Medicine guide

Ezetimibe

10 mg · Tablet

Prescription only
Dietary Cholesterol Absorption Inhibitor

Active substance: Ezetimibe
Made by: AvPAK
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-01-13

What it is

Dietary Cholesterol Absorption Inhibitor

Used for

In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in

The label’s usual adult dose

The recommended dose of ezetimibe tablet is 10 mg orally once daily, administered with or without food.

Full directions ↓

Do not take it if

Ezetimibe tablets are contraindicated in patients with a known hypersensitivity to ezetimibe or any of the excipients in ezetimibe tablets.

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

23other products contain Ezetimibe — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Ezetimibe tablets are indicated:

In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in
adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).
In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH.
In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in
adults with mixed hyperlipidemia.
In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in
adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH).
As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in
adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia. When ezetimibe tablets are used in combination with a statin, fenofibrate, or other LDL- C lowering therapies, refer to the Prescribing Information of these products for information on the safe and effective use. Ezetimibe tablets are indicated:
In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in
adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).
In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH.
In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in
adults with mixed hyperlipidemia.
In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in
adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH).
As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in
adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia. When ezetimibe tablets are used in combination with a statin, fenofibrate, or other LDL- C lowering therapies, refer to the Prescribing Information of these products for information on the safe and effective use.

From the official label · 2026-01-13 · DailyMed

How it works

From this product’s own US prescribing label.

Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine.
The molecular target of ezetimibe has been shown to be the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1), which is involved in the intestinal uptake of cholesterol and phytosterols.

Peak level after4–12 h

Half-life22 h

Mostly cleared after≈ 5 daysfive half-lives — our arithmetic

The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.

How the body breaks it down

Ezetimibe is primarily metabolized in the small intestine and liver via glucuronide conjugation (a phase II reaction) with subsequent biliary and renal excretion.

With food

Effect of Food Concomitant food administration (high-fat or non-fat meals) had no effect on the extent of absorption of ezetimibe when administered as ezetimibe 10 mg tablets.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-01-13

Do not take it if

Ezetimibe tablets are contraindicated in patients with a known hypersensitivity to ezetimibe or any of the excipients in ezetimibe tablets.
Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported [see Adverse Reactions (6.2)].
When used in combination with a statin, fenofibrate, or other LDL-C lowering therapy, ezetimibe is contraindicated in patients for whom a statin, fenofibrate, or other LDL-C lowering therapy are contraindicated.
Refer to the Prescribing Information of these products for a list of their contraindications [see Warnings and Precautions (5.1)].
Hypersensitivity to ezetimibe or any excipient of ezetimibe tablets.
(4) When used in combination with a statin, fenofibrate, or other LDL-C lowering therapy, ezetimibe is contraindicated in patients for whom a statin, fenofibrate, or other LDL-C lowering therapy are contraindicated.
Refer to the Prescribing Information of these products for a list of their contraindications.
(4)

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

The recommended dose of ezetimibe tablet is 10 mg orally once daily, administered with or without food.
If as dose is missed, take the missed dose as soon as possible. Do not double the next dose.
Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating ezetimibe tablet.
Administer ezetimibe tablet at least 2 hours before or 4 hours after administration of a bile acid sequestrant [see Drug Interactions (7)]. 10 mg orally once daily, with or without food (2) Administer ezetimibe tablets either 2 hours before or 4 hours after administration of a bile acid sequestrant. (2) Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating ezetimibe tablets. (2)

