Simvastatin: uses, dosing, side effects & brands
Simvastatin is a hmg-coa reductase inhibitor sold in the U.S. under 2 brand and generic names, for coronary artery disease, hypercholesterolemia and hyperlipoproteinemias. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Hmg-Coa Reductase Inhibitor
- Treats (across its forms)
- Coronary Artery Disease, Hypercholesterolemia and Hyperlipoproteinemias
- Available as
- Tablet · Suspension
- Sold as
- 2 products — Zocor and Flolipid
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Half-life
- about 2 hours (short) in typical adults
- What the pharmacy pays
- about $0.93 for a 30-count supply — not your price
How Zocor is dosed
From the FDA label for Zocor (application NDA019766). Other simvastatin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Important Dosage and Administration Information: ( 2.1 ) ZOCOR is no longer marketed in the 5 mg and 80 mg strengths. For dosing with the 5 mg strength, use another simvastatin product. Take ZOCOR orally once daily in the evening. Maximum recommended dosage is ZOCOR 40 mg once daily. An 80 mg daily dosage of ZOCOR is restricted to patients who have been taking simvastatin 80 mg daily chronically (e.g., for 12 months or more) without evidence of muscle toxicity. For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving ZOCOR 40 mg daily, prescribe alternative LDL-C lowering treatment. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating, and adjust the dosage if necessary. Adults: Recommended dosage is 20 mg to 40 mg once daily. ( 2.2 ) Pediatric Patients Aged 10 Years and Older with HeFH: Recommended dosage is 10 mg to 40 mg once daily. ( 2.3 ) Patients with Severe Renal Impairment: Recommended starting dosage is simvastatin 5 mg once daily. ( 2.4 , 8.6 ) See full prescribing information for ZOCOR dosage modifications due to drug interactions. ( 2.5 ) 2.1 Important Dosage and Administration Information ZOCOR is no longer marketed in the 5 mg and 80 mg strengths. For dosing with the 5 mg strength, use another simvastatin product. Take ZOCOR orally once daily in the evening. The maximum recommended dosage is…
Everything below is the FDA label for Zocor (tablet). Simvastatin is also sold as suspension, and those are different medicines to take — follow the label for the one you were prescribed.
Zocor side effects
The following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] Hepatic Dysfunction [see Warnings and Precautions (5.3) ] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4) ] Most common adverse reactions (incidence ≥5%) are upper respiratory infection, headache, abdominal pain, constipation, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In clinical studies, 2,423 adult patients were exposed to ZOCOR with a median duration of follow-up of approximately 18 months. The most commonly reported adverse reactions (incidence ≥5%) in these ZOCOR clinical studies were: upper respiratory infections (9%), headache (7%), abdominal pain (7%), constipation (7%), and nausea (5%). Overall, 1.4% of patients discontinued ZOCOR due to adverse reactions. The most common…
Who shouldn’t take Zocor
ZOCOR 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, danazol or gemfibrozil [see Drug Interactions (7.1) ] . Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ] . Hypersensitivity to simvastatin or any excipients in ZOCOR. Hypersensitivity reactions, including anaphylaxis, angioedema and Stevens-Johnson syndrome, have been reported [see Adverse Reactions (6.2) ] . Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications, and nefazodone) ( 4 , 7.1 ) Concomitant use of cyclosporine, danazol or gemfibrozil ( 4 , 7.1 ) Acute liver failure or decompensated cirrhosis ( 4 , 5.3 ) Hypersensitivity to simvastatin or any excipient in ZOCOR ( 4 , 6.2 )
Zocor drug interactions
See full prescribing information for details regarding concomitant use of ZOCOR with other drugs or grapefruit juice that increase the risk of myopathy and rhabdomyolysis. ( 2.5 , 7.1 ) Coumarin Anticoagulants: Obtain INR before ZOCOR initiation and monitor INR during ZOCOR dosage initiation or adjustment. ( 7.2 ) Digoxin: During ZOCOR initiation, monitor digoxin levels. ( 7.2 ) 7.1 Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with ZOCOR ZOCOR is a substrate of CYP3A4 and of the transport protein OATP1B1. ZOCOR exposure can be significantly increased with concomitant administration of inhibitors of CYP3A4 and OATP1B1. Table 2 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when used concomitantly with ZOCOR and instructions for preventing or managing them [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ] . Table 2: Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with ZOCOR Strong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with ZOCOR increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher ZOCOR dosages. Intervention: Concomitant use of strong CYP3A4 inhibitors with ZOCOR is contraindicated [see