Drug Safety Alert: IPC Links Erythromycin Use to Fixed Drug Eruption
New Delhi: The Indian Pharmacopoeia Commission (IPC), in its latest Drug Safety Alert for September 2025, has reported a safety signal indicating that the antibiotic Erythromycin may be associated with the adverse drug reaction (ADR) Fixed Drug Eruption.
In connection with the above, the IPC has advised healthcare professionals, patients, and consumers to closely monitor the potential occurrence of this adverse reaction when administering erythromycin.
This alert follows an analysis of adverse drug reaction reports available in the Pharmacovigilance Programme of India (PvPI) database. The review of data revealed a possible association between erythromycin use and the occurrence of fixed drug eruption.
Erythromycin is a macrolide antibiotic commonly used as an alternative to penicillin in hypersensitive patients. It is indicated in the treatment of a wide range of infections including pneumonia, Legionnaires’ disease, syphilis, chancroid, chlamydia, non-gonococcal urethritis, prostatitis, lymphogranuloma venereum, campylobacter enteritis, relapsing fever, diphtheria, whooping cough prophylaxis, upper respiratory tract infections, acne vulgaris, and sycosis vulgaris.
The alert highlights Fixed Drug Eruption (FDE) as the suspected adverse drug reaction. Fixed drug eruption (FDE) is a distinctive type of cutaneous drug reaction that characteristically recurs in the same locations upon re-exposure to the offending drug. Acute FDE usually presents with a single or a small number of dusky red or violaceous plaques that resolve, leaving post-inflammatory hyperpigmentation. Rare severe atypical variants of FDE, including multiple, non-pigmenting, and generalized bullous variants, share clinical features with Stevens-Johnson syndrome/toxic epidermal necrolysis.
Following the PvPI data review, erythromycin has been listed as the suspected drug associated with the above ADR.
| S. No. | Suspected Drug | Indication(s) | Adverse Drug Reaction |
|---|---|---|---|
| 1 | Erythromycin | Alternative to penicillin in hypersensitive patients; pneumonia; legionnaires’ disease; syphilis; chancroid; chlamydia; non-gonococcal urethritis; prostatitis; lymphogranuloma venereum; campylobacter enteritis; relapsing fever; diphtheria and whooping cough prophylaxis; upper respiratory tract infection; acne vulgaris; sycosis vulgaris. | Fixed Drug Eruption |
In light of the above, the Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, has advised healthcare professionals, patients, and consumers to remain vigilant for signs of fixed drug eruption associated with erythromycin use.
Further, the safety alert states that if such reactions are encountered, they should be reported to the National Coordination Centre – PvPI (NCC-PvPI), IPC by filling the Suspected Adverse Drug Reaction Reporting Form/Medicines Side Effect Reporting Form for Consumers (available at the IPC website) or through the PvPI Helpline 1800-180-3024 (toll-free).
To view the official alert, click the link below:
