{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "imiquimod",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "No adult dose in this label - read the full label before dosing.",
        "source": "Read and found silent: the US FDA label for imiquimod (Imiquimod), retrieved 2026-08-29",
        "cached_file": "labels/imiquimod.json",
        "verbatim": false
      }
    ],
    "child": [
      {
        "text": "AK and sBCC are not conditions generally seen within the pediatric population. The safety and efficacy of Imiquimod Cream for AK or sBCC in patients less than 18 years of age have not been established. Safety and efficacy in patients with external genital/perianal warts below the age of 12 years have not been established.",
        "source": "US FDA label for imiquimod (Imiquimod), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/imiquimod.json",
        "verbatim": true
      },
      {
        "text": "Children aged 2-5 years received doses of 12.5 mg (one packet) or 25 mg (two packets) of imiquimod and had median multiple-dose peak serum drug levels of approximately 0.2 or 0.5 ng/mL, respectively.",
        "source": "US FDA label for imiquimod (Imiquimod), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/imiquimod.json",
        "verbatim": true
      },
      {
        "text": "Children aged 6-12 years received doses of 12.5 mg, 25 mg, or 37.5 mg (three packets) and had median multiple dose serum drug levels of approximately 0.1, 0.15, or 0.3 ng/mL, respectively.",
        "source": "US FDA label for imiquimod (Imiquimod), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/imiquimod.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 imiquimod (Imiquimod), retrieved 2026-08-29",
        "cached_file": "labels/imiquimod.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 imiquimod (Imiquimod), retrieved 2026-08-29",
        "cached_file": "labels/imiquimod.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Category C: Note: The Maximum Recommended Human Dose (MRHD) was set at 2 packets per treatment of Imiquimod Cream (25 mg imiquimod) for the animal multiple of human exposure ratios presented in this label.",
        "source": "US FDA label for imiquimod (Imiquimod), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/imiquimod.json",
        "verbatim": true
      },
      {
        "text": "If higher doses than 2 packets of imiquimod cream are used clinically, then the animal multiple of human exposure would be reduced for that dose.",
        "source": "US FDA label for imiquimod (Imiquimod), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/imiquimod.json",
        "verbatim": true
      },
      {
        "text": "A non-proportional increase in systemic exposure with increased dose of imiquimod cream was noted in the clinical pharmacokinetic study conducted in actinic keratosis subjects [see Clinical Pharmacology ( 12.3 )].",
        "source": "US FDA label for imiquimod (Imiquimod), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/imiquimod.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "It is not known whether imiquimod is excreted in human milk following use of Imiquimod Cream.",
        "source": "US FDA label for imiquimod (Imiquimod), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/imiquimod.json",
        "verbatim": true
      },
      {
        "text": "Because many drugs are excreted in human milk, caution should be exercised when Imiquimod Cream is administered to nursing women.",
        "source": "US FDA label for imiquimod (Imiquimod), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/imiquimod.json",
        "verbatim": true
      },
      {
        "text": "Oral doses of 1, 1.5, 3 and 6 mg/kg/day imiquimod were administered to male rats from 70 days prior to mating through the mating period and to female rats from 14 days prior to mating through parturition and lactation.",
        "source": "US FDA label for imiquimod (Imiquimod), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/imiquimod.json",
        "verbatim": true
      }
    ]
  }
}