Ezetimibe

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Ezetimibe on Prescriptsy

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Ezetimibe is a cholesterol absorption inhibitor prescribed to lower low-density lipoprotein (LDL) cholesterol in adults with primary hypercholesterolaemia, homozygous familial hypercholesterolaemia, or homozygous sitosterolaemia.

It works by a mechanism distinct from statins, blocking the Niemann-Pick C1-Like 1 (NPC1L1) transporter protein in the small intestine to reduce the absorption of dietary and biliary cholesterol.

Ezetimibe is available as a 10 mg tablet taken once daily and is classified as a prescription-only medicine (POM) in the United Kingdom.

It can be used as monotherapy when a statin is not tolerated or as add-on therapy alongside a statin for more effective LDL reduction.

Elevated LDL cholesterol is one of the primary modifiable risk factors for atherosclerotic cardiovascular disease (ASCVD), including coronary heart disease, ischaemic stroke, and peripheral arterial disease.

In the UK, cardiovascular disease remains the second leading cause of death, and approximately 7.6 million people live with heart and circulatory conditions.

NICE guideline CG181 recommends statin therapy as first-line pharmacological treatment for cardiovascular risk reduction, with ezetimibe positioned as an important second-line or adjunctive therapy.

This page provides a comprehensive clinical guide to ezetimibe, covering its mechanism of action, clinical evidence, dosing, side effects, safety information, and how to obtain a prescription in the United Kingdom.

Important safety information about ezetimibe

Before reading further, note the following key safety points.

• When ezetimibe is used in combination with a statin, all the statin's contraindications and warnings apply, including the contraindication in pregnancy and active liver disease.
• Report unexplained muscle pain, tenderness, or weakness to your GP promptly, especially if accompanied by fever or malaise.
• Ezetimibe should be taken at least 2 hours before or 4 hours after a bile acid sequestrant to avoid reduced absorption.
• Liver function tests should be performed before starting ezetimibe/statin combination therapy.
• Report any suspected adverse reactions to the MHRA via the Yellow Card scheme at yellowcard.mhra.gov.uk.

Understanding cholesterol and cardiovascular risk

Cholesterol is a waxy, fat-like substance essential for cell membrane structure, hormone production, and bile acid synthesis. It circulates in the blood within lipoprotein particles.

LDL cholesterol (often called "bad cholesterol") carries cholesterol from the liver to peripheral tissues and, when present in excess, deposits it within arterial walls, contributing to the formation of atherosclerotic plaques.

Over time, these plaques narrow and harden arteries, restricting blood flow and increasing the risk of heart attack and stroke.

High-density lipoprotein (HDL) cholesterol ("good cholesterol") performs the reverse function, transporting cholesterol back to the liver for excretion.

The body obtains cholesterol from two sources: endogenous synthesis in the liver (the majority) and dietary absorption from the small intestine.

Statins reduce endogenous synthesis by inhibiting the enzyme HMG-CoA reductase. Ezetimibe targets the other source by blocking intestinal absorption.

Because these mechanisms are complementary, combining a statin with ezetimibe produces a greater LDL reduction than either agent alone, supporting the treat-to-target approach advocated by current lipid management guidelines.

How ezetimibe works: mechanism of action

Ezetimibe selectively inhibits the Niemann-Pick C1-Like 1 (NPC1L1) protein, a sterol transporter located on the luminal surface of enterocytes (absorptive cells) in the jejunum of the small intestine.

NPC1L1 is the primary gateway through which dietary cholesterol (from food) and biliary cholesterol (recycled from bile) enter enterocytes for packaging into chylomicrons and subsequent delivery to the liver via the lymphatic system and bloodstream.

By blocking NPC1L1, ezetimibe reduces intestinal cholesterol absorption by approximately 50%.

The resulting decrease in cholesterol delivery to the liver triggers a compensatory upregulation of hepatic LDL receptor expression.

More LDL receptors on the liver surface means increased clearance of LDL cholesterol from the circulating blood, lowering serum LDL levels.

As monotherapy, ezetimibe typically reduces LDL cholesterol by 15 to 20%.

When added to a statin, the inhibition of both intestinal absorption and hepatic synthesis produces an additional 20 to 25% LDL reduction beyond what the statin achieves alone.

