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.8 This is especially relevant since most reporting of ARDs is the result of spontaneous monitoring 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.8
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 disorders
SOC 0500 Psychiatric disorders SOC 1230 Platelet, bleeding, and clotting disorders
SOC 0600 Gastrointestinal system disorders SOC 1300 Urinary system disorders
SOC 0700 Kidney 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

This discussion is based primarily on the 30 most common ADRs that can occur with therapeutic doses of drugs in the top 200 dispensed by U.S. community pharmacies.9 The top 200 drugs are 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.9
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. Dyspnea1,2 27. Anaphylaxis2
08. Fatigue1 18. Hypotension1,2 28. Xerostomia1
09. Insomnia1 19. Depression1 29. Fever1
10. Pruritus2 20. Paresthesia1 30. 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.10 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.