Olanzapine

DRUG INFORMATION

  ADULT
    - ( 2.5 , 2.6 ) Safety of co-administration of doses above 18 mg olanzapine with 75
      mg fluoxetine has not been evaluated in adults.
      Source: US FDA label for olanzapine (Olanzapine), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.5 ) 2.1 Schizophrenia Adults Dose Selection — Oral olanzapine should be
      administered on a once-a-day schedule without regard to meals, generally beginning
      with 5 mg to 10 mg initially, with a target dose of 10 mg/day within several days.
      Source: US FDA label for olanzapine (Olanzapine), section 'dosage and
      administration', retrieved 2026-08-29
    - When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are
      recommended.
      Source: US FDA label for olanzapine (Olanzapine), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of oral olanzapine in the treatment of schizophrenia
      and manic or mixed episodes associated with bipolar I disorder were established in
      short-term studies in adolescents (ages 13 to 17 years). Use of olanzapine in
      adolescents is supported by evidence from adequate and well-controlled studies of
      olanzapine in which 268 adolescents received olanzapine in a range of 2.5 mg/day
      to 20 mg/day [see Clinical Studies ( 14.1 , 14.2 )] .
      Source: US FDA label for olanzapine (Olanzapine), section 'pediatric use',
      retrieved 2026-08-29
    - Use of olanzapine in adolescents is supported by evidence from adequate and well-
      controlled studies of olanzapine in which 268 adolescents received olanzapine in a
      range of 2.5 mg/day to 20 mg/day [see Clinical Studies ( 14.1 , 14.2 )] .
      Source: US FDA label for olanzapine (Olanzapine), section 'pediatric use',
      retrieved 2026-08-29
    - ( 2.5 , 2.6 ) Safety of co-administration of doses above 12 mg olanzapine with 50
      mg fluoxetine has not been evaluated in children and adolescents ages 10 to 17.
      Source: US FDA label for olanzapine (Olanzapine), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No kidney-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for olanzapine (Olanzapine),
      retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Olanzapine monotherapy is not indicated for treatment of treatment resistant
      depression (major depressive disorder in patients who do not respond to 2
      antidepressants of adequate dose and duration in the current episode).
      Source: US FDA label for olanzapine (Olanzapine), section 'dosage and
      administration', retrieved 2026-08-29

  PREGNANCY
    - Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors
      pregnancy outcomes in women exposed to atypical antipsychotics, including
      Olanzapine Tablets, during pregnancy.
      Source: US FDA label for olanzapine (Olanzapine), section 'pregnancy', retrieved
      2026-08-29
    - Healthcare providers are encouraged to register patients by contacting the
      National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit
      http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
      Source: US FDA label for olanzapine (Olanzapine), section 'pregnancy', retrieved
      2026-08-29
    - Risk Summary Neonates exposed to antipsychotic drugs, including olanzapine, during
      the third trimester are at risk for extrapyramidal and/or withdrawal symptoms
      following delivery (see Clinical Considerations) .
      Source: US FDA label for olanzapine (Olanzapine), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Infertility Females Based on the pharmacologic action of olanzapine (D 2 receptor
      antagonism), treatment with olanzapine may result in an increase in serum
      prolactin levels, which may lead to a reversible reduction in fertility in females
      of reproductive potential [see Warnings and Precautions ( 5.15 )] .
      Source: US FDA label for olanzapine (Olanzapine), section 'nursing mothers',
      retrieved 2026-08-29
    - In an oral rabbit teratology study, fetal toxicity manifested as increased
      resorptions and decreased fetal weight, occurred at a maternally toxic dose of 30
      mg/kg/day (30 times the daily oral MRHD based on mg/m 2 body surface area). 8.2
      Lactation Risk Summary Olanzapine is present in human milk.
      Source: US FDA label for olanzapine (Olanzapine), section 'use in specific
      populations', retrieved 2026-08-29
    - There are reports of excess sedation, irritability, poor feeding and
      extrapyramidal symptoms (tremors and abnormal muscle movements) in infants exposed
      to olanzapine through breast milk (see Clinical Considerations) .
      Source: US FDA label for olanzapine (Olanzapine), section 'use in specific
      populations', retrieved 2026-08-29