EZETIMIBE AND SIMVASTATIN

N/A

Manufactured by Organon LLC

29,702 FDA adverse event reports analyzed

Last updated: 2026-04-14

About EZETIMIBE AND SIMVASTATIN

EZETIMIBE AND SIMVASTATIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Organon LLC. The most commonly reported adverse reactions for EZETIMIBE AND SIMVASTATIN include NAUSEA, DRUG INEFFECTIVE, FATIGUE, DIZZINESS, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for EZETIMIBE AND SIMVASTATIN.

Top Adverse Reactions

NAUSEA1,009 reports
DRUG INEFFECTIVE817 reports
FATIGUE770 reports
DIZZINESS730 reports
PAIN702 reports
MYALGIA667 reports
DYSPNOEA644 reports
ASTHENIA601 reports
DIARRHOEA600 reports
HEADACHE563 reports
PAIN IN EXTREMITY547 reports
ARTHRALGIA527 reports
MYOCARDIAL INFARCTION519 reports
WEIGHT DECREASED502 reports
BLOOD GLUCOSE INCREASED476 reports
FALL474 reports
VOMITING462 reports
RHABDOMYOLYSIS446 reports
ANXIETY444 reports
RENAL FAILURE439 reports
CHEST PAIN420 reports
FLUSHING407 reports
PRURITUS400 reports
INSOMNIA390 reports
DEPRESSION379 reports
HYPERTENSION377 reports
MALAISE367 reports
BACK PAIN357 reports
MUSCLE SPASMS356 reports
WEIGHT INCREASED304 reports
CEREBROVASCULAR ACCIDENT303 reports
OEDEMA PERIPHERAL303 reports
ABDOMINAL PAIN UPPER302 reports
FEELING ABNORMAL302 reports
CONSTIPATION300 reports
CARDIAC FAILURE CONGESTIVE294 reports
RASH290 reports
DECREASED APPETITE285 reports
CHRONIC KIDNEY DISEASE279 reports
GAIT DISTURBANCE279 reports
MUSCULAR WEAKNESS277 reports
PNEUMONIA267 reports
OFF LABEL USE263 reports
ANAEMIA259 reports
CORONARY ARTERY DISEASE256 reports
HYPOTENSION254 reports
DEATH252 reports
COUGH251 reports
PARAESTHESIA251 reports
ABDOMINAL PAIN235 reports
BLOOD PRESSURE INCREASED229 reports
TREMOR229 reports
PYREXIA226 reports
DRUG HYPERSENSITIVITY216 reports
ATRIAL FIBRILLATION212 reports
DIABETES MELLITUS210 reports
BLOOD CHOLESTEROL INCREASED205 reports
SOMNOLENCE205 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED202 reports
DEHYDRATION202 reports
VISION BLURRED202 reports
PANCREATITIS200 reports
ACUTE KIDNEY INJURY199 reports
HYPERHIDROSIS199 reports
LOSS OF CONSCIOUSNESS199 reports
URINARY TRACT INFECTION195 reports
GASTROOESOPHAGEAL REFLUX DISEASE193 reports
RENAL FAILURE ACUTE192 reports
INJURY184 reports
CONFUSIONAL STATE177 reports
ERYTHEMA177 reports
HYPOAESTHESIA177 reports
ABDOMINAL DISCOMFORT176 reports
DRUG DOSE OMISSION176 reports
TYPE 2 DIABETES MELLITUS174 reports
CARDIAC DISORDER172 reports
DRUG INTERACTION172 reports
SYNCOPE172 reports
PALPITATIONS167 reports
GASTROINTESTINAL HAEMORRHAGE155 reports
DYSPEPSIA152 reports
MEMORY IMPAIRMENT152 reports
BLOOD GLUCOSE DECREASED151 reports
ALOPECIA146 reports
BALANCE DISORDER137 reports
DRY MOUTH136 reports
ALANINE AMINOTRANSFERASE INCREASED135 reports
CONTUSION135 reports
MUSCULOSKELETAL PAIN135 reports
ABDOMINAL DISTENSION134 reports
HYPERSENSITIVITY133 reports
ASPARTATE AMINOTRANSFERASE INCREASED132 reports
CONDITION AGGRAVATED132 reports
FEELING HOT132 reports
DYSGEUSIA131 reports
HEART RATE INCREASED130 reports
DYSPHAGIA128 reports
CHEST DISCOMFORT127 reports
SINUSITIS127 reports
OSTEOARTHRITIS125 reports

Report Outcomes

Out of 15,049 classified reports for EZETIMIBE AND SIMVASTATIN:

Serious 62.8%Non-Serious 37.2%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female7,799 (53.6%)
Male6,682 (46.0%)
Unknown56 (0.4%)

Reports by Age

Age 65306 reports
Age 64301 reports
Age 68293 reports
Age 58291 reports
Age 60290 reports
Age 63285 reports
Age 70281 reports
Age 71277 reports
Age 61276 reports
Age 59265 reports
Age 67260 reports
Age 72258 reports
Age 66256 reports
Age 62255 reports
Age 74242 reports
Age 75242 reports
Age 73241 reports
Age 69234 reports
Age 57215 reports
Age 77213 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with EZETIMIBE AND SIMVASTATIN?

This profile reflects 29,702 FDA FAERS reports that mention EZETIMIBE AND SIMVASTATIN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for EZETIMIBE AND SIMVASTATIN?

Frequently reported terms in FAERS include NAUSEA, DRUG INEFFECTIVE, FATIGUE, DIZZINESS, PAIN, MYALGIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures EZETIMIBE AND SIMVASTATIN?

Labeling and FAERS entries often list Organon LLC in connection with EZETIMIBE AND SIMVASTATIN. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.