Association between terbinafine and arthralgia, fever and urticaria: symptoms or syndrome?

Purpose The antifungal agent terbinafine has been approved for marketing in The Netherlands since 1992. Adverse drug reactions (ADRs) may occur in abo ut 10% of the patients, the majority gastrointestinal disorders and skin re actions. Since the introduction of terbinafine, the Netherlands Pharmacovig ilance Foundation Lareb received eight reports of arthralgia during the use of this drug. In four reports the additional presence of skin reactions wa s mentioned, two of these reports concerned urticaria. Two patients who rep orted arthralgia also had a fever. These reports were described in more det ail, and analysed statistically in order to determine whether symptoms are interrelated. Methods All reports with known gender and a reporting date between 1 March 1992 and 1 January 1999, concerning patients older than 10 years, were incl uded. The extent to which the symptoms urticaria, fever and arthralgia were interrelated was examined by logistic regression modelling. Results Case series as well as the results of the statistical analysis show a clustering of symptoms among reports of patients using terbinafine. Both urticaria and arthralgia were statistically significantly associated with reports on terbinafine compared to all other reports in the database. Conclusion The findings might point towards a clustering of these symptoms in patients using terbinafine. Possibly these symptoms have a shared aetiol ogy, presumably an immunological reaction. Copyright (C) 2001 John Wiley & Sons, Ltd.