CDSCO Mandates Skin Reaction Warning On Aceclofenac And Ibuprofen Labels To Improve Patient Safety

The Central Drugs Standard Control Organisation (CDSCO) has directed all State Licensing Authorities (SLAs) to ensure that manufacturers of the widely used painkillers aceclofenac and ibuprofen include "Fixed Drug Eruption" (FDE) as a known adverse drug reaction in the package inserts and promotional literature accompanying these medicines.

FDE is a distinctive allergic skin reaction in which one or more sharply defined reddish or dark patches appear after taking a particular medicine. The hallmark of the condition is that the lesions recur at exactly the same site whenever the individual is exposed again to the offending drug.

The patches may be accompanied by itching, burning, swelling or blistering and, after healing, often leave behind persistent dark pigmentation.

The CDSCO directive follows recommendations from the National Coordination Centre of the Pharmacovigilance Programme of India (NCC-PvPI) under the Indian Pharmacopoeia Commission (IPC) after safety signals emerging from adverse drug reaction reports were reviewed by expert committees.

Though the decision does not alter the approved use of either medicine, experts said it is an important step towards safer prescribing and greater patient awareness. Aceclofenac and ibuprofen belong to the class of non-steroidal anti-inflammatory drugs (NSAIDs), among the most commonly prescribed and over-the-counter medicines for pain, fever and inflammation. Their widespread use means that even uncommon adverse reactions can affect a significant number of people.

While the eruption reaction on skin is generally not life-threatening, repeated exposure can result in more extensive skin involvement and greater discomfort. Recognising the condition early and discontinuing the offending medicine usually prevents recurrence and avoids unnecessary investigations or prolonged treatment.

Since NSAIDs are frequently self-medicated for headaches, body aches, arthritis, dental pain and fever, people often continue taking the same medicine despite repeated episodes, unaware that it is the trigger.

Including the warning in prescribing information is expected to prompt doctors to ask about previous skin reactions before prescribing these medicines and encourage patients to report suspicious symptoms promptly. It will also help pharmacists counsel consumers, especially those purchasing the drugs without a prescription.

The regulatory action stems from safety monitoring undertaken under the Pharmacovigilance Programme of India. The NCC-PvPI analysed Individual Case Safety Reports (ICSRs) received from Adverse Drug Reaction Monitoring Centres across the country. These reports, entered into the national VigiFlow database, indicated a possible association between aceclofenac and ibuprofen formulations and Fixed Drug Eruption.

The findings were reviewed by the 24th Signal Review Panel meeting held in November 2023. The panel, comprising experienced clinicians, pharmacologists, regulatory experts and academicians, had evaluated the available evidence and concluded that the adverse reaction warranted regulatory attention.

Based on its assessment, the panel recommended that the prescribing information for formulations containing aceclofenac and ibuprofen should explicitly list Fixed Drug Eruption as a recognised adverse drug reaction.

The recommendation was subsequently examined by the Subject Expert Committee (Analgesics and Orthopaedics) during its meeting in May 2026. After detailed deliberations, the committee endorsed the proposal and advised that manufacturers update the package inserts and promotional literature of both medicines.

Acting on the committee's advice, Drugs Controller General (India) Dr. Rajeev Singh Raghuvanshi issued separate circulars directing State Licensing Authorities to instruct manufacturers under their jurisdiction to incorporate the warning and report the action taken.

Experts said that updating package inserts is among the least disruptive yet most effective regulatory interventions.

“Rather than restricting access to medicines that remain safe and effective for the vast majority of patients, the approach equips doctors and patients with better information to recognise uncommon but clinically important adverse reactions,” said a dermatologist.