VALIUM FDA MedWatch Direct Reports Summary
These tables and charts are created from 892 voluntary U.S. reports for VALIUM (DIAZEPAM) reported by individuals to the FDA via the MedWatch Reporting System from 2004 through April 28, 2026.
For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS VALIUM Report.
Top Adverse Effects Associated with VALIUM (from U.S. FDA Medwatch Reports)
Side Effect # of FDA Reports 1 PAIN 77 2 HEADACHE 76 3 NAUSEA 72 4 DIZZINESS 70 5 FATIGUE 69 6 ANXIETY 67 7 INSOMNIA 65 8 LACK OF STRENGTH AND ENERGY (ASTHENIA) 52 9 SUICIDAL IDEATION 52 10 DEPRESSION 51 11 DIARRHEA 51 12 DRUG INEFFECTIVE 51 13 SHORTNESS OF BREATH 48 14 PRODUCT SUBSTITUTION ISSUE 44 15 VOMITING 43 16 JOINT PAIN 40 17 MUSCLE SPASMS 40 18 MALAISE 39 19 WITHDRAWAL SYNDROME 37 20 FEELING ABNORMAL 36 21 TREMOR 35 22 RASH 32 23 FALL 31 24 GAIT DISTURBANCE 31 25 MUSCLE PAIN 28
VALIUM Total Medwatch Safety Reports by Patient Sex
| Male | Female | Unknown | Total |
|---|---|---|---|
| 253 | 605 | 34 | 892 |
| Medwatch Reporter Type | Count |
| Consumer | 453 |
| Physician | 29 |
| Pharmacist | 106 |
| Other Health Professional | 94 |
| Lawyer | 1 |
| Top Indications | |
| Product used for unknown indication | |
| Agitation | |
| Bipolar disorder | |
| Insomnia | |
| Depression | |
Type of Outcome Reported
Serious: 673
Not Serious: 219
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.
Suspected Role
Primary Suspect: 891
Concomitant Drugs: 836
Note: A single MedWatch report can list more than one drug. This summary includes VALIUM identified as the suspect drug or as a concomitantly taken drug.
FDA Safety-Related Labeling Changes
VALIUM (DIAZEPAM) Rx Drug:
FDA Safety-related Labeling Changes
Have experience (good or bad) with VALIUM? Rate VALIUM at Ask a Patient.
For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.
NOTES
This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.
After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"
The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.
Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."
FDA uses the "MedDRA" classification system to describe reported adverse
reactions. MedDRA is a standardized medical terminology that facilitates
sharing of regulatory information internationally. In some cases, "patient
friendly" terms for the layman designated by MedDRA have been substituted
for medical jargon. Please
contact us
with questions about this report.