Drug Safety Information for VALIUM (Diazepam)

Safety-related Labeling Changes for VALIUM (DIAZEPAM) Rx Drug: FDA Link

Safety-related Labeling Changes for DIASTAT (DIAZEPAM) Rx Drug: FDA Link

Adverse Drug Reactions for VALIUM* (Diazepam)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with VALIUM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Toxicity to various agents2804
2Nausea2456
3Drug ineffective*2206
4Pain2125
5Anxiety2102
6Drug abuse2011
7Headache1977
8Fatigue1945
9Completed suicide1927
10Dizziness*1914
11Depression*1828
12Dyspnoea1771
13Vomiting1724
14Insomnia1664
15Fall1599
16Overdose1587
17Death1501
18Somnolence*1481
19Diarrhoea1478
20Convulsion1365

* This side effect also appears in "Top 10 Side Effects of VALIUM " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking VALIUM
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication31425
2Anxiety*13808
3Muscle spasms*4063
4Insomnia*2767
5Depression2483
6Convulsion2245
7Sleep disorder1412
8Pain1231
9Agitation1046
10Panic attack*860

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for VALIUM

Total Reports Filed with FDA: 227735


Number of FDA Adverse Event Reports by Patient Age for VALIUM

Total Reports Filed with FDA: 227735*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Diazepam (Sibazon, Relanium, Diazepam intensol, Q-pam, Stesolid, Valrelease, Seduxen, Faustan, Atensine, Zetran, Apaurin, Diazemuls, Dizac, Diastat acudial, Diazepam, Diastat, Valium)

Charts are based on 227735 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and VALIUM Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.