simvastatin
Brand names: Zocor
Ezetimibe and simvastatin is a combination medicine that helps lower bad cholesterol (LDL-C) in your blood. It can also reduce the risk of heart problems like heart attack and stroke.
Drug Pricing (NADAC)
Brand Price
$8.96/unit
Generic Price
$0.03/unit
Generic Savings
100%
Generic Available
Yes (7 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine is used to lower high LDL cholesterol.
Common side effects
Headache, Upper respiratory tract infection, Muscle pain
Key warnings
This medicine can cause muscle problems, including rhabdomyolysis, which can lead to kidney damage and death.
How It Works
Ezetimibe and simvastatin works in two ways to lower cholesterol. Ezetimibe stops your body from absorbing cholesterol from food. Simvastatin blocks a substance your body needs to make cholesterol.
How to Take It
Take this medicine once a day in the evening. You can take it with or without food. The usual dose is 10/10 mg to 10/40 mg daily. Your doctor may change your dose based on your cholesterol levels.
Pregnancy & Breastfeeding
Do not take this medicine if you are pregnant. It can harm your unborn baby. Talk to your doctor if you are breastfeeding or plan to breastfeed, as it is not recommended during treatment with this medicine.
Missed Dose
If you miss a dose, take it as soon as you remember. Do not take two doses at the same time.
Storage
Store at room temperature, away from heat and moisture. Keep the container tightly closed.
Side Effects (from patient reports)
Based on 109,346 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 245,754 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2002–2025.
Total Reports
245,754
Death-Related Reports
21,913
Hospitalization Reports
94,740
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 13,574 |
| 2 | NAUSEA | 12,945 |
| 3 | DYSPNOEA | 12,431 |
| 4 | DIARRHOEA | 11,813 |
| 5 | DRUG INEFFECTIVE | 11,353 |
| 6 | DIZZINESS | 10,971 |
| 7 | FALL | 9,198 |
| 8 | ASTHENIA | 9,141 |
| 9 | PAIN | 9,097 |
| 10 | HEADACHE | 8,818 |
| 11 | MYALGIA | 8,327 |
| 12 | VOMITING | 8,100 |
| 13 | MALAISE | 7,604 |
| 14 | ARTHRALGIA | 7,562 |
| 15 | DRUG INTERACTION | 7,251 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
This medicine can cause muscle problems, including rhabdomyolysis, which can lead to kidney damage and death. The risk is higher if you are over 65, have kidney problems, or take certain other medicines. Tell your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or feel sick. This medicine can also cause liver problems. Your doctor may do blood tests to check your liver before and during treatment.
Known Drug Interactions
Intervention: For patients taking verapamil, diltiazem, or dronedarone, do not exceed ezetimibe and simvastatin 10 mg/10 mg daily.
Mechanism: Diltiazem blocks the enzymes that break down simvastatin, causing the drug to stay in your body longer. This can lead to a higher risk of muscle pain or damage.
What to do: Your doctor should limit your simvastatin dose to 10 mg daily while you are taking diltiazem.
Intervention: For patients taking verapamil, diltiazem, or dronedarone, do not exceed ezetimibe and simvastatin 10 mg/10 mg daily.
Mechanism: Verapamil slows down the process your body uses to get rid of simvastatin, which can cause the drug to reach toxic levels. This increases the risk of serious muscle injury.
What to do: Do not take more than 10 mg of simvastatin per day if you are also taking verapamil.
Cyclosporine, Danazol, or Gemfibrozil Clinical Impact: The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine, danazol, or gemfibrozil with ezetimibe and simvastatin. Intervention: Concomitant use of cyclosporine, danazol, or gemfibrozil with ezetimibe and simvastatin is contraindicated [see Contraindications ( 4 )].
Mechanism: Cyclosporine prevents your body from processing simvastatin correctly, which can cause a dangerous amount of the drug to build up. This significantly increases the risk of severe muscle breakdown.
What to do: Avoid taking these two drugs together because the combination is unsafe and can cause severe muscle damage.
Amiodarone, Dronedarone, Ranolazine, or Calcium Channel Blockers Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, dronedarone, ranolazine, or calcium channel blockers with ezetimibe and simvastatin. For patients taking amiodarone, amlodipine, or ranolazine, do not exceed ezetimibe and simvastatin 10 mg/20 mg daily [see Dosage and Administration ( 2.3 )].
Mechanism: Amiodarone interferes with how your body breaks down simvastatin, leading to higher levels of the medicine in your blood. This makes muscle damage more likely to happen.
What to do: If you are taking amiodarone, your daily dose of simvastatin should not go above 20 mg.
Amiodarone, Dronedarone, Ranolazine, or Calcium Channel Blockers Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, dronedarone, ranolazine, or calcium channel blockers with ezetimibe and simvastatin. Intervention: For patients taking verapamil, diltiazem, or dronedarone, do not exceed ezetimibe and simvastatin 10 mg/10 mg daily.
Mechanism: Dronedarone slows down the removal of simvastatin from your body, which can cause the drug to build up to unsafe levels. This increases the risk of serious muscle problems.
What to do: Your daily dose of simvastatin should be limited to 10 mg while you are taking dronedarone.
Common Questions
Can I take this medicine with other cholesterol-lowering drugs?
How often will my cholesterol be checked?
What should I do if I have muscle pain?
Can I drink grapefruit juice while taking this medicine?
Are there any foods I should avoid?
How long will I need to take this medicine?
What happens if I stop taking this medicine?
Can this medicine cure my high cholesterol?
Will this medicine cause weight gain?
Can I take this medicine if I have kidney problems?
What are the common side effects of simvastatin?
Does simvastatin interact with other medications?
What drug class is simvastatin?
Is there a generic version of simvastatin?
Is simvastatin safe during pregnancy?
Has simvastatin been recalled?
Active Recalls
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Preferred Pharmaceuticals, Inc.
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What the FDA Data Shows for simvastatin
The FDA label for simvastatin (sold under brand names such as Zocor) classifies it as a prescription-only medication in the HMG-CoA Reductase Inhibitor (Statin) class. This medicine is used to lower high LDL cholesterol. Official labeling lists 4 commonly reported side effects, including Headache, Upper respiratory tract infection, Muscle pain.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 109,346 voluntary reports. The database also lists 41 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.03 versus $8.96 for the brand — a 100% generic savings.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: April 14, 2024
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages