Drug side effects
diazepam Side Effects
The reactions most often reported to the FDA for diazepam (also sold as Valium), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 117,869
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 1996 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 diazepam come from 117,869 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 117,869 reports to the FDA Adverse Event Reporting System (FAERS) for diazepam (Valium): 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
117,869
Reports Mentioning Death
22,544
19.1% of reports — not proof the medicine caused the death
Hospitalizations
40,899
34.7% 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 22,544 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| TOXICITY TO VARIOUS AGENTS | 6,437 |
| COMPLETED SUICIDE | 3,918 |
| DEATH | 3,915 |
| DRUG ABUSE | 3,687 |
| CARDIAC ARREST | 1,670 |
| OVERDOSE | 1,619 |
| CARDIO-RESPIRATORY ARREST | 1,405 |
| RESPIRATORY ARREST | 1,216 |
| DRUG INTERACTION | 1,159 |
| POISONING | 810 |
| ACCIDENTAL OVERDOSE | 648 |
| PNEUMONIA | 645 |
| PULMONARY OEDEMA | 640 |
| DRUG DEPENDENCE | 594 |
| DRUG TOXICITY | 539 |
| RESPIRATORY DEPRESSION | 502 |
| INTENTIONAL PRODUCT MISUSE | 444 |
| DEPRESSED LEVEL OF CONSCIOUSNESS | 443 |
| INTENTIONAL OVERDOSE | 430 |
Reactions in Hospitalization Reports
Top reactions in 40,899 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| NAUSEA | 2,439 |
| TOXICITY TO VARIOUS AGENTS | 2,421 |
| VOMITING | 2,371 |
| FALL | 2,304 |
| SOMNOLENCE | 2,282 |
| PNEUMONIA | 2,177 |
| COMA | 2,167 |
| DYSPNOEA | 2,146 |
| PAIN | 2,118 |
| DRUG ABUSE | 2,060 |
| HYPOTENSION | 1,966 |
| OVERDOSE | 1,925 |
| ANXIETY | 1,916 |
| FATIGUE | 1,807 |
| DRUG INTERACTION | 1,799 |
| CONFUSIONAL STATE | 1,760 |
| PYREXIA | 1,711 |
| HEADACHE | 1,665 |
Nearby, Related Medications
What the FAERS Data Reveals About diazepam Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 117,869 voluntary reports linked to diazepam and its brand equivalents (Valium), spanning 1996 through 2025. Of those, 22,544 (19.1%) listed death as an outcome and 40,899 (34.7%) 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, 58% were female and 42% male; age distribution skews toward 45-64, with 32,331 reports in that bracket. The single most reported reaction is toxicity to various agents with 9,167 submissions, followed by drug abuse and nausea.
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 diazepam's 117,869.
Read our methodology - how this data is sourced, computed, and verified.