title: Skin rash during treatment with generic itraconazole.
abstract: Generic drugs have the same active substance, the same pharmaceutical form, the same therapeutic indications and a similar bioequivalence with the reference medicinal product (branded). Although a similar efficacy is postulated, some cases of clinical inefficacy during treatment with generic formulations have been reported. In this case, we describe a woman with onychomycosis that developed a skin rash during treatment with a generic formulation of itraconazole. Drug administration and its re-challenge confirmed the association between itraconazole and skin rash. Both Naranjo probability scale and World Health Organization causality assessment scale documented a probable association between generic-itraconazole and skin rash. The switch from generic formulation to brand one induced an improvement of symptoms. Since we are unable to evaluate the role of each excipient in the development of skin rash, we cannot rule out their involvement. However, more data are necessary to better define the similarities or differences between branded and generic formulations.
authors.affiliation: Department of General Medicine, Cosenza, University of Catanzaro, Italy ; Department of Health Science, Regional Center on drug information, Mater Domini University Hospital, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: De Vuono
authors.affiliation: Department of Health Science, Regional Center on drug information, Mater Domini University Hospital, Italy ; Department of Chair of Pharmacology, School of Medicine, University of Catanzaro, Italy.
authors.forename: Caterina
authors.initials: C
authors.lastname: Palleria
authors.affiliation: Department of Health Science, Regional Center on drug information, Mater Domini University Hospital, Italy ; Department of Chair of Pharmacology, School of Medicine, University of Catanzaro, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Scicchitano
authors.affiliation: Department of Health Science, Regional Center on drug information, Mater Domini University Hospital, Italy ; Department of Chair of Pharmacology, School of Medicine, University of Catanzaro, Italy.
authors.forename: Aida
authors.initials: A
authors.lastname: Squillace
authors.affiliation: Department of Health Science, Regional Center on drug information, Mater Domini University Hospital, Italy ; Department of Chair of Pharmacology, School of Medicine, University of Catanzaro, Italy.
authors.forename: Giovambattista
authors.initials: G
authors.lastname: De Sarro
authors.affiliation: Department of Health Science, Regional Center on drug information, Mater Domini University Hospital, Italy ; Department of Chair of Pharmacology, School of Medicine, University of Catanzaro, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Gallelli
keywords: Brand-itraconazole; generic-itraconazole; onychomycosis; skin rash