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PAROXETINE
PAROXETINE is a drug. It is currently FDA-approved (first approved 1992).
Paroxetine is a small molecule serotonin transporter inhibitor that belongs to the drug class of inhibitors. It has been studied for various conditions including depression, anxiety disorders, and cardiovascular diseases, often in combination with other treatments such as exercise and antipsychotics.
At a glance
| Generic name | PAROXETINE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1992 |
Approved indications
Boxed warnings
- 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 full prescribing information for complete boxed warning. Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. Paroxetine is not approved for use in pediatric patients. ( 5.1 , 8.4 )
Common side effects
- Nausea
- Asthenia
- Sweating
- Somnolence
- Tremor
- Dizziness
- Decreased appetite
- Dry mouth
- Constipation
- Insomnia
- Abnormal ejaculation
- Libido decreased
Key clinical trials
- A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors (PHASE1, PHASE2)
- A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
- Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
- Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging Mechanisms (NA)
- Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities (PHASE4)
- Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation (NA)
- Effect of SC-ICBT for Adults With OCD：A Three-Arm Randomized Controlled Trial (NA)
- Building Ukraine's Strength in PTSD Treatment and Research (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- PAROXETINE CI brief — competitive landscape report
- PAROXETINE updates RSS · CI watch RSS
Frequently asked questions about PAROXETINE
What is PAROXETINE?
When was PAROXETINE approved?
What development phase is PAROXETINE in?
What are the side effects of PAROXETINE?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing