Adapalene

DRUG INFORMATION

  ADULT
    - Adapalene cream should be applied to affected areas of the skin, once daily at
      nighttime. A thin film of the cream should be applied to the skin areas where acne
      lesions appear, using enough to cover the entire affected area lightly. A mild
      transitory sensation of warmth or slight stinging may occur shortly after the
      application of adapalene cream.
      Source: US FDA label for adapalene (Adapalene), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness in pediatric patients below the age of 12 have not been
      established.
      Source: US FDA label for adapalene (Adapalene), 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 adapalene (Adapalene),
      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 adapalene (Adapalene),
      retrieved 2026-08-29

  PREGNANCY
    - No teratogenic effects were seen in rats at oral doses of 0.15 to 5.0 mg/kg/day
      adapalene (up to 20 times the MRHD based on mg/m 2 comparisons).
      Source: US FDA label for adapalene (Adapalene), section 'pregnancy', retrieved
      2026-08-29
    - However, adapalene administered orally at doses of ≥ 25 mg/kg, (100 times the MRHD
      for rats or 200 times MRHD for rabbits) has been shown to be teratogenic.
      Source: US FDA label for adapalene (Adapalene), section 'pregnancy', retrieved
      2026-08-29
    - Cutaneous teratology studies in rats and rabbits at doses of 0.6, 2.0, and 6.0
      mg/kg/day (24 times the MRHD for rats or 48 times the MRHD for rabbits) exhibited
      no fetotoxicity and only minimal increases in supernumerary ribs in rats.
      Source: US FDA label for adapalene (Adapalene), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING   [ CAUTION ]
    The label allows it only when the benefit is judged to outweigh the risk. Read the
      quote below.
    - It is not known whether this drug is excreted in human milk.
      Source: US FDA label for adapalene (Adapalene), section 'nursing mothers',
      retrieved 2026-08-29
    - Because many drugs are excreted in human milk, caution should be exercised when
      adapalene cream is administered to a nursing woman.
      Source: US FDA label for adapalene (Adapalene), section 'nursing mothers',
      retrieved 2026-08-29