Paroxetine

The mechanism of action of paroxetine in the treatment of MDD, SAD, OCD, PD, GAD, and PTSD is unknown, but is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin (5-hydroxy-tryptamine, 5-HT).

• 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 ( 1 ): Major Depressive Disorder (MDD) Obsessive Compulsive Disorder (OCD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Generalized Anxiety Disorder (GAD) Posttraumatic Stress Disorder (PTSD)ICD-10: F32.9, F41.0, F41.1, F42.9, F43.10

• Paroxetine tablets are contraindicated in patients: Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7) ]. Taking thioridazine because of risk of QT prolongation [see Warnings and Precautions ( 5.3 , Drug Interactions ( 7 )] Taking pimozide because of risk of QT prolongation [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )].contraindicated

Recommended starting and maximum daily dosage for MDD, OCD, PD, and PTSD: ( 2.2 ) Indication Starting Daily Dose Maximum Daily Dose MDD 20 mg 50 mg OCD 20 mg 60 mg PD 10 mg 60 mg PTSD 20 mg 50 mg Recommended starting dosage for SAD and GAD is 20 mg daily. ( 2.3 ) Elderly patients, patients with severe renal impairment or severe hepatic impairment: Starting dosage is 10 mg daily. Maximum dosage is 40 mg daily. ( 2.4 ) When discontinuing paroxetine tablets, reduce dosage gradually. ( 2.6 , 5.7 ) 2.1 Administration Information Administer paroxetine tablets as a single daily dose in the morning, with or without food. 2.2 Recommended Dosage for MDD, OCD, PD, and PTSD The recommended starting dosages and maximum dosages of paroxetine tablets in patients with MDD, OCD, PD, and PTSD are presented in Table 1. In patients with an inadequate response, increase dosage in increments of 10 mg per day at intervals of at least 1 week, depending on tolerability. Table 1 Recommended Daily Dosage of Paroxetine Tablets in Patients with MDD, OCD, PD, and PTSD Indication Starting Dose Maximum Dose MDD 20 mg 50 mg OCD 20 mg 60 mg PD 10 mg 60 mg PTSD 20 mg 50 mg 2.3 Recommended Dosage for SAD and GAD SAD The starting and recommended dosage in patients with SAD is 20 mg daily. In clinical trials the effectiveness of paroxetine tablets was demonstrated in patients dosed in a range of 20 mg to 60 mg daily.

Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If occurs, discontinue paroxetine and serotonergic agents and initiate supportive measures. ( 5.2 ) Embryofetal Toxicity: May cause fetal harm. Meta-analyses of epidemiological studies have shown increased risk (less than 2-fold) of cardiovascular malformations with exposure during the first trimester. ( 5.4 , 8.1 ) Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, other antiplatelet drugs, warfarin, and other anticoagulant drugs may increase risk. ( 5.5 ) Activation of Mania/Hypomania: Screen patients for bipolar disorder. ( 5.6 ) Seizures: Use with caution in patients with seizure disorders. ( 5.8 ) Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ( 5.9 ) Sexual Dysfunction: paroxetine may cause symptoms of sexual dysfunction. ( 5.13 ) 5.1 Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied.

The following adverse reactions are included in more detail in other sections of the prescribing information: Hypersensitivity reactions to paroxetine [see Contraindications ( 4 )] Suicidal Thoughts and Behaviors [see Warnings and Precautions ( 5.1 )] Serotonin Syndrome [see Warnings and Precautions ( 5.2 )] Embryofetal Toxicity [see Warnings and Precautions ( 5.4 )] Increased Risk of Bleeding [see Warnings and Precautions ( 5.5 )] Activation of Mania/Hypomania [see Warnings and Precautions ( 5.6 )] Discontinuation Syndrome [see Warnings and Precautions ( 5.7 )] Seizures [see Warnings and Precautions ( 5.8 )] Angle-closure Glaucoma [see Warnings and Precautions ( 5.9 )] Hyponatremia [see Warnings and Precautions ( 5.10 )] Bone Fracture [see Warnings and Precautions ( 5.12 )] Sexual Dysfunction [see Warnings and Precautions ( 5.13 )] Most common adverse reactions (≥ 5% and at least twice placebo) are abnormal ejaculation, asthenia, constipation, decreased appetite, diarrhea, dizziness, dry mouth, female genital disorder, impotence, infection, insomnia, libido decreased, male genital disorder, nausea, nervousness, somnolence, sweating, tremor, yawn. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Pregnancy: SSRI use, particularly later in pregnancy, may increase the risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, irritability) in the neonate. ( 8.1 ) 8.1 Pregnancy Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions ( 5.5 ) and Clinical Considerations]. Paroxetine is associated with a less than 2-fold increase in cardiovascular malformations when administered to a pregnant woman during the first trimester. While individual epidemiological studies on the association between paroxetine use and cardiac malformations have reported inconsistent findings, some meta-analyses of epidemiological studies have identified an increased risk of cardiovascular malformations (see Data). There are risks of persistent pulmonary hypertension of the newborn (PPHN) (see Data) and/or poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including paroxetine during pregnancy. There also are risks associated with untreated depression in pregnancy (see Clinical Considerations).

