What are the most common side effects of SIMVASTATIN?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for SIMVASTATIN. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is SIMVASTATIN the same as SIMVASTATIN?

SIMVASTATIN is a brand name for SIMVASTATIN. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

SIMVASTATIN

Q: What is SIMVASTATIN used for?

SIMVASTATIN (brand name SIMVASTATIN) is a Statin indicated for 1 INDICATIONS AND USAGE Simvastatin tablets USP are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease.

Q: How does SIMVASTATIN work?

SIMVASTATIN works through the following mechanism: 12.1 Mechanism of Action Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration. Simvastatin acid and its metabolites are inhibitors of HMG-CoA reductase, the rate-limiting enzyme that converts HMG-CoA to mevalonate, a precursor of cholesterol..

Statin

Brand names: SIMVASTATIN, Zocor

Oral

Mechanism of Action

12.1 Mechanism of Action Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration. Simvastatin acid and its metabolites are inhibitors of HMG-CoA reductase, the rate-limiting enzyme that converts HMG-CoA to mevalonate, a precursor of cholesterol.

Indications

1 INDICATIONS AND USAGE Simvastatin tablets USP are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death

non-fatal myocardial infarction and stroke

and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease

cerebrovascular disease

peripheral vascular disease

and/or diabetes

Contraindications

• 4 CONTRAINDICATIONS Simvastatin is contraindicated in the following conditions: Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals
• macrolide antibiotics
• anti-viral medications
• and nefazodone) [see DRUG INTERACTIONS ( 7.1 )]. Concomitant use of cyclosporine
• including anaphylaxis

FDA Warnings

5 WARNINGS AND PRECAUTIONS Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher simvastatin dosage
Chinese patients may be at higher risk for myopathy
Temporarily discontinue simvastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis
Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing simvastatin dosage

Known Side Effects

14 documented side effects by frequency

Fatigue

1-10%

Nausea

1-10%

Shortness of Breath

1-10%

Diarrhea

1-10%

Drug Not Working

1-10%

Dizziness

1-10%

Weakness

1-10%

Falls

1-10%

Headache

1-10%

Muscle Pain

1-10%

Vomiting

1-10%

Joint Pain

1-10%

General Unwellness

1-10%

Limb Pain

0.1-1%

Community Discussions

No community discussions found for SIMVASTATIN yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → SIMVASTATIN openFDA label JSON → SIMVASTATIN FAERS adverse-event reports → SIMVASTATIN ClinicalTrials.gov → completed Phase 2+ trials of SIMVASTATIN

Compare With

13 available comparisons

Formulations

Dosage Forms

Tablet

Route

Oral