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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.

ATORVASTATIN\EZETIMIBE: 1,236 Adverse Event Reports & Safety Profile

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1,236
Total FAERS Reports
50 (4.0%)
Deaths Reported
540
Hospitalizations
1,236
As Primary/Secondary Suspect
76
Life-Threatening
63
Disabilities

Active Ingredient: ATORVASTATIN CALCIUM\EZETIMIBE ·

First Report: 20000101 · Latest Report: 20250815

What Are the Most Common ATORVASTATIN\EZETIMIBE Side Effects?

#1 Most Reported
Myalgia
130 reports (10.5%)
#2 Most Reported
Acute kidney injury
60 reports (4.9%)
#3 Most Reported
Pain
45 reports (3.6%)

All ATORVASTATIN\EZETIMIBE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Myalgia 130 10.5% 0 13
Acute kidney injury 60 4.9% 0 47
Pain 45 3.6% 0 24
Pain in extremity 43 3.5% 0 17
Dizziness 42 3.4% 0 16
Malaise 42 3.4% 3 25
Pyrexia 41 3.3% 0 35
Rhabdomyolysis 40 3.2% 1 30
Arthralgia 39 3.2% 0 17
Headache 39 3.2% 0 18
Hepatic cytolysis 39 3.2% 0 24
Dyspnoea 36 2.9% 0 22
Muscle spasms 36 2.9% 0 6
Interstitial lung disease 35 2.8% 2 24
Nausea 35 2.8% 0 19
Blood creatine phosphokinase increased 34 2.8% 0 4
Cough 34 2.8% 0 24
Rash 34 2.8% 0 24
Drug-induced liver injury 32 2.6% 0 17
Hepatocellular injury 31 2.5% 0 21

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

Gender: 39.0% female, 61.0% male. Average age: 65.6 years. Most reports from: FR. View detailed demographics →

Is ATORVASTATIN\EZETIMIBE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2003 5 0 0
2007 1 0 0
2010 1 0 0
2011 1 0 0
2012 1 0 1
2013 17 0 13
2014 8 1 1
2015 29 0 5
2016 90 4 33
2017 87 1 36
2018 146 6 78
2019 72 0 27
2020 79 0 24
2021 109 8 74
2022 78 3 49
2023 139 23 53
2024 105 0 65
2025 43 0 34

View full timeline →

What Is ATORVASTATIN\EZETIMIBE Used For?

IndicationReports
Dyslipidaemia 239
Hypercholesterolaemia 202
Product used for unknown indication 152
Hyperlipidaemia 62
Coronary artery disease 46
Type iia hyperlipidaemia 40
Prophylaxis 36
Myocardial infarction 29
Myocardial ischaemia 27
Cardiovascular event prophylaxis 23

ATORVASTATIN\EZETIMIBE vs Alternatives: Which Is Safer?

ATORVASTATIN\EZETIMIBE vs ATOSIBAN ATORVASTATIN\EZETIMIBE vs ATOVAQUONE ATORVASTATIN\EZETIMIBE vs ATOVAQUONE\PROGUANIL ATORVASTATIN\EZETIMIBE vs ATRACURIUM ATORVASTATIN\EZETIMIBE vs ATRIPLA ATORVASTATIN\EZETIMIBE vs ATROPINE ATORVASTATIN\EZETIMIBE vs ATROPINE\ATROPINE ATORVASTATIN\EZETIMIBE vs ATROPINE\DIPHENOXYLATE ATORVASTATIN\EZETIMIBE vs AUBAGIO ATORVASTATIN\EZETIMIBE vs AUGMENTIN

Official FDA Label for ATORVASTATIN\EZETIMIBE

Official prescribing information from the FDA-approved drug label.