Imiquimod has the potential to exacerbate inflammatory conditions of the skin (should be used with caution in patients with autoimmune conditions). Imiquimod cream should be used with caution in organ transplant patients. Not recommended until skin has healed after any previous drug or surgical treatment. Occlusive dressing not recommended with imiquimod cream therapy. The excipients methylhydroxybenzoate, propylhydroxybenzoate, cetyl alcohol and stearyl alcohol may cause allergic reactions. Intense local inflammatory reactions including skin weeping or erosion can occur (may be accompanied, or even preceded, by flu-like systemic signs and symptoms including malaise, pyrexia, nausea, myalgias and rigors; an interruption of dosing should be considered). Should be used with caution in patients with reduced hematologic reserve. Severe local inflammatory reactions of the female external genitalia can lead to severe vulvar swelling, and this to urinary retention (dosing should be interrupted or discontinued). Avoid exposure to sunlight and sunlamps. Safety and efficacy not established for repeat courses of treatment to the same area for AK. Not recommended for treatment of BCC subtypes other than the superficial variant. Treatment of urethral, intra-vaginal, cervical, rectal or intra-anal viral disease not recommended. Safety and efficacy in immunosuppressed patients not established.