Ezetimibe

Pronunciation: eh-ZET-ih-myb.

Generic name
ezetimibe
Drug class
Cholesterol absorption inhibitor
Form
Tablet, 10 mg
Route
Oral
Legal status
Prescription-only

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Ezetimibe Apotex (5) · Full directory

What ezetimibe is and how it works

Ezetimibe is a prescription-only cholesterol-lowering medicine that works differently from statins: it reduces the amount of cholesterol absorbed from food and bile in the small intestine, rather than blocking the liver's own cholesterol production. (1) (2)

Ezetimibe is often prescribed alongside a statin for extra LDL cholesterol lowering, or alone if a statin cannot be used or tolerated. Take it exactly as your prescriber directs, alongside a cholesterol-friendly diet.

Mechanism of action: how ezetimibe works

Ezetimibe selectively inhibits the NPC1L1 sterol transporter at the intestinal brush border, blocking absorption of dietary and biliary cholesterol without affecting absorption of fat-soluble vitamins, triglycerides, or bile acids. It does not inhibit hepatic cholesterol synthesis, giving a complementary mechanism to statins. (1) (4)

What ezetimibe is used for

High cholesterol (primary hypercholesterolaemia)

Used alone or with a statin, as an add-on to diet, to lower total cholesterol, LDL cholesterol, and other lipid markers in adults with primary high cholesterol, including a hereditary form called heterozygous familial hypercholesterolaemia. Approved for adolescents 10 years and older with the hereditary form when combined with a statin. (1) (6)

Mixed high cholesterol/triglycerides

Used together with fenofibrate to lower cholesterol and triglycerides in people with mixed hyperlipidaemia. (1) (4)

Homozygous familial hypercholesterolaemia and sitosterolaemia

Used with a statin for the rare, severe hereditary condition homozygous familial hypercholesterolaemia, and used alone for homozygous familial sitosterolaemia (a rare disorder of plant-sterol absorption). (1) (4)

Reducing cardiovascular event risk (UK/EU label)

In the UK and EU label, ezetimibe combined with a statin is also indicated to reduce the risk of cardiovascular events (such as heart attack) in people with coronary heart disease or a recent acute coronary syndrome, based on the IMPROVE-IT trial. (2)

Before taking ezetimibe

Do not take / not appropriate for

  • Do not take ezetimibe if you have had a serious allergic reaction to it or any of its ingredients. (all countries) (1)
  • If you take ezetimibe together with a statin, that combination is not used during pregnancy or breastfeeding, or if you have active liver disease or unexplained persistently abnormal liver blood tests -- your prescriber will review the statin's own restrictions as well. (all countries) (2) (4)

Tell your clinician about

  • Any history of liver problems or abnormal liver blood tests.
  • Any history of muscle problems (myopathy) or unexplained muscle pain/weakness.
  • All other medicines you take, especially statins, fenofibrate or other fibrates, ciclosporin, or cholesterol-binding resins (bile acid sequestrants) such as cholestyramine.
  • Pregnancy, plans for pregnancy, or breastfeeding, especially if you are also taking a statin.
(1) (2)

How to take ezetimibe

  • Take one 10 mg tablet once daily, at any time of day, with or without food.
  • Do not halve the tablet.
  • If you also take a cholesterol-binding resin (a bile acid sequestrant such as cholestyramine), take ezetimibe at least 2 hours before or 4 hours after it, since taking them together reduces how much ezetimibe is absorbed.
  • Continue any lipid-lowering diet your prescriber has recommended while taking ezetimibe.
(1) (2) (6)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

If you miss a dose, take it as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a missed one. Contact your prescriber or pharmacist if you are unsure.

Overdose

Seek urgent medical advice if you or someone else has taken more ezetimibe than prescribed, especially if combined with a statin or fenofibrate, even without symptoms. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Headache and tiredness (fatigue).

What to notice: Headache and tiredness (fatigue).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Diarrhoea, abdominal pain, and flatulence.

What to notice: Diarrhoea, abdominal pain, and flatulence.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Joint pain (arthralgia), and, when combined with a statin, muscle pain (myalgia).

