Drug Safety Information for DEPAKENE (Valproic acid)

Safety-related Labeling Changes for DEPAKENE (VALPROIC ACID) Rx Drug: FDA Link

Safety-related Labeling Changes for STAVZOR (VALPROIC ACID) Discontinued Drug: FDA Link

Adverse Drug Reactions for DEPAKENE* (Valproic acid)

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 DEPAKENE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Convulsion1696
2Drug interaction1377
3Pyrexia1106
4Somnolence951
5Epilepsy943
6Toxicity to various agents900
7Drug ineffective852
8Completed suicide799
9Vomiting660
10Confusional state607
11Fall584
12Thrombocytopenia584
13Overdose548
14Rash538
15Tremor508
16Agitation500
17Pneumonia494
18Nausea485
19Condition aggravated472
20Alanine aminotransferase increased452

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

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

Reason # of FDA Reports
1Epilepsy*17413
2Product used for unknown indication11962
3Convulsion*5355
4Maternal exposure during pregnancy3268
5Bipolar disorder2854
6Maternal exposure timing unspecified1251
7Affective disorder1127
8Schizophrenia984
9Convulsion prophylaxis808
10Partial seizures796

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


Types of Adverse Events for DEPAKENE

Total Reports Filed with FDA: 96851


Number of FDA Adverse Event Reports by Patient Age for DEPAKENE

Total Reports Filed with FDA: 96851*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Valproic acid (Valproate, Depakine, Sodium valproate, Valproic, Convulsofin, Ergenyl, Semisodium valproate, Magnesium valproate, Valproate magnesium, Valproate semisodium, Stavzor, Valproic acid, Depakene)

Charts are based on 96851 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 DEPAKENE 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.