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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

EZETIMIBE\SIMVASTATIN: 1,960 Adverse Event Reports & Safety Profile

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1,960
Total FAERS Reports
127 (6.5%)
Deaths Reported
634
Hospitalizations
1,960
As Primary/Secondary Suspect
153
Life-Threatening
98
Disabilities

First Report: 1980 · Latest Report: 20250721

What Are the Most Common EZETIMIBE\SIMVASTATIN Side Effects?

#1 Most Reported
Myalgia
244 reports (12.4%)
#2 Most Reported
Acute kidney injury
132 reports (6.7%)
#3 Most Reported
Rhabdomyolysis
113 reports (5.8%)

All EZETIMIBE\SIMVASTATIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Myalgia 244 12.5% 0 25
Acute kidney injury 132 6.7% 16 106
Rhabdomyolysis 113 5.8% 6 75
Drug hypersensitivity 112 5.7% 0 2
Arthralgia 89 4.5% 0 14
Diarrhoea 71 3.6% 5 34
Muscle spasms 70 3.6% 0 7
No adverse event 68 3.5% 0 4
Fatigue 66 3.4% 0 20
Rash 54 2.8% 0 10
Off label use 49 2.5% 0 19
Blood creatine phosphokinase increased 47 2.4% 0 8
Pain in extremity 47 2.4% 0 10
Depression 46 2.4% 2 12
Nausea 46 2.4% 0 11
Dyspnoea 45 2.3% 0 21
Lactic acidosis 44 2.2% 14 19
Pruritus 44 2.2% 5 12
Drug ineffective 43 2.2% 0 8
Muscular weakness 41 2.1% 0 6

Who Reports EZETIMIBE\SIMVASTATIN Side Effects? Age & Gender Data

Gender: 49.2% female, 50.8% male. Average age: 65.3 years. Most reports from: US. View detailed demographics →

Is EZETIMIBE\SIMVASTATIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 3 0 0
2001 3 0 2
2002 5 0 0
2003 7 0 0
2004 2 0 0
2005 10 1 5
2006 12 1 3
2007 19 0 10
2008 26 2 8
2009 22 1 12
2010 27 1 13
2011 33 3 12
2012 36 1 12
2013 46 4 14
2014 97 6 35
2015 160 17 81
2016 91 4 40
2017 121 5 37
2018 123 27 33
2019 103 6 57
2020 66 2 25
2021 66 8 15
2022 77 0 54
2023 56 0 23
2024 20 3 7
2025 7 0 3

View full timeline →

What Is EZETIMIBE\SIMVASTATIN Used For?

IndicationReports
Product used for unknown indication 374
Dyslipidaemia 302
Hypercholesterolaemia 204
Blood cholesterol increased 134
Hyperlipidaemia 68
Coronary artery disease 50
Blood cholesterol abnormal 48
Acute coronary syndrome 47
Type iia hyperlipidaemia 40
Blood cholesterol 37

EZETIMIBE\SIMVASTATIN vs Alternatives: Which Is Safer?

EZETIMIBE\SIMVASTATIN vs EZOGABINE EZETIMIBE\SIMVASTATIN vs FACTOR XIII CONCENTRATE EZETIMIBE\SIMVASTATIN vs FAM-TRASTUZUMAB DERUXTECAN-NXKI EZETIMIBE\SIMVASTATIN vs FAMCICLOVIR EZETIMIBE\SIMVASTATIN vs FAMOTIDINE EZETIMIBE\SIMVASTATIN vs FAMOTIDINE\IBUPROFEN EZETIMIBE\SIMVASTATIN vs FARICIMAB EZETIMIBE\SIMVASTATIN vs FARICIMAB-SVOA EZETIMIBE\SIMVASTATIN vs FARICIMAB\FARICIMAB-SVOA EZETIMIBE\SIMVASTATIN vs FASLODEX

Official FDA Label for EZETIMIBE\SIMVASTATIN

Official prescribing information from the FDA-approved drug label.