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Ezetimibe is not recommended in patients with moderate or severe hepatic impairment.
( 5.4 , 8.7 , 12.3 ) Liver enzyme abnormalities and monitoring:
Persistent elevations in hepatic transaminase can occur when ezetimibe is added to a statin.
Therefore, when ezetimibe is added to statin therapy, monitor hepatic transaminase levels before and during treatment according to the recommendations for the individual statin used.
( 5.2 ) Skeletal muscle effects (e.g., myopathy and rhabdomyolysis):
Cases of myopathy and rhabdomyolysis have been reported in patients treated with ezetimibe co-administered with a statin and with ezetimibe administered alone.
Risk for skeletal muscle toxicity increases with higher doses of statin, advanced age (>65), hypothyroidism, renal impairment, and depending on the statin used, concomitant use of other drugs.
( 5.3 , 6.2 )
5.1 Risks Associated with Combination Treatment with a Statin, Fenofibrate, or Other LDL-C Lowering Therapies If ezetimibe is administered with a statin, fenofibrate, or other LDL-C lowering therapies, refer to the Prescribing Information of these products for a description of their risks including, but not limited to, the warnings and precautions [see Contraindications (4)].
5.2 Liver Enzymes Increases in serum transaminases have been reported with use of ezetimibe [see Adverse Reactions (6.1)].
In controlled clinical combination studies of ezetimibe initiated concurrently with a statin, the incidence of consecutive elevations (≥ 3 X ULN) in hepatic transaminase levels was 1.3% for patients treated with ezetimibe administered with statins and 0.4% for patients treated with statins alone.
Perform liver enzyme testing as clinically indicated and consider withdrawal of ezetimibe if increases in ALT or AST ≥ 3 X ULN persist.
5.3 Myopathy/Rhabdomyolysis Ezetimibe may cause myopathy [muscle pain, tenderness, or weakness associated with elevated creatine kinase (CK)] and rhabdomyolysis [see Adverse Reactions (6.1)].
In post-marketing reports, most patients who developed rhabdomyolysis were taking a statin or other agents known to be associated with an increased risk of rhabdomyolysis, such as fibrates.
If myopathy is suspected, discontinue ezetimibe and other concomitant medications, as appropriate.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk Summary There are insufficient data on ezetimibe use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
In animal reproduction studies, no adverse developmental effects were observed in pregnant rats and rabbits orally administered ezetimibe during the period of organogenesis at doses that resulted in up to 10 and 150 times, respectively, the human exposure at the MRHD, based on AUC (see Data).
Ezetimibe should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
When ezetimibe is administered with a statin, refer to the Prescribing Information for the statin.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data In oral (gavage) embryo-fetal development studies of ezetimibe conducted in rats (gestation days 6 to 15) and rabbits (gestation days 7 to 19), there was no evidence of maternal toxicity or embryolethal effects at the doses tested (250, 500, 1,000 mg/kg/day).
In rats, increased incidences of common fetal skeletal findings (extra pair of thoracic ribs, unossified cervical vertebral centra, shortened ribs) were observed at 1,000 mg/kg/day (~10 times the human exposure at 10 mg daily based on AUC0-24hr for total ezetimibe).
In rabbits treated with ezetimibe, an increased incidence of extra thoracic ribs was observed at 1,000 mg/kg/day (150 times the human exposure at 10 mg daily based on AUC0-24hr for total ezetimibe).
The animal-to-human exposure multiple for total ezetimibe at the no-observed effect level was 6 times for rat and 134 times for rabbit.
Fetal exposure to ezetimibe (conjugated and unconjugated) was confirmed in subsequent placental transfer studies conducted using a maternal dose of 1,000 mg/kg/day.
The fetal maternal plasma exposure ratio (total ezetimibe) was 1.5 for rats on gestation day 20 and 0.03 for rabbits on gestation day 22.
The effect of ezetimibe on prenatal and postnatal development and maternal function was evaluated in pregnant rats at doses of 100, 300 or 1,000 mg/kg/day from gestation day 6 through lactation day 21.
No maternal toxicity or adverse developmental outcomes were observed up to and including the highest dose tested (17 times the human exposure at 10 mg daily based on AUC0-24hr for total ezetimibe).
Multiple-dose studies of ezetimibe given in combination with statins in rats and rabbits during organogenesis resulted in higher ezetimibe and statin exposures.
Reproductive findings occurred at lower doses in combination therapy compared to monotherapy.
Risk Summary There is no information about the presence of ezetimibe in human milk.
Ezetimibe is present in rat milk (see Data).
When a drug is present in animal milk, it is likely that the drug will be present in human milk.
There is no information about the effects of ezetimibe on the breastfed infant or the effects of ezetimibe on milk production.
Ezetimibe should not be used in nursing mothers unless the potential benefit justifies the potential risk to the infant.
Data Ezetimibe was present in the milk of lactating rats.
The pup to maternal plasma ratio for total ezetimibe was 0.5 on lactation day 12.
IN SPECIFIC POPULATIONS
8.1 Pregnancy Risk Summary There are insufficient data on ezetimibe use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
