Lipid-Lowering Agent Pregnancy: Ezetimibe should be given to pregnant women only if clearly necessary — no clinical data are available on use during pregnancy; animal studies of ezetimibe monotherapy showed no evidence of direct or indirect harmful effects. Ezetimibe should not be used during lactation. Ezetimibe co-administered with a statin is contraindicated during pregnancy and lactation.

Ezetimibe

Brand names: Ezetrol

Ezetimibe is a lipid-lowering drug used, usually alongside a statin, to lower LDL-cholesterol — or on its own when a statin is not tolerated.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 10 mg (one tablet)

Route: Oral

Frequency: Once daily, at any time of day, with or without food

The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment. When ezetimibe is added to a statin, either the indicated usual initial dose of that particular statin or the already established higher statin dose should be continued — consult the dosage instructions for that statin. For incremental cardiovascular event reduction in patients with coronary heart disease and a history of an acute coronary syndrome event, ezetimibe 10 mg may be administered with a statin with proven cardiovascular benefit. Co-administration with a bile acid sequestrant: dose ezetimibe either at least 2 hours before or at least 4 hours after the sequestrant. Elderly: no dosage adjustment required. Hepatic impairment: no dosage adjustment in mild impairment (Child-Pugh 5 to 6); treatment is not recommended in moderate (Child-Pugh 7 to 9) or severe (Child-Pugh above 9) liver dysfunction. Paediatric: initiation of treatment must be performed under review of a specialist; safety and efficacy in children aged 6 to 17 years has not been established and no recommendation on a posology can be made; safety and efficacy in children under 6 years has not been established and no data are available. When given with a statin in children, consult the dosage instructions for that statin. SPC section 4.5 was not captured in the fetched bundle; the interactions listed are drawn from sections 4.2 and 4.4.

Dose adjustments

Renal

No dosage adjustment is required for renally impaired patients (section 4.2).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

US labelling (FDA)

Reference — US labelling, may differ from UK

• Dose range is 10 mg/10 mg/day to 10 mg/40 mg/day. ( 2.1 ) • Recommended usual starting dose is 10 mg/10 mg or 10 mg/20 mg/day. ( 2.1 ) • Due to the increased risk of myopathy, including rhabdomyolysis, use of the 10 mg/80 mg dose of ezetimibe and simvastatin tablets should be restricted to patients who have been taking ezetimibe and simvastatin tablets 10 mg/80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity. ( 2.2 ) • Patients who are currently tolerating the 10 mg/80 mg dose of ezetimibe and simvastatin tablets who need to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin should be switched to an …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2025-07-18. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

Hypersensitivity to the active substance or to any of the excipients
Ezetimibe co-administered with a statin is contraindicated during pregnancy and lactation
Ezetimibe co-administered with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases
When co-administered with a statin, refer also to the contraindications in the SPC for that statin

Side effects

Headache (common)
Abdominal pain, diarrhoea, flatulence (common)
Myalgia (common); myopathy and rhabdomyolysis (frequency not known)
Fatigue (common)
ALT and/or AST increased (common); blood CPK increased, abnormal liver function tests (uncommon)
Hypersensitivity including rash, urticaria, anaphylaxis and angio-oedema (frequency not known)

Interactions

Bile acid sequestrants — dose ezetimibe at least 2 hours before or at least 4 hours after the sequestrant (section 4.2)
Statins — consecutive transaminase elevations (3 times the upper limit of normal or greater) have been observed with co-administration; perform liver function tests at initiation of therapy and according to the recommendations for the statin (section 4.4)
Statins and other agents known to be associated with an increased risk of rhabdomyolysis — most patients who developed rhabdomyolysis were taking a statin concomitantly with ezetimibe; discontinue ezetimibe, any statin and these agents immediately if myopathy is suspected or CPK exceeds 10 times the upper limit of normal (section 4.4)
Fenofibrate — co-administration studied in clinical trials (section 4.8)

Clinical monograph

How it works

It inhibits intestinal cholesterol absorption at the NPC1L1 transporter; combined with a statin, the LDL-lowering effects are additive.

Prescribing in practice

It is generally well tolerated.
Add it when a statin alone does not reach the LDL target, or use it where statins are contraindicated or not tolerated.
Check liver enzymes when it is used together with a statin.

Monitoring

Review lipid response; check liver enzymes when combined with a statin.

Counselling the patient

It is usually added to, not a replacement for, a statin.
Continue lifestyle measures.
Report muscle symptoms if you are also taking a statin.

Evidence & guidelines

Recommended as add-on or alternative lipid-lowering therapy (NICE TA385 / NG238).

Reference: NICE NG185; IMPROVE-IT Trial (NEJM 2015); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

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