NAFDAC Discontinues Registration of Oral Ketoconazole Over Serious Liver Safety Risks

Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) has officially discontinued the registration of ketoconazole tablets, pulling the plug on the oral antifungal medicine due to severe safety risks, primarily drug-induced liver injury. The regulatory directive targets systemic oral formulations, such as Ketoral-200 mg tablets, whose registration status in NAFDAC’s database now reflects as inactive. However, regulatory officials and health experts emphasize that the move is not a blanket ban on all ketoconazole products.

Topical formulations including creams, ointments, and shampoos remain approved and available. Because skin-applied treatments result in minimal systemic absorption, they do not carry the same hepatotoxic risks as oral doses.

International regulators particularly the European Medicines Agency (EMA) and the United States' Food and Drug Administration (FDA) have long restricted or suspended oral ketoconazole due to severe liver toxicity that routine monitoring cannot prevent.

NAFDAC's directive requires Nigerian healthcare providers to verify prescription formulations, refer patients taking oral ketoconazole back to prescribers for safer alternatives, and avoid automatic antifungal substitutions without assessing specific patient and infection factors.

Oral ketoconazole retains a narrow, highly specialized role in managing conditions like Cushing’s syndrome under strict specialist oversight. However, for everyday fungal conditions, Nigerian regulators have made it clear: the risk of oral ketoconazole outweighs the reward.