In animal reproduction studies, no adverse developmental effects were observed in pregnant rats and rabbits orally administered ezetimibe during the period of organogenesis at doses that resulted in up to 10 and 150 times, respectively, the human exposure at the MRHD, based on AUC (see Data).
Ezetimibe should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
When ezetimibe is administered with a statin, refer to the Prescribing Information for the statin.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data In oral (gavage) embryo-fetal development studies of ezetimibe conducted in rats (gestation days 6 to 15) and rabbits (gestation days 7 to 19), there was no evidence of maternal toxicity or embryolethal effects at the doses tested (250, 500, 1,000 mg/kg/day).
In rats, increased incidences of common fetal skeletal findings (extra pair of thoracic ribs, unossified cervical vertebral centra, shortened ribs) were observed at 1,000 mg/kg/day (~10 times the human exposure at 10 mg daily based on AUC0-24hr for total ezetimibe).
In rabbits treated with ezetimibe, an increased incidence of extra thoracic ribs was observed at 1,000 mg/kg/day (150 times the human exposure at 10 mg daily based on AUC0-24hr for total ezetimibe).
The animal-to-human exposure multiple for total ezetimibe at the no-observed effect level was 6 times for rat and 134 times for rabbit.
Fetal exposure to ezetimibe (conjugated and unconjugated) was confirmed in subsequent placental transfer studies conducted using a maternal dose of 1,000 mg/kg/day.
The fetal maternal plasma exposure ratio (total ezetimibe) was 1.5 for rats on gestation day 20 and 0.03 for rabbits on gestation day 22.
The effect of ezetimibe on prenatal and postnatal development and maternal function was evaluated in pregnant rats at doses of 100, 300 or 1,000 mg/kg/day from gestation day 6 through lactation day 21.
No maternal toxicity or adverse developmental outcomes were observed up to and including the highest dose tested (17 times the human exposure at 10 mg daily based on AUC0-24hr for total ezetimibe).
Multiple-dose studies of ezetimibe given in combination with statins in rats and rabbits during organogenesis resulted in higher ezetimibe and statin exposures.
Reproductive findings occurred at lower doses in combination therapy compared to monotherapy.
8.2 Lactation Risk Summary There is no information about the presence of ezetimibe in human milk.
Ezetimibe is present in rat milk (see Data).
When a drug is present in animal milk, it is likely that the drug will be present in human milk.
There is no information about the effects of ezetimibe on the breastfed infant or the effects of ezetimibe on milk production.
Ezetimibe should not be used in nursing mothers unless the potential benefit justifies the potential risk to the infant.
Data Ezetimibe was present in the milk of lactating rats.
The pup to maternal plasma ratio for total ezetimibe was 0.5 on lactation day 12.
8.4 Pediatric Use The safety and effectiveness of ezetimibe in combination with a statin as an adjunct to diet to reduce LDL-C have been established in pediatric patients 10 years of age and older with HeFH.
Use of ezetimibe for this indication is based on a double-blind, placebo-controlled clinical trial in 248 pediatric patients (142 males and 106 postmenarchal females) 10 years of age and older with HeFH [see Clinical Studies (14)].
In this limited controlled trial, there was no significant effect on growth or sexual maturation in the adolescent males or females, or on menstrual cycle length in females.
The safety and effectiveness of ezetimibe in combination with a statin, and other LDL-C lowering therapies, to reduce LDL-C have been established in pediatric patients 10 years of age and older with HoFH.
Use of ezetimibe for this indication is based on a 12-week double-blind, placebo-controlled clinical trial followed by an uncontrolled extension period in 7 pediatric patients 11 years of age and older with HoFH [see Clinical Studies (14)].
The safety and effectiveness of ezetimibe as an adjunct to diet for the reduction of elevated sitosterol and campesterol levels have been established in
adults and pediatric patients 9 years of age and older with homozygous familial sitosterolemia.
Use of ezetimibe for this indication is based on an 8-week double-blind, placebo-controlled clinical trial in 4 patients 9 years of age and older with homozygous sitosterolemia with elevated plasma sitosterol levels (>5 mg/dL) [see Clinical Studies (14)].
The safety and effectiveness of ezetimibe have not been established in pediatric patients younger than 10 years of age with HeFH or HoFH, in pediatric patients younger than 9 years of age with homozygous familial sitosterolemia, or in pediatric patients with other types of hyperlipidemia.
8.5 Geriatric Use Of the 2,396 patients who received ezetimibe in clinical trials, 669 (28%) were 65 years of age and older, and 111 (5%) were 75 years of age and older.
Of the 11,308 patients who received ezetimibe in combination with a statin in clinical trials, 3587 (32%) were 65 years of age and older, and 924 (8%) were 75 years of age and older [see Clinical Studies (14)].
No overall differences in safety or effectiveness of ezetimibe have been observed between patients 65 years of age and older and younger patients.
No clinically meaningful differences in the pharmacokinetics of ezetimibe were observed in geriatric patients compared to younger adult patients [see Clinical Pharmacology (12.3)].
8.6 Renal Impairment No dosage adjustment of ezetimibe is necessary in patients with renal impairment.
8.7 Hepatic Impairment Ezetimibe is not recommended for use in patients with moderate to severe hepatic impairment (Child-Pugh B or C) due to the unknown effects of the increased exposure to ezetimibe [see Clinical Pharmacology (12.3)].