Contraindications (4) ] . If treatment with a CYP3A4 inhibitor is unavoidable, suspend ZOCOR during the course of strong CYP3A4 inhibitor treatment. Examples: Select azole anti-fungals (e.g., itraconazole, ketoconazole, posaconazole, and voriconazole), select macrolide antibiotics (e.g., erythromycin and clarithromycin), select HIV protease inhibitors (e.g., nelfinavir, ritonavir, and darunavir/ritonavir), select HCV protease inhibitors (e.g., boceprevir and telaprevir), cobicistat-containing products, and nefazodone. Cyclosporine, Danazol, or Gemfibrozil Clinical Impact: The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine, danazol, or gemfibrozil with ZOCOR. Gemfibrozil may cause myopathy when given alone. Intervention: Concomitant use of cyclosporine, danazol, or gemfibrozil with ZOCOR is contraindicated [see Contraindications (4) ] . 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 ZOCOR. Intervention: For patients taking verapamil, diltiazem, or dronedarone, do not exceed ZOCOR 10 mg daily. For patients taking amiodarone, amlodipine, or ranolazine, do not exceed ZOCOR 20 mg daily [see Dosage and Administration (2.5) ] . Lomitapide Clinical Impact: Simvastatin exposure is approximately doubled with concomitant use of lomitapide and the risk of myopathy and rhabdomyolysis is increased. Intervention: Reduce the dose of ZOCOR by 50% if initiating lomitapide. Do not exceed ZOCOR 20 mg daily (or ZOCOR 40 mg daily for patients who have previously taken an 80 mg daily dosage of ZOCOR chronically) while taking lomitapide [see Dosage and Administration (2.1 , 2.5) ] . Daptomycin Clinical Impact: Cases of rhabdomyolysis have been reported with simvastatin administered with daptomycin. Both ZOCOR and daptomycin can cause myopathy and rhabdomyolysis when given alone and the risk of myopathy and rhabdomyolysis may be increased by coadministration. Intervention: If treatment with daptomycin is required, consider temporarily suspending ZOCOR during the course of daptomycin treatment. Niacin Clinical Impact: Cases of myopathy and rhabdomyolysis have been observed with concomitant use of lipid modifying dosages of niacin-containing products (≥1 gram/day niacin) with ZOCOR. The risk of myopathy is greater in Chinese patients. In a clinical study (median follow-up 3.9 years) of patients at high risk of CVD and with well-controlled LDL-C levels on simvastatin 40 mg/day with or without ezetimibe 10 mg/day, there was no incremental benefit on cardiovascular outcomes with the addition of lipid-modifying doses of niacin. Intervention: Concomitant use of ZOCOR with lipid-modifying dosages of niacin is not recommended in Chinese patients [see Use in Specific Populations (8.8) ] . For non-Chinese patients, consider if the benefit of using lipid-modifying doses of niacin concomitantly with ZOCOR outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of either drug. Fibrates (other than Gemfibrozil) Clinical Impact: Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with ZOCOR. Intervention: Consider if the benefit of using fibrates concomitantly with ZOCOR outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of either drug. Colchicine Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with ZOCOR. Intervention: Consider if the benefit of using colchicine concomitantly with ZOCOR outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of either drug. Grapefruit Juice Clinical Impact: Grapefruit juice can raise the plasma levels of simvastatin and may increase the risk of myopathy and rhabdomyolysis. Intervention: Avoid grapefruit juice when taking ZOCOR. 7.2 ZOCOR Effects on Other Drugs Table 3 presents ZOCOR’s effect on other drugs and instructions for preventing or managing them. Table 3: ZOCOR Effects on Other Drugs Coumarin Anticoagulants Clinical Impact: ZOCOR may potentiate the effect of coumarin anticoagulants and increase the INR. The concomitant use of ZOCOR (20 to 40 mg) and coumarin anticoagulants increased the INR from a baseline of 1.7 to 1.8 in healthy subjects and from 2.6 to 3.4 in patients with hyperlipidemia. There are postmarketing reports of clinically evident bleeding and/or increased INR in patients taking concomitant statins and warfarin. Intervention: In patients taking coumarin anticoagulants, obtain an INR before starting ZOCOR and frequently enough after initiation, dose titration, or discontinuation to ensure that no significant alteration in INR occurs. Once the INR is stable, monitor INR at regularly recommended intervals. Digoxin Clinical Impact: Concomitant use of digoxin with ZOCOR may result in elevated plasma digoxin concentrations [see Clinical Pharmacology (12.3) ] . Intervention: Monitor digoxin levels in patients taking digoxin when ZOCOR is initiated.
Simvastatin and food
Grapefruit & grapefruit juice
Avoid grapefruit and grapefruit juice with this medicine unless your pharmacist or the label says it's fine — check, because not every drug in a class is affected the same way.
