{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "paroxetine",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "• 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",
        "cached_file": "labels/paroxetine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/paroxetine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/paroxetine.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/paroxetine.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "( 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",
        "cached_file": "labels/paroxetine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/paroxetine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/paroxetine.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "( 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",
        "cached_file": "labels/paroxetine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/paroxetine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/paroxetine.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/paroxetine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/paroxetine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/paroxetine.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "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",
        "cached_file": "labels/paroxetine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/paroxetine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/paroxetine.json",
        "verbatim": true
      }
    ]
  }
}