{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "adapalene",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "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",
        "cached_file": "labels/adapalene.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/adapalene.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/adapalene.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "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",
        "cached_file": "labels/adapalene.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/adapalene.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/adapalene.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/adapalene.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "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",
        "cached_file": "labels/adapalene.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/adapalene.json",
        "verbatim": true
      }
    ]
  },
  "verdicts": {
    "lactation": {
      "level": "caution",
      "line": "The label allows it only when the benefit is judged to outweigh the risk. Read the quote below.",
      "set_by": "Set from the label's own words, not from a reading of them: 'caution should be exercised when adapalene cream is administered to a nursing'."
    }
  }
}