Safety of Oral Terbinafine

Terbinafine (LamisilR) treatment of toenail onychomycosis in patients with insulin-dependent and non-insulin-dependent diabetes mellitus: a multicentre trial

“…Since terbinafine was first released in the U.K. in 1991, it has been used by more than 15 million people, mainly for the treatment of dermatomycosis and onychomycosis, with excellent cure rates and few adverse events 14,21 . The present multicentre trial was carried out to determine the efficacy, safety and tolerability of a 12‐week continuous treatment with terbinafine 250 mg daily in toenail onychomycosis in caucasian patients with DM treated with insulin and/or oral antidiabetic agents; well‐defined primary (mycological cure: negative microscopy and culture) and secondary (clinical cure: 100% toenail clearing; complete cure: mycological and clinical cure) efficacy criteria were used.…”

“…Although there have been many clinical studies of the antifungal drug terbinafine, almost all have concentrated on the treatment of onychomycosis in non‐diabetic populations, and only limited data are available on its use in diabetic patients 12,14–20 . However, studies specifically evaluating the efficacy and safety of antifungal drugs such as terbinafine in the treatment of onychomycosis in diabetic patients may be of interest, because this is a special population with multiple concomitant diseases, and frequently exposed to many concurrent medications.…”

Treatment of Tinea Capitis

“…Therefore, discontinuation related to adverse events is infrequent and occurs at a rate of 1.6% based on the largest clinical trial studying the use of terbinafine in tinea capitis [22]. Post-market surveillance of 25,884 patients reported an adverse event incidence rate of 10.5%, with gastrointestinal system (4.9%) and skin (2.3%) being the most frequently involved organs [42]. Serious adverse events are rare and are further listed in Table 3.…”

Is systemic autoimmune disease a risk factor for terbinafine-induced erythema multiforme?

“…In the literature, we found 13 reports of EM, two cases of Stevens–Johnson syndrome and two of Lyell’s syndrome associated with terbinafine. 1–8 Two of the described EM patients had systemic LE. 3 , 4 We are aware of another case of terbinafine‐induced EM in a patient with LE (Novartis data, on file).…”