Postmarketing surveillance of oral terbinafine in the UK: report of a large cohort study

1 The safety profile of terbinafine, the first orally active allylamine, was monitored in the UK in a post‐marketing setting. The study recruited 10 361 patients, a number which is approximately 5% of the population who received oral terbinafine in the UK during the period of the study.

2 Follow‐up data were available on 9879 patients. During the course of the study 14.5% patients reported medical events. 49% were thought to be possibly or probably related to terbinafine treatment. Seventy‐four of the events (<1%) were classified as 'serious’and of these only five were assessed as possibly or probably related to treatment.

3 Taste disturbance occurred in 0.6% of the patients and emerged as the only new adverse reaction probably attributable to terbinafine: this was significantly commoner in females and reversible on stopping treatment, with a median time to recovery of 42 days.

4 The study approach successfully combined hospital based dermatology outpatient and general practice centres. Source data verification was conducted on 13% of the cohort selected randomly.

5 Overall, the denominator‐based description of the safety profile in actual practice shows terbinafine to be well‐tolerated against a wide background of age and coexisting illness.

DOI: 10.1111/j.1365-2125.1996.tb00110.x

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