Metabolism

Nonlinearity in pharmacokinetics is observed with increasing doses of paroxetine. In a meta-analysis of paroxetine from 4 studies done in healthy volunteers following multiple dosing of 20 mg/day to 40 mg/day, males did not exhibit a significantly lower C max or AUC than females.

The following have been reported with paroxetine tablet overdosage: Seizures, which may be delayed, and altered mental status including coma. Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol. Serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk). Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a paroxetine overdose. Consider contacting a Poison Center (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

• Dec 29, 1992NDANDA020031Apotex
• Feb 16, 1999NDANDA020936Apotex
• Jul 30, 2003ANDAANDA075356Apotex
• Mar 7, 2007ANDAANDA077584Zydus Pharms Usa
• Jul 25, 2007ANDAANDA078406Aurobindo Pharma
• Mar 13, 2008ANDAANDA078902Mylan
• Jun 21, 2010ANDAANDA076968Oxford Pharms
• Jun 28, 2013NDANDA204516Legacy Pharma

1. 1Drug Ineffective6,2536.9%
2. 2Drug Withdrawal Syndrome6,2056.9%
3. 3Nausea6,1006.8%
4. 4Dizziness5,4346.0%
5. 5Fatigue5,3836.0%
6. 6Anxiety5,3715.9%
7. 7Headache4,7885.3%
8. 8Depression4,2884.7%
9. 9Insomnia3,8734.3%
10. 10Diarrhoea3,8614.3%
11. 11Vomiting3,2703.6%
12. 12Suicidal Ideation3,2093.6%
13. 13Drug Exposure During Pregnancy3,1913.5%
14. 14Weight Increased3,1583.5%
15. 15Pain3,1113.4%

Recent PubMed references pinned to Paroxetine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Optimizing Mirtazapine Initial Dosing: A Population Analysis of the Effects of BMI, Paroxetine and Fluvoxamine.
  Drug design, development and therapy · 2026 · Yan H, Huang W, Xia H, et al.
  PMID 42261444DOI 10.2147/DDDT.S601238
• Clinical CYP2D6-Mediated Pharmacokinetic Drug-Drug Interactions of DA-8010 with Paroxetine or Mirabegron in Healthy Korean Participants.
  Drug design, development and therapy · 2026 · Ryu H, Cho JY, Lee DY, et al.
  PMID 42232095DOI 10.2147/DDDT.S594709
• Electroacupuncture Combined With Paroxetine Improves Depression-Like Behavior in Rats by Regulating SIRT2/AMPAR in the Hippocampal Dentate Gyrus.
  Journal of integrative neuroscience · 2026 · Zhang Z, Huang S, Li Z, et al.
  PMID 42052772DOI 10.31083/JIN44692
• Neurobehavioral toxicity of paroxetine in Gambusia affinis: Dissociated behavioral syndromes and impaired monoaminergic neurotransmission.
  Environmental pollution (Barking, Essex : 1987) · 2026 · Wang M, Cui L, Wang H, et al.
  PMID 41903904DOI 10.1016/j.envpol.2026.128028
• Paroxetine as a Therapeutic Agent in Inflammatory Osteolysis: Mechanistic Insights and Efficacy.
  Drug design, development and therapy · 2026 · Huang J, Wang Z, Liu J, et al.
  PMID 41868178DOI 10.2147/DDDT.S561725
• Hippocampal energy metabolism reprogramming underlies individual differences in paroxetine-facilitated contextual fear extinction.
  Behavioural brain research · 2026 · Fan Z, Gong X, Xu H, et al.
  PMID 41839375DOI 10.1016/j.bbr.2026.116162
• Antifungal effects of paroxetine and fluoxetine, synergism with antifungal drugs, and mode of action against Candida spp.
  Mycologia · 2026 · Rodrigues DS, de Farias Cabral VP, Moreira LEA, et al.
  PMID 41817161DOI 10.1080/00275514.2026.2616853
• Effect of the antidepressant drug paroxetine in downregulating the biofilm-adhering genes in Staphylococcus aureus: In vitro and in silico studies.
  Medicine · 2026 · AlKhalidi HM, Ali AH, Abo-Ouf AM, et al.
  PMID 41790700DOI 10.1097/MD.0000000000047907

