Valproic Acid: Side Effects, Uses & Monitoring
1.1 Mania Divalproex sodium delayed release tablets are a valproate and are indicated for the treatment of the manic episodes associated with bipolar disorder.
- Data source
- FDA labeling via NIH DailyMed (label 3de4f119…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Headache | 31% |
| Tremor | 25% |
| Thrombocytopenia | 24% |
| Nausea | 22% |
| Somnolence | 19% |
| Diplopia | 16% |
| Insomnia | 15% |
| Diarrhea | 13% |
| Dizziness | 12% |
| Vomiting | 12% |
| Anorexia | 12% |
| Amblyopia/blurred vision | 12% |
| Flu syndrome | 12% |
| Infection | 12% |
| Accidental injury | 11% |
| Nervousness | 11% |
| Asthenia | 10% |
| Abdominal pain | 9% |
| Dyspepsia | 9% |
| Weight gain | 9% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
1.1 Mania Divalproex sodium delayed release tablets are a valproate and are indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. The efficacy of divalproex sodium delayed release tablets were established in 3-week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania [see Clinical Studies (14.1 )]. The safety and effectiveness of divalproex sodium delayed release tablets for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium delayed release tablets for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient. 1.2 Epilepsy Divalproex sodium delayed release tablets are indicated as monotherapy and adjunctive therapy in the treatment of patien…
Conditions associated with Valproic Acid in labeling
Bipolar Disorder
A mood disorder characterized by alternating periods of mania/hypomania and depression....
Epilepsy
A neurological disorder characterized by recurrent, unprovoked seizures. Management focuses on seizure control...
Migraine
A neurological condition causing recurrent moderate-to-severe headaches, often with nausea, light sensitivity,...
Frequently Asked Questions
What is Valproic Acid used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Valproic Acid?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Valproic Acid. Individual risk varies.
Does Valproic Acid require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Valproic Acid.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.