Simvastatin
Gerosim, Simvastad, Simvastatin, Simvatin · ATC code C10AA01
Brand names: Gerosim, Simvastad, Simvatin, Zocord, Simva, Simvabeta, Simvacor, Simvahexal, Zocor, Lipvakol, Simta
- Key facts
- Active substance
- Simvastatin
- ATC code
- C10AA01
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-29
Key facts
Simvastatin is an HMG-CoA reductase inhibitor (statin). Per the US prescribing information, it is used to reduce cardiovascular risk in high-risk patients and as an adjunct to diet in lipid disorders.
What it is used for
- Reducing total mortality and the risk of coronary death, myocardial infarction, stroke and revascularization in adults at high risk of coronary heart disease events
- Lowering LDL-C in primary hyperlipidemia and heterozygous familial hypercholesterolemia (adults and children aged 10 years and older)
- Adjunct in homozygous familial hypercholesterolemia
- Primary dysbetalipoproteinemia and hypertriglyceridemia in adults
Dosing
- Take once daily in the evening
- Adults: 20 mg to 40 mg once daily; maximum recommended dose 40 mg
- 80 mg daily is restricted to patients already taking it chronically (e.g. 12 months or more) without muscle toxicity
- Children 10 years and older with HeFH: 10 mg to 40 mg daily
- Severe renal impairment (CLcr 15 to 29 mL/min): starting dose 5 mg once daily
- With verapamil, diltiazem or dronedarone not above 10 mg; with amiodarone, amlodipine or ranolazine not above 20 mg; with lomitapide reduce the dose by 50%
Contraindications
- Concomitant strong CYP3A4 inhibitors (select azole antifungals, macrolide antibiotics, antivirals, nefazodone)
- Concomitant cyclosporine, danazol or gemfibrozil
- Acute liver failure or decompensated cirrhosis
- Hypersensitivity to simvastatin or any excipient
Important warnings
- Myopathy and rhabdomyolysis with acute kidney injury, rarely fatal; risk is dose-related and higher at 80 mg, with interacting drugs and in Chinese patients
- Immune-mediated necrotizing myopathy
- Hepatic dysfunction
- Increases in HbA1c and fasting serum glucose
Side effects
- Most common (≥5%): upper respiratory infections (9%), headache (7%), abdominal pain (7%), constipation (7%), nausea (5%)
- Myalgia, arthralgia, gastrointestinal disorders
- Rarely myopathy and rhabdomyolysis
Interactions
- Strong CYP3A4 inhibitors, cyclosporine, danazol, gemfibrozil: contraindicated
- Verapamil, diltiazem, dronedarone, amiodarone, amlodipine, ranolazine, lomitapide: dose limits
- Niacin, fibrates, colchicine, daptomycin: increased myopathy risk
- Avoid grapefruit juice
Pregnancy and breastfeeding
- Discontinue when pregnancy is recognized (or weigh ongoing therapeutic needs); may cause fetal harm based on its mechanism
- Breastfeeding during treatment is not recommended; see the full prescribing information
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Patient information (US)
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
Austria
- GerosimG.L. Pharma Gmbh · 1 register entry
- SimvastadStada Arzneimittel Gmbh · 1 register entry
- Simvastatin1a Pharma Gmbh, Teva B.V, Krka, D.D., Novo Mesto, Genericon Pharma Gesellschaft M.B.H., Bluefish Pharmaceuticals Ab, +pharma Arzneimittel Gmbh, Actavis Group Ptc Ehf., Sandoz Gmbh, Hexal Pharma Gmbh, Merck Gesellschaft Mbh · 11 register entries
- SimvatinG.L. Pharma Gmbh · 2 register entries
- ZocordOrganonhealthcare Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Germany
- SimvaBasics Gmbh, Aristo Pharma Gmbh (Art 57), Tad Pharma Gmbh · 5 register entries
- SimvabetaBetapharm Arzneimittel Gmbh · 3 register entries
- SimvacorHexal Ag · 1 register entry
- SimvahexalHexal Ag · 1 register entry
- Simvastatin1 A Pharma Gmbh, Ratiopharm Gmbh, Aaa-Pharma Gmbh, Bluefish Pharmaceuticals Ab, Heumann Pharma Gmbh & Co. Generica Kg, Puren Pharma Gmbh & Co. Kg, Stadapharm Gmbh, Dexcel Pharma Gmbh, Viatris Germany Gmbh, Abz-Pharma Gmbh, Aliud Pharma Gmbh · 14 register entries
- ZocorOrganonhealthcare Gmbh · 2 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Turkey
- LipvakolNOBEL İLAÇ SAN. VE TİC. A.Ş. · 5 register entries
- SimtaULKAR İLAÇ PAZARLAMA LTD. ŞTİ. · 3 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
USA
- ZocorOrganon LLC · 1 register entry
Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29
Brand names in 27 more European countries
- Belgium
- Simvastatin Ab, Simvastatin Sandoz, Simvastatine Eg, Simvastatine Teva, Simvastatine Viatris, Zocor
- Bulgaria
- Simvacor, Акталипид, Вазилип, Зокор, Неосимва, Симвастатин Al, Симвастатин Генерикон, Холеста
- Croatia
- Lipex, Lipterra, Protecta, Simvastatin Genericon, Simvax, Vasilip
- Cyprus
- Kymazol, Priacin, Zocor, Zovar
- Czechia
- Simvastatin Ratiopharm, Simvastatin Viatris
- Denmark
- Perichol, Simvastatin Hexal, Simvastatin Krka, Simvastatin Sandoz, Simvastatin Stada, Simvastatin Teva, Simvastatin Viatris, Vasilip
- Estonia
- Simvacor, Simvastatin Ratiopharm, Vasilip
- Finland
- Lipcut, Simvastatin Krka, Simvastatin Orion, Simvastatin Ratiopharm, Simvastatin Viatris, Zocor
- France
- Simvastatine Accord Healthcare, Simvastatine Almus, Simvastatine Arrow Lab, Simvastatine Biogaran, Simvastatine Cristers, Simvastatine Eg, Simvastatine Evolugen, Simvastatine Sandoz, Simvastatine Teva, Simvastatine Viatris, Simvastatine Zentiva, Simvastatine Zydus France, Zocor
- Greece
- Antichol, Bevostatin, Extrastatin, Glipal, Goldastatin, Ipramid, Kymazol, Kymoral, Lepur, Lip-Down, Lipexal, Lipomin, Lipopress, Liporex, Medistatin, Nezatin, Nitastin, Normotherin, Placol, Priacin, Prizelip, Raptor, Ravostan, Redusterol, Simvacor, Simvalid, Simvaprol, Simvastatin Lapapharm, Simvastatin Medicus, Simvastatin Norma, Simvasterol, Simvatin, Sivinar, Sotovastin, Stasiva, Statinum, Stativer, Tremital, Vastatin, Velkastatin, Veristin®, Veritrat, Zocor
- Hungary
- Sicor, Simvacol, Simvastatin, Vasilip, Zocor
- Iceland
- Simvastatin Actavis, Simvastatin Bluefish, Simvastatin Krka, Simvastatin Viatris
- Ireland
- Simtan, Simvastatin Bluefish, Simvastatin Generics [uk], Simvastatin Genthon, Simvastatin Krka, Simvastatin Mcdermott, Simvastatin Teva, Sivatin, Zocor
- Italy
