Abstract
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.