1R. G. Kar Medical College and Hospital, Kolkata, India
2Department of Pharmacology, R.G. Kar Medical College and Hospital, Kolkata, India
Fixed drug eruption is an immune-mediated cutaneous adverse drug reaction characterized by recurrent lesions at fixed anatomical sites. Generalized bullous fixed drug eruption is rare but clinically significant, often mimicking severe conditions such as Stevens–Johnson syndrome or toxic epidermal necrolysis. We report a case of a 60-year-old male who developed generalized bullous fixed drug eruption following six days of ornidazole and ofloxacin therapy. Clinical presentation included multiple hyperpigmented patches, bullous lesions over the trunk and extremities, and mucosal erosions involving lips and oral cavity. Immediate withdrawal of the offending agents, systemic corticosteroids, topical therapy, and infection prophylaxis led to stabilization and recovery. This case underscores the importance of differentiating generalized bullous fixed drug eruption from other severe cutaneous adverse reactions, recognizing its recurrence at fixed sites, and documenting pigmentation on healing as distinguishing features. Prompt drug withdrawal, supportive therapy, and pharmacovigilance reporting are essential to ensure patient safety and improve drug monitoring practices.
Fixed drug eruption is an immune-mediated cutaneous adverse drug reaction characterized by recurrent lesions at fixed anatomical sites¹. Generalized bullous fixed drug eruption is rare but clinically significant, often mimicking Stevens–Johnson syndrome or toxic epidermal necrolysis⁵,⁶.
Case Presentation
A 60-year-old male presented with generalized fixed drug eruption characterized by multiple hyperpigmented patches and bullous lesions distributed over chest, abdomen, limbs, and back (1). He also had raw mucosal lesions involving lips and oral cavity. He was on ornidazole and ofloxacin fixed dose therapy for 6 days before onset (2,3).
Images representing: A case of fixed drug eruption induced by ornidazole involving chest, abdomen, trunk, lips and oral cavity.
Differential Diagnosis
DISCUSSION
Generalized bullous fixed drug eruption is rare but clinically significant, often mimicking Stevens–Johnson syndrome or toxic epidermal necrolysis⁵,⁶. Both fluoroquinolones and nitroimidazoles are documented triggers²,³. Mucosal involvement is frequent, with oral and genital erosions¹,². Immediate withdrawal of the causative drug is essential⁷. Systemic corticosteroids, topical therapy, and antihistamines help control inflammation⁵. Pharmacovigilance reporting ensures drug safety monitoring⁷.
Management and Outcome:
Immediate withdrawal of the offending drugs, systemic corticosteroids, topical therapy, and infection prophylaxis led to stabilization
CONCLUSION
This case highlights generalized bullous fixed drug eruption as a serious adverse drug reaction requiring prompt recognition and management⁶. Differentiation from Stevens–Johnson syndrome or toxic epidermal necrolysis is crucial, with recurrence at fixed sites and pigmentation on healing as distinguishing features. Adverse drug reaction reporting remains vital for patient safety⁷.
Acknowledgment
I solemnly acknowledge institutional support from R.G. Kar Medical College and Hospital. The case report is written following all the ethical guidelines.
Conflict of Interest
The authors declare no conflict of interest.
REFERENCES
Ankita Chowdhury*, Koustuv Chowdhary, Ornidazole Induced Fixed Drug Eruption: A Case Report, Int. J. Med. Pharm. Sci., 2026, 2 (5), 431-432. https://doi.org/10.5281/zenodo.20097647
10.5281/zenodo.20097647