Fluoxetine is considered the most stimulating of the SSRIs (that is, it is most prone to causing insomnia and agitation).BOOK, Koda-Kimble MA, Alldredge BK, Applied therapeutics: the clinical use of drugs, 2012, Wolters Kluwer Health/Lippincott Williams & Wilkins, Baltimore, 978-1-60913-713-7, 10th, It also appears to be the most prone of the SSRIs for producing dermatologic reactions (e.g. urticaria (hives), rash, itchiness, etc.).

Sexual dysfunction

{{See also|Selective serotonin reuptake inhibitor#Sexual dysfunction}}Sexual dysfunction, including loss of libido, erectile dysfunction, lack of vaginal lubrication, and anorgasmia, are some of the most commonly encountered adverse effects of treatment with fluoxetine and other SSRIs. While early clinical trials suggested a relatively low rate of sexual dysfunction, more recent studies in which the investigator actively inquires about sexual problems suggest that the incidence is >70%.JOURNAL, Clark MS, Jansen K, Bresnahan M, Clinical inquiry: How do antidepressants affect sexual function?, The Journal of Family Practice, 62, 11, 660–1, November 2013, 24288712, In 2019, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommended that packaging leaflets of selected SSRIs and SNRIs should be amended to include information regarding a possible risk of persistent sexual dysfunction.BOOK,www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-13-16-may-2019-prac-meeting_en.pdf, European Medicines Agency, 11 June 2019, PRAC recommendations on signals: Adopted at the 13-16 May 2019 PRAC meeting, 5, 19 July 2023, Following on the European assessment, a safety review by Health Canada “could neither confirm nor rule out a causal link{{spaces}}... which was long lasting in rare cases”, but recommended that “healthcare professionals inform patients about the potential risk of long-lasting sexual dysfunction despite discontinuation of treatment”.JOURNAL, SSRIs, SNRIs: risk of persistent sexual dysfunction, Reactions Weekly, Springer, 1838, 5, 16 January 2021, 5, 10.1007/s40278-021-89324-7, 231669986,

Antidepressant discontinuation syndrome

Fluoxetine’s longer half-life makes it less common to develop antidepressant discontinuation syndrome following cessation of therapy, especially when compared with antidepressants with shorter half-lives such as paroxetine.JOURNAL, Bhat V, Kennedy SH, Recognition and management of antidepressant discontinuation syndrome, Journal of Psychiatry & Neuroscience, 42, 4, E7–E8, June 2017, 28639936, 5487275, 10.1503/jpn.170022, JOURNAL, Warner CH, Bobo W, Warner C, Reid S, Rachal J, Antidepressant discontinuation syndrome, American Family Physician, 74, 3, 449–56, August 2006, 16913164, Although gradual dose reductions are recommended with antidepressants with shorter half-lives, tapering may not be necessary with fluoxetine.JOURNAL, Gabriel M, Sharma V, Antidepressant discontinuation syndrome, CMAJ, 189, 21, E747, May 2017, 28554948, 5449237, 10.1503/cmaj.160991,

Pregnancy

Antidepressant exposure (including fluoxetine) is associated with shorter average duration of pregnancy (by three days), increased risk of preterm delivery (by 55%), lower birth weight (by 75 g), and lower Apgar scores (by 5-HT5-HTαM! scope=“col” colspan=“3” style="text-align:center; background:papayawhip” |