Paroxetine

What it is and how it works

Mechanism of Action The mechanism of action of paroxetine tablets 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).

Indications

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 tablets are 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)

Dosage and administration (summary)

Recommended starting and maximum daily dosage for MDD, OCD, PD, and PTSD: 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. Elderly patients, patients with severe renal impairment or severe hepatic impairment: Starting dosage is 10 mg daily. Maximum dosage is 40 mg daily. When discontinuing paroxetine tablets, reduce dosage gradually. ( 2.6 , 5.7 ) Administration Information Administer paroxetine tablets as a single daily dose in the morning, with or without food.

Contraindications

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 . Taking thioridazine because of risk of QT prolongation Taking pimozide because of risk of QT prolongation . With known hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) to paroxetine or any of the inactive ingredients in paroxetine tablets .

Warnings and precautions

Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If occurs, discontinue paroxetine tablets and serotonergic agents and initiate supportive measures. 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.

Pregnancy

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 .

Storage and supply

Paroxetine tablets, USP are capsule-shaped tablets supplied as: 30 mg, beige to light brown, debossed with ‘712’ on one side and ‘HH’ on the other side NDC: 70518-2598-00 NDC: 70518-2598-01 NDC: 70518-2598-02 OUTER PACKAGING: 30 in 1 BOX PACKAGING: 1 in 1 POUCH OUTER PACKAGING: 50 in 1 BOX Store tablets at 20°C to 25°C (68°F to 77°F).

Source: Paroxetine Hydrochloride Hemihydrate (Paroxetine) — US FDA prescribing information, 2026-07-08, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.