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Divalproex

Divalproex is a brand of Divalproex.

Divalproex sodium delayed-release tablets are an anti-epileptic drug indicated for: Treatment of manic episodes associated with bipolar disorder ( 1.1.

Checked against the official label · Updated

Prescription medicine Oral Safety alerts on record

Divalproex: quick answers

Used for
Divalproex sodium delayed-release tablets are an anti-epileptic drug indicated for: Treatment of manic episodes associated with bipolar disorder ( 1.1 ) Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures;.
Children
Prescription
Prescription medicine in the United States; rules differ by country.

From the official label (Dec 2025). Your prescription and pharmacist come first.

How to use Divalproex

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Serious warning: LIFE THREATENING ADVERSE REACTIONS WARNING: LIFE THREATENING ADVERSE REACTIONS See full prescribing information for complete boxed warning. Hepatotoxicity, including fatalities, usually during the first 6 months of treatment. Children under the age of two years and patients with mitochondrial disorders are at higher risk. …
Who it is for

Divalproex sodium delayed-release tablets are an anti-epileptic drug indicated for: Treatment of manic episodes associated with bipolar disorder ( 1.1 ) Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1.2 ) Prophylaxis of migraine headaches ( 1.3 ) 1.1 Mania Divalproex sodium is a valproate and is 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. …

How to take it and how often
  • Divalproex sodium delayed-release tablets are intended for oral administration
  • Divalproex sodium delayed-release tablets should be swallowed whole and should not be crushed or chewed
  • Patients should be informed to take divalproex sodium delayed-release tablets every day as prescribed
  • If a dose is missed it should be taken as soon as possible, unless it is almost time for the next dose
  • If a dose is skipped, the patient should not double the next dose
  • Divalproex sodium delayed-release tablets are administered orally in divided doses
  • Divalproex sodium delayed-release tablets should be swallowed whole and should not be crushed or chewed
  • Mania: Initial dose is 750 mg daily, increasing as rapidly as possible to achieve therapeutic response or desired plasma level
  • The maximum recommended dosage is 60 mg/kg/day
  • Complex Partial Seizures: Start at 10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day to achieve optimal clinical response; if response is not satisfactory, check valproate plasma level; see full prescribing information for conversion to monotherapy
  • The maximum recommended dosage is 60 mg/kg/day
  • Absence Seizures: Start at 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day until seizure control or limiting side effects
  • The maximum recommended dosage is 60 mg/kg/day
  • Migraine: The recommended starting dose is 250 mg twice daily, thereafter increasing to a maximum of 1,000 mg/day as needed . …
Strengths it comes in

Divalproex sodium delayed-release tablets, USP are supplied as: 125 mg (as valproic acid) rose-colored tablets 250 mg (as valproic acid) peach-colored tablets 500 mg (as valproic acid) light pink-colored tablets Tablets: 125 mg, 250 mg and 500 mg ( 3 )

Children
  • Experience has indicated that pediatric patients under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those with the aforementioned conditions [see Boxed Warning and Warnings and Precautions ]
  • When divalproex sodium is used in this patient group, it should be used with extreme caution and as a sole agent
  • The benefits of therapy should be weighed against the risks. …
Older adults

No patients above the age of 65 years were enrolled in double-blind prospective clinical trials of mania associated with bipolar illness. In a case review study of 583 patients, 72 patients (12%) were greater than 65 years of age. A higher percentage of patients above 65 years of age reported accidental injury, infection, pain, somnolence, and tremor. Discontinuation of valproate was occasionally associated with the latter two events. …

While you are taking it
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide)
  • Hepatotoxicity Warn patients and guardians that nausea, vomiting, abdominal pain, anorexia, diarrhea, asthenia, and/or jaundice can be symptoms of hepatotoxicity and, therefore, require further medical evaluation promptly [see Warnings and Precautions ]
  • Pancreatitis Warn patients and guardians that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis and, therefore, require further medical evaluation promptly [see Warnings and Precautions ] . …
Talk to a doctor first if
  • Divalproex sodium delayed-release tablets should not be administered to patients with hepatic disease or significant hepatic dysfunction [see Warnings and Precautions ]
  • Divalproex sodium delayed-release tablets are contraindicated in patients known to have mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG; e.g., Alpers-Huttenlocher Syndrome) and children under two years of age who are suspected of having a POLG-related disorder [see Warnings and Precauti …
Medicines it may not mix with

Hepatic enzyme-inducing drugs (e.g., phenytoin, carbamazepine, phenobarbital, primidone, rifampin) can increase valproate clearance, while enzyme inhibitors (e.g., felbamate) can decrease valproate clearance. Therefore increased monitoring of valproate and concomitant drug concentrations and dosage adjustment are indicated whenever enzyme-inducing or inhibiting drugs are introduced or withdrawn ( 7.1 ) Aspirin, carbapenem antibiotics, estrogen-containing hormonal contraceptives, methotrexate: Monitoring of valproate concentrations is recommended ( 7.1 ) Co-administration of valproate can affect the pharmacokinetics of other drugs (e.g. …

