Drug Safety Information for DEPAKOTE ER (Divalproex sodium)

Safety-related Labeling Changes for DEPAKOTE (DIVALPROEX SODIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for DEPAKOTE ER (DIVALPROEX SODIUM) Rx Drug: FDA Link

Adverse Drug Reactions for DEPAKOTE ER* (Divalproex sodium)

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 DEPAKOTE ER
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Convulsion1961
2Weight increased*1272
3Diabetes mellitus1243
4Pain*1231
5Drug ineffective1199
6Tremor1047
7Anxiety*1009
8Nausea*1006
9Depression915
10Type 2 diabetes mellitus910
11Headache*889
12Somnolence*883
13Fatigue*869
14Dizziness*835
15Insomnia*833
16Vomiting798
17Fall768
18Emotional distress691
19Confusional state662
20Diarrhoea649

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

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

Reason # of FDA Reports
1Product used for unknown indication11143
2Bipolar disorder*7704
3Convulsion*7333
4Maternal exposure timing unspecified6163
5Epilepsy*2819
6Maternal exposure during pregnancy2150
7Depression*2016
8Affective disorder1624
9Migraine*1243
10Bipolar i disorder1154

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


Types of Adverse Events for DEPAKOTE ER

Total Reports Filed with FDA: 114215


Number of FDA Adverse Event Reports by Patient Age for DEPAKOTE ER

Total Reports Filed with FDA: 114215*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Divalproex sodium (Acido valproico, Depakote cp, Divalproex, Va, Depakote er, Depakote, Divalproex sodium)

Charts are based on 114215 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 DEPAKOTE ER 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.