Risk factors for the development of specific noncardiovascular adverse effects associated with amiodarone.

Noncardiovascular adverse effects associated with amiodarone result in substantial morbidity. Adverse effects involving the skin, liver, thyroid, and lungs have been reported in as many as 57%, 55%, 11%, and 13% of patients, respectively. Although risk factors for some amiodarone-induced adverse effects have been identified, risk factors for these specific side effects have not been systematically evaluated. Therefore, risk factors for development of amiodarone-induced dermatologic, hepatic, thyroid, or pulmonary adverse effects were identified using univariate analysis in 44 patients receiving the drug for supraventricular or ventricular arrhythmias (mean duration of therapy 99.5 +/- 110.8 weeks). Dermatologic side effects occurred in 4 (9.1%) patients. Patients who experienced dermatologic side effects were younger than patients who did not (mean age, 48.3 +/- 15.8 years versus 60.1 +/- 9.5 years, respectively; P = .03). Patients younger than 60 years of age were more likely to develop photosensitivity or blue-gray skin discoloration than those aged 60 or older (P = .05). Hepatic adverse effects occurred in 3 (6.8%) patients. Left ventricular ejection fraction was lower in those who developed hepatic adverse effects than in those who did not (15.0 +/- 4.0% versus 39.1 +/- 13.9%, P = .005). Adverse thyroid effects occurred in 6 (13.6%) patients; and pulmonary fibrosis occurred in 2 (4.5%) patients. No specific risk factors for adverse thyroid effects or pulmonary fibrosis were revealed. In conclusion, age less than 60 may be a risk factor for amiodarone-induced dermatologic adverse effects, whereas severely depressed left ventricular ejection fraction may be a risk factor for hepatic side effects associated with amiodarone.