DEPAKOTE: 368 Adverse Event Reports & Safety Profile
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368
Total FAERS Reports
8 (2.2%)
Deaths Reported
86
Hospitalizations
368
As Primary/Secondary Suspect
12
Life-Threatening
20
Disabilities
First Report: 1990 · Latest Report: 20140522
What Are the Most Common DEPAKOTE Side Effects?
#1 Most Reported
Foetal exposure during pregnancy
50 reports (13.6%)
#2 Most Reported
Pain
47 reports (12.8%)
#3 Most Reported
Convulsion
46 reports (12.5%)
All DEPAKOTE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Foetal exposure during pregnancy | 50 | 13.6% | 3 | 2 |
| Pain | 47 | 12.8% | 2 | 4 |
| Convulsion | 46 | 12.5% | 0 | 13 |
| Anhedonia | 40 | 10.9% | 2 | 0 |
| Emotional distress | 38 | 10.3% | 1 | 1 |
| Loss of employment | 38 | 10.3% | 2 | 0 |
| Physical disability | 36 | 9.8% | 2 | 0 |
| Social problem | 36 | 9.8% | 2 | 0 |
| Deformity | 35 | 9.5% | 2 | 0 |
| Life expectancy shortened | 35 | 9.5% | 2 | 0 |
| Tension | 30 | 8.2% | 1 | 0 |
| Anxiety | 29 | 7.9% | 0 | 5 |
| Drug ineffective | 28 | 7.6% | 0 | 1 |
| Injury | 25 | 6.8% | 0 | 0 |
| Weight increased | 25 | 6.8% | 0 | 7 |
| Somnolence | 20 | 5.4% | 1 | 9 |
| Tremor | 20 | 5.4% | 1 | 8 |
| Depression | 19 | 5.2% | 0 | 6 |
| Drug hypersensitivity | 19 | 5.2% | 0 | 1 |
| Congenital anomaly | 18 | 4.9% | 0 | 0 |
Who Reports DEPAKOTE Side Effects? Age & Gender Data
Average age: 44.2 years. Most reports from: US. View detailed demographics →
Is DEPAKOTE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 1 | 0 | 1 |
| 2002 | 2 | 0 | 2 |
| 2003 | 4 | 0 | 2 |
| 2006 | 2 | 0 | 1 |
| 2008 | 3 | 1 | 0 |
| 2009 | 6 | 0 | 0 |
| 2010 | 4 | 0 | 3 |
| 2011 | 10 | 0 | 2 |
| 2012 | 19 | 0 | 5 |
| 2013 | 74 | 1 | 28 |
| 2014 | 45 | 1 | 25 |
What Is DEPAKOTE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 108 |
| Bipolar disorder | 62 |
| Maternal exposure timing unspecified | 50 |
| Convulsion | 35 |
| Epilepsy | 21 |
| Depression | 8 |
| Mania | 5 |
DEPAKOTE vs Alternatives: Which Is Safer?
DEPAKOTE vs DERMATOPHAGOIDES FARINAE
DEPAKOTE vs DERMATOPHAGOIDES FARINAE\DERMATOPHAGOIDES PTERONYSSINUS
DEPAKOTE vs DERMATOPHAGOIDES PTERONYSSINUS
DEPAKOTE vs DESFLURANE
DEPAKOTE vs DESIPRAMINE
DEPAKOTE vs DESLORATADINE
DEPAKOTE vs DESMOPRESSIN
DEPAKOTE vs DESOGESTREL
DEPAKOTE vs DESOGESTREL\ETHINYL ESTRADIOL
DEPAKOTE vs DESONIDE
Official FDA Label for DEPAKOTE
Official prescribing information from the FDA-approved drug label.