midazolam Side Effects
Also known as: Versed
Analysis of 24,014 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
24,014
Death-Related
4,573
19.0% of reports
Hospitalizations
11,054
46.0% 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 4,573 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 688 |
| DRUG INEFFECTIVE | 430 |
| OFF LABEL USE | 424 |
| CARDIAC ARREST | 392 |
| TOXICITY TO VARIOUS AGENTS | 368 |
| HYPOTENSION | 293 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 288 |
| PNEUMONIA | 273 |
| RESPIRATORY FAILURE | 273 |
| ACUTE KIDNEY INJURY | 243 |
| RENAL FAILURE | 218 |
| SEPSIS | 216 |
| DYSPNOEA | 193 |
| PYREXIA | 178 |
| SEPTIC SHOCK | 178 |
| THROMBOCYTOPENIA | 158 |
| DRUG INTERACTION | 155 |
| METABOLIC ACIDOSIS | 154 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 148 |
| CARDIO-RESPIRATORY ARREST | 145 |
Reactions in Hospitalization Reports
Top reactions in 11,054 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DRUG INEFFECTIVE | 1,635 |
| OFF LABEL USE | 1,127 |
| HYPOTENSION | 697 |
| PYREXIA | 602 |
| DRUG INTERACTION | 593 |
| SEIZURE | 563 |
| TOXICITY TO VARIOUS AGENTS | 485 |
| ACUTE KIDNEY INJURY | 458 |
| ANAEMIA | 422 |
| CARDIAC ARREST | 401 |
| PNEUMONIA | 398 |
| NAUSEA | 359 |
| DYSPNOEA | 356 |
| RESPIRATORY FAILURE | 356 |
| STATUS EPILEPTICUS | 352 |
| TACHYCARDIA | 352 |
| PAIN | 339 |
| VOMITING | 338 |
| ABDOMINAL PAIN | 336 |
| SEROTONIN SYNDROME | 334 |
Nearby — Related Medications
What the FAERS Data Reveals About midazolam Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 24,014 voluntary reports linked to midazolam and its brand equivalents (Versed), spanning 2004 through 2025. Of those, 4,573 (19.0%) listed death as an outcome and 11,054 (46.0%) 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, 48% were female and 52% male; age distribution skews toward 18-44, with 5,375 reports in that bracket. The single most reported reaction is drug ineffective with 2,984 submissions, followed by off label use and seizure.
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.