HMG-CoA Reductase Inhibitor · Brand: Zocor
Simvastatin Side Effects: Common, Serious & FDA Warnings
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FDA-Approved For
Quick answer
Based on 261,000+ FDA adverse event reports, the most-reported simvastatin reactions include fatigue, nausea, and dyspnoea. No active recalls are on record. The FDA-approved label does not carry a boxed warning.
For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.
Common Side Effects of Simvastatin
The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for simvastatin. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.
| Reaction | Reports | % of total |
|---|---|---|
| Fatigue | 14,382 | 5.5% |
| Nausea | 13,964 | 5.3% |
| Dyspnoea | 13,098 | 5.0% |
| Diarrhoea | 12,440 | 4.8% |
| Dizziness | 11,725 | 4.5% |
| Asthenia | 9,739 | 3.7% |
| Pain | 9,754 | 3.7% |
| Headache | 9,408 | 3.6% |
| Myalgia | 9,001 | 3.4% |
| Vomiting | 8,583 | 3.3% |
Serious Outcomes and FDA Warnings
FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.
| Outcome flag | Reports | % of total |
|---|---|---|
| Serious reports (any flag) | — | — |
| Hospitalization | — | — |
| Death reported as outcome FAERS outcome flag, not a reaction term. The patient was on the drug when the report was filed; causation is not established. | 6,639 | 2.5% |
From the FDA-approved label, Section 5.1: Myopathy and Rhabdomyolysis
Simvastatin may cause myopathy and rhabdomyolysis. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis in patients treated with statins, including simvastatin. In clinical studies of 24,747 simvastatin -treated patients with a median follow-up of 4 years, the incidence of myopathy, defined as unexplained muscle weakness, pain, or tenderness accompanied by creatinine kinase (CK) increases greater than ten times the upper limit of normal (10xULN), were approximately 0.03%, 0.08%, and 0.61% in patients treated with simvastatin 20 mg, 40 mg, and 80 mg daily, respectively.Show full Section 5.1
In another clinical study of 12,064 simvastatin -treated patients (with a history of myocardial infarction) with a mean follow-up of 6.7 years, the incidences of myopathy in patients taking simvastatin 20 mg and 80 mg daily were approximately 0.02% and 0.9%, respectively. The incidences of rhabdomyolysis (defined as myopathy with a CK >40xULN) in patients taking simvastatin 20 mg and 80 mg daily were approximately 0% and 0.4%, respectively [see ADVERSE REACTIONS ( 6.1 )]. Risk Factors for Myopathy Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs (including other lipid-lowering therapies), and higher simvastatin dosage; Chinese patients on simvastatin may be at higher risk for myopathy [see CONTRAINDICATIONS ( 4 ), DRUG INTERACTIONS ( 7.1 ), AND USE IN SPECIFIC POPULATIONS ( 8.8 )]. The risk of myopathy is increased by elevated plasma levels of simvastatin and simvastatin acid. The risk is also greater in patients taking simvastatin 80 mg daily compared with patients taking lower simvastatin dosages and compared with patients using other statins with similar or greater LDL-C-lowering efficacy [see ADVERSE REACTIONS ( 6.1 )]. Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis The concomitant use of strong CYP3A4 inhibitors with simvastatin is contraindicated. If short-term treatment with strong CYP3A4 inhibitors is required, temporarily suspend simvastatin during the duration of strong CYP3A4 inhibitor treatment. The concomitant use of simvastatin with gemfibrozil, cyclosporine, or danazol is also contraindicated [see CONTRAINDICATIONS ( 4 ) AND DRUG INTERACTIONS ( 7.1 )]. Simvastatin dosage modifications are recommended for patients taking lomitapide, verapamil, diltiazem, dronedarone, amiodarone, amlodipine or ranolazine [see DOSAGE AND ADMINISTRATION ( 2.5 )]. Simvastatin use should be temporarily suspended in patients taking daptomycin. Lipid modifying doses (≥1 gram/day) of niacin, fibrates, colchicine, and grapefruit juice may also increase the risk of myopathy and rhabdomyolysis [see DRUG INTERACTIONS ( 7.1 )]. Use the 80 mg daily dosage of simvastatin only in patients who have been taking simvastatin 80 mg daily chronically without evidence of muscle toxicity [see DOSAGE AND ADMINISTRATION ( 2.1 )] . If patients treated with an 80 mg daily dosage of simvastatin tablet USP are prescribed an interacting drug that increases the risk for myopathy and rhabdomyolysis, switch to an alternate statin [SEE DRUG INTERACTIONS ( 7.1 )]. Discontinue simvastatin if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Muscle symptoms and CK increases may resolve if simvastatin is discontinued. Temporarily discontinue simvastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis, e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the simvastatin dosage and advise patients receiving an 80 mg daily dosage of simvastatin tablet USP of the increased risk of myopathy and rhabdomyolysis. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
From the FDA-approved label, Section 5.4: Increases in HbA1c and Fasting Serum Glucose Levels
Increases in HbA1c and fasting serum glucose levels have been reported with statins, including simvastatin. Optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices.