Ezetimibe undergoes rapid glucuronidation in the intestinal wall and liver to form an active metabolite (ezetimibe-glucuronide), which is also pharmacologically active at the NPC1L1 transporter.

This enterohepatic recycling contributes to the drug's prolonged duration of action, allowing once-daily dosing.

Ezetimibe has minimal effects on triglycerides and HDL cholesterol, and its action is independent of CYP450 enzymes, resulting in a low potential for drug interactions.

Clinical evidence for ezetimibe

IMPROVE-IT trial

The landmark IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) study was a randomised, double-blind trial of over 18,000 patients who had been hospitalised for an acute coronary syndrome within the preceding 10 days.

Patients received either simvastatin 40 mg plus ezetimibe 10 mg or simvastatin 40 mg plus placebo.

Over a median follow-up of 6 years, the ezetimibe/simvastatin group achieved a mean LDL cholesterol of 1.4 mmol/L compared with 1.8 mmol/L in the simvastatin-alone group.

This additional LDL reduction was associated with a statistically significant 6.4% relative reduction in the primary composite endpoint of cardiovascular death, major coronary events, and non-fatal stroke.

The trial provided definitive evidence that lowering LDL cholesterol with ezetimibe on top of statin therapy reduces cardiovascular events.

SHARP trial

The Study of Heart and Renal Protection (SHARP) evaluated simvastatin 20 mg plus ezetimibe 10 mg versus placebo in over 9,000 patients with chronic kidney disease.

The combination produced a 17% relative reduction in major atherosclerotic events (coronary death, myocardial infarction, non-haemorrhagic stroke, or arterial revascularisation).

This study established the benefit of ezetimibe/statin combination therapy in patients with chronic kidney disease, a population at very high cardiovascular risk.

Ezetimibe monotherapy evidence

Several studies have evaluated ezetimibe as monotherapy in patients intolerant of statins.

The GAUSS-3 trial, while primarily an evolocumab study, included an ezetimibe comparison arm and confirmed meaningful LDL reductions in statin-intolerant patients.

In clinical practice, ezetimibe monotherapy is widely used in the UK for patients who cannot tolerate any statin, including at low doses, due to muscle symptoms, liver enzyme elevations, or other adverse effects.

UK prescribing guidelines

NICE guideline CG181 (Cardiovascular disease: risk assessment and reduction) recommends atorvastatin 20 mg as first-line therapy for primary prevention in adults with a 10-year cardiovascular risk of 10% or more, and atorvastatin 80 mg for secondary prevention in adults with established cardiovascular disease.

If the target LDL reduction (greater than 40% for primary prevention, or a non-HDL cholesterol target for secondary prevention) is not achieved with the maximum tolerated statin dose, NICE recommends adding ezetimibe.

Ezetimibe is also recommended as monotherapy when statins are contraindicated or not tolerated.

NICE Technology Appraisal TA385 specifically recommends ezetimibe for the treatment of primary hypercholesterolaemia in adults, as monotherapy when a statin is contraindicated or not tolerated, or in combination with a statin when a statin alone does not adequately control cholesterol.

The BNF lists ezetimibe as a lipid-regulating drug and provides comprehensive prescribing guidance.

Dosage and administration

The dose of ezetimibe is 10 mg once daily for all adult patients, taken at any convenient time with or without food.

There is only one dose strength, and no titration is required. If ezetimibe is used alongside a statin, both medicines can be taken at the same time.

If a bile acid sequestrant is also prescribed, ezetimibe should be taken at least 2 hours before or 4 hours after the sequestrant to avoid reduced absorption.

No dose adjustment is needed in elderly patients or in those with renal impairment. Ezetimibe is not recommended in moderate to severe hepatic impairment.

Liver function tests should be performed before initiating ezetimibe/statin combination therapy and at regular intervals thereafter, in line with the statin's monitoring requirements.

Side effects of ezetimibe

Common side effects

Ezetimibe is generally well tolerated. Headache, abdominal pain, diarrhoea, and flatulence are the most commonly reported adverse effects in clinical trials.

These are usually mild and do not require dose adjustment or treatment discontinuation.

When used in combination with a statin, the side effect profile is dominated by the statin's effects; the addition of ezetimibe does not significantly increase the incidence of statin-related adverse events.

Uncommon and rare side effects

Uncommon side effects include fatigue, myalgia, and elevated hepatic transaminases. Allergic reactions including rash, urticaria, and angioedema have been reported rarely.

