What is PAROXETINE HYDROCHLORIDE HEMIHYDRATE used for?

PAROXETINE HYDROCHLORIDE HEMIHYDRATE (brand name Paroxetine) is a SSRI indicated for See full prescribing information.

What are the most common side effects of PAROXETINE HYDROCHLORIDE HEMIHYDRATE?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for PAROXETINE HYDROCHLORIDE HEMIHYDRATE. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is PAROXETINE HYDROCHLORIDE HEMIHYDRATE the same as Paroxetine?

Paroxetine is a brand name for PAROXETINE HYDROCHLORIDE HEMIHYDRATE. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Q: How does PAROXETINE HYDROCHLORIDE HEMIHYDRATE work?

PAROXETINE HYDROCHLORIDE HEMIHYDRATE works through the following mechanism: 12.1 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)..

SSRI

Brand names: Paroxetine

Oral

Mechanism of Action

12.1 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

See full prescribing information

Contraindications

• 4 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 [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 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone
Meta-analyses of epidemiological studies have shown increased risk (less than 2-fold) of cardiovascular malformations with exposure during the first trimester
1 ) Increased Risk of Bleeding : Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, other antiplatelet drugs, warfarin, and other anticoagulant drugs may increase risk
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

Known Side Effects

11 documented side effects by frequency

Drug Not Working

1-10%

Nausea

1-10%

Dizziness

1-10%

Anxiety

1-10%

Fatigue

1-10%

Headache

1-10%

Depression

1-10%

Insomnia

1-10%

Diarrhea

1-10%

Vomiting

0.1-1%

Weight Gain

0.1-1%

Community Discussions

No community discussions found for PAROXETINE HYDROCHLORIDE HEMIHYDRATE yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → PAROXETINE HYDROCHLORIDE HEMIHYDRATE openFDA label JSON → PAROXETINE HYDROCHLORIDE HEMIHYDRATE FAERS adverse-event reports → PAROXETINE HYDROCHLORIDE HEMIHYDRATE ClinicalTrials.gov → completed Phase 2+ trials of PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Compare With

12 available comparisons

Formulations

Dosage Forms

Tablet

Route

Oral