Imiquimod

DRUG INFORMATION

  ADULT
    - 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

  CHILD
    - 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
    - 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
    - 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

  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 imiquimod (Imiquimod),
      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 imiquimod (Imiquimod),
      retrieved 2026-08-29

  PREGNANCY
    - 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
    - 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
    - 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

  BREASTFEEDING
    - 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
    - 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
    - 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