Atomoxetine

DRUG INFORMATION

  ADULT
    - ( 2.3 ) Age and Body Weight Starting Dosage Target Dosage 1 Maximum Total Daily
      Dose 1 Pediatrics who weigh less than 70 kg 0.5 mg/kg/day 1.2 mg/kg/day 1.4
      mg/kg/day or 100 mg/day (whichever is less) Pediatrics who weigh 70 kg or more and
      adults 40 mg/day 80 mg/day 100 mg/day 1 Administer either as once daily dosage in
      the morning or as evenly divided twice daily dosage in the morning and late
      afternoon/early evening.
      Source: US FDA label for atomoxetine (Atomoxetine Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - There is no data that supports increased effectiveness at a dosage higher than 100
      mg/day [see Clinical Studies ( 14 )].
      Source: US FDA label for atomoxetine (Atomoxetine Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - Prior to initiating treatment with atomoxetine capsules, screen patients for a
      personal or family history of bipolar disorder, mania, or hypomania. ( 2.1 , 5.6 )
      See table below for the recommended atomoxetine capsule dosage.
      Source: US FDA label for atomoxetine (Atomoxetine Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of atomoxetine for the treatment of ADHD have been
      established in pediatric patients 6 years of age and older. Anyone considering the
      use of atomoxetine in a pediatric patient should balance the potential risks with
      the clinical need [see Boxed Warning and Warnings and Precautions ( 5.1 , 5.3 ,
      5.4 , 5.10 )]. The atomoxetine pharmacokinetics in pediatric patients 6 years of
      age and older were similar to those in adults.
      Source: US FDA label for atomoxetine (Atomoxetine Hydrochloride), section
      'pediatric use', retrieved 2026-08-29
    - Prior to initiating treatment with atomoxetine capsules, screen patients for a
      personal or family history of bipolar disorder, mania, or hypomania. ( 2.1 , 5.6 )
      See table below for the recommended atomoxetine capsule dosage.
      Source: US FDA label for atomoxetine (Atomoxetine Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - Rats were treated with 1, 10, or 50 mg/kg/day (approximately 0.2, 2, and 8 times,
      respectively, the maximum human dose on a mg/m 2 basis) of atomoxetine given by
      gavage from the early postnatal period (Day 10 of age) through adulthood.
      Source: US FDA label for atomoxetine (Atomoxetine Hydrochloride), 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 atomoxetine (Atomoxetine
      Hydrochloride), retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - For the recommended dosage in patients with hepatic impairment, see Full
      Prescribing Information.
      Source: US FDA label for atomoxetine (Atomoxetine Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - Moderate HI (Child-Pugh Class B), the recommended initial and target atomoxetine
      capsules dosage is 50% of the recommended dosage in patients with normal hepatic
      function [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3
      )].
      Source: US FDA label for atomoxetine (Atomoxetine Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - Mild HI (Child-Pugh Class A), the recommended initial and target atomoxetine
      capsules dosage is the same as those with normal hepatic function. 2.5 Recommended
      Dosage with Concomitant Use of Strong CYP2D6 Inhibitors or in CYP2D6 Poor
      Metabolizers Consider genetic testing to determine the patient’s CYP2D6
      metabolizer status.
      Source: US FDA label for atomoxetine (Atomoxetine Hydrochloride), 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 ADHD drugs, including atomoxetine, during
      pregnancy.
      Source: US FDA label for atomoxetine (Atomoxetine Hydrochloride), section
      'pregnancy', retrieved 2026-08-29
    - Healthcare providers are encouraged to register patients by calling the National
      Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting
      https://womensmentalhealth.org/adhd-medications/ Risk Summary Available published
      studies with atomoxetine use in pregnant women are insufficient to establish a
      drug-associated risk of major birth defects, miscarriage or adverse maternal or
      fetal outcomes.
      Source: US FDA label for atomoxetine (Atomoxetine Hydrochloride), section
      'pregnancy', retrieved 2026-08-29
    - Some animal reproduction studies of atomoxetine had adverse developmental
      outcomes.
      Source: US FDA label for atomoxetine (Atomoxetine Hydrochloride), section
      'pregnancy', retrieved 2026-08-29

  BREASTFEEDING
    - In one of 2 studies in which rats were dosed prior to mating through the periods
      of organogenesis and lactation, decreased pup weight and decreased pup survival
      were observed at doses corresponding to 5-6 times the MRHD on a mg/m 2 basis.
      Source: US FDA label for atomoxetine (Atomoxetine Hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29
    - Rats were treated with up to approximately 50 mg/kg/day of atomoxetine
      (approximately 6 times the MRHD on a mg/m 2 basis) in the diet from 2 weeks
      (females) or 10 weeks (males) prior to mating through the periods of organogenesis
      and lactation.
      Source: US FDA label for atomoxetine (Atomoxetine Hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29
    - No adverse fetal effects were seen when pregnant rats were treated with up to 150
      mg/kg/day (approximately 17 times the MRHD on a mg/m 2 basis) by gavage throughout
      the period of organogenesis. 8.2 Lactation Risk Summary There are no data on the
      presence of atomoxetine or its metabolite in human milk, the effects on the
      breastfed child, or the effects on milk production.
      Source: US FDA label for atomoxetine (Atomoxetine Hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29