Fluoxetine

DRUG INFORMATION

  ADULT
    - Studies comparing fluoxetine 20, 40, and 60 mg/day to placebo indicate that 20
      mg/day is sufficient to obtain a satisfactory response in Major Depressive
      Disorder in most cases.
      Source: US FDA label for fluoxetine (Fluoxetine), section 'dosage and
      administration', retrieved 2026-08-29
    - Consequently, a dose of 20 mg/day, administered in the morning, is recommended as
      the initial dose.
      Source: US FDA label for fluoxetine (Fluoxetine), section 'dosage and
      administration', retrieved 2026-08-29
    - Doses above 20 mg/day may be administered on a once-a-day (morning) or BID
      schedule (i.e., morning and noon) and should not exceed a maximum dose of 80
      mg/day.
      Source: US FDA label for fluoxetine (Fluoxetine), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Use of Fluoxetine in Children — The efficacy of fluoxetine for the treatment of
      Major Depressive Disorder was demonstrated in two 8 to 9 week placebo-controlled
      clinical trials with 315 pediatric outpatients ages 8 to ≤ 18 [ see Clinical
      Studies ( ) ] . The efficacy of fluoxetine for the treatment of OCD was
      demonstrated in one 13 week placebo-controlled clinical trial with 103 pediatric
      outpatients ages 7 to < 18 [ see Clinical Studies ( ) ] .
      Source: US FDA label for fluoxetine (Fluoxetine), section 'pediatric use',
      retrieved 2026-08-29
    - The high dose of 30 mg/kg/day exceeded a maximum tolerated dose.
      Source: US FDA label for fluoxetine (Fluoxetine), section 'pediatric use',
      retrieved 2026-08-29
    - Plasma exposures (AUC) to fluoxetine in juvenile rats receiving 3, 10, or 30
      mg/kg/day doses in this study are approximately 0.1 to 0.2, 1 to 2, and 5 to 10
      times, respectively, the average exposure in pediatric patients receiving the MRHD
      of 20 mg/day.
      Source: US FDA label for fluoxetine (Fluoxetine), section 'pediatric use',
      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 fluoxetine (Fluoxetine),
      retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Hepatic Impairment — As with many other medications, a lower or less frequent
      dosage should be used in patients with hepatic impairment [ see Clinical
      Pharmacology ( ) and Use in Specific Populations ( ) ] .
      Source: US FDA label for fluoxetine (Fluoxetine), section 'dosage and
      administration', retrieved 2026-08-29
    - Safety and effectiveness of fluoxetine and olanzapine in combination in patients <
      10 years of age for depressive episodes associated with Bipolar I Disorder have
      not been established () • Hepatic Impairment: Lower or less frequent dosing may be
      appropriate in patients with cirrhosis () 8.1 Pregnancy Teratogenic Effects
      Pregnancy Category C — Fluoxetine should be used during pregnancy only if the
      potential benefit justifies the potential risk to the fetus.
      Source: US FDA label for fluoxetine (Fluoxetine), section 'use in specific
      populations', retrieved 2026-08-29
    - Clinical studies of olanzapine and fluoxetine in combination did not include
      sufficient numbers of patients ≥ 65 years of age to determine whether they respond
      differently from younger patients. 8.6 Hepatic Impairment In subjects with
      cirrhosis of the liver, the clearances of fluoxetine and its active metabolite,
      norfluoxetine, were decreased, thus increasing the elimination half-lives of these
      substances.
      Source: US FDA label for fluoxetine (Fluoxetine), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY   [ CAUTION ]
    The label allows it only when the benefit is judged to outweigh the risk. Read the
      quote below.
    - Teratogenic Effects Pregnancy Category C — Fluoxetine should be used during
      pregnancy only if the potential benefit justifies the potential risk to the fetus.
      Source: US FDA label for fluoxetine (Fluoxetine), section 'pregnancy', retrieved
      2026-08-29
    - All pregnancies have a background risk of birth defects, loss, or other adverse
      outcome regardless of drug exposure.
      Source: US FDA label for fluoxetine (Fluoxetine), section 'pregnancy', retrieved
      2026-08-29
    - Treatment of Pregnant Women During the First Trimester — There are no adequate and
      well-controlled clinical studies on the use of fluoxetine in pregnant women.
      Source: US FDA label for fluoxetine (Fluoxetine), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Because fluoxetine is excreted in human milk, nursing while on fluoxetine is not
      recommended.
      Source: US FDA label for fluoxetine (Fluoxetine), section 'nursing mothers',
      retrieved 2026-08-29
    - In one breast-milk sample, the concentration of fluoxetine plus norfluoxetine was
      70.4 ng/mL.
      Source: US FDA label for fluoxetine (Fluoxetine), section 'nursing mothers',
      retrieved 2026-08-29
    - The concentration in the mother’s plasma was 295 ng/mL.
      Source: US FDA label for fluoxetine (Fluoxetine), section 'nursing mothers',
      retrieved 2026-08-29