Drug Safety Information for CLORAZEPATE DIPOTASSIUM (Clorazepate dipotassium)

Safety-related Labeling Changes for TRANXENE (CLORAZEPATE DIPOTASSIUM) Rx Drug: FDA Link

Adverse Drug Reactions for CLORAZEPATE DIPOTASSIUM* (Clorazepate dipotassium)

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 CLORAZEPATE DIPOTASSIUM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Somnolence*170
2Fall166
3Nausea165
4Dyspnoea155
5Drug interaction147
6Anxiety144
7Drug ineffective*141
8Convulsion138
9Confusional state136
10Asthenia135
11Depression127
12Dizziness126
13Pyrexia121
14Diarrhoea120
15Fatigue118
16Vomiting116
17Suicide attempt112
18Headache111
19Overdose110
20Coma107

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

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

Reason # of FDA Reports
1Product used for unknown indication1953
2Anxiety*1452
3Depression450
4Insomnia149
5Convulsion149
6Ill-defined disorder149
7Premedication118
8Bipolar disorder97
9Sedation97
10Epilepsy81

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


Types of Adverse Events for CLORAZEPATE DIPOTASSIUM

Total Reports Filed with FDA: 18584


Number of FDA Adverse Event Reports by Patient Age for CLORAZEPATE DIPOTASSIUM

Total Reports Filed with FDA: 18584*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Clorazepate dipotassium (Clorazepate, Gen-xene, Chlorazepate, Clorazepato, Tranxene sd, Tranxene t-tab, Tranxene, Tranxilium)

Charts are based on 18584 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 CLORAZEPATE DIPOTASSIUM 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.