Grapefruit Juice and Some Drugs Don't Mix — U.S. FDA ↗
Every simvastatin product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Tablet | Generic | $1 | View → | |
| 2 | Not yet rated | Prescription | Suspension | Generic | $1 | View → |
What simvastatin pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| LL;C05 | 80 mg | red | capsule | — |
| LL;C03 | 20 mg | brown | oval | — |
| LL;C04 | 40 mg | red | round | — |
| LL;C03 | 20 mg | brown | oval | — |
| LL;C02 | 10 mg | pink | oval | — |
| LL;C05 | 80 mg | red | capsule | — |
| B304;80 | 80 mg | pink | capsule | — |
| LL;C04 | 40 mg | red | round | — |
| A;15 | 5 mg | yellow | round | — |
| LL;C03 | 20 mg | brown | oval | — |
| B301;10 | 10 mg | orange | oval | — |
| LL;C02 | 10 mg | pink | oval | — |
Combination products containing simvastatin
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Simvastatin recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long simvastatin keeps
No simvastatin label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does simvastatin expire? The in-use limits and storage rules from its labelsSimvastatin and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for simvastatin: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo relevant published information exists on the use of simvastatin during breastfeeding. Because of a concern with disruption of infant lipid metabolism, the consensus is that simvastatin should not be used during breastfeeding. However, others have argued that children homozygous for familial hypercholesterolemia are treated with statins beginning at 1 year of age, that statins have low oral bioavailability, and risks to the breastfed infant are low, especially with rosuvastatin and pravastatin. Until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
National Institute of Child Health and Human Development, record revised July 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about simvastatin
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 213,171 reports naming simvastatin, and the FDA flagged 74% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- fatigue11,990 reports
- nausea11,053 reports
- dyspnoea10,793 reports
- diarrhoea10,643 reports
- dizziness9,549 reports
- fall7,995 reports
- headache7,760 reports
- asthenia7,553 reports
Read these as a signal, not a rate. A report does not mean simvastatin caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 26, 2026.
How long simvastatin stays in your system
The elimination half-life of simvastatin is about 2 hours (short) in typical adults. The FDA/DailyMed simvastatin label does not print an explicit numeric elimination half-life; it states plasma total radioactivity peaks at 4 hours and falls to about 10% of peak by 12 hours postdose. Published pharmacokinetics put the parent drug's elimination half-life at roughly 2 hours (some studies show wide individual variation, up to ~6 h mean with a 2-29 h range). Simvastatin's active beta-hydroxyacid metabolite (simvastatin acid) has a similar, NOT longer, half-life of about 1.9 hours, so there is no long-lived active metabolite to worry about.
Simvastatin tablet, film coated — DailyMed (FDA label), Clinical Pharmacology / Pharmacokinetics ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related guides
Related calculators
Frequently asked questions
What is Zocor?
Zocor (Simvastatin) is a HMG-CoA reductase inhibitor used to treat Coronary Artery Disease, Hypercholesterolemia, Hyperlipoproteinemias, Hypertriglyceridemia.
What kind of drug is simvastatin?
The FDA classifies simvastatin as a hmg-coa reductase inhibitor. Statins block HMG-CoA reductase, the key enzyme the liver uses to make cholesterol. With less cholesterol being produced, the liver pulls more LDL ("bad") cholesterol out of the blood, lowering overall blood cholesterol levels. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does simvastatin stay in your system?
The elimination half-life of simvastatin is about 2 hours (short) in typical adults — that is how long the body takes to clear half of a dose. The FDA/DailyMed simvastatin label does not print an explicit numeric elimination half-life; it states plasma total radioactivity peaks at 4 hours and falls to about 10% of peak by 12 hours postdose. Published pharmacokinetics put the parent drug's elimination half-life at roughly 2 hours (some studies show wide individual variation, up to ~6 h mean with a 2-29 h range). Simvastatin's active beta-hydroxyacid metabolite (simvastatin acid) has a similar, NOT longer, half-life of about 1.9 hours, so there is no long-lived active metabolite to worry about. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take simvastatin with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run simvastatin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is simvastatin sold under?
We track 2 simvastatin-containing products in the U.S.: Zocor and Flolipid. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does simvastatin come in?
Across the brands we track, simvastatin is currently marketed as tablet and suspension, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic simvastatin?
We do not currently list a generic-labelled simvastatin product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Has simvastatin been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions simvastatin. The most recent: Ezetimibe and Simvastatin Tablets (May 19, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
What should I avoid while taking simvastatin?
Food: grapefruit and grapefruit juice (and, for some drugs, seville oranges) — see the food section above for what each one does and whether it means avoiding it or just being consistent. This is what the FDA label and our cited sources say — it is not a complete list. Your pharmacist can check your own combination.
Cite this page
- APA
- pharmaranks. (2026, July 24). Simvastatin: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/simvastatin
- MLA
- “Simvastatin: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/simvastatin.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for simvastatin on DailyMed (NIH) ↗.