Ezetimibe
Ezegelan, Ezetimib, Ezetrol · ATC code C10AX09
Also known as: Ezetimib · Brand names: Ezegelan, Ezetrol, Ezetad, Ezetimibe Mylan, Ezetimibe Organon, Viemm, Colebyn, Ezelipin, Ezetec, Kolez, Zetia
- Key facts
- Active substance
- Ezetimibe
- ATC code
- C10AX09
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-27
Key facts
Ezetimibe is a cholesterol absorption inhibitor. Per the US prescribing information, it lowers elevated LDL cholesterol alone or with a statin or fenofibrate, and is used in sitosterolemia.
What it is used for
- Primary hyperlipidemia including heterozygous familial hypercholesterolemia (HeFH) in adults, with a statin or alone
- HeFH in pediatric patients 10 years and older, with a statin
- Mixed hyperlipidemia in adults, with fenofibrate
- Homozygous familial hypercholesterolemia in adults and children 10 years and older
- Homozygous familial sitosterolemia from 9 years of age
Dosing
- 10 mg orally once daily, with or without food
- Missed dose: take as soon as possible; do not double the next dose
- Assess LDL-C as early as 4 weeks after starting
- Take at least 2 hours before or 4 hours after a bile acid sequestrant
Contraindications
- Hypersensitivity to ezetimibe or any excipient
- In combination: any contraindication of the statin, fenofibrate or other LDL-C lowering therapy
Important warnings
- In combination, the risks of the statin or fenofibrate apply
- Transaminase elevations, mainly with statins; consider withdrawal if ALT/AST ≥3 X ULN persists
- Myopathy and rhabdomyolysis, mostly with statins or fibrates; discontinue if suspected
Side effects
- Monotherapy: upper respiratory tract infection (4.3%), diarrhea (4.1%), arthralgia (3.0%)
- Sinusitis, pain in extremity, fatigue, influenza
- Serious: liver enzyme abnormalities, myopathy, rhabdomyolysis
- Hypersensitivity reactions including anaphylaxis and angioedema
Interactions
- Cyclosporine: increases both ezetimibe and cyclosporine concentrations; monitor cyclosporine levels
- Fibrates and bile acid sequestrants: see the table in the full text
Pregnancy and breastfeeding
- Insufficient data; use in pregnancy only if the potential benefit justifies the potential risk
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. 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)
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
- EzegelanG.L. Pharma Gmbh · 1 register entry
- Ezetimib1a Pharma Gmbh, Teva B.V, Genericon Pharma Gesellschaft M.B.H., Glenmark Arzneimittel Gmbh, +pharma Arzneimittel Gmbh, Actavis Group Ptc Ehf., Zentiva, K.S., Accord Healthcare B.V., Sandoz Gmbh, Stada Arzneimittel Gmbh, Hcs Bvba · 11 register entries
- EzetrolOrganonhealthcare Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- EzetadTad Pharma Gmbh · 1 register entry
