Are excipients really inert ingredients? A review of adverse reactions to excipients in oral dermatologic medications in Canada

Abstract

Background: Whereas several literature reviews have discussed the role of excipients in drug-related reactions, no article has focused specifically on those found in oral dermatologic medications.

Methods: The Compendium of Pharmaceuticals and Specialties (CPS) was used to reference the inert ingredients found in oral dermatologic medications. An extensive literature review was subsequently conducted using PubMed and MEDLINE to document adverse reactions to these excipients.

Results: Sixty-three oral dermatologic medications were reviewed. Lactose was commonly used as a filler. Several medications indicated that they were dye, tartrazine, or gluten free. Three medications were found to contain soybean oil and one was found to contain peanut oil.

Conclusions: Although there are documented reactions to excipients in other products in the literature, few reports outline reactions to excipients in oral dermatologic medications. Whether this low frequency is accurate or whether it is due to a lack of reporting remains unknown. If the latter reasoning is correct, dermatologists must be more aware of these possible reactions. This article serves as a reference guide for dermatologists to aid in prescribing medications to individuals with known sensitivities and to assist in working up patients with suspected reactions to inert ingredients.