Drug Safety Information for OXAZEPAM (Oxazepam)

Adverse Drug Reactions for OXAZEPAM* (Oxazepam)

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 OXAZEPAM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Toxicity to various agents366
2Drug interaction295
3Fall232
4Dyspnoea205
5Confusional state196
6Fatigue182
7Vomiting180
8Nausea170
9Overdose166
10Dizziness*163
11Diarrhoea155
12Death151
13Asthenia151
14Hyponatraemia147
15Hypotension142
16Pyrexia142
17Somnolence*141
18Loss of consciousness138
19Anxiety*138
20Malaise129

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

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

Reason # of FDA Reports
1Product used for unknown indication2475
2Anxiety*913
3Insomnia*453
4Depression361
5Sleep disorder277
6Ill-defined disorder116
7Sedation113
8Suicide attempt78
9Anxiety disorder77
10Intentional overdose69

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


Types of Adverse Events for OXAZEPAM

Total Reports Filed with FDA: 22322


Number of FDA Adverse Event Reports by Patient Age for OXAZEPAM

Total Reports Filed with FDA: 22322*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Oxazepam (Zaxopam, Tazepam, Serax, Adumbran, Oxazepam)

Charts are based on 22322 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 OXAZEPAM 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.