Paroxetine — uses, dosing, side effects & the brands that sell it · pharmaranks
Paroxetine: uses, dosing, side effects & brands
Paroxetine is a serotonin reuptake inhibitor sold in the U.S. under 6 brand and generic names, for feeding and eating disorders, depressive disorder and obsessive-compulsive disorder. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
Key facts
Drug class
Serotonin Reuptake Inhibitor
Treats
Feeding and Eating Disorders, Depressive Disorder and Obsessive-Compulsive Disorder
From the FDA label for Paroxetine Mesylate (application ANDA207139). Other paroxetine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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…
Paroxetine side effects
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. 6.1 Clinical Trials Experience Because clinical trials…
Every paroxetine product we track (6)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Paroxetine pill imprints
Imprint
Strength
Colour
Shape
Maker
710;HH
10 mg
brown
capsule
—
M;N4
40 mg
blue
round
—
M;N;1
10 mg
blue
oval
—
APO;097
10 mg
white
oval
—
APO;083
20 mg
white
oval
—
APO;084
30 mg
white
Frequently asked questions
What is paroxetine?
Paroxetine tablets, USP contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans -4 R -(4'-fluorophenyl)-3 S -[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C 19 H 20 FNO 3 •HCl•1/2H 2 O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is: Paroxetine hydrochloride, USP is an odorless, white to off-white crystalline powder, having a melting point range of 120°C to 138°C. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in dichloromethane and slightly soluble in water. Paroxetine tablets are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide. Image
What kind of drug is paroxetine?
The FDA classifies paroxetine as a serotonin reuptake inhibitor. Selective serotonin reuptake inhibitors (SSRIs) block the transporter that pulls serotonin back into nerve cells, so more of this mood-related chemical stays in the gaps between neurons to keep signaling. They act mainly on serotonin, which tends to mean fewer side effects than older antidepressants. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take paroxetine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run paroxetine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is paroxetine sold under?
We track 6 paroxetine-containing products in the U.S.: Paroxetine Mesylate, Paroxetine Hydrochloride, Paxil, Paxil CR, Brisdelle and Pexeva. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Who shouldn’t take paroxetine
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 )]. • With known hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) to paroxetine or any of the inactive ingredients in paroxetine tablets [ see Adverse Reactions ( 6.1 ), ( 6.2 )]. • Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within 14 days of discontinuing a MAOI. ( 4 , 5.3 , 7 ) • Concomitant use of pimozide or thioridazine. ( 4 , 5.3 , 7 ) • Known hypersensitivity to paroxetine or to any of the inactive ingredients in paroxetine tablets. ( 4 )
Paroxetine drug interactions
Table 9 presents clinically significant drug interactions with paroxetine. Table 9 Clinically Significant Drug Interactions with Paroxetine Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact The concomitant use of SSRIs, including paroxetine, and MAOIs increases the risk of serotonin syndrome. Intervention Paroxetine is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration ( 2.5 ), Contraindications ( 4 ), Warnings and Precautions ( 5.2 )] . Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Pimozide and Thioridazine Clinical Impact Increased plasma concentrations of pimozide and thioridazine, drugs with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias. Intervention Paroxetine is contraindicated in patients taking pimozide or thioridazine [see Contraindications ( 4 )] . Other Serotonergic Drugs Clinical Impact The concomitant use of serotonergic drugs with paroxetine increases the risk of serotonin syndrome. Intervention Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of paroxetine and/or concomitant serotonergic drugs [see Warnings and Precautions ( 5.2 )] . Examples other…
Across the brands we track, paroxetine is currently marketed as capsule, suspension, tablet and tablet, extended release, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic paroxetine?
Yes. Our catalog lists 2 generic paroxetine products alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.