85/100 · Critical
Manufactured by Actavis Pharma, Inc.
High Safety Concerns with Valproic Acid, Particularly for Severe Reactions
57,615 FDA adverse event reports analyzed
Last updated: 2026-05-12
VALPROIC ACID is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Actavis Pharma, Inc.. Based on analysis of 57,615 FDA adverse event reports, VALPROIC ACID has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for VALPROIC ACID include DRUG INEFFECTIVE, DRUG INTERACTION, OFF LABEL USE, TOXICITY TO VARIOUS AGENTS, SEIZURE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VALPROIC ACID.
Valproic Acid has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 57,615 adverse event reports for this medication, which is primarily manufactured by Actavis Pharma, Inc..
The most commonly reported adverse events include Drug Ineffective, Drug Interaction, Off Label Use. Of classified reports, 94.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Severe reactions such as death, suicide, and status epilepticus are common.
Over 94% of reported reactions are serious, indicating high risk. Multiple drug interactions and warnings are present, especially for pregnant women.
Patients taking Valproic Acid should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Valproic acid can cause severe interactions and warnings, especially with other antiepileptic drugs and during pregnancy. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Valproic Acid received a safety concern score of 85/100 (high concern). This is based on a 94.1% serious event ratio across 30,463 classified reports. The score accounts for 57,615 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 14,186, Female: 12,199, Unknown: 240. The most frequently reported age groups are age 54 (915 reports), age 38 (391 reports), age 3 (379 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 30,463 classified reports for VALPROIC ACID:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Valproic acid can cause severe interactions and warnings, especially with other antiepileptic drugs and during pregnancy.
If you are taking Valproic Acid, here are important things to know. The most commonly reported side effects include drug ineffective, drug interaction, off label use, toxicity to various agents, seizure. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should strictly follow prescribed dosages and avoid abrupt discontinuation. Pregnant women or those planning to become pregnant should consult their healthcare provider before using Valproic acid. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight is stringent, with frequent updates on safety concerns and warnings.
The FDA has received approximately 57,615 adverse event reports associated with Valproic Acid. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Valproic Acid include Drug Ineffective, Drug Interaction, Off Label Use, Toxicity To Various Agents, Seizure. By volume, the top reported reactions are: Drug Ineffective (3,647 reports), Drug Interaction (3,444 reports), Off Label Use (2,046 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Valproic Acid.
Out of 30,463 classified reports, 28,663 (94.1%) were classified as serious and 1,800 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Valproic Acid break down by patient sex as follows: Male: 14,186, Female: 12,199, Unknown: 240. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Valproic Acid adverse events are: age 54: 915 reports, age 38: 391 reports, age 3: 379 reports, age 53: 378 reports, age 58: 364 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Valproic Acid adverse event reports is Actavis Pharma, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Valproic Acid include: Completed Suicide, Somnolence, Depression, Condition Aggravated, Overdose. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Valproic Acid to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Valproic Acid has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Severe reactions such as death, suicide, and status epilepticus are common.
Key safety signals identified in Valproic Acid's adverse event data include: Severe reactions like death and suicide are frequent.. Status epilepticus and convulsions are significant safety signals.. Pregnancy exposure is a critical safety concern.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Valproic acid can cause severe interactions and warnings, especially with other antiepileptic drugs and during pregnancy. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Valproic Acid.
Patients should strictly follow prescribed dosages and avoid abrupt discontinuation. Pregnant women or those planning to become pregnant should consult their healthcare provider before using Valproic acid.
Valproic Acid has 57,615 adverse event reports on file with the FDA. Over 94% of reported reactions are serious, indicating high risk. The volume of reports for Valproic Acid reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is stringent, with frequent updates on safety concerns and warnings. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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