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Paroxetine

Generic Name
Paroxetine
Brand Names
Paxil, Pexeva
Drug Type
Small Molecule
Chemical Formula
C19H20FNO3
CAS Number
61869-08-7
Unique Ingredient Identifier
41VRH5220H

Overview

Paroxetine is a selective serotonin reuptake inhibitor (SSRI) drug commonly known as Paxil. It has a variety of uses, including the treatment of anxiety disorders, major depression, posttraumatic stress disorder, and symptoms of menopause, among others. It was approved by the FDA in the early 1990s and marketed by SmithKline Beecham. A unique feature of this drug is that it is highly potent and selective in its inhibition of serotonin reuptake and has little effect on other neurotransmitters. Because of its potent inhibition of serotonin reuptake, paroxetine is more likely to cause withdrawal effects upon cessation. Paroxetine is well tolerated in most patients with a similar adverse effect profile to other members of its drug class. The controlled release formulation was designed to decrease the likelihood of nausea that is sometimes associated with paroxetine.

Indication

Paroxetine is indicated for the management of depression, obsessive-compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, posttraumatic stress disorder. One form of paroxetine, commercially known as Brisdelle, is used to manage mild to moderate vasomotor symptoms of menopause. Off-label, paroxetine may be used for the treatment of premature ejaculation or irritable bowel syndrome (IBS).

Associated Conditions

  • Generalized Anxiety Disorder
  • Irritable Bowel Syndrome (IBS)
  • Major Depressive Disorder (MDD)
  • Obsessive Compulsive Disorder (OCD)
  • Panic Disorder
  • Post Traumatic Stress Disorder (PTSD)
  • Premature Ejaculation
  • Premenstrual Dysphoric Disorder (PMDD)
  • Social Anxiety Disorder (SAD)
  • Vasomotor Symptoms Associated With Menopause

Research Report

Published: Jul 25, 2025

A Comprehensive Monograph on Paroxetine: Pharmacology, Clinical Profile, and Comparative Analysis

Section 1: Drug Identification and Physicochemical Properties

This section establishes the fundamental identity of paroxetine, detailing its chemical nomenclature, structural properties, and the various salt formulations that are critical to understanding its clinical applications and research context.

1.1 Nomenclature and Identifiers

Paroxetine is a well-established small molecule drug belonging to the selective serotonin reuptake inhibitor (SSRI) class of antidepressants.[1] Its generic name is recognized internationally, with variants including Paroxetina and Paroxetinum.[1] Chemically, it is classified as a phenylpiperidine derivative and contains several key functional groups, including a benzodioxole, an organofluorine compound, and an aromatic ether, and is functionally related to monofluorobenzene.[2]

The precise chemical structure is defined by its stereochemistry, with the biologically active form being the (−)-(3S,4R)-diastereomer.[2] This specificity is reflected in its formal IUPAC (International Union of Pure and Applied Chemistry) names:

(−)-(3S,4R)-4-(p-fluorophenyl)-3-((3,4-(methylenedioxy)phenoxy)methyl)piperidine and (3S-trans)-3-((1,3-benzodioxol-5-yloxy)methyl)-4-(4-fluorophenyl)piperidine.[1]

For unambiguous identification across scientific and regulatory databases, paroxetine is assigned a series of unique identifiers. The most prominent of these are:

  • DrugBank ID: DB00715 [1]
  • CAS (Chemical Abstracts Service) Number: 61869-08-7 for the parent base molecule [1]
  • PubChem Compound ID (CID): 43815 [3]

Additional identifiers facilitate cross-referencing in various databases, including ChEBI (CHEBI:7936), ChEMBL (CHEMBL490), KEGG (D02362), and the FDA UNII code (41VRH5220H).[2] During its development, it was also known by research codes such as BRL 29060 and FG-7051.[1]

Continue reading the full research report

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2017/11/06
Phase 1
Completed
2017/09/11
Phase 4
Completed
2017/09/07
Phase 2
Completed
2017/05/11
Phase 4
Completed
Rio de Janeiro State University
2017/02/15
Not Applicable
Completed
Jules Desmeules
2016/10/13
Phase 4
Completed
2016/09/08
N/A
Terminated
2016/08/02
Phase 4
Completed
2016/02/12
Phase 1
Completed
USWM, LLC (dba US WorldMeds)
2016/01/14
Not Applicable
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Physicians Total Care, Inc.
54868-5347
ORAL
12.5 mg in 1 1
9/8/2011
Physicians Total Care, Inc.
54868-2976
ORAL
20 mg in 1 1
1/5/2012
Apotex Corp
60505-3666
ORAL
40 mg in 1 1
1/18/2023
State of Florida DOH Central Pharmacy
53808-0753
ORAL
30 mg in 1 1
5/29/2010
Chartwell RX, LLC
62135-425
ORAL
12.5 mg in 1 1
12/13/2022
State of Florida DOH Central Pharmacy
53808-0749
ORAL
20 mg in 1 1
5/29/2010
Mylan Pharmaceuticals Inc.
0378-7003
ORAL
30 mg in 1 1
2/27/2024
Westminster Pharmaceuticals, LLC
69367-336
ORAL
25 mg in 1 1
9/30/2023
Mylan Pharmaceuticals Inc.
0378-7002
ORAL
20 mg in 1 1
2/27/2024
Oxford Pharmaceuticals, LLC
69584-672
ORAL
20 mg in 1 1
6/1/2022

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