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Table 3 includes a list of drugs with clinically important drug interactions when administered concomitantly with ezetimibe and instructions for preventing or managing them.
Cyclosporine: Combination increases exposure of ezetimibe and cyclosporine.
Cyclosporine concentrations should be monitored in patients taking ezetimibe concomitantly.
( 7.1 , 12.3 ) Fenofibrate: Combination increases exposure of ezetimibe.
If cholelithiasis is suspected in a patient receiving ezetimibe and fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered.
( 6.1 , 7.3 ) Fibrates:
Co-administration of ezetimibe with fibrates other than fenofibrate is not recommended until use in patients is adequately studied.
( 7.2 ) Cholestyramine: Combination decreases exposure of ezetimibe.
( 2.3 , 7.4 , 12.3 ) 1

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

In the event of overdose, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

Quoted from the official label, section “Overdosage”.

Use in children

The safety and effectiveness of ezetimibe in combination with a statin as an adjunct to diet to reduce LDL-C have been established in pediatric patients 10 years of age and older with HeFH.
Use of ezetimibe for this indication is based on a double-blind, placebo-controlled clinical trial in 248 pediatric patients (142 males and 106 postmenarchal females) 10 years of age and older with HeFH [see Clinical Studies (14)].
In this limited controlled trial, there was no significant effect on growth or sexual maturation in the adolescent males or females, or on menstrual cycle length in females.
The safety and effectiveness of ezetimibe in combination with a statin, and other LDL-C lowering therapies, to reduce LDL-C have been established in pediatric patients 10 years of age and older with HoFH.
Use of ezetimibe for this indication is based on a 12-week double-blind, placebo-controlled clinical trial followed by an uncontrolled extension period in 7 pediatric patients 11 years of age and older with HoFH [see Clinical Studies (14)].
The safety and effectiveness of ezetimibe as an adjunct to diet for the reduction of elevated sitosterol and campesterol levels have been established in
adults and pediatric patients 9 years of age and older with homozygous familial sitosterolemia.
Use of ezetimibe for this indication is based on an 8-week double-blind, placebo-controlled clinical trial in 4 patients 9 years of age and older with homozygous sitosterolemia with elevated plasma sitosterol levels (>5 mg/dL) [see Clinical Studies (14)].
The safety and effectiveness of ezetimibe have not been established in pediatric patients younger than 10 years of age with HeFH or HoFH, in pediatric patients younger than 9 years of age with homozygous familial sitosterolemia, or in pediatric patients with other types of hyperlipidemia.

Quoted from the official label, section “Pediatric Use”.

Use in older people

Of the 2,396 patients who received ezetimibe in clinical trials, 669 (28%) were 65 years of age and older, and 111 (5%) were 75 years of age and older.
Of the 11,308 patients who received ezetimibe in combination with a statin in clinical trials, 3587 (32%) were 65 years of age and older, and 924 (8%) were 75 years of age and older [see Clinical Studies (14)].
No overall differences in safety or effectiveness of ezetimibe have been observed between patients 65 years of age and older and younger patients.
No clinically meaningful differences in the pharmacokinetics of ezetimibe were observed in geriatric patients compared to younger adult patients [see Clinical Pharmacology (12.3)].

Quoted from the official label, section “Geriatric Use”.

Side effects

The following serious adverse reactions are discussed in greater detail in other sections of the label:
