72/100 · Elevated
Manufactured by AbbVie Inc.
Divalproex Sodium Safety Profile: Common Reactions and Serious Events
87,440 FDA adverse event reports analyzed
Last updated: 2026-05-12
DIVALPROEX SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AbbVie Inc.. Based on analysis of 87,440 FDA adverse event reports, DIVALPROEX SODIUM has a safety score of 72 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 DIVALPROEX SODIUM include DRUG INEFFECTIVE, SEIZURE, WEIGHT INCREASED, NAUSEA, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DIVALPROEX SODIUM.
Divalproex Sodium has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 87,440 adverse event reports for this medication, which is primarily manufactured by Abbvie Inc..
The most commonly reported adverse events include Drug Ineffective, Seizure, Weight Increased. Of classified reports, 67.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Seizures and weight changes are common side effects.
Serious events such as falls, convulsions, and death are reported. Drug interactions and overuse are significant concerns. Psychiatric symptoms like depression and anxiety are frequently reported. Diabetes and hypertension are notable long-term risks.
Patients taking Divalproex Sodium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Divalproex sodium can interact with other drugs, and overuse can lead to serious adverse events. It is important to follow prescribed dosages and avoid drug interactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Divalproex Sodium received a safety concern score of 72/100 (elevated concern). This is based on a 67.0% serious event ratio across 45,253 classified reports. The score accounts for 87,440 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 21,269, Male: 19,667, Unknown: 311. The most frequently reported age groups are age 50 (615 reports), age 52 (609 reports), age 56 (542 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 45,253 classified reports for DIVALPROEX SODIUM:
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.
Divalproex sodium can interact with other drugs, and overuse can lead to serious adverse events. It is important to follow prescribed dosages and avoid drug interactions.
If you are taking Divalproex Sodium, here are important things to know. The most commonly reported side effects include drug ineffective, seizure, weight increased, nausea, off label use. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosages strictly to avoid overuse and serious adverse events. Inform your healthcare provider about all medications you are taking to avoid drug interactions. Regularly monitor for psychiatric symptoms and report any changes to your healthcare provider. 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.
The FDA closely monitors Divalproex sodium for safety. Regular medical check-ups are recommended to manage potential side effects and monitor for serious events.
The FDA has received approximately 87,440 adverse event reports associated with Divalproex Sodium. 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 Divalproex Sodium include Drug Ineffective, Seizure, Weight Increased, Nausea, Off Label Use. By volume, the top reported reactions are: Drug Ineffective (2,976 reports), Seizure (2,499 reports), Weight Increased (2,137 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Divalproex Sodium.
Out of 45,253 classified reports, 30,298 (67.0%) were classified as serious and 14,955 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 Divalproex Sodium break down by patient sex as follows: Female: 21,269, Male: 19,667, Unknown: 311. 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 Divalproex Sodium adverse events are: age 50: 615 reports, age 52: 609 reports, age 56: 542 reports, age 47: 529 reports, age 51: 503 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 Divalproex Sodium adverse event reports is Abbvie 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 Divalproex Sodium include: Fatigue, Pain, Somnolence, Tremor, Fall. 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 Divalproex Sodium 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.
Divalproex Sodium has a safety concern score of 72 out of 100 (elevated 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. Seizures and weight changes are common side effects.
Key safety signals identified in Divalproex Sodium's adverse event data include: Seizures and convulsions are among the most serious reported events.. Weight changes, both increased and decreased, are common.. Psychiatric symptoms including depression and anxiety are frequently reported.. Drug interactions and overuse are significant safety signals.. Diabetes and hypertension are noted as long-term risks.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Divalproex sodium can interact with other drugs, and overuse can lead to serious adverse events. It is important to follow prescribed dosages and avoid drug interactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Divalproex Sodium.
Follow prescribed dosages strictly to avoid overuse and serious adverse events. Inform your healthcare provider about all medications you are taking to avoid drug interactions. Regularly monitor for psychiatric symptoms and report any changes to your healthcare provider.
Divalproex Sodium has 87,440 adverse event reports on file with the FDA. Serious events such as falls, convulsions, and death are reported. The volume of reports for Divalproex Sodium reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Divalproex sodium for safety. Regular medical check-ups are recommended to manage potential side effects and monitor for serious events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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