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Ezetimibe Side Effects

The most commonly reported side effects of ezetimibe include fatigue, nausea, and diarrhoea, based on 88,075 FDA adverse event reports from 2004 to 2025. 3.6% of reports found the drug to be ineffective.

Ezetimibe side effects

Percentages show how often each reaction appears relative to total reports for ezetimibe.

1
Fatigue4.8%4,204
2
Nausea4.0%3,518
3
Diarrhoea3.9%3,449
4
Myalgia3.8%3,381
5
Drug Ineffective3.6%3,181
6
Dyspnoea3.2%2,855
7
Dizziness3.2%2,790
8
Headache3.2%2,776
9
Arthralgia2.9%2,550
10
Pain2.8%2,466
11
Off Label Use2.7%2,384
12
Asthenia2.7%2,372
13
Fall2.5%2,169
14
Malaise2.3%2,052
15
Vomiting2.2%1,976

These are voluntary reports and do not establish that ezetimibe caused these reactions.

Report severity

65.6%Serious57,804 reports
30.3%Hospitalizations26,726 reports
5.8%Fatal5,106 reports

Seriousness is determined by the reporter, not by OpenClaim.

Ezetimibe drug interactions

Other drugs that appear in adverse event reports alongside ezetimibe. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Simvastatin6.8%5,959
2
Atorvastatin-calcium6.6%5,842
3
Rosuvastatin5.0%4,446
4
Evolocumab2.9%2,528
5
Aspirin2.6%2,256
6
Adalimumab2.4%2,119
7
Metformin2.3%2,063
8
Omeprazole2.3%2,019
9
Niacin2.1%1,876
10
Lenalidomide2.1%1,816
11
Esomeprazole1.7%1,533
12
Amlodipine1.5%1,350
13
Hydrochlorothiazide1.5%1,340
14
Exenatide-synthetic1.5%1,317
15
Pravastatin-sodium1.5%1,279

Taken alongside

1
Aspirin25.9%22,775
2
Simvastatin17.7%15,554
3
Atorvastatin-calcium15.0%13,246
4
Levothyroxine-sodium13.7%12,091
5
Metoprolol13.4%11,834
6
Metformin12.7%11,221
7
Amlodipine12.2%10,714
8
Furosemide11.2%9,871
9
Acetaminophen11.1%9,800
10
Rosuvastatin11.1%9,736
11
Ergocalciferol11.0%9,676
12
Omeprazole9.8%8,659
13
Lisinopril9.0%7,893
14
Insulin8.6%7,574
15
Hydrochlorothiazide8.4%7,370

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports ezetimibe side effects

48.9% of ezetimibe adverse event reports involve female patients and 43.4% involve male patients. The largest age group is elderly at 58%. These figures reflect who reports side effects, not underlying risk.

Sex

Female48.9%
Male43.4%
Unknown7.7%

Age group

< 20.2%
2–110.1%
12–170.1%
18–6441.2%
65+58.4%

What is ezetimibe used for

Conditions and purposes for which patients were taking ezetimibe when the adverse event was reported.

Abdominal DiscomfortAcute Coronary SyndromeAcute Myocardial InfarctionAdjuvant TherapyAlopecia AreataAlopecia TotalisAlopecia UniversalisAnalgesic TherapyAngina PectorisAngina UnstableAngiopathyAntibiotic TherapyAnticoagulant TherapyAntifungal ProphylaxisAntiplatelet Therapy

Showing 15 of 522 indications

Ezetimibe brand names and reporting trend

Ezetimibe is sold under the brand name Nexlizet.

Brand names

Nexlizet37,366

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking ezetimibe with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.