Guanfacine

DRUG INFORMATION

  ADULT
    - • Recommended dose: 1 mg to 7 mg (0.05-0.12 mg/kg target weight based dose range)
      once daily in the morning or evening based on clinical response and tolerability (
      2.2 ) . • Begin at a dose of 1 mg once daily and adjust in increments of no more
      than 1 mg/week ( 2.2 ) . • Do not crush, chew or break tablets before swallowing (
      2.1 ) . • Do not administer with high-fat meals, because of increased exposure (
      2.1 ) .
      Source: US FDA label for guanfacine (Guanfacine Extended-Release), section 'dosage
      and administration', retrieved 2026-08-29
    - Begin at a dose of 1 mg/day, and adjust in increments of no more than 1 mg/week.
      Source: US FDA label for guanfacine (Guanfacine Extended-Release), section 'dosage
      and administration', retrieved 2026-08-29
    - To balance the exposure-related potential benefits and risks, the recommended
      target dose range depending on clinical response and tolerability for guanfacine
      extended-release tablets is 0.05 to 0.12 mg/kg/day (total daily dose between 1 to
      7 mg) (See Table 1 ).
      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 guanfacine (Guanfacine
      Extended-Release), section 'dosage and administration', retrieved 2026-08-29

  CHILD
    - • Recommended dose: 1 mg to 7 mg (0.05-0.12 mg/kg target weight based dose range)
      once daily in the morning or evening based on clinical response and tolerability (
      2.2 ) . • Begin at a dose of 1 mg once daily and adjust in increments of no more
      than 1 mg/week ( 2.2 ) . • Do not crush, chew or break tablets before swallowing (
      2.1 ) . • Do not administer with high-fat meals, because of increased exposure (
      2.1 ) .
      Source: US FDA label for guanfacine (Guanfacine Extended-Release), section 'dosage
      and administration', retrieved 2026-08-29
    - In a study where juvenile rats were treated with guanfacine alone from 7 to 59
      days of age, development was delayed as indicated by a slight delay in sexual
      maturation and decreased body weight gain in males at 2 mg/kg/day and in females
      at 3 mg/kg/day.
      Source: US FDA label for guanfacine (Guanfacine Extended-Release), section
      'pediatric use', retrieved 2026-08-29
    - The No Adverse Effect Level (NOAEL) for delayed sexual maturation was 1 mg/kg/day,
      which is equivalent to the MRHD of 4 mg/day, on a mg/m 2 basis.
      Source: US FDA label for guanfacine (Guanfacine Extended-Release), section
      'pediatric use', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - These findings were not observed with guanfacine alone at 1 mg/kg/day or
      methylphenidate alone at 50 mg/kg/day. 8.5 Geriatric Use The safety and efficacy
      of guanfacine extended-release tablets in geriatric patients have not been
      established. 8.6 Renal Impairment It may be necessary to reduce the dosage in
      patients with significant impairment of renal function [see Clinical Pharmacology
      ( 12.3 ) ] .
      Source: US FDA label for guanfacine (Guanfacine Extended-Release), section 'use in
      specific populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - These findings were not observed with guanfacine alone at 1 mg/kg/day or
      methylphenidate alone at 50 mg/kg/day. 8.5 Geriatric Use The safety and efficacy
      of guanfacine extended-release tablets in geriatric patients have not been
      established. 8.6 Renal Impairment It may be necessary to reduce the dosage in
      patients with significant impairment of renal function [see Clinical Pharmacology
      ( 12.3 ) ] .
      Source: US FDA label for guanfacine (Guanfacine Extended-Release), section 'use in
      specific populations', retrieved 2026-08-29

  PREGNANCY
    - Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors
      pregnancy outcomes in women exposed to ADHD medications, including guanfacine
      extended-release tablets, during pregnancy.
      Source: US FDA label for guanfacine (Guanfacine Extended-Release), 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.
      Source: US FDA label for guanfacine (Guanfacine Extended-Release), section
      'pregnancy', retrieved 2026-08-29
    - Risk Summary Available data with guanfacine over decades of use in pregnant women
      have not identified a drug-associated risk of major birth defects, miscarriage or
      adverse maternal or fetal outcomes.
      Source: US FDA label for guanfacine (Guanfacine Extended-Release), section
      'pregnancy', retrieved 2026-08-29

  BREASTFEEDING
    - Higher doses (13.5 times the MRHD in both rabbits and rats) were associated with
      reduced fetal survival and maternal toxicity. 8.2 Lactation Risk Summary There are
      no data on the presence of guanfacine in human milk or the effects on the
      breastfed infant.
      Source: US FDA label for guanfacine (Guanfacine Extended-Release), section 'use in
      specific populations', retrieved 2026-08-29
    - If a drug is present in animal milk, it is likely that the drug will be present in
      human milk.
      Source: US FDA label for guanfacine (Guanfacine Extended-Release), section 'use in
      specific populations', retrieved 2026-08-29
    - The developmental and health benefits of breastfeeding should be considered along
      with the mother’s clinical need for guanfacine extended-release tablets and any
      potential adverse effects on the breastfed child from guanfacine extended-release
      tablets or from the underlying maternal condition.
      Source: US FDA label for guanfacine (Guanfacine Extended-Release), section 'use in
      specific populations', retrieved 2026-08-29