Liver enzyme abnormalities [see Warnings and Precautions (5.2)]
Rhabdomyolysis and myopathy [see Warnings and Precautions (5.3)] Common adverse reactions in clinical trials:
° Ezetimibe administered alone (incidence ≥ 2% and greater than placebo):
upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue, and influenza. (6.1) ° Ezetimibe co-administered with a statin (incidence ≥ 2% and greater than statin alone):
nasopharyngitis, myalgia, upper respiratory tract infection, arthralgia, diarrhea, back pain, influenza, pain in extremity, and fatigue. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. Monotherapy In 10 double-blind, placebo-controlled clinical trials, 2,396 patients with primary hyperlipidemia (age range 9 to 86 years; 50% female, 90% White, 5% Black or African American, 2% Asian, 3% other races; 3% identified as Hispanic or Latino ethnicity) and elevated LDL-C were treated with ezetimibe 10 mg daily for a median treatment duration of 12 weeks (range 0 to 39 weeks). Adverse reactions reported in ≥ 2% of patients treated with ezetimibe and at an incidence greater than placebo in placebo-controlled studies of ezetimibe is shown in Table 1. Combination with a Statin In 28 double-blind, controlled (placebo or active-controlled) clinical trials, 11,308 patients with primary hyperlipidemia (age range 10 to 93 years, 48% female, 85% White, 7% Black or African American, 3% Asian, 5% other races; 4% identified as Hispanic or Latino ethnicity) and elevated LDL-C were treated with ezetimibe 10 mg/day concurrently with or added to on-going statin therapy for a median treatment duration of 8 weeks (range 0 to 112 weeks). The incidence of consecutive increased transaminases (≥ 3 X ULN) was higher in patients receiving ezetimibe administered with statins (1.3%) than in patients treated with statins alone (0.4%). Adverse reactions reported in ≥ 2% of patients treated with ezetimibe + statin and at an incidence greater than statin are shown in Table 2. Combination with Fenofibrate This clinical trial involving 625 patients with mixed dyslipidemia (age range 20 to 76 years; 44% female, 79% White, 1% Black or African American, 20% other races; 11% identified as Hispanic or Latino ethnicity) treated for up to 12 weeks and 576 patients treated for up to an additional 48 weeks evaluated co-administration of ezetimibe and fenofibrate. Incidence rates for clinically important elevations (≥ 3 X ULN, consecutive) in hepatic transaminase levels were 4.5% and 2.7% for fenofibrate monotherapy (n=188) and ezetimibe co-administered with fenofibrate (n=183), respectively, adjusted for treatment exposure. Corresponding incidence rates for cholecystectomy were 0.6% and 1.7% for fenofibrate monotherapy and ezetimibe co-administered with fenofibrate, respectively [see Drug Interactions (7)]. 1 1 6.2 Post-Marketing Experience Because the reactions below are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following additional adverse reactions have been identified during post-approval use of ezetimibe:
Blood Disorders :
thrombocytopenia Gastrointestinal Disorders:
abdominal pain; pancreatitis; nausea Hepatobiliary Disorders :
elevations in liver transaminases, including elevations more than 5 X ULN; hepatitis; cholelithiasis; cholecystitis Immune System Disorders :
Hypersensitivity reactions including:
anaphylaxis, angioedema, rash, and urticaria Musculoskeletal Disorders :
elevated creatine phosphokinase; myopathy/rhabdomyolysis Nervous System Disorders :
dizziness; paresthesia; depression; headache Skin and Subcutaneous Tissue Disorders:
erythema multiforme To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993; email drugsafety@avkare.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

