Paroxetine

DRUG INFORMATION

  ADULT
    - • Shake oral suspension well before administration ( 2.1 ) • 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.
      Source: US FDA label for paroxetine (PAROXETINE HYDROCHLORIDE), section 'dosage
      and administration', retrieved 2026-08-29
    - 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.
      Source: US FDA label for paroxetine (PAROXETINE HYDROCHLORIDE), section 'dosage
      and administration', retrieved 2026-08-29
    - Table 1: Recommended Daily Dosage of Paroxetine Oral Suspension 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.
      Source: This line points to a numbered table that this card does not show - read
      that table in the label before you dose. US FDA label for paroxetine (PAROXETINE
      HYDROCHLORIDE), section 'dosage and administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of paroxetine in pediatric patients have not been
      established [see Box Warning]. Effectiveness was not demonstrated in three
      placebo-controlled trials in 752 paroxetine-treated pediatric patients with MDD.
      Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric
      patients [see Boxed Warning, Warnings and Precautions (5.1) ].
      Source: US FDA label for paroxetine (PAROXETINE HYDROCHLORIDE), section 'pediatric
      use', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - ( 2.3 ) • Elderly patients, patients with severe renal impairment or severe
      hepatic impairment: Starting dosage is 10 mg daily.
      Source: US FDA label for paroxetine (PAROXETINE HYDROCHLORIDE), section 'dosage
      and administration', retrieved 2026-08-29
    - 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. 2.4 Screen for
      Bipolar Disorder Prior to Starting Paroxetine Oral Suspension Prior to initiating
      treatment with paroxetine oral suspension or another antidepressant, screen
      patients for a personal or family history of bipolar disorder, mania, or hypomania
      [see Warnings and Precautions (5.6) ].
      Source: US FDA label for paroxetine (PAROXETINE HYDROCHLORIDE), section 'dosage
      and administration', retrieved 2026-08-29
    - The initial dosage of paroxetine should be reduced in patients with severe renal
      impairment and in patients with severe hepatic impairment [see Dosage and
      Administration (2.4) , Clinical Pharmacology (12.3) ].
      Source: US FDA label for paroxetine (PAROXETINE HYDROCHLORIDE), section 'use in
      specific populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - ( 2.3 ) • Elderly patients, patients with severe renal impairment or severe
      hepatic impairment: Starting dosage is 10 mg daily.
      Source: US FDA label for paroxetine (PAROXETINE HYDROCHLORIDE), section 'dosage
      and administration', retrieved 2026-08-29
    - 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. 2.4 Screen for
      Bipolar Disorder Prior to Starting Paroxetine Oral Suspension Prior to initiating
      treatment with paroxetine oral suspension or another antidepressant, screen
      patients for a personal or family history of bipolar disorder, mania, or hypomania
      [see Warnings and Precautions (5.6) ].
      Source: US FDA label for paroxetine (PAROXETINE HYDROCHLORIDE), section 'dosage
      and administration', retrieved 2026-08-29
    - SSRIs including paroxetine, have been associated with cases of clinically
      significant hyponatremia in elderly patients, who may be at greater risk for this
      adverse reaction [see Warnings and Precautions (5.7) ]. 8.6 Renal and Hepatic
      Impairment Increased plasma concentrations of paroxetine occur in patients with
      renal and hepatic impairment.
      Source: US FDA label for paroxetine (PAROXETINE HYDROCHLORIDE), section 'use in
      specific populations', retrieved 2026-08-29

  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] .
      Source: US FDA label for paroxetine (PAROXETINE HYDROCHLORIDE), section
      'pregnancy', retrieved 2026-08-29
    - Paroxetine is associated with a less than 2-fold increase in cardiovascular
      malformations when administered to a pregnant woman during the first trimester.
      Source: US FDA label for paroxetine (PAROXETINE HYDROCHLORIDE), section
      'pregnancy', retrieved 2026-08-29
    - 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 ).
      Source: US FDA label for paroxetine (PAROXETINE HYDROCHLORIDE), section
      'pregnancy', retrieved 2026-08-29

  BREASTFEEDING
    - Renal and Hepatic Impairment Increased plasma concentrations of paroxetine occur
      in patients with renal and hepatic impairment.
      Source: US FDA label for paroxetine (PAROXETINE HYDROCHLORIDE), section 'nursing
      mothers', retrieved 2026-08-29
    - The initial dosage of paroxetine should be reduced in patients with severe renal
      impairment and in patients with severe hepatic impairment [see Dosage and
      Administration (2.4) , Clinical Pharmacology (12.3) ].
      Source: US FDA label for paroxetine (PAROXETINE HYDROCHLORIDE), section 'nursing
      mothers', retrieved 2026-08-29
    - When paroxetine was administered to female rats during the last trimester of
      gestation and continued through lactation, there was an increase in the number of
      pup deaths during the first four days of lactation.
      Source: US FDA label for paroxetine (PAROXETINE HYDROCHLORIDE), section 'use in
      specific populations', retrieved 2026-08-29