simvastatin Side Effects
Also known as: Zocor
Analysis of 245,754 adverse event reports submitted to the FDA from 2002 to 2025.
Total Reports
245,754
Death-Related
21,913
8.9% of reports
Hospitalizations
94,740
38.6% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 21,913 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 6,325 |
| SEPSIS | 1,509 |
| DYSPNOEA | 1,384 |
| PNEUMONIA | 1,384 |
| RENAL FAILURE | 1,320 |
| NAUSEA | 1,138 |
| FALL | 1,106 |
| MYOCARDIAL INFARCTION | 1,052 |
| ASTHENIA | 1,039 |
| VOMITING | 1,030 |
| ACUTE KIDNEY INJURY | 1,017 |
| DIARRHOEA | 997 |
| CARDIAC ARREST | 995 |
| COMPLETED SUICIDE | 901 |
| FATIGUE | 895 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 867 |
| RESPIRATORY FAILURE | 854 |
| ABDOMINAL PAIN | 848 |
| ANAEMIA | 813 |
| OFF LABEL USE | 784 |
Reactions in Hospitalization Reports
Top reactions in 94,740 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DYSPNOEA | 6,628 |
| FALL | 6,061 |
| NAUSEA | 5,342 |
| DIARRHOEA | 4,933 |
| PNEUMONIA | 4,868 |
| ASTHENIA | 4,556 |
| FATIGUE | 4,543 |
| VOMITING | 4,525 |
| DIZZINESS | 4,469 |
| DRUG INTERACTION | 4,237 |
| RHABDOMYOLYSIS | 4,086 |
| ACUTE KIDNEY INJURY | 4,048 |
| ANAEMIA | 3,973 |
| MYOCARDIAL INFARCTION | 3,680 |
| HYPOTENSION | 3,599 |
| PAIN | 3,548 |
| MALAISE | 3,409 |
| PYREXIA | 3,296 |
| CHEST PAIN | 3,187 |
| DEHYDRATION | 3,078 |
Nearby — Related Medications
What the FAERS Data Reveals About simvastatin Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 245,754 voluntary reports linked to simvastatin and its brand equivalents (Zocor), spanning 2002 through 2025. Of those, 21,913 (8.9%) listed death as an outcome and 94,740 (38.6%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 51% were female and 49% male; age distribution skews toward 75+, with 55,999 reports in that bracket. The single most reported reaction is fatigue with 13,574 submissions, followed by nausea and dyspnoea.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.