Advise the patient to read the FDA-Approved Patient Labeling (Patient Information).
Inform patients that ezetimibe may cause liver enzyme elevations [see Warnings and Precautions (5.2)].
17.1 Muscle Pain Advise patients that ezetimibe may cause myopathy and rhabdomyolysis.
Inform patients that the risk is also increased when taking certain types of medication and they should discuss all medication, both prescription and over the counter, with their healthcare provider.
Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions (5.3), and Drug Interactions (7)].
17.2 Pregnancy Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if ezetimibe should be discontinued [see Use in Specific Populations (8.1)].
17.3 Breast-feeding Advise patients who have a lipid disorder and are breastfeeding to discuss the options with their healthcare provider [see Use in Specific Populations (8.2)].
17.4 Missed Dose Instruct patients to take ezetimibe tablets only as prescribed.
If a dose is missed, it should be taken as soon as possible.
Advise patients not to double their next dose.
Manufactured for: AvKARE Pulaski, TN 38478 Mfg.
Rev. 04-2024-06 AV Rev. 11/24 (A)

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Ezetimibe tablets USP, 10 mg are white to off-white, capsule-shaped tablets debossed with "AA69" on one side and plain on other side. Tablets:
10 mg ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

Ezetimibe tablets USP, 10 mg are supplied as white to off-white, capsule-shaped tablets debossed with “AA69” on one side and plain on other side.
They are supplied as follows:
NDC 50268-298-12 (10 tablets per card, 2 cards per carton) Dispensed in Unit Dose Package.
For Institutional Use Only.
Storage
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Protect from moisture.

Quoted from the official label, section “How Supplied”.

What is in it

Ezetimibe is a dietary cholesterol absorption inhibitor.
The chemical name of ezetimibe is 1-(4- fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4- hydroxyphenyl)-2-azetidinone.
The molecular formula is C24H21F2NO3.
Its molecular weight is 409.4 and its structural formula is::
Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water.
Ezetimibe, USP has a melting point of about 163°C and is stable at ambient temperature.
Ezetimibe tablets, USP are available as a tablet for oral administration containing 10 mg of ezetimibe, USP and the following inactive ingredients:
croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, and sodium lauryl sulfate. structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Lactoselactose monohydrateMilk sugar: matters with lactose intolerance or a milk allergy.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (24)

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Details

Made by	AvPAK
Active substance	Ezetimibe
Strength	10 mg
Form	Tablet
Route	Oral
Packs	20 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET in 1 BLISTER PACK
NDC	50268-298

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

23 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

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