{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "quetiapine",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication Initial Dose and Titration Recommended Dose Maximum Dose Schizophrenia-Adults Day 1: 25 mg twice 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 quetiapine (Quetiapine fumarate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/quetiapine.json",
        "verbatim": true
      },
      {
        "text": "Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.",
        "source": "US FDA label for quetiapine (Quetiapine fumarate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/quetiapine.json",
        "verbatim": true
      },
      {
        "text": "Day 2: Twice daily dosing totaling 100 mg.",
        "source": "US FDA label for quetiapine (Quetiapine fumarate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/quetiapine.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "In general, the adverse reactions observed in children and adolescents during the clinical trials were similar to those in the adult population with few exceptions. Increases in systolic and diastolic blood pressure occurred in children and adolescents and did not occur in adults.",
        "source": "US FDA label for quetiapine (Quetiapine fumarate), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/quetiapine.json",
        "verbatim": true
      },
      {
        "text": "Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days. 150 to 750 mg/day 750 mg/day Schizophrenia-Adolescents (13 to 17 years) Day 1: 25 mg twice daily.",
        "source": "US FDA label for quetiapine (Quetiapine fumarate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/quetiapine.json",
        "verbatim": true
      },
      {
        "text": "Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. 400 to 800 mg/day 800 mg/day Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy Day 1: 25 mg twice daily.",
        "source": "US FDA label for quetiapine (Quetiapine fumarate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/quetiapine.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "The mean plasma clearance of quetiapine was reduced by 30% to 50% in elderly patients when compared to younger patients [see Clinical Pharmacology (12.3) and Dosage and Administration (2.3) ] . 8.6 Renal Impairment Clinical experience with quetiapine in patients with renal impairment is limited [see Clinical Pharmacology (12.3) ] .",
        "source": "US FDA label for quetiapine (Quetiapine fumarate), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/quetiapine.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient. 2.4 Dose Modifications in Hepatically Impaired Patients Patients with hepatic impairment should be started on 25 mg/day.",
        "source": "US FDA label for quetiapine (Quetiapine fumarate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/quetiapine.json",
        "verbatim": true
      },
      {
        "text": "The mean plasma clearance of quetiapine was reduced by 30% to 50% in elderly patients when compared to younger patients [see Clinical Pharmacology (12.3) and Dosage and Administration (2.3) ] . 8.6 Renal Impairment Clinical experience with quetiapine in patients with renal impairment is limited [see Clinical Pharmacology (12.3) ] .",
        "source": "US FDA label for quetiapine (Quetiapine fumarate), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/quetiapine.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Category C: Risk Summary There are no adequate and well-controlled studies of quetiapine use in pregnant women.",
        "source": "US FDA label for quetiapine (Quetiapine fumarate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/quetiapine.json",
        "verbatim": true
      },
      {
        "text": "In limited published literature, there were no major malformations associated with quetiapine exposure during pregnancy.",
        "source": "US FDA label for quetiapine (Quetiapine fumarate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/quetiapine.json",
        "verbatim": true
      },
      {
        "text": "In animal studies, embryo-fetal toxicity occurred.",
        "source": "US FDA label for quetiapine (Quetiapine fumarate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/quetiapine.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Quetiapine was excreted into human milk.",
        "source": "US FDA label for quetiapine (Quetiapine fumarate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/quetiapine.json",
        "verbatim": true
      },
      {
        "text": "Because of the potential for serious adverse reactions in nursing infants from quetiapine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother’s health.",
        "source": "US FDA label for quetiapine (Quetiapine fumarate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/quetiapine.json",
        "verbatim": true
      },
      {
        "text": "In published case reports, the level of quetiapine in breast milk ranged from undetectable to 170 μg/L.",
        "source": "US FDA label for quetiapine (Quetiapine fumarate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/quetiapine.json",
        "verbatim": true
      }
    ]
  }
}