- Ezetimib1 A Pharma Gmbh, Maxmind Pharmaceutical S.L., Aristo Pharma Gmbh (Art 57), Micro Labs Gmbh, Ratiopharm Gmbh, Puren Pharma Gmbh & Co. Kg, Medical Valley Invest Ab, Glenmark Arzneimittel Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Vivanta Generics S.R.O., Zentiva Pharma Gmbh, Accord Healthcare B.V., Basics Gmbh, Ascend Gmbh, Stadapharm Gmbh, Betapharm Arzneimittel Gmbh, Denk Pharma Gmbh & Co. Kg, Abz-Pharma Gmbh, Aliud Pharma Gmbh · 21 register entries
- Ezetimibe MylanViatris Germany Gmbh · 1 register entry
- Ezetimibe OrganonOrganonhealthcare Gmbh · 1 register entry
- EzetrolOrganonhealthcare Gmbh · 1 register entry
- ViemmOrganonhealthcare Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- ColebynSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- EzelipinCELTİS İLAÇ SAN. TİC. A.Ş. · 2 register entries
- EzetecNEUTEC İLAÇ SAN. TİC. A.Ş · 2 register entries
- EzetrolORGANON TURKEY İLAÇLARI LİMİTED ŞİRKETİ · 1 register entry
- KolezBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
USA
- ZetiaOrganon LLC · 1 register entry
Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28
Brand names in 27 more European countries
- Belgium
- Ezetimib Ab, Ezetimibe Eg, Ezetimibe Krka, Ezetimibe Sandoz, Ezetimibe Teva, Ezetimibe Viatris, Ezetrol, Ezgal
- Bulgaria
- Езен, Езетимиб Адамед, Езетимиб Актавис, Езетимиб Нoукор, Езетрол, Езитра, Изовурекс
- Croatia
- Elanix, Ezetrol, Ezoleta, Isovurex
- Cyprus
- Erezel, Ezetimibe Accord, Ezetimibe Msn, Ezetrol, Zetiraf
- Czechia
- Egitim, Ezen, Ezetimib Stada, Ezetimib Teva, Ezetimib Viatris, Ezetimibe Olpha, Ezetimibe Vivanta, Ezetrol, Ezoleta, Isovurex, Noveze, Tezzimi
- Denmark
- Carditimib, Cildar, Coltowan, Ezetebmib Stada, Ezetimib Actavis, Ezetimib Krka, Ezetimib Medical Valley, Ezetimib Richter, Ezetimib Sandoz, Ezetimib Viatris, Ezetimibe Accord, Ezetimibe Zentiva, Ezetrol, Intestat
- Estonia
- Ezetimibe Accord, Ezetimibe Elvim, Ezetimibe Olpha, Ezoleta
- Finland
- Ezetimib Krka, Ezetimib Liconsa, Ezetimib Medical Valley, Ezetimib Sandoz, Ezetimib Stada, Ezetimib Vivanta, Ezetimibe Accord, Ezetimibe Orion, Ezetimibe Ratiopharm, Ezetrol
- France
- Ezetimibe Accord, Ezetimibe Almus, Ezetimibe Arrow, Ezetimibe Biogaran, Ezetimibe Cristers, Ezetimibe Eg, Ezetimibe Evolugen, Ezetimibe Krka, Ezetimibe Microlabs, Ezetimibe Olpha, Ezetimibe Sandoz, Ezetimibe Teva, Ezetimibe Viatris, Ezetimibe Zentiva, Ezetimibe Zydus, Ezetrol
- Greece
- Cildar, Delipid, Erezel, Ezefril/Heremco, Ezegros, Ezetiben, Ezetimibe Sandoz, Ezetimibe Velka, Ezetrol, Mibezet, Olufsent, Quver, Zertya, Zetiraf, Zetratak-S
- Hungary
- Coltowan, Ezetimib Egis, Ezetimib Stada, Ezetimib Teva, Ezetimibe Sandoz, Ezetrol, Ezoleta, Zayon
- Iceland
- Ezetimib Actavis, Ezetimib Krka, Ezetimib Medical Valley, Ezetimibe Accord, Ezetrol
- Ireland
- Ezetimibe Accord Healthcare Ireland, Ezetimibe Krka, Ezetimibe Rowa, Ezetrol
- Italy
- Absorcol, Corintus, Dyslizet, Ezelip, Ezetimibe Accord, Ezetimibe Alter, Ezetimibe Aurobindo, Ezetimibe Doc Generici, Ezetimibe Eg, Ezetimibe Krka, Ezetimibe Mylan, Ezetimibe Olpha, Ezetimibe Pensa, Ezetimibe Sandoz, Ezetimibe Tecnigen, Ezetimibe Teva, Ezetimibe Zentiva, Ezetrol, Kobey, Mibecol, Trizibe, Zetia