What to notice: Joint pain (arthralgia), and, when combined with a statin, muscle pain (myalgia).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Upper respiratory tract infection symptoms and sinusitis.

What to notice: Upper respiratory tract infection symptoms and sinusitis.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Signs of a liver problem — high caution

Symptoms: Yellowing of the skin or eyes (jaundice), unusual tiredness, loss of appetite, dark urine, or pain in the upper right abdomen.

Action: Tell your prescriber promptly. Liver blood tests are used to monitor for this, especially when ezetimibe is combined with a statin or fenofibrate; a clinician will decide on any change to treatment based on the results. (1) (6)

Signs of a muscle problem (myopathy) or, rarely, severe muscle breakdown (rhabdomyolysis) — high caution

Symptoms: Unexplained muscle pain, tenderness, or weakness, especially with fever or dark ('cola-coloured') urine.

Action: Tell your prescriber promptly, especially if you are also taking a statin or fibrate, which increases this risk; a clinician or emergency service will decide on next steps. (1) (4)

Signs of a serious allergic reaction — emergency

Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing; widespread rash or hives.

Action: Seek emergency medical help immediately. (4)

Interactions

  • Ciclosporin (cyclosporine): taking it with ezetimibe can raise the blood levels of both medicines; your prescriber will monitor ciclosporin levels. (1) (2)
  • Fibrate medicines other than fenofibrate are generally avoided in combination, due to an increased risk of gallstones (cholelithiasis); combination with fenofibrate itself requires monitoring for the same reason. (1) (2)
  • Cholesterol-binding resins (bile acid sequestrants) such as cholestyramine reduce how much ezetimibe is absorbed -- take ezetimibe at least 2 hours before or 4 hours after these medicines. (1) (6)
  • Statins: no major additional pharmacokinetic interaction is described beyond the shared liver-enzyme and muscle-symptom monitoring already recommended for the combination. (2)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Ezetimibe alone should only be used in pregnancy if the potential benefit clearly justifies the potential risk to the baby -- discuss with your prescriber. If ezetimibe is combined with a statin, that combination is not used during pregnancy, in line with the statin's own restrictions. (1) (2) (3) (4) (5) (6)

Breastfeeding

Ezetimibe alone is not usually recommended while breastfeeding unless your prescriber judges the benefit outweighs the risk; combined with a statin, it is not used during breastfeeding. (1) (2) (3) (4) (5) (6)

Children

Approved for adolescents 10 years and older with hereditary high cholesterol when combined with a statin, and from 9 years for a rare sitosterol-absorption disorder (regional age thresholds vary slightly); not recommended in younger children. (1) (2) (3) (4) (5) (6)

Hepatic Impairment

No adjustment needed for mild liver impairment; ezetimibe is not recommended in people with moderate or severe liver dysfunction. (1) (2) (3) (4) (5) (6)

Renal Impairment

No dose adjustment is needed for ezetimibe monotherapy in kidney impairment; special combination dosing with simvastatin applies in significant chronic kidney disease (see how-to-take). (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Baseline lipid panel
  • Liver function tests, especially if starting alongside a statin or fenofibrate

During treatment

  • Periodic liver function tests as your prescriber advises, particularly during combination therapy.
  • Watching for unexplained muscle pain, tenderness, or weakness.
  • Follow-up lipid panel to check response to treatment.
(1) (4)

Storage

Store at room temperature, between 20-25C (68-77F). Protect from moisture. Keep out of reach of children.

Study the drug class: Cholesterol absorption inhibitors

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information and UK SmPC; verify against the current full label before prescribing.

United States

Indication: Primary hyperlipidaemia (including HeFH), mixed hyperlipidaemia with fenofibrate, HoFH, homozygous sitosterolaemia

Dose summary: 10 mg orally once daily, with or without food, alone or combined with a statin or fenofibrate as indicated. Space >=2h before/4h after a bile acid sequestrant.

