Overview

• EMA’s Pharmacovigilance Risk Assessment Committee identified a possible link between systemic diclofenac and fixed drug eruptions that present as red, swollen lesions and can leave persistent dark discoloration
• The Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) has required package leaflets for diclofenac tablets, capsules and injections to include this newly recognized reaction
• Topical diclofenac gels are not covered by the mandatory warning but continue to carry separate information on local skin irritation and other known gel-specific side effects
• Patients are advised to discontinue systemic diclofenac immediately if they notice skin discoloration, swelling, itching or blisters and to consult a healthcare professional before re-use
• Regulators emphasize that the overall benefit–risk balance of diclofenac remains unchanged and oblige EU countries to implement the updated warnings by September 4, 2025