Clomipramine

DRUG INFORMATION

  ADULT
    - Initial Treatment/Dose Adjustment (Adults) Treatment with clomipramine
      hydrochloride capsules, USP should be initiated at a dosage of 25 mg daily and
      gradually increased, as tolerated, to approximately 100 mg during the first 2
      weeks.
      Source: US FDA label for clomipramine (CLOMIPRAMINE HYDROCHLORIDE), section
      'dosage and administration', retrieved 2026-08-29
    - Thereafter, the dosage may be increased gradually over the next several weeks, up
      to a maximum of 250 mg daily.
      Source: US FDA label for clomipramine (CLOMIPRAMINE HYDROCHLORIDE), section
      'dosage and administration', retrieved 2026-08-29
    - Initial Treatment/Dose Adjustment (Children and Adolescents) As with adults, the
      starting dose is 25 mg daily and should be gradually increased (also given in
      divided doses with meals to reduce gastrointestinal side effects) during the first
      2 weeks, as tolerated, up to a daily maximum of 3 mg/kg or 100 mg, whichever is
      smaller.
      Source: US FDA label for clomipramine (CLOMIPRAMINE HYDROCHLORIDE), section
      'dosage and administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness in the pediatric population other than pediatric patients
      with OCD have not been established ( see BOX WARNING and WARNINGS , Clinical
      Worsening and Suicide Risk ). Anyone considering the use of clomipramine
      hydrochloride capsules, USP in a child or adolescent must balance the potential
      risks with the clinical need.
      Source: US FDA label for clomipramine (CLOMIPRAMINE HYDROCHLORIDE), section
      'pediatric use', retrieved 2026-08-29
    - The treatment regimens described below are based on those used in controlled
      clinical trials of clomipramine hydrochloride capsules, USP in 520 adults, and 91
      children and adolescents with OCD. During initial titration, clomipramine
      hydrochloride capsules, USP should be given in divided doses with meals to reduce
      gastrointestinal side effects.
      Source: US FDA label for clomipramine (CLOMIPRAMINE HYDROCHLORIDE), section
      'dosage and administration', retrieved 2026-08-29
    - Initial Treatment/Dose Adjustment (Children and Adolescents) As with adults, the
      starting dose is 25 mg daily and should be gradually increased (also given in
      divided doses with meals to reduce gastrointestinal side effects) during the first
      2 weeks, as tolerated, up to a daily maximum of 3 mg/kg or 100 mg, whichever is
      smaller.
      Source: US FDA label for clomipramine (CLOMIPRAMINE HYDROCHLORIDE), 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 clomipramine (CLOMIPRAMINE
      HYDROCHLORIDE), retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for clomipramine (CLOMIPRAMINE
      HYDROCHLORIDE), retrieved 2026-08-29

  PREGNANCY
    - No teratogenic effects were observed in studies performed in rats and mice at
      doses up to 100 mg/kg, which is 24 times the maximum recommended human daily dose
      (MRHD) on a mg/kg basis and 4 times (rats) and 2 times (mice) the MRHD on a mg/m 2
      basis.
      Source: US FDA label for clomipramine (CLOMIPRAMINE HYDROCHLORIDE), section
      'pregnancy', retrieved 2026-08-29
    - Slight nonspecific embryo/fetotoxic effects were seen in the offspring of treated
      rats given 50 and 100 mg/kg and of treated mice given 100 mg/kg.
      Source: US FDA label for clomipramine (CLOMIPRAMINE HYDROCHLORIDE), section
      'pregnancy', retrieved 2026-08-29
    - There are no adequate or well-controlled studies in pregnant women.
      Source: US FDA label for clomipramine (CLOMIPRAMINE HYDROCHLORIDE), section
      'pregnancy', retrieved 2026-08-29

  BREASTFEEDING
    - Clomipramine hydrochloride capsules, USP have been found in human milk.
      Source: US FDA label for clomipramine (CLOMIPRAMINE HYDROCHLORIDE), section
      'nursing mothers', retrieved 2026-08-29
    - Because of the potential for adverse reactions, 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.
      Source: US FDA label for clomipramine (CLOMIPRAMINE HYDROCHLORIDE), section
      'nursing mothers', retrieved 2026-08-29