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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.

Background

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

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/01/29
Phase 4
Recruiting
2025/01/08
Phase 2
Recruiting
2024/01/30
Phase 1
Completed
Asceneuron S.A.
2024/01/30
Phase 3
Recruiting
Mostafa Bahaa
2024/01/12
Phase 3
Not yet recruiting
aya ramadan ashmawy sarhan
2023/10/04
Phase 1
Completed
2023/09/22
N/A
Active, not recruiting
2023/09/06
Phase 3
Recruiting
Federico II University
2023/08/15
Phase 1
Completed
2023/02/13
Phase 2
Recruiting
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Lannett Company, Inc.
62175-472
ORAL
37.5 mg in 1 1
10/4/2021
Sebela Pharmaceuticals Inc.
54766-202
ORAL
20 mg in 1 1
8/31/2023
Preferred Pharmaceuticals, Inc
68788-0797
ORAL
10 mg in 1 1
11/2/2023
Apotex Corp
60505-4518
ORAL
20 mg in 1 1
12/25/2023
Preferred Pharmaceuticals, Inc
68788-9074
ORAL
20 mg in 1 1
11/2/2023
Sebela Pharmaceuticals Inc.
54766-204
ORAL
40 mg in 1 1
8/31/2023
State of Florida DOH Central Pharmacy
53808-0754
ORAL
40 mg in 1 1
5/29/2010
Rhodes Pharmaceuticals L.P.
42858-705
ORAL
25 mg in 1 1
9/30/2023
Rhodes Pharmaceuticals L.P.
42858-703
ORAL
12.5 mg in 1 1
9/30/2023
Physicians Total Care, Inc.
54868-1819
ORAL
25 mg in 1 1
12/9/2011

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
Apo-Paroxetine 20mg Tablet
SIN13485P
TABLET, FILM COATED
20.0mg
7/10/2008
SEROXAT CR TABLET 25 mg
SIN12583P
TABLET, EXTENDED RELEASE
25mg
8/30/2004
SEROXAT CR TABLET 12.5 mg
SIN12584P
TABLET, EXTENDED RELEASE
12.5 mg
8/30/2004

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Paroxetine Hydrochloride Tablets
国药准字H20031106
化学药品
片剂
8/23/2024
Paroxetine Hydrochloride Tablets
国药准字H20133084
化学药品
片剂
10/25/2022
Paroxetine Hydrochloride Tablets
国药准字H20243196
化学药品
片剂
2/20/2024
Paroxetine Hydrochloride Tablets
国药准字H10950043
化学药品
片剂
4/23/2020
Paroxetine Hydrochloride Tablets
国药准字H20040533
化学药品
片剂
5/12/2020
Paroxetine Hydrochloride Tablets
国药准字H20213120
化学药品
片剂
2/2/2021
Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets
国药准字H20243637
化学药品
缓释制剂
4/30/2024
Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets
国药准字H20243634
化学药品
片剂
4/30/2024
Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets
国药准字H20203422
化学药品
片剂
8/12/2020
Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets
国药准字H20249181
化学药品
片剂
10/22/2024

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.
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