Objective: To determine whether atopic dermatitis (AD) patients treated with tacrolimus ointment experienced an increased risk of non-melanoma skin cancer (NMSC). Methods: Data were collected from 9813 adult and paediatric patients with AD who applied 0.03% or 0.1% tacrolimus ointment twice daily and were examined every 3 months during the tacrolimus ointment development programme. Results: Thirteen adult patients were diagnosed with NMSC during the follow-up period. All patients with NMSC were white adults and 12 were over 40 years of age. Based on 1718 patient-years of tacrolimus ointment exposure in patients ≥40 years of age, the calculated incidence of NMSC did not suggest an increased risk of first NMSC over that of a similarly aged US cohort. Conclusion: This study does not indicate an increased risk for the development of NMSC in patients with AD treated with tacrolimus ointment for a mean duration of 208 days with a maximum observation period of 1479 days. © 2005 Taylor & Francis Group Ltd.