NIACIN EXTENDED-RELEASE/LOVASTATIN-ORAL (cont.)
SIDE EFFECTS: This medication may cause flushing and a feeling of warmth about the face and neck within the first two hours of taking a dose. These effects may last for one to two hours. Headache, dizziness, a fast heartbeat, redness/itching/tingling of the skin, or swelling of the arms/legs may occur as well. The frequency and intensity of these effects should subside after several weeks as your body adjusts to the medication. Stomach upset, nausea, and diarrhea may also occur. If these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: increased thirst, change in the amount of urine, blurred vision, unusual tiredness or fatigue, easy bruising or bleeding. 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 highly unlikely but very serious side effects occur: fainting, yellowing eyes and skin, dark urine, severe fatigue, persistent nausea, severe stomach/abdominal pain. 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, severe itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Before taking lovastatin/niacin, tell your doctor or pharmacist if you are allergic to it; or to other "statins"; 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, active peptic ulcer disease, serious bleeding problems (e.g., arterial bleeding). Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., unstable angina), kidney disease, history of liver disease, underactive thyroid (hypothyroidism), diabetes, gout, history of stomach/abdominal problems (e.g., ulcers), low phosphate blood levels, 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: recent or scheduled major surgery, trauma, serious illness (e.g., sepsis, severe metabolic/endocrine/electrolyte disorders), very low blood pressure, uncontrolled seizures. This drug may make you dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position. Limit alcoholic beverages. Daily use of alcohol may increase your chance for serious side effects. Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug, 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 women of child-bearing age use effective birth control measures while taking this drug since lovastatin may cause fetal harm. This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug. 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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