The 10 most recently updated of 317 ClinicalTrials.gov registrations naming Paroxetine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD
  Active not recruiting · Phase 4 · Interventional · 304 enrolled · University of Pennsylvania
  NCT04961190updated 2026-06-09
• A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
  Completed · Observational · 999 enrolled · Astellas Pharma Global Development, Inc.
  NCT06049797updated 2026-06-05
• 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
  Recruiting · Phase 1 · Phase 2 · Interventional · 980 enrolled · BioNTech SE
  NCT07070232updated 2026-05-22
• Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation
  Completed · Interventional · 120 enrolled · Boston Medical Group
  NCT04207723updated 2026-05-12
• Deprescription of Antidepressants in Primary Care (DAPriCare)
  Not yet recruiting · Early phase 1 · Interventional · 325 enrolled · University of Huelva
  NCT06796946updated 2026-05-04
• Paroxetine Safety and Efficacy in Rheumatoid Arthritis
  Completed · Phase 3 · Interventional · 100 enrolled · Mostafa Bahaa
  NCT06231745updated 2026-05-04
• Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
  Recruiting · Observational · 1,600 enrolled · Duke University
  NCT03511118updated 2026-04-24
• Treatment of Tinnitus With Migraine Medications
  Completed · Phase 4 · Interventional · 78 enrolled · University of California, Irvine
  NCT04404439updated 2026-04-16
• Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities
  Not yet recruiting · Phase 4 · Interventional · 25 enrolled · University Hospitals Cleveland Medical Center
  NCT06997198updated 2026-04-09
• Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging Mechanisms
  Not yet recruiting · Interventional · 123 enrolled · Lishu Gao
  NCT07392645updated 2026-02-06

CPIC-curated drug–gene pairs for Paroxetine. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• CYP2C19CPIC C
  CYP2D6, CYP2C19, CYP2B6, SLC6A4, HTR2A and Serotonin Reuptake Inhibitor Antidepressants
• CYP2D6CPIC AClinPGx 1A
  CYP2D6, CYP2C19, CYP2B6, SLC6A4, HTR2A and Serotonin Reuptake Inhibitor Antidepressants
• FKBP5CPIC D (provisional)ClinPGx 3
• GRIK4CPIC C (provisional)
• HTR1ACPIC D (provisional)ClinPGx 3
• HTR2ACPIC CClinPGx 3
  CYP2D6, CYP2C19, CYP2B6, SLC6A4, HTR2A and Serotonin Reuptake Inhibitor Antidepressants
• SLC6A4CPIC CClinPGx 3
  CYP2D6, CYP2C19, CYP2B6, SLC6A4, HTR2A and Serotonin Reuptake Inhibitor Antidepressants

Frequently asked questions

How does Paroxetine work?

The mechanism of action of paroxetine in the treatment of MDD, SAD, OCD, PD, GAD, and PTSD is unknown, but is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin (5-hydroxy-tryptamine, 5-HT).

What is Paroxetine used for?

According to FDA labeling, Paroxetine carries indications including: 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 ( 1 ): Major Depressive Disorder (MDD) Obsessive Compulsive Disorder (OCD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Generalized Anxiety Disorder (GAD) Posttraumatic Stress Disorder (PTSD). This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Paroxetine?

Paroxetine is classified as Selective serotonin reuptake inhibitors, Serotonin Reuptake Inhibitor, Monoamine Oxidase Inhibitors, Serotonin Uptake Inhibitors, Increased Brain Stem Serotonin Activity.

What are the brand names for Paroxetine?

Paroxetine is marketed under brand names including Brisdelle, Paxil, Pexeva.

What are the contraindications for Paroxetine?

Paroxetine labeling lists contraindications including: Paroxetine tablets are contraindicated in patients: Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7) ]. Taking thioridazine because of risk of QT prolongation [see Warnings and Precautions ( 5.3 , Drug Interactions ( 7 )] Taking pimozide because of risk of QT prolongation [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )].. Always consult the full prescribing information and a clinician.