Prescription medication · HMG-CoA Reductase Inhibitor (Statin)
simvastatin
Also sold as Zocor.
Data updated 2026-05-15
- 245,754
- FDA reportsHeavily reported
- 41
- InteractionsMany interactions
- 99% less
- Generic vs brandHuge savings
- 1
- Recall record
What the data shows
simvastatin (Zocor) is a prescription HMG-CoA Reductase Inhibitor (Statin), in the top 5% of tracked drugs by FAERS report volume (245,754 FDA reports), whose generic costs a fraction of the brand (about 99% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$8.96/unit
Generic Price
$0.03/unit
Generic Savings
99%
Generic Available
Yes (7 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
NADAC price trail: SIMVASTATIN 10 MG TABLET
Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -12.1% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| October 23, 2024 | $0.0316/EA | - | 1 |
| December 18, 2024 | $0.0278/EA | -12.1% | 25 |
What it does
Information not available.
Common side effects
Headache, Upper respiratory tract infection, Muscle pain
Key warnings
No specific warnings noted. Always follow your prescriber's instructions.
Side Effects (from patient reports)
Based on 245,754 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for simvastatin, by number of reports
- Fatigue
Fatigue
13,574 reports
- Nausea
Nausea
12,945 reports
- Dyspnoea
Dyspnoea
12,431 reports
- Diarrhoea
Diarrhoea
11,813 reports
- Dizziness
Dizziness
10,971 reports
- Fall
Fall
9,198 reports
- Asthenia
Asthenia
9,141 reports
- Pain
Pain
9,097 reports
- Headache
Headache
8,818 reports
- Myalgia
Myalgia
8,327 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for simvastatin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where simvastatin sits
simvastatin has more FDA adverse-event reports than 96% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is simvastatin; the line is the median (50th percentile).
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
Reports Mentioning Death
21,913
8.9% of reports — not proof of cause
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 |
| 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 |
| 16 | PAIN IN EXTREMITY | 6,951 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
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?
Has simvastatin been recalled?
Active Recalls
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Preferred Pharmaceuticals, Inc.
Related Medications in HMG-CoA Reductase Inhibitor (Statin)
Other drugs grouped near simvastatin - same-class peers and common alternatives.
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atorvastatin
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bempedoic acid/ezetimibe
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Nexlizet is a combination medicine that helps lower cholesterol.
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cholestyramine
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for simvastatin: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 245,754.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 8.92%.
- adenosine Δ 0.00 pts · 1,547 reports · Endogenous Nucleoside (Antiarrhythmic) 8.92%death share
- clomipramine Δ 0.01 pts · 4,403 reports · Tricyclic Antidepressant (TCA) 8.93%death share
- glyburide Δ 0.03 pts · 23,902 reports · Sulfonylurea 8.88%death share
- risedronate Δ 0.04 pts · 30,089 reports · Bisphosphonate 8.96%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on simvastatin
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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. Regulatory labeling describes its approved uses and the patient populations studied in pre-market trials. 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 245,754 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 99% 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: April 14, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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