- Latvia
- Ezetimibe Accord, Ezetimibe Elvim, Ezetimibe Olpha, Ezoleta
- Lithuania
- Coltowan, Ezetimibe Elvim, Ezetimibe Olpha, Ezoleta
- Luxembourg
- Ezetimib Ratiopharm, Ezetimibe Eg, Ezetimibe Viatris, Ezetrol, Ezgal
- Malta
- Ezetimibe Msn, Ezoleta
- Netherlands
- Ezdivule, Ezetimibe Accord, Ezetimibe Aristo, Ezetimibe Aurobindo, Ezetimibe Biohorm, Ezetimibe Cf, Ezetimibe Glenmark, Ezetimibe Krka, Ezetimibe Medical Valley, Ezetimibe Noucor, Ezetimibe Sandoz, Ezetimibe Teva, Ezetimibe Viatris, Ezetimibe Vivanta, Ezetrol
- Norway
- Ezetimib Actavis, Ezetimib Krka, Ezetimib Medical Valley, Ezetimib Sandoz, Ezetimib Vivanta, Ezetimibe Accord, Ezetimibe Zentiva, Ezetrol
- Poland
- Coltowan, Etibax, Ezehron, Ezen, Ezetimibe Aurovitas, Ezetimibe Genoptim, Ezoleta, Isovurex, Lipegis
- Portugal
- Ezetimiba Alter, Ezetimiba Aristo, Ezetimiba Aurovitas, Ezetimiba Azevedos, Ezetimiba Bluepharma, Ezetimiba Ciclum, Ezetimiba Farmoz, Ezetimiba Generis, Ezetimiba Gp, Ezetimiba Krka, Ezetimiba Lumec Tolife - Produtos Farmacéuticos, Ezetimiba Mylan, Ezetimiba Pentafarma, Ezetimiba Pharmakern, Ezetimiba Rafarm, Ezetimiba Ratiopharm, Ezetimiba Sandoz, Ezetimiba Strami, Ezetimiba Tecnigen, Ezetimiba Tetrafarma, Ezetimiba Teva, Ezetimiba Tolife, Ezetimiba Vitória, Ezetimiba Zentiva, Ezetrol, Vyeve
- Romania
- Cexado, Coltowan, Ezetimib Accord, Ezetimib Gemax Pharma, Ezetimib Noucor, Ezetrol, Ezoleta, Isovurex
- Slovakia
- Ezen, Ezetimib Accord, Ezetimib Stada, Ezetimib Teva, Ezetimibe Glenmark, Ezetimibe Medreg, Ezetimibe Olpha, Ezetimibe Sandoz, Ezetrol, Ezoleta, Lipobon
- Slovenia
- Elanix, Ezetrol, Ezoleta, Isovurex
- Spain
- Absorcol, Azibe, Ezetimiba Accord, Ezetimiba Almus, Ezetimiba Alter, Ezetimiba Aristo, Ezetimiba Aurovitas, Ezetimiba Cinfa, Ezetimiba Combix, Ezetimiba Kern Pharma, Ezetimiba Krka, Ezetimiba Mabo, Ezetimiba Normon, Ezetimiba Olpha, Ezetimiba Pensa, Ezetimiba Ratiopharm, Ezetimiba Sandoz, Ezetimiba Stada, Ezetimiba Sun, Ezetimiba Tarbis, Ezetimiba Tecnigen, Ezetimiba Teva-Ratiopharm, Ezetimiba Viatris, Ezetimiba Viso Farmacéutica, Ezetrol
- Sweden
- Ezetimib Actavis, Ezetimib Krka, Ezetimib Medical Valley, Ezetimib Sandoz, Ezetimib Stada, Ezetimib Vivanta, Ezetimibe Accord, Ezetimibe Viatris, Ezetimibe Zentiva, Ezetrol
EMA – Article 57 product data (EU/EEA), 2026-10-28
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Sources
- U.S. Food and Drug Administration. EZETIMIBE (Accord Healthcare Inc.) – Prescribing Information, 2025-10-14. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ceecdbe9-5404-4a93-a488-9211cd103058
- EMA – Article 57 product data (EU/EEA), 2026-10-28. 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), 2026-10-28. 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), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
Editorial: Medelix editorial team · last updated 2026-10-27 · 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.