amlodipine/atorvastatin-oral (cont.)
SIDE EFFECTS: Headache, dizziness, drowsiness, flushing, diarrhea, stomach/abdominal pain, weakness, or joint pain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. This drug may infrequently cause muscle damage (which can rarely lead to a very serious, possibly fatal, condition called rhabdomyolysis). Seek immediate medical attention 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: irregular heartbeat, swelling of the hands or feet. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: worsening chest pain (attacks are more frequent, more severe, or last longer), yellowing of the eyes or skin, dark urine, severe fatigue, severe stomach/abdominal pain, persistent nausea, change in the amount of urine. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, severe swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Before taking amlodipine/atorvastatin, tell your doctor or pharmacist if you are allergic to it; or to other "statins" such as lovastatin, pravastatin, simvastatin, fluvastatin, rosuvastatin; 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: active liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease, history of liver disease, kidney disease, under active thyroid (hypothyroidism), alcohol use. The rare development of severe muscle damage (see Side Effects) can infrequently lead to serious kidney problems. This medication is usually temporarily stopped if you have any condition which can increase your risk of developing kidney problems. Before stopping your medication, notify your doctor immediately if you have any of the following conditions: major surgery, trauma, serious illness (e.g., sepsis, severe metabolic/endocrine/electrolyte disorders), very low blood pressure, uncontrolled seizures. Limit alcoholic beverages. Daily use of alcohol may increase your chance for serious side effects. This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially muscle damage. This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. It is recommended that young girls and women of child-bearing age use effective birth control measures to prevent pregnancy while taking this drug since atorvastatin may cause fetal harm. Of this combination product, atorvastatin is the one known to pass into breast milk. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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