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

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. Dizziness¹	11. Thrombocytopenia¹	21. Anxiety¹
02. Nausea¹	12. Abdominal pain¹	22. Palpitation¹
03. Headache¹	13. Somnolence¹	23. Tremor¹
04.Vomiting¹	14. Allergic reactions²	24. Arthralgia²
05. Diarrhea¹	15. Dyspepsia¹	25. Anorexia¹
06. Rash²	16. Urticaria²	26. Nervousness¹
07. Constipation¹	17. Dyspnea^1,2	27. Anaphylaxis²
08. Fatigue¹	18. Hypotension^1,2	28. Xerostomia¹
09. Insomnia¹	19. Depression¹	29. Fever¹
10. Pruritus²	20. Paresthesia¹	30. Taste disturbances¹
Possible primary mechanisms of ARDs: “on-target,” “off-target,” cytotoxic reactions. 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.

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