Global InformationParoxetine information
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| Trade names | Paxil, Seroxat, Loxamine |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a698032 |
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| Routes of administration | Oral (By mouth) |
| Drug class | Selective serotonin reuptake inhibitor (SSRI) |
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| Bioavailability | Extensively absorbed from the GI tract, but extensive first-pass metabolism in the liver[3][4][5][6] |
| Protein binding | 93–95%[3][4][5] |
| Metabolism | Extensive, liver (mostly CYP2D6-mediated)[3][4][5] |
| Elimination half-life | 21 hours[3][4][5] |
| Excretion | Kidney (64%; 2% unchanged and 62% as metabolites), faecal (36%; <1% unchanged)[3][4][5] |
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| ECHA InfoCard | 100.112.096 |
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| Formula | C19H20FNO3 |
| Molar mass | 329.371 g·mol−1 |
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Paroxetine, sold under the brand names Paxil and Seroxat among others, is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class.[7] It is used to treat major depressive disorder, obsessive-compulsive disorder, panic disorder, social anxiety disorder, post-traumatic stress disorder, generalized anxiety disorder, and premenstrual dysphoric disorder.[7] It has also been used in the treatment of premature ejaculation and hot flashes due to menopause.[7][8] It is taken orally (by mouth).[7]
Common side effects include drowsiness, dry mouth, loss of appetite, sweating, trouble sleeping, and sexual dysfunction.[7] Serious side effects may include suicidal thoughts in those under the age of 25, serotonin syndrome, and mania.[7] While the rate of side effects appears similar compared to other SSRIs and SNRIs, antidepressant discontinuation syndromes may occur more often.[9][10] Use in pregnancy is not recommended, while use during breastfeeding is relatively safe.[11] It is believed to work by blocking the reuptake of the chemical serotonin by neurons in the brain.[7]
Paroxetine was approved for medical use in the United States in 1992 and initially sold by GlaxoSmithKline.[7][12] It is on the World Health Organization's List of Essential Medicines.[13] It is available as a generic medication.[14] In 2021, it was the 95th most commonly prescribed medication in the United States, with more than 7 million prescriptions.[15][16] In 2018, it was in the top 10 of most prescribed antidepressants in the United States.[17] In 2012, the United States Department of Justice fined GlaxoSmithKline $3 billion for withholding data, unlawfully promoting use in those under 18, and preparing an article that misleadingly reported the effects of paroxetine in adolescents with depression following its clinical trial study 329.[18][19][20]
- ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
- ^ Anvisa (31 March 2023). "RDC Nº 784 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial" [Collegiate Board Resolution No. 784 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control] (in Brazilian Portuguese). Diário Oficial da União (published 4 April 2023). Archived from the original on 3 August 2023. Retrieved 3 August 2023.
- ^ a b c d e Sandoz Pty Ltd (18 January 2012). "Product Information Paroxetine Sandoz 20Mg Film-Coated Tablets" (PDF). Therapeutic Goods Administration. Archived from the original on 4 September 2015. Retrieved 22 November 2013.
- ^ a b c d e Mylan Institutional Inc. (January 2012). "Paroxetine (paroxetine hydrochloride hemihydrate) tablet, film coated". DailyMed. U.S. National Library of Medicine. Archived from the original on 23 October 2013. Retrieved 22 November 2013.
- ^ a b c d e Sandoz Limited (21 March 2013). "Paroxetine 20 mg Tablets – Summary of Product Characteristics (SPC)". electronic Medicines Compendium. Datapharm Ltd. Archived from the original on 3 December 2013. Retrieved 22 November 2013.
- ^ "Paxil, Paxil CR (paroxetine) dosing, indications, interactions, adverse effects, and more". Medscape Reference. WebMD. Archived from the original on 10 November 2015. Retrieved 22 November 2013.
- ^ a b c d e f g h "Paroxetine Hydrochloride Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Archived from the original on 6 March 2019. Retrieved 3 March 2019.
- ^ Fischer A (28 June 2013). "FDA approves the first non-hormonal treatment for hot flashes associated with menopause" (Press release). Food and Drug Administration. Archived from the original on 18 January 2017.
- ^ Hosenbocus S, Chahal R (February 2011). "SSRIs and SNRIs: A review of the Discontinuation Syndrome in Children and Adolescents". Journal of the Canadian Academy of Child and Adolescent Psychiatry. 20 (1): 60–67. PMC 3024727. PMID 21286371.
- ^ Pae CU, Patkar AA (February 2007). "Paroxetine: current status in psychiatry". Expert Review of Neurotherapeutics. 7 (2): 107–120. doi:10.1586/14737175.7.2.107. PMID 17286545. S2CID 34636522.
- ^ "Paroxetine Pregnancy and Breastfeeding Warnings". Drugs.com. Archived from the original on 3 December 2018. Retrieved 3 March 2019.
- ^ Food and Drug Administration (2011). Approved Drug Products with Therapeutic Equivalence Evaluations – FDA Orange Book 31st Edition (2011): FDA Orange Book 31st Edition (2011). DrugPatentWatch.com. p. 344. ISBN 9781934899816. Archived from the original on 6 March 2019. Retrieved 4 March 2019.
- ^ World Health Organization (2021). World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. hdl:10665/345533. WHO/MHP/HPS/EML/2021.02.
- ^ British national formulary: BNF 76 (76 ed.). Pharmaceutical Press. 2018. p. 363. ISBN 9780857113382.
- ^ "The Top 300 of 2021". ClinCalc. Archived from the original on 15 January 2024. Retrieved 14 January 2024.
- ^ "Paroxetine - Drug Usage Statistics". ClinCalc. Retrieved 14 January 2024.
- ^ Grohol JM (15 December 2019). "Top 25 Psychiatric Medications for 2018". psychcentral.com. Archived from the original on 25 October 2020. Retrieved 26 September 2020.
- ^ "GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data" (Press release). United States Department of Justice, Office of Public Affairs. 2 July 2012. Archived from the original on 9 September 2014. Retrieved 6 October 2015.
The United States alleges that, among other things, GSK participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy.
- ^ United States ex rel. Greg Thorpe, et al. v. GlaxoSmithKline PLC, and GlaxoSmithKline LLC, pp. 3–19 (D. Mass. 26 October 2011), Text, archived from the original on 19 October 2014.
- ^ Thomas K, Schmidt MS (2 July 2012). "Glaxo Agrees to Pay $3 Billion in Fraud Settlement". The New York Times. Archived from the original on 2 March 2017. Retrieved 28 February 2017.