TheraRadar
Data updated: Mar 29, 2026

PAROXETINE

PAROXETINE HYDROCHLORIDE
Neurology Approved 2014-10-31

Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of several psychiatric conditions in adult patients. It is approved for the management of major depressive disorder, obsessive compulsive disorder, and panic disorder. Additionally, the medication is used to treat social anxiety disorder, generalized anxiety disorder, and posttraumatic stress disorder.

Source: FDA Label • PRINSTON INC
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How PAROXETINE Works

The exact mechanism of action for paroxetine in treating its indicated conditions is unknown. Its therapeutic effects are presumed to be linked to the potentiation of serotonergic activity within the central nervous system. This process occurs through the inhibition of the neuronal reuptake of serotonin, also known as 5-hydroxytryptamine (5-HT).

Source: FDA Label
1
Indication
--
Phase 3 Trials
11
Years on Market

Details

Status
Prescription
First Approved
2014-10-31
Routes
ORAL
Dosage Forms
TABLET

Companies

PRINSTON INC
Active Ingredient: PAROXETINE HYDROCHLORIDE

PAROXETINE Approval History

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What PAROXETINE Treats

6 indications

PAROXETINE is approved for 6 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Major Depressive Disorder
  • Obsessive Compulsive Disorder
  • Panic Disorder
  • Social Anxiety Disorder
  • Generalized Anxiety Disorder
  • Posttraumatic Stress Disorder
Source: FDA Label

PAROXETINE Boxed Warning

BOXED WARNING WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )]. Paroxetine is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See ...

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Key Completed Trials

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Trial Timeline

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Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PAROXETINE FDA Label Details

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Indications & Usage

Paroxetine tablets are indicated in adults for the treatment of: Major depressive disorder (MDD) Obsessive compulsive disorder (OCD) Panic disorder (PD) Social anxiety disorder (SAD) Generalized anxiety disorder (GAD) Posttraumatic stress disorder (PTSD) Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of : Major Depressive Disorder (MDD) Obsessive Compulsive Disorder (OCD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Generalized Anxiety Disorder (GAD) Posttraumatic Stress Disorder (PTSD)

⚠️ BOXED WARNING

BOXED WARNING WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts...

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Data Sources

FDA Approval: ANDA203854 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.