Mevacor Side Effects

Generic Name: lovastatin

Note: This document contains side effect information about lovastatin. Some of the dosage forms listed on this page may not apply to the brand name Mevacor.

Some side effects of Mevacor 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

Along with its needed effects, lovastatin (the active ingredient contained in Mevacor) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lovastatin:

Less common
  • Bladder pain
  • bloody or cloudy urine
  • chest tightness
  • cough
  • dark-colored urine
  • difficult, burning, or painful urination
  • difficulty with moving
  • fever
  • frequent urge to urinate
  • headache
  • joint pain
  • lower back or side pain
  • muscle aching, cramps, spasms, or stiffness
  • muscle pain, tenderness, or weakness
  • pain or tenderness around the eyes and cheekbones
  • shortness of breath
  • stuffy or runny nose
  • swollen joints
  • trouble with breathing
  • unusual tiredness or weakness

Some side effects of lovastatin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Acid or sour stomach
  • belching
  • bloated or full feeling
  • blurred vision
  • diarrhea
  • difficulty having a bowel movement (stool)
  • dizziness
  • excess air or gas in the stomach or intestines
  • heartburn
  • indigestion
  • lack or loss of strength
  • nausea
  • passing gas
  • rash
  • stomach discomfort, upset, or pain

For Healthcare Professionals

Applies to lovastatin: oral tablet, oral tablet extended release

Hepatic

Persistent elevations in liver function tests to three times normal values have been reported in up to 2% of patients on lovastatin (the active ingredient contained in Mevacor) 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 Overall, 1.5% of patients were withdrawn from study due to elevations in serum transaminases.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

Gastrointestinal side effects are among the most common complaints in patients on lovastatin (the active ingredient contained in Mevacor) 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.

Musculoskeletal

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 (the active ingredient contained in Mevacor) 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

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

Nervous system side effects of lovastatin (the active ingredient contained in Mevacor) 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

Renal side effects of lovastatin (the active ingredient contained in Mevacor) have included acute renal failure secondary to rhabdomyolysis.

Dermatologic

Dermatologic side effects associated with the administration of lovastatin (the active ingredient contained in Mevacor) 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

Endocrine side effects of lovastatin (the active ingredient contained in Mevacor) 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

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

Immunologic side effects of lovastatin (the active ingredient contained in Mevacor) 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

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 (the active ingredient contained in Mevacor) on the human lens.

Metabolic

Metabolic side effects of lovastatin (the active ingredient contained in Mevacor) 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

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).

Genitourinary

Halkin, et al report a case in which use of both lovastatin (the active ingredient contained in Mevacor) 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

Oncologic side effects have been associated with many lipid-lowering drugs, including tumor growth in rodents. Lovastatin (the active ingredient contained in Mevacor) 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

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.

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