Lovastatin Side Effects
Some side effects of lovastatin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to lovastatin: oral tablet, oral tablet extended release
Get emergency medical help if you have any of these signs of an allergic reaction while taking lovastatin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking lovastatin and call your doctor at once if you have any of these serious side effects:
unexplained muscle pain, tenderness, or weakness;
fever, unusual tiredness, and dark colored urine;
confusion, memory problems;
swelling, weight gain, urinating less than usual or not at all;
high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss); or
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects of lovastatin may include:
mild muscle pain;
stomach pain or indigestion;
sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to lovastatin: oral tablet, oral tablet extended release
Persistent elevations in liver function tests to three times normal values have been reported in up to 2% of patients on lovastatin in clinical trials. Overall, 1.5% of patients were withdrawn from study due to elevations in serum transaminases. While most patients remained asymptomatic with these elevations, cases of cholestatic jaundice and hepatitis have been reported.
Liver function tests should be closely monitored. Lovastatin should be discontinued in patients with persistent, significant elevations (three times the upper limit of normal) in liver function parameters.
Hepatic side effects of lovastatin include elevations in liver function tests (to 2%). Other hepatic side effects reported with HMG-CoA reductase inhibitors are hepatitis, including chronic active hepatitis, cholestatic jaundice, fatty change in the liver, cirrhosis, and fulminant hepatic necrosis.
Gastrointestinal side effects are among the most common complaints in patients on lovastatin. These effects tend to be mild and transient in nature and will often dissipate with continued therapy.
Gastrointestinal side effects associated with the administration of lovastatin have included flatulence (to 6%), abdominal pain (to 6%), diarrhea (to 6%), constipation (to 5%), nausea (to 5%), dyspepsia, and heartburn. Other gastrointestinal side effects of HMG-CoA reductase inhibitors have included pancreatitis, anorexia, and vomiting.
HMG-CoA reductase inhibitors (statins) have been associated with rare cases of severe myopathy and rhabdomyolysis, accompanied by increases in creatine kinase, myoglobinuria, proteinuria, and renal failure. These conditions appear to be dose related, usually occurring with doses greater than 30 mg per day. The incidence and severity of myopathy may be increased by concomitant administration of lovastatin with drugs that can cause myopathy when given alone, such as gemfibrozil and other fibrates, niacin, and potent inhibitors of CYP450 3A4 (i.e., cyclosporine, antifungal azoles, macrolide antibiotics, large amounts of grapefruit juice). Other variables associated with an increased risk of statin-induced myopathy include, advanced age, small body stature, female gender, renal and/or hepatic dysfunction, perioperative periods, hypothyroidism, diabetes mellitus, and alcoholism.
Milder forms of myotoxicity (i.e., myalgia) are commonly reported and occur in approximately 5% to 7% of patients taking a statin drug.
Patients should be instructed to report promptly symptoms of muscle pain, weakness, or tenderness. If such symptoms develop, creatine kinase should be measured, and if markedly elevated, lovastatin should be discontinued. The value of routine monitoring of creatine kinase is not known. In some studies up to 11% of patients experienced elevations in creatine kinase while on lovastatin. In most cases these elevations were mild, transient, and not associated with clinical symptoms.
Itraconazole used concomitantly with lovastatin has led to one reported case of severe rhabdomyolysis in a 63-year-old woman. Caution should be exercised when HMG-CoA reductase inhibitors and azole antifungals are prescribed concurrently.
Musculoskeletal side effects of lovastatin have included elevations in creatine kinase, muscle cramps, myopathy, and rhabdomyolysis. Other musculoskeletal side effects reported with HMG-CoA reductase inhibitors have included arthralgia, myalgia, tendon rupture, and dermatomyositis.
In addition, some data have suggested that exposure to HMG-CoA reductase inhibitors is associated with a decreased risk of bone fractures in persons older than 50 years of age.
Hematologic side effects including hemolytic anemia, thrombocytopenia, thrombotic thrombocytopenic purpura (TTP), and leukopenia have occurred with some HMG-CoA reductase inhibitors. These effects may be manifestations of a hypersensitivity reaction.
Nervous system side effects of lovastatin have included headache (9%) and dizziness (2%). In addition, one study demonstrated an increase in sleep latency and total wake time in patients treated with lovastatin as compared to patients treated with pravastatin. Other nervous system side effects reported with HMG-CoA reductase inhibitors have included cranial nerve dysfunction, tremor, vertigo, memory loss, drowsiness, weight loss, decline in cognitive function, paresthesias, peripheral neuropathy, and peripheral nerve palsy.
Renal side effects of lovastatin have included acute renal failure secondary to rhabdomyolysis.
Dermatologic side effects associated with the administration of lovastatin have included rash and pruritus. Other dermatologic side effects reported with HMG-CoA reductase inhibitors have included erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity, purpura, and alopecia. These effects may be manifestations of a hypersensitivity reaction.
Endocrine side effects of lovastatin have included hypospermia. Other endocrine side effects of HMG-CoA reductase inhibitors have included gynecomastia and thyroid dysfunction. In addition, acid maltase deficiency (the genetic disorder also referred to as Pompe's Disease) has been revealed following HMG-CoA therapy in at least one presymptomatic patient.
Hypersensitivity reactions are reported rarely with HMG-CoA reductase inhibitors and have included anaphylaxis, angioedema, lupus erythematous-like syndrome, polymyalgia rheumatic, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever (including severe hyperthermia), chills, flushing, malaise, dyspnea, and toxic epidermal necrolysis.
Immunologic side effects of lovastatin have included a lupus-like syndrome with positive ANA and elevated ESR. Other immunologic side effects of HMG-CoA reductase inhibitors have included polymyalgia rheumatica and vasculitis.
Ocular side effects of HMG-CoA reductase inhibitors have included progression of cataracts and ophthalmoplegia. There is no evidence to support adverse effects of lovastatin on the human lens.
Metabolic side effects of lovastatin have included a case report of hyperkalemia in a patient with mild renal insufficiency on concomitant lisinopril. A positive rechallenge implicated lovastatin as a confounding factor in this case.
Psychiatric side effects of HMG-CoA reductase inhibitors have included decreased libido, anxiety, insomnia, depression, suicidal thoughts, delusions, paranoia, agitation, and nightmares. Psychiatric side effects reported postmarketing have included cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
Halkin, et al report a case in which use of both lovastatin and pravastatin on different occasions in the same patient led to reversible impotence. The impotence resolved within 2 weeks after discontinuation of the HMG-CoA reductase inhibitor.
Genitourinary side effects associated with the administration of HMG-CoA reductase inhibitors have included erectile dysfunction, impotence, and testicular pain.
Oncologic side effects have been associated with many lipid-lowering drugs, including tumor growth in rodents. Lovastatin has been specifically associated with hepatocellular carcinomas and adenomas and pulmonary adenomas. Long-term clinical trials are needed to define the risk of cancer in humans.
Other side effects reported postmarketing have included abdominal discomfort, abdominal pain, dyspepsia, nausea, asthenia, fatigue, malaise, hepatitis, jaundice, fatal and nonfatal hepatic failure, dizziness, hypoesthesia, insomnia, depression, interstitial lung disease, erectile dysfunction and muscle spasms.
More lovastatin resources
- lovastatin Advanced Consumer (Micromedex) - Includes Dosage Information
- lovastatin MedFacts Consumer Leaflet (Wolters Kluwer)
- Lovastatin Prescribing Information (FDA)
- Lovastatin Professional Patient Advice (Wolters Kluwer)
- Lovastatin Monograph (AHFS DI)
- Altocor Consumer Overview
- Altoprev extended-release tablets MedFacts Consumer Leaflet (Wolters Kluwer)
- Altoprev Prescribing Information (FDA)
- Mevacor Prescribing Information (FDA)
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