Post-marketing reports include rare cases of hepatitis, pancreatitis, thrombocytopenia, cholecystitis, and cholelithiasis (gallstones).

The theoretical risk of gallstones relates to increased biliary cholesterol excretion, though clinical trial data have not confirmed a definitive increase.

Muscle effects

Myalgia has been reported with ezetimibe both as monotherapy and in combination with statins. When muscle symptoms occur during combination therapy, the statin component is usually responsible.

However, if muscle symptoms persist after statin dose reduction or discontinuation, ezetimibe should also be considered as a potential cause.

Report unexplained muscle pain, tenderness, or weakness to your GP.

When to seek urgent medical advice

Contact your GP or NHS 111 if you develop unexplained muscle pain or weakness (especially with fever), yellowing of the skin or eyes, dark urine, persistent nausea, or right upper abdominal pain.

Seek emergency care (call 999 or attend A&E) if you experience signs of severe allergic reaction (swelling of face, lips, or throat, difficulty breathing).

Report any suspected adverse reactions to the MHRA via the Yellow Card scheme at yellowcard.mhra.gov.uk .

Warnings and precautions

Hepatic impairment

Ezetimibe is not recommended in patients with moderate to severe hepatic impairment.

When used in combination with a statin, liver function tests should be performed before initiation and at appropriate intervals thereafter.

The statin should be discontinued if transaminases rise to more than three times the upper limit of normal.

Pregnancy and breastfeeding

Ezetimibe is not recommended during pregnancy due to insufficient human safety data. The ezetimibe/statin combination is contraindicated in pregnancy.

Women of childbearing potential should use effective contraception during combination treatment.

Ezetimibe should not be used during breastfeeding as it is not known whether the drug passes into human breast milk.

Statin combination warnings

When ezetimibe is combined with a statin, all precautions, contraindications, and monitoring requirements for the statin apply.

This includes monitoring for muscle toxicity (creatine kinase measurement if symptomatic), liver function testing, and awareness of drug interactions that may increase statin exposure (such as CYP3A4 inhibitors with atorvastatin and simvastatin, or OATP1B1 inhibitors with all statins).

Drug interactions

Bile acid sequestrants reduce ezetimibe absorption: separate dosing by at least 2 hours before or 4 hours after.

Ciclosporin increases ezetimibe levels: use with caution and monitor in transplant patients. Fibrates may increase ezetimibe exposure and gallstone risk: use with caution and monitor for biliary symptoms.

Warfarin: monitor INR when ezetimibe is started or stopped, as a modest interaction has been observed.

How to get ezetimibe in the UK

Ezetimibe is available on NHS prescription from your GP.

It is widely available as a generic medicine and is one of the most commonly prescribed lipid-lowering agents in the UK.

An authorised online prescriber registered with the GPhC can also prescribe ezetimibe following a clinical consultation and review of blood test results showing cholesterol levels.

The NHS prescription charge in England is currently 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Lifestyle measures alongside ezetimibe

Ezetimibe should be used alongside a heart-healthy diet and lifestyle, not as a replacement for them.

NICE recommends dietary modifications including reducing saturated fat intake, increasing dietary fibre, eating at least five portions of fruit and vegetables daily, and replacing saturated fats with unsaturated alternatives.

Regular physical activity, maintaining a healthy weight, limiting alcohol intake, and stopping smoking all contribute to reducing cardiovascular risk.

Your GP or practice nurse can provide tailored lifestyle advice, and referral to a dietitian may be appropriate for patients needing more intensive dietary support.

When to seek medical advice

Contact your GP or NHS 111 if you experience persistent side effects, if your cholesterol levels remain above target despite treatment, or if you develop any new symptoms that concern you.

Attend regular blood test appointments so your GP can monitor your cholesterol levels, liver function, and overall cardiovascular risk.

Report any suspected adverse reactions via the MHRA Yellow Card scheme at yellowcard.mhra.gov.uk .

Sources

• Ezetimibe 10 mg Tablets, Summary of Product Characteristics (EMC)
• Ezetimibe, British National Formulary (BNF)
• NICE CG181: Cardiovascular disease: risk assessment and reduction
• NICE TA385: Ezetimibe for treating primary heterozygous-familial and non-familial hypercholesterolaemia
• High cholesterol, NHS
• MHRA Yellow Card Scheme