Warnings

Hepatotoxicity; evaluate high risk populations and monitor serum liver tests ( 5.1 ) Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable ( 5.2 , 5.3 , 5.4 ) Pancreatitis; divalproex sodium delayed-release tablets should ordinarily be discontinued ( 5.5 ) Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium delayed-release tablets, increase the risk of suicidal though …

Possible side effects

The following serious adverse reactions are described below and elsewhere in the labeling: Hepatic failure [see Warnings and Precautions (5.1) ] Birth defects [see Warnings and Precautions (5.2) ] Decreased IQ following in utero exposure [see Warnings and Precautions (5.3) ] Pancreatitis [see Warnings and Precautions (5.5) ] Hyperammonemic encephalopathy [see Warnings and Precautions (5.6 , 5.9 , 5.10) ] Suicidal behavior and ideation [see Warnings and Precautions (5.7) ] Bleeding and other hematopoietic disorders [see Warnings and Precautions (5.8) ] Hypothermia [see Warnings and Precautions (5.11) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan hypersensitivity r …

Pregnancy and breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including divalproex sodium delayed-release tablets, during pregnancy. …

If you take too much

Overdosage with valproate may result in somnolence, heart block, deep coma, and hypernatremia. Fatalities have been reported; however patients have recovered from valproate levels as high as 2,120 mcg/mL. In overdose situations, the fraction of drug not bound to protein is high and hemodialysis or tandem hemodialysis plus hemoperfusion may result in significant removal of drug. The benefit of gastric lavage or emesis will vary with the time since ingestion. General supportive measures should be applied with particular attention to the maintenance of adequate urinary output. …

How to store it

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2025-12-11.

Same medicine, other brands

Products with Divalproex as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

Divalproex SodiumDIVALPROEX SODIUM 250 mg/1 · Tablet, Film Coated, Extended Release · BluePoint Laboratories
NDC 68001-646Label
Divalproex SodiumDIVALPROEX SODIUM 250 mg/1 · Tablet, Delayed Release · Major Pharmaceuticals
NDC 0904-6860Label
Divalproex SodiumDIVALPROEX SODIUM 500 mg/1 · Tablet, Delayed Release · REMEDYREPACK INC.
NDC 70518-1558Label
Divalproex SodiumDIVALPROEX SODIUM 500 mg/1 · Tablet, Film Coated, Extended Release · A-S Medication Solutions
NDC 50090-7841Label
Divalproex SodiumDIVALPROEX SODIUM 125 mg/1 · Tablet, Delayed Release · Rising Pharma Holdings, Inc.
NDC 57237-106Label

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30.U.S. FDA Class II
26 Jun 2026 · Bionpharma Inc. · OngoingPresence of Foreign Tablets/Capsules
Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal PharmaceutiU.S. FDA Class II
26 Dec 2023 · Amneal Pharmaceuticals of New York, LLC · TerminatedFailed dissolution specifications
Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal PharmaceuticaU.S. FDA Class II
27 Jul 2022 · Amneal Pharmaceuticals of New York, LLC · TerminatedFailed dissolution specifications.
Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun PharmaceutU.S. FDA Class II
27 Jun 2022 · SUN PHARMACEUTICAL INDUSTRIES INC · TerminatedFailed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Divalproex

Type the registration number on the pack, or scan it with your camera.

Or take photos of the pack
3 free checks left today Official sources: U.S. FDA · EMA (EU) · Health Canada · WHO alerts

Questions about Divalproex

What is in Divalproex?

Divalproex contains Divalproex. Other brands with the same active ingredient work the same way; the dose and strength on your pack are what matter.

What is Divalproex used for?

Divalproex sodium delayed-release tablets are an anti-epileptic drug indicated for: Treatment of manic episodes associated with bipolar disorder ( 1.1 ) Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1.2 ) Prophylaxis of migraine headaches ( 1.3 ) 1.1 Mania Divalproex sod (From the official U.S. FDA label.)

How do I take Divalproex?

Follow your prescription or the leaflet in your pack. The official label says: Divalproex sodium delayed-release tablets are intended for oral administration. Divalproex sodium delayed-release tablets should be swallowed whole and should not be crushed or chewed. Patients should be informed to take divalproex sodium delayed-release tablets every day as prescribed. If a dose is missed it should be taken as soon as possible, unless it is almost time for the…

Do I need a prescription for Divalproex?

Usually yes. Divalproex is a prescription medicine in most countries. Rules differ by country.

What brands contain Divalproex?

Divalproex is sold under names such as Depakote, