Nimesulide-Associated Generalized Bullous Fixed Drug Eruption: A Rare Pharmacovigilance Case Report
Abstract
Generalized Bullous Fixed Drug Eruption (GBFDE) is a severe variant of Fixed Drug Eruption (FDE) characterized by widespread dusky erythematous plaques and blistering, often mimicking Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN). Early distinction is critical, as misdiagnosis can lead to delayed or inappropriate management. We report a case of nimesulide-induced GBFDE in a 32-year-old male who developed rapidly progressing dusky plaques and flaccid bullae within 24 hours of self-medicating with an over-the-counter Nimesulide formulation. A prior similar episode following exposure to the same drug strongly supported the diagnosis. Prompt withdrawal of the drug, systemic corticosteroids, and supportive care led to rapid clinical improvement. This case highlights the diagnostic challenges, the dangers of over-the-counter NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) use, and the importance of pharmacovigilance reporting, given that only three cases of nimesulide-associated GBFDE have been documented to date. Increased awareness among clinicians is essential to prevent morbidity and recognize this rare but potentially life-threatening adverse reaction.
Fields of Study & Subjects
Drug-Induced Adverse Reactions
Pharmacovigilance and Adverse Drug Reactions
Inflammatory mediators and NSAID effects
Publication details
- Journal / source
- Cureus
- Publisher
- Springer Science and Business Media LLC
- Volume
- 18
- Issue
- 1
- Pages
- e101371–e101371
- Publication date
- 12 January 2026
- Language
- EN