- Alpheus, Krustat, Lipenil, Liponorm, Medipo, Omistat, Setorilin, Simbatrix, Simvastatina Abc, Simvastatina Almus, Simvastatina Alter, Simvastatina Aurobindo, Simvastatina Doc, Simvastatina Eg, Simvastatina Hexal, Simvastatina Krka, Simvastatina Mylan, Simvastatina Pensa, Simvastatina Sandoz, Simvastatina Sun, Simvastatina Tecnigen, Simvastatina Teva Italia, Simvastatina Zentiva, Sincol, Sinvacor, Sinvalip, Sinvat, Sivastin, Vastgen, Xipocol, Zocor
- Latvia
- Simvacor
- Lithuania
- Simvacor
- Luxembourg
- Simvastatin Ratiopharm, Simvastatin Sandoz, Simvastatine Eg, Simvastatine Viatris, Zocor
- Malta
- Priacin, Simtan, Simvacor, Simvastatin
- Netherlands
- Simvastatin Aurobindo, Simvastatin Teva, Simvastatine Accord, Simvastatine Bioorganics, Simvastatine Cf, Simvastatine Sandoz, Simvastatine Teva, Simvastatine Viatris, Zocor
- Norway
- Simvastatin Bluefish, Simvastatin Hexal, Simvastatin Krka, Simvastatin Sandoz, Simvastatin Teva, Simvastatin Viatris, Zocor
- Poland
- Apo-Simva, Simcovas, Simvacard, Simvachol, Simvagen, Simvahexal, Simvastatin Aurovitas, Simvastatin Bluefish, Simvasterol, Vasilip, Vastan, Ximve, Zocor
- Portugal
- Simvastatin Ratiopharm, Simvastatina Ratiopharm, Simvastatina Teva, Sinpor, Sinvastatina Alter, Sinvastatina Aurobindo, Sinvastatina Aurovitas, Sinvastatina Azevedos, Sinvastatina Baldacci, Sinvastatina Basi, Sinvastatina Beapy Bluemed Unipessoal, Sinvastatina Biolipe, Sinvastatina Bluefish, Sinvastatina Bluepharma, Sinvastatina Farmoz, Sinvastatina Generis, Sinvastatina Germed, Sinvastatina Gp, Sinvastatina Lipaz, Sinvastatina Mepha, Sinvastatina Pharmakern, Sinvastatina Quimedical, Sinvastatina Ratiopharm, Sinvastatina Ritisca, Sinvastatina Sandoz, Sinvastatina Stada, Sinvastatina Tecnigen, Sinvastatina Tetrafarma, Sinvastatina Teva, Sinvastatina Tolife, Sinvastatina Viatris, Sinvastatina Vitória, Sinvastatina Wynn, Sinvastatina Zentiva, Sinvastatina Zera, Sivales, Zocor
- Romania
- Simvacard, Simvastatin Terapia, Simvastatină Arena, Sintenal, Vasilip
- Slovakia
- Simvacard, Simvastatin Ratiopharm
- Slovenia
- Simvastatin Lek, Sinvacor, Vasilip
- Spain
- Alcosin, Pantok, Simvastatina Almus, Simvastatina Alter, Simvastatina Aurovitas, Simvastatina Benel, Simvastatina Cinfa, Simvastatina Cinfamed, Simvastatina Combix, Simvastatina Davur, Simvastatina Kern Pharma, Simvastatina Mabo-Farma, Simvastatina Normon, Simvastatina Pensa, Simvastatina Sandoz, Simvastatina Simvastatina Davur, Simvastatina Stada, Simvastatina Sun, Simvastatina Tarbis, Simvastatina Tecnigen, Simvastatina Teva-Ratio, Simvastatina Viatris, Simvastatina Vir, Zocor
- Sweden
- Simvastatin Bluefish, Simvastatin Brown, Simvastatin Krka, Simvastatin Sandoz, Simvastatin Stada, Simvastatin Sun, Simvastatin Teva, Zocord
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Sources
- U.S. Food and Drug Administration. Simvastatin (Quallent Pharmaceuticals Health LLC) – Prescribing Information, 2024-07-23. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2b4255a7-f9f5-4235-8dbb-b0f03acbd624
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.