Paroxetine Hydrochloride Medication Guide

Conditions This Medication May Treat

Based on Bridgeway's clinical use. See the FDA "Uses" section below for approved indications.

Anxiety Disorders Depression Obsessive-Compulsive Disorder (OCD) Post-Traumatic Stress Disorder (PTSD)

Uses (FDA Indications) (FDA source)

1 INDICATIONS AND USAGE 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 ( 1 ): Major Depressive Disorder (MDD) Obsessive Compulsive Disorder (OCD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Generalized Anxiety Disorder (GAD) Posttraumatic Stress Disorder (PTSD)

Dosage Forms & Strengths (FDA source)

3 DOSAGE FORMS AND STRENGTHS Paroxetine tablets, USP are available as: 30-mg beige to light brown tablets, debossed with ‘712’ on one side and ‘HH’ on the other side. Tablets: 30 mg tablets. ( 3 )

Warnings & Precautions (FDA source)

5 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. ( 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 tablets 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. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 2. …

Common Side Effects (FDA source)

6 ADVERSE REACTIONS 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 Solco Healthcare US, LLC. at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

Drug Interactions (FDA source)

7 DRUG INTERACTIONS Table 9 presents clinically significant drug interactions with paroxetine tablets. Table 9: Clinically Significant Drug Interactions with Paroxetine Tablets Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact The concomitant use of SSRIs, including paroxetine tablets, and MAOIs increases the risk of serotonin syndrome. Intervention Paroxetine tablets are 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 tablets are contraindicated in patients taking pimozide or thioridazine [see Contraindications ( 4 )]. Other Serotonergic Drugs Clinical Impact The concomitant use of serotonergic drugs with paroxetine tablets 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 tablets and/or concomitant serotonergic drugs [see Warnings and Precautions ( 5.2 )] . Examples other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort. …

Interactions With Other Medications We Cover

FDA label text for Paroxetine Hydrochloride or a related medication mentions the following combinations. Check any two medications with our interaction tool →

• Paroxetine Hydrochloride + Aripiprazole — Moderate
• Paroxetine Hydrochloride + Amphetamine — Minor
• Paroxetine Hydrochloride + Fluvoxamine Maleate — Minor
• Paroxetine Hydrochloride + Lithium Carbonate — Minor
• Paroxetine Hydrochloride + Buspirone Hydrochloride — Minor
• Paroxetine Hydrochloride + Atomoxetine Hydrochloride — Minor
• Paroxetine Hydrochloride + Venlafaxine Hydrochloride — Minor
• Paroxetine Hydrochloride + Risperidone — Minor
• Paroxetine Hydrochloride + Duloxetine Hydrochloride — Minor
• Paroxetine Hydrochloride + Bupropion Hydrochloride — Minor
• Paroxetine Hydrochloride + Clomipramine Hydrochloride — Minor

About this interaction data. These interactions were identified by automatically scanning FDA prescribing-label text for medications in Bridgeway's library. This is not a complete list and is not a substitute for review by your prescriber or pharmacist, who use comprehensive clinical databases. Always share your full medication list with your care team. How we source this data →

Contraindications (FDA source)

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 ), 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 )

Use in Specific Populations (FDA source)

8 USE IN SPECIFIC POPULATIONS 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 tablets are 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 tablets during pregnancy. There also are risks associated with untreated depression in pregnancy (see Clinical Considerations). For women who intend to become pregnant or who are in their first trimester of pregnancy, paroxetine should be initiated only after consideration of the other available treatment options. …

Most-Reported Adverse Events (FAERS)

Of 91,207 adverse-event reports mentioning Paroxetine Hydrochloride submitted to the FDA, the most frequently reported reactions are:

• Drug Ineffective — 6,311 reports
• Drug Withdrawal Syndrome — 6,210 reports
• Nausea — 6,139 reports
• Dizziness — 5,469 reports
• Fatigue — 5,430 reports
• Anxiety — 5,396 reports
• Headache — 4,832 reports
• Depression — 4,322 reports
• Diarrhoea — 3,923 reports
• Insomnia — 3,890 reports

Source: FDA Adverse Event Reporting System (FAERS). These are voluntary, unverified reports from patients and providers worldwide — they do not mean the medication caused the reaction, and report counts reflect how widely a drug is used as much as its safety profile.

Recent FDA Recalls

There are 4 ongoing FDA recalls involving Paroxetine Hydrochloride. See full medication safety feed →