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See the DrugPatentWatch profile for Terbinafine
Terbinafine has been withdrawn from some markets or restricted in certain countries due to safety concerns—most notably severe skin reactions and liver-related adverse effects that regulators considered serious enough to warrant action.
Regulatory actions involving terbinafine commonly focus on: - Serious liver injury (including cases of severe hepatitis or liver failure). - Severe cutaneous reactions (for example, reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis). These risks are the main reason terbinafine has faced market withdrawals or strengthened prescribing restrictions in some jurisdictions.
Withdrawals have varied by country and by product/manufacturer. In some places, regulators have pulled specific formulations, while in others they have restricted use, added stronger warnings, or required tighter monitoring rather than a complete market withdrawal.
If terbinafine is unavailable, clinicians often consider other antifungals depending on the condition being treated (for example, topical azoles like clotrimazole or oral options like itraconazole or fluconazole, guided by the infection type and patient risk factors).
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