Recommended Topic Related To:

Mevacor

"Nov. 5, 2012 (Los Angeles) -- An IV infusion of "good" HDL cholesterol seems to rapidly remove cholesterol out of plaque-clogged arteries following a heart attack, a small, early study suggests.

The goal of the new treatment is to red"...

Mevacor

Mevacor Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Mevacor (lovastatin) is a cholesterol-lowering medication belonging to the class of drugs known as statins. Mevacor is supplied in tablet form and is prescribed to treat elevated blood cholesterol levels. Mevacor is available in generic form. Mevacor should be used in addition to dietary modifications as part of a treatment plan to lower cholesterol levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce cardiovascular risk. Side effects of Mevacor are uncommon and typically of brief duration. These may include muscle pain, tenderness, or weakness; mild stomach pain, gas, bloating, stomach upset, or heartburn; nausea; constipation; or diarrhea.

Dosing of Mevacor is a single administration once daily or a divided dose taken twice daily. In rare cases, lovastatin can cause rhabdomyolysis, a condition that results in the breakdown of skeletal muscle tissue and which can lead to kidney failure. This medication can also cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Those who have liver disease or are breast-feeding should not take Mevacor. Many drugs can interact with lovastatin, including (but not limited to) cholestyramine (Questran), colestipol (Colestid), danazol (Danocrine), gemfibrozil (Lopid), and fenofibrate (Tricor). Patients taking Mevacor should be sure to tell their doctor about all the prescription and over-the-counter medications used.

Our Mevacor Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Mevacor in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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;
  • chest pain;
  • 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 may include:

  • headache;
  • mild muscle pain;
  • joint pain;
  • back pain;
  • mild nausea;
  • stomach pain or indigestion;
  • constipation; or
  • 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Mevacor (Lovastatin) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Mevacor Overview - Patient Information: Side Effects

SIDE EFFECTS: Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very small number of people taking lovastatin may have mild memory problems or confusion. If these rare effects occur, talk to your doctor.

This drug may infrequently cause muscle problems (which can rarely lead to very serious conditions called rhabdomyolysis and autoimmune myopathy). Tell your doctor right away if you develop any of these symptoms during treatment and if these symptoms persist after your doctor stops this drug: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine.

This medication may rarely cause liver problems. If you notice any of the following rare but serious side effects, tell your doctor immediately: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Mevacor (Lovastatin)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Mevacor FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

MEVACOR is generally well tolerated; adverse reactions usually have been mild and transient.

Phase III Clinical Studies

In Phase III controlled clinical studies involving 613 patients treated with MEVACOR, the adverse experience profile was similar to that shown below for the 8,245-patient EXCEL study (see Expanded Clinical Evaluation of Lovastatin [EXCEL] Study).

Persistent increases of serum transaminases have been noted (see WARNINGS, Liver Dysfunction). About 11% of patients had elevations of CK levels of at least twice the normal value on one or more occasions. The corresponding values for the control agent cholestyramine was 9 percent. This was attributable to the noncardiac fraction of CK. Large increases in CK have sometimes been reported (see WARNINGS, Myopathy/Rhabdomyolysis).

Expanded Clinical Evaluation of Lovastatin (EXCEL) Study

MEVACOR was compared to placebo in 8,245 patients with hypercholesterolemia (total-C 240-300 mg/dL [6.2-7.8 mmol/L]) in the randomized, double-blind, parallel, 48-week EXCEL study. Clinical adverse experiences reported as possibly, probably or definitely drug-related in ≥ 1% in any treatment group are shown in the table below. For no event was the incidence on drug and placebo statistically different.

  Placebo
(N = 1663) %
MEVACOR 20 mg q.p.m.
(N = 1642) %
MEVACOR 40 mg q.p.m.
(N = 1645) %
MEVACOR 20 mg b.i.d.
(N = 1646) %
MEVACOR 40 mg b.i.d.
(N = 1649) %
Body As a Whole
  Asthenia 1.4 1.7 1.4 1.5 1.2
Gastrointestinal
  Abdominal pain 1.6 2.0 2.0 2.2 2.5
  Constipation 1.9 2.0 3.2 3.2 3.5
  Diarrhea 2.3 2.6 2.4 2.2 2.6
  Dyspepsia 1.9 1.3 1.3 1.0 1.6
  Flatulence  4.2 3.7 4.3 3.9 4.5
  Nausea 2.5 1.9 2.5 2.2 2.2
Musculoskeletal
  Muscle cramps 0.5 0.6 0.8 1.1 1.0
  Myalgia 1.7 2.6 1.8 2.2 3.0
Nervous System/ Psychiatric
  Dizziness 0.7 0.7 1.2 0.5 0.5
  Headache 2.7 2.6 2.8 2.1 3.2
Skin
  Rash 0.7 0.8 1.0 1.2 1.3
Special Senses
  Blurred vision 0.8 1.1 0.9 0.9 1.2

Other clinical adverse experiences reported as possibly, probably or definitely drug-related in 0.5 to 1.0 percent of patients in any drug-treated group are listed below. In all these cases the incidence on drug and placebo was not statistically different. Body as a Whole: chest pain; Gastrointestinal: acid regurgitation, dry mouth, vomiting; Musculoskeletal: leg pain, shoulder pain, arthralgia; Nervous System/Psychiatric: insomnia, paresthesia; Skin: alopecia, pruritus; Special Senses: eye irritation.

