SSRI antidepressant medication
Paroxetine Trade names Paxil, others AHFS /Drugs.com Monograph MedlinePlus a698032 License data
Pregnancy category Routes of administration Oral (By mouth)Drug class Selective serotonin reuptake inhibitor (SSRI)ATC code Legal status
AU : S4 (Prescription only)
BR : Class C1 (Other controlled substances)[ 2]
CA : ℞-only
UK : POM (Prescription only)
US : WARNING [ 1] Rx-only
In general: ℞ (Prescription only)
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]
(3S ,4R )-3-[(2H -1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine
CAS Number PubChem CID IUPHAR/BPS DrugBank ChemSpider UNII KEGG ChEBI ChEMBL CompTox Dashboard (EPA ) ECHA InfoCard 100.112.096 Formula C 19 H 20 F N O 3 Molar mass 329.371 g·mol−1 3D model (JSmol )
c1cc(ccc1[C@@H]2CCNC[C@H]2COc3ccc4c(c3)OCO4)F
InChI=1S/C19H20FNO3/c20-15-3-1-13(2-4-15)17-7-8-21-10-14(17)11-22-16-5-6-18-19(9-16)24-12-23-18/h1-6,9,14,17,21H,7-8,10-12H2/t14-,17-/m0/s1
Y Key:AHOUBRCZNHFOSL-YOEHRIQHSA-N
Y
N Y (what is this?) (verify)
Paroxetine , sold under the brand name Paxil 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 2022, it was the 92nd 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]
^ "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 (2023). The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023) . Geneva: World Health Organization. hdl :10665/371090 . WHO/MHP/HPS/EML/2023.02.
^ British national formulary: BNF 76 (76 ed.). Pharmaceutical Press. 2018. p. 363. ISBN 9780857113382 .
^ "The Top 300 of 2022" . ClinCalc . Archived from the original on 30 August 2024. Retrieved 30 August 2024 .
^ "Paroxetine Drug Usage Statistics, United States, 2013 - 2022" . ClinCalc . Retrieved 30 August 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 .