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.
|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.
|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|
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.