Mevacor Side Effects

Generic Name: lovastatin

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

Not all side effects for Mevacor may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to lovastatin: oral tablet, oral tablet extended release

In addition to its needed effects, some unwanted effects may be caused by lovastatin (the active ingredient contained in Mevacor). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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
  • stuffy or runny nose
  • swollen joints
  • trouble with breathing
  • unusual tiredness or weakness

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

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 Overall, 1.5% of patients were withdrawn from study due to elevations in serum transaminases.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.[Ref]

Common (1% to 10%): Elevations in liver function tests
Frequency not reported: Hepatitis (including chronic active hepatitis), cholestatic jaundice, fatty change in the liver, cirrhosis, fulminant hepatic necrosis[Ref]

Gastrointestinal

Common (1% to 10%): Flatulence, abdominal pain, diarrhea, constipation, nausea
Frequency not reported: Dyspepsia, heartburn, anorexia, vomiting
Postmarketing reports: Abdominal discomfort[Ref]

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.[Ref]

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.

Exposure to HMG-CoA reductase inhibitors is associated with a decreased risk of bone fractures in persons older than 50.[Ref]

Frequency not reported: Elevations in creatine kinase, muscle cramps, myopathy, rhabdomyolysis, arthralgia, myalgia, tendon rupture, dermatomyositis[Ref]

Hematologic

Frequency not reported: Hemolytic anemia, thrombocytopenia, thrombotic thrombocytopenic purpura (TTP), leukopenia (These effects may be manifestations of a hypersensitivity reaction)[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Frequency not reported: Cranial nerve dysfunction, tremor, vertigo, memory loss, drowsiness, weight loss, decline in cognitive function, paresthesias, peripheral neuropathy, peripheral nerve palsy
Postmarketing reports: Asthenia, fatigue, malaise, hypoesthesia, insomnia[Ref]

Renal

Frequency not reported: Acute renal failure secondary to rhabdomyolysis[Ref]

Dermatologic

Frequency not reported: Rash, pruritus, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity, purpura, alopecia (These effects may be manifestations of a hypersensitivity reaction)[Ref]

Endocrine

Frequency not reported: Hypospermia, gynecomastia, thyroid dysfunction, acid maltase deficiency (the genetic disorder also referred to as Pompe's Disease), pancreatitis[Ref]

Hypersensitivity

Frequency not reported: 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, toxic epidermal necrolysis[Ref]

Immunologic

Frequency not reported: Lupus-like syndrome with positive ANA and elevated ESR, polymyalgia rheumatica, vasculitis[Ref]

Ocular

Frequency not reported: Progression of cataracts, ophthalmoplegia[Ref]

Metabolic

Very rare (less than 0.01%): Hyperkalemia[Ref]

Psychiatric

Frequency not reported: Decreased libido, anxiety, insomnia, depression, suicidal thoughts, delusions, paranoia, agitation, nightmares[Ref]

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.[Ref]

Frequency not reported: Erectile dysfunction, impotence, testicular pain[Ref]

Oncologic

Frequency not reported: Tumor growth, hepatocellular carcinomas and adenomas. pulmonary adenomas (all in rodents)[Ref]

Respiratory

Postmarketing reports: Interstitial lung disease

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