CDSCO Directs Inclusion of Fixed Drug Eruption Warning in Metronidazole Prescribing Information
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has directed all State and Union Territory Licensing Authorities to instruct manufacturers of metronidazole formulations to update the package inserts and promotional literature of their products by including Fixed Drug Eruption (FDE) as a recognised adverse drug reaction (ADR).
The directive, issued by the Office of the Drugs Controller General (India) [DCG(I)] on July 6, 2026, follows a multi-stage pharmacovigilance assessment undertaken under the Pharmacovigilance Programme of India (PvPI) and subsequent expert review by the Subject Expert Committee (SEC) on Antimicrobial & Antiparasitic Drugs.
The National Coordination Centre for Pharmacovigilance Programme of India (NCC-PvPI), Indian Pharmacopoeia Commission (IPC), Ghaziabad, had forwarded recommendations arising from the assessment of adverse drug reaction (ADR) reports pertaining to metronidazole formulations, which were discussed during the 25th Signal Review Panel meeting held on October 30, 2024.
During the meeting, the PvPI evaluated Patient Population Incidence–Adverse Drug Reactions (PPIs-ADR) based on Individual Case Safety Reports (ICSRs) and recommended that CDSCO take appropriate regulatory measures to incorporate "Fixed Drug Eruption" as an adverse drug reaction in the Prescribing Information Leaflet (PIL) of metronidazole-based medical products marketed in the country.
Fixed Drug Eruption (FDE) is a distinctive cutaneous adverse drug reaction characterised by the appearance of one or more well-defined, round or oval, reddish to violaceous patches or plaques that recur at the same site each time the offending drug is administered. The lesions usually resolve after discontinuation of the drug but often leave behind residual hyperpigmentation. Although FDE is generally self-limiting, severe or widespread forms may occasionally occur and require prompt recognition and withdrawal of the causative medicine.
The recommendations of the NCC-PvPI were subsequently reviewed by the Subject Expert Committee (SEC) on Antimicrobial & Antiparasitic Drugs during its meeting held on April 9, 2026, at CDSCO Headquarters, New Delhi.
After detailed deliberations, the Committee recommended:
"CDSCO should request the State Drugs Controllers to direct the manufacturers to incorporate 'Fixed Drug Eruption (FDE)' associated with Metronidazole as ADR in the corresponding Prescribing Information Leaflet (PIL) of the drug."
The recommendation of the SEC has been accepted by the Office of the Drugs Controller General (India). Accordingly, CDSCO has instructed all State and UT Licensing Authorities:
"You are requested to direct the manufacturers of Metronidazole formulations under your jurisdiction to mention "Fixed Drug Eruption" as an adverse drug reaction in the Package insert/Promotional Literature of the drug."
To view the official notice, click the link below:
