Valproic Acid: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Valproic Acid. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| 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 across placebo-controlled trial tables summarized in current labeling.
Labeled uses
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…
Medical disclaimer: Always consult a qualified healthcare professional about any medication.