Valproate Sodium
20,100 adverse event reports submitted to the FDA (2001–2026)
Top Reported Adverse Events
The most frequently reported events in association with Valproate Sodium in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Ineffective 1,428 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Drug Interaction 1,230 reports
A report that two or more medications may have affected each other when taken together.
Full definition in the glossary →Off Label Use 1,125 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Foetal Exposure During Pregnancy 1,043 reports
A report noting that a developing baby was exposed to a medication during pregnancy. This is a tracking category for monitoring, not a description of harm by itself. Also spelled fetal in American English.
Full definition in the glossary →Somnolence 976 reports
Drowsiness or strong sleepiness.
Full definition in the glossary → See all drugs reporting this event →Epilepsy 832 reports
A condition of the brain that causes repeated seizures. It often appears in reports as a condition being treated.
Full definition in the glossary →Seizure 777 reports
A sudden burst of electrical activity in the brain that can cause shaking, altered awareness, or other temporary changes.
Full definition in the glossary →Toxicity to Various Agents 770 reports
A broad reporting category used when the body has a harmful response, sometimes involving more than one substance.
Full definition in the glossary →Pyrexia 750 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Vomiting 617 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Convulsion 612 reports
Uncontrolled shaking of the body caused by sudden muscle contractions, often associated with a seizure.
Full definition in the glossary →Neutropenia 536 reports
A low level of neutrophils, a type of white blood cell that fights infection.
Full definition in the glossary →Diarrhoea 524 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Condition Aggravated 517 reports
A report that the person's existing health condition got worse. This describes a worsening of something the person already had, not necessarily a new problem caused by the drug.
Full definition in the glossary →Weight Increased 510 reports
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 9,414 |
| Female | 8,400 |
| Unknown | 76 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 2,707 |
| 18-34 | 2,966 |
| 35-49 | 3,013 |
| 50-64 | 2,994 |
| 65-74 | 1,397 |
| 75+ | 949 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Valproate Sodium. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 12,635 |
| Hospitalization | 8,610 |
| Death | 1,806 |
| Life-Threatening | 1,589 |
| Non-Serious | 1,173 |
| Disability | 743 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Valproate Sodium. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 488 |
| 2005 | 543 |
| 2006 | 670 |
| 2007 | 461 |
| 2008 | 630 |
| 2009 | 1,078 |
| 2010 | 655 |
| 2011 | 1,323 |
| 2012 | 1,029 |
| 2013 | 290 |
| 2014 | 276 |
| 2015 | 280 |
| 2016 | 262 |
| 2017 | 462 |
| 2018 | 530 |
| 2019 | 451 |
| 2020 | 412 |
| 2021 | 2,059 |
| 2022 | 2,947 |
| 2023 | 1,826 |
| 2024 | 1,699 |
| 2025 | 1,442 |
| 2026 (partial) | 283 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Valproate Sodium
In FDA adverse event reports that mention Valproate Sodium, these medications appeared most often in the same report.
- Levetiracetam (2,564 reports)
- Clozapine (2,523 reports)
- Lamotrigine (2,443 reports)
- Quetiapine (2,262 reports)
- Levetiracetam In (2,041 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026