Quetiapine

DRUG INFORMATION

  ADULT
    - 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
    - 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
    - Day 2: Twice daily dosing totaling 100 mg.
      Source: US FDA label for quetiapine (Quetiapine fumarate), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - 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
    - 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
    - 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

  RENAL IMPAIRMENT
    - 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

  HEPATIC IMPAIRMENT
    - 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
    - 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

  PREGNANCY
    - 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
    - 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
    - In animal studies, embryo-fetal toxicity occurred.
      Source: US FDA label for quetiapine (Quetiapine fumarate), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Quetiapine was excreted into human milk.
      Source: US FDA label for quetiapine (Quetiapine fumarate), section 'nursing
      mothers', retrieved 2026-08-29
    - 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
    - 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