Abstract Objective: To investigate the efficacy and safety of imiquimod 5% cream in the treatment of anogenital warts in a female population. Methods: In two open-label studies, female patients with anogenital warts applied imiquimod 5% cream three times a week for up to 16 weeks. Patients who cleared their warts were monitored for a 6-month follow-up period. Patients could be re-treated with imiquimod 5% cream for up to an additional 16 weeks if their warts recurred or new warts developed during the follow-up period. The treatment period could also be extended for up to an additional 16 weeks if patients only experienced partial clearance during the initial 16-week treatment period. Results: Of the female patients who applied imiquimod 5% cream, 75% (449/600) experienced complete clearance of their warts (treatment failure analysis). This includes 46 patients who experienced total clearance when they applied imiquimod for longer than 16 weeks as their warts had only partially cleared in the initial 16 weeks of therapy. During the 6 months of follow-up after the initial treatment period, 15% of patients had recurrent warts. Thirty-nine (75%) of those patients experienced total clearance again after they re-applied imiquimod for up to an additional 16 weeks. The most frequently observed local skin reaction was erythema. Conclusion: In these studies, imiquimod 5% cream was an effective and well-tolerated treatment for anogenital warts in females and continued to be safe and effective in the small proportion of patients who needed to re-apply imiquimod after wart recurrence.