SIDE EFFECTS: Also see Warning section. Diarrhea, nausea, vomiting, or dizziness may occur. If any of these effects persist or worsen, notify your doctor promptly. This drug, when used in combination with simvastatin, may infrequently cause muscle damage (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor immediately if you develop: muscle pain/tenderness/weakness (especially with fever or unusual tiredness). Tell your doctor immediately if any of these unlikely but serious side effects occur: severe dizziness, slowed heartbeat, uncontrolled shaking/tremor, unexplained weight gain, swelling of the hands or feet, irregular pulse, vision changes (e.g., seeing halos, blurred vision, loss of vision), easy bruising/bleeding, persistent sore throat. This drug may cause skin reactions similar to a serious sunburn. Infrequently with long-term amiodarone treatment, you may develop blue-gray discoloring of the skin, particularly of the face and hands. This effect is not harmful and usually reverses, sometimes incompletely, after the drug is stopped. Avoiding prolonged sun exposure may help to prevent this effect. See also Precautions. In the unlikely event you have a serious allergic reaction to this drug, seek immediate medical attention. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Before taking amiodarone tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: cardiogenic shock, certain types of irregular heartbeats or heart rhythms (e.g., severe sinus node dysfunction resulting in marked sinus bradycardia, second or third degree atrioventricular block, bradycardia with associated syncope except when a pacemaker is used). Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, heart problems (e.g., congestive heart failure, low blood pressure), lung diseases, thyroid problems, upcoming major surgery, electrolyte problems such as low potassium or low magnesium. This drug may make you dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. This medication may make you more sensitive to the sun. Avoid prolonged sun exposure. Use a sunscreen and wear protective clothing when outdoors. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially slowing of the heartbeat. A preservative (benzyl alcohol) which may be found in this product or in the liquid used to mix this product (diluent) can infrequently cause serious problems (sometimes death), if given in large amounts (more than 100 mg/kg daily) to an infant during the first months of life (neonatal period). The risk is also greater with low birth weight infants. Symptoms include sudden gasping, low blood pressure, or a very slow heartbeat. Report these symptoms to the doctor immediately should they occur. If possible, a preservative-free product should be used when treating neonates. This medication is not recommended for use during pregnancy due to the potential for fetal harm. Consult your doctor for more details. Amiodarone passes into breast milk. Breast-feeding is not recommended while using this drug.