Drug side effects
simvastatin Side Effects
The reactions most often reported to the FDA for simvastatin (also sold as Zocor), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 245,754
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2002 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of simvastatin come from 245,754 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 245,754 reports to the FDA Adverse Event Reporting System (FAERS) for simvastatin (Zocor): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
245,754
Reports Mentioning Death
21,913
8.9% of reports — not proof the medicine caused the death
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 |
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.
How to read these numbers
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.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to simvastatin's 245,754.
Read our methodology - how this data is sourced, computed, and verified.