Renal context: No dose adjustment required for renal impairment in the US label. (1)

New Zealand

Indication: Primary hypercholesterolaemia, HoFH

Dose summary: 10 mg once daily; in CKD with eGFR <60 combined with simvastatin, ezetimibe 10 mg + simvastatin 20 mg once daily in the evening.

Renal context: No adjustment for monotherapy; specific combination dosing in CKD as above. (6)

Mechanism of action

Hepatic guidance

Not recommended in moderate-to-severe hepatic impairment; liver function tests recommended at initiation of combination therapy and periodically thereafter.

Overdose note

Limited overdose experience; ezetimibe has been well tolerated in short-term studies at doses well above the therapeutic dose. Manage supportively. (1) (4)

Frequently asked questions

Is ezetimibe available in the US, UK, Europe, Canada, Australia, and New Zealand?

Yes, ezetimibe is approved and available (mostly as a generic medicine, alongside some branded versions) in all of these regions. (1) (2) (3) (4) (5) (6)

Can I take ezetimibe instead of a statin?

Ezetimibe can be used alone if a statin is not suitable or not tolerated, but it is most often prescribed alongside a statin for greater cholesterol lowering. Whether it replaces or adds to a statin is a decision for your prescriber based on your individual risk and tolerance. (2)

Does timing matter if I also take a bile-acid-binding medicine like cholestyramine?

Yes. Cholestyramine and similar bile acid sequestrants can reduce how much ezetimibe your body absorbs by more than half. Take ezetimibe at least 2 hours before, or at least 4 hours after, a bile acid sequestrant. (1)

What is the mechanism of action of ezetimibe?

Ezetimibe selectively inhibits the NPC1L1 sterol transporter at the intestinal brush border, blocking absorption of dietary and biliary cholesterol without affecting absorption of fat-soluble vitamins, triglycerides, or bile acids. It does not inhibit hepatic cholesterol synthesis, giving a complementary mechanism to statins. (1) (4)

What is the generic name of Ezetimibe?

The generic name is ezetimibe. (1)

What class of drug is ezetimibe?

Ezetimibe is classed as: Cholesterol absorption inhibitor. (1)

References

  1. ZETIA (ezetimibe) tablets -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Organon LLC · United States · accessed 2026-07-29 · source 1
  2. Ezetrol 10 mg Tablets -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Organon Pharma (UK) Limited · United Kingdom · accessed 2026-07-29 · source 2
  3. Public Assessment Report -- Ezetimibe/Atorvastatine Egis 10 mg/10, 20, 40 mg hard capsules (ezetimibe/atorvastatin), decentralised procedure NL/H/4530/001-003/DCMedicines Evaluation Board (MEB), the Netherlands -- national/decentralised-procedure regulator, an EU member state competent authority · European Union · accessed 2026-07-29 · source 3
  4. EZETROL (ezetimibe tablets, 10 mg) Product MonographHealth Canada product monograph, Organon Canada Inc. · Canada · accessed 2026-07-29 · source 4
  5. EZETIMIBE APOTEX ezetimibe 10 mg tablet -- ARTG entryTherapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-29 · source 5
  6. Ezemibe (ezetimibe 10 mg tablet) New Zealand Data SheetMedsafe (New Zealand regulator) New Zealand Data Sheet · New Zealand · accessed 2026-07-29 · source 6

Brand names by country

Single-ingredient ezetimibe names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Zetia10 mg · organon llc

United Kingdom

  • Ezetrol (2)MHRA licensed emc smpc confirmed · 10 mg · Organon Pharma (UK) Limited

Canada

  • EZETROL
  • ACH-EZETIMIBE

Australia

  • Ezetimibe Apotex (5)TGA ARTG registered confirmed · 10 mg · Arrotex Pharmaceuticals Pty Ltd

New Zealand

  • Ezemibe (6)Medsafe approved confirmed · 10 mg · not specified in fetched source
View brands in additional countries.

European Union

Ezetimibe (genericised, national/decentralised-procedure authorisations across EU member states) (3)

This page provides general reference information about ezetimibe and is not a substitute for advice from the prescriber managing your treatment. All dosing and treatment decisions should be made with your prescriber.

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