Clinical Manifestations of ADRs

The Council of International Organizations of Medical Sciences (CIOMS) published guidelines on diagnostic criteria and basic requirements for standardized reporting of ADRs. ⁸ This is especially relevant since most reporting is based on single cases. The CIOMS codified ADRs under 21 major headings and defined 179 conditions considered reportable. However, there is no specific major heading for ADRs affecting oral tissues.

ARDs related to immune-mediated and idiosyncratic mechanisms among the 30 most common ADRs associated with therapeutic doses of drugs in the top 200 dispensed by U.S. community pharmacies include rash, pruritus, allergic reactions, urticaria, arthralgia, and anaphylaxis.⁹ In addition, less common ADRs affecting oral tissues, rare oncogenic and teratogenic ADRs, and some secondary ADRs are discussed.

DailyMed is the official website for FDA-approved label (package insert) information.¹⁰ It provides a centralized, standard, comprehensive, up-to-date, look-up-and-download resource for package inserts submitted to the FDA by pharmaceutical companies. The website is user-friendly, it includes strengthened warnings undergoing FDA review, and it is a reliable resource for information on known potential ADRs related to specific drugs.