In the EXCEL study (see CLINICAL PHARMACOLOGY, Clinical Studies), 4.6% of the patients treated up to 48 weeks were discontinued due to clinical or laboratory adverse experiences which were rated by the investigator as possibly, probably or definitely related to therapy with MEVACOR. The value for the placebo group was 2.5%.

Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS)

In AFCAPS/TexCAPS (see CLINICAL PHARMACOLOGY, Clinical Studies) involving 6,605 participants treated with 20-40 mg/day of MEVACOR (n=3,304) or placebo (n=3,301), the safety and tolerability profile of the group treated with MEVACOR was comparable to that of the group treated with placebo during a median of 5.1 years of follow-up. The adverse experiences reported in AFCAPS/TexCAPS were similar to those reported in EXCEL (see ADVERSE REACTIONS, Expanded Clinical Evaluation of Lovastatin (EXCEL) Study).

Concomitant Therapy

In controlled clinical studies in which lovastatin was administered concomitantly with cholestyramine, no adverse reactions peculiar to this concomitant treatment were observed. The adverse reactions that occurred were limited to those reported previously with lovastatin or cholestyramine. Other lipid-lowering agents were not administered concomitantly with lovastatin during controlled clinical studies. Preliminary data suggests that the addition of gemfibrozil to therapy with lovastatin is not associated with greater reduction in LDL-C than that achieved with lovastatin alone. In uncontrolled clinical studies, most of the patients who have developed myopathy were receiving concomitant therapy with cyclosporine, gemfibrozil or niacin (nicotinic acid). The combined use of lovastatin with cyclosporine or gemfibrozil should be avoided. Caution should be used when prescribing other fibrates or lipid-lowering doses ( ≥ 1 g/day) of niacin with lovastatin (see WARNINGS, Myopathy/Rhabdomyolysis).

The following effects have been reported with drugs in this class. Not all the effects listed below have necessarily been associated with lovastatin therapy.

Skeletal: muscle cramps, myalgia, myopathy, rhabdomyolysis, arthralgias.

There have been rare reports of immune-mediated necrotizing myopathy associated with statin use (see WARNINGS, Myopathy/Rhabdomyolysis).

Neurological: dysfunction of certain cranial nerves (including alteration of taste, impairment of extraocular movement, facial paresis), tremor, dizziness, vertigo, paresthesia, peripheral neuropathy, peripheral nerve palsy, psychic disturbances, anxiety, insomnia, depression.

There have been rare postmarketing reports of 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).

Hypersensitivity Reactions: An apparent hypersensitivity syndrome has been reported rarely which has included one or more of the following features: anaphylaxis, angioedema, lupus erythematous-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme, including Stevens-Johnson syndrome.

Gastrointestinal: pancreatitis, hepatitis, including chronic active hepatitis, cholestatic jaundice, fatty change in liver; and rarely, cirrhosis, fulminant hepatic necrosis, and hepatoma; anorexia, vomiting, fatal and non-fatal hepatic failure.

Skin: alopecia, pruritus. A variety of skin changes (e.g., nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails) have been reported.

Reproductive: gynecomastia, loss of libido, erectile dysfunction.

Eye: progression of cataracts (lens opacities), ophthalmoplegia.

Laboratory Abnormalities

elevated transaminases, alkaline phosphatase, γ-glutamyl transpeptidase, and bilirubin; thyroid function abnormalities.

Adolescent Patients (ages 10-17 years)

In a 48-week controlled study in adolescent boys with heFH (n=132) and a 24-week controlled study in girls who were at least 1 year post-menarche with heFH (n=54), the safety and tolerability profile of the groups treated with MEVACOR (10 to 40 mg daily) was generally similar to that of the groups treated with placebo (see CLINICAL PHARMACOLOGY, Clinical Studies in Adolescent Patients and PRECAUTIONS, Pediatric Use).

Read the entire FDA prescribing information for Mevacor (Lovastatin) »

A A A

Mevacor - User Reviews

Mevacor User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Mevacor sorted by most helpful. Patient Discussions FAQs

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.


Cholesterol Management

Tips to keep it under control.