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Adverse Drug Reactions - Part I

Course Number: 536

Clinical Manifestations of ADRs

The Council of International Organizations of Medical Sciences (CIOMS) in their publication “Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use” established guidelines for the diagnosis of ADRs and basic requirements for standardized reporting.14 This is especially relevant since most reporting of ARDs is the result of spontaneous identification of single cases. The CIOMS codified ADRs under 21 major headings (Table 4) and defined 179 conditions considered reportable.

Table 4. Major categories of ADRs.14

SOC 0100Skin and Appendages DisordersSOC 1020Myocardial, Endocardial, Pericardial, and Valve Disorders
SOC 0200Musculo-skeletal System DisordersSOC 1030Heart Rate and Rhythm Disorders
SOC 0300Collagen DiseaseSOC 1040Vascular (Extra-Cardiac) Disorders
SOC 0410Central and Peripheral Nervous System DisordersSOC 1100Respiratory System Disorders
SOC 0431Vision DisordersSOC 1210Red Blood Cell Disorders
SOC 0432Hearing and Vestibular DisordersSOC 1220White Blood Cell and RES (Reticulo-Endothelial System) Disorders
SOC 0500Psychiatric DisordersSOC 1230Platelet, Bleeding, and Clotting Disorders
SOC 0600Gastrointestinal System SisordersSOC 1300Urinary System Disorders
SOC 0700Liver and Biliary System DisordersSOC 1500Fetal Disorders
SOC 0800Metabolic and Nutritional DisordersSOC 1810Body as a Whole – General Disorders
SOC 1010Cardiovascular Disorders, General

This course primarily focuses on the 30 most common ADRs that occured with therapeutic doses of drugs in the top 200 dispensed by U.S. community pharmacies in 2008.15 The top 200 drugs were associated with 9829 individual potential ADRs. The 30 most common ADRs were determined by multiplying each potential ADR by the prescription volume of each drug in the top 200 (Box A). In addition, less common ADRs that relate to dental therapeutics and/or manifest in the head and neck area are presented.

Box A. The 30 Most Prevalent ADRs Associated With the Top 200 Drugs Dispensed in 2008.15

01. Dizziness111. Thrombocytopenia121. Anxiety1
02. Nausea112. Abdominal pain122. Palpitation1
03. Headache113. Somnolence123. Tremor1
04.Vomiting114. Allergic reactions224. Arthralgia2
05. Diarrhea115. Dyspepsia125. Anorexia1
06. Rash216. Urticaria226. Nervousness1
07. Constipation117. Dyspnea1,227. Anaphylaxis2
08. Fatigue118. Hypotension1,228. Xerostomia1
09. Insomnia119. Depression129. Fever1
10. Pruritus220. Paresthesia130. Taste disturbances1
  1. Possible primary mechanisms of ARDs: “on-target,” “off-target,” cytotoxic reactions.
  2. Possible primary mechanisms of ADRs: immune-mediated and idiosyncratic reactions.

DailyMed  is the official website for FDA-approved label (package insert) information.16 The website provides a standard, comprehensive, up-to-date, look-up-and-download resource for package inserts. The labeling information on the website is the most recent submitted to the FDA by pharmaceutical companies. The information is formatted to make it easy to read, includes strengthened warnings undergoing FDA review, and it is a reliable resource for information on potential ADRs related to specific drugs.