Simvastatin Recalls
FDA enforcement actions matched to simvastatin via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.
No recalls are on record for this drug in the FDA enforcement database.
Show 10 closed recalls (2014 to 2023)
Includes resolved and terminated recalls matched to simvastatin. Most recent first.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2023-03-08 | CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. | Class II | 1,190,484 bottles | Terminated |
| 2023-03-08 | CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. | Class II | 205,631 bottles | Terminated |
| 2023-03-08 | CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. | Class II | 256,648 bottles | Terminated |
| 2023-03-08 | CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. | Class II | 1,394,208 bottles | Terminated |
| 2023-03-08 | CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. | Class II | 291,378 bottles | Terminated |
| 2020-04-22 | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Aurobindo Pharma USA Inc. | Class II | 26976 units | Terminated |
| 2019-09-04 | Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B Aurobindo Pharma USA Inc. | Class III | 2,352/1000 count bottles | Terminated |
| 2018-01-24 | Presence of foreign substance: metallic razor blade was found in one bottle. Hetero Labs, Ltd. - Unit III | Class III | N/A | Terminated |
| 2015-03-18 | Failed Impurities/Degradation Specifications: Product failed a known impurity specification. Micro Labs Usa, Inc S | Class III | 13464 bottles | Terminated |
| 2014-11-19 | Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification. Micro Labs Usa, Inc S | Class III | 1,008 bottles | Terminated |
Simvastatin Shortages
FDA-listed shortages of simvastatin products. Strength and dosage-form level detail.
No active or recent shortages of simvastatin are listed. We refresh this view daily.
Is Simvastatin Safe?
Simvastatin is FDA-approved and the label does not carry a boxed warning. The label's Warnings and Precautions section covers myopathy and rhabdomyolysis (Section 5.1), immune-mediated necrotizing myopathy (Section 5.2), hepatic dysfunction (Section 5.3), increases in hba1c and fasting serum glucose levels (Section 5.4).
As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.
FDA-Approved Indications
Simvastatin is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.
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, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia.Show full Indications and Usage
In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia. Simvastatin tablets USP are an HMG-CoA reductase inhibitor 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, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.
Frequently Asked Questions
What are the most-reported side effects of simvastatin?
Fatigue, nausea, and dyspnoea are among the most-reported reactions in FDA FAERS data for simvastatin. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.
Is simvastatin the same as Zocor?
Simvastatin is the generic name; Zocor is a brand name for the same active ingredient. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.
Has simvastatin been recalled?
Yes. Simvastatin has closed recalls on record in the FDA enforcement database; no recalls are currently active. Reasons are dominated by CGMP deviations, contamination or foreign material, and mislabeling. See the recalls table on this page for dates, firm names, and lot quantities.
What do FDA recall classes mean?
Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.
Data Sources & Methodology
How each section of this page is sourced, and how often the data is refreshed.
| Source | Endpoint | Refresh |
|---|---|---|
| FAERS reactions | openFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports. | Daily |
| Recalls | openFDA /drug/enforcement.json. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here. | 6 hours |
| Shortages | FDA Drug Shortages list. | Daily |
| Boxed warnings & label sections | openFDA /drug/label.json. Labels are stable; monthly cadence is sufficient. | Monthly |
| Condition categories | Synonym-mapped from drug_labels.indications. Methodology at /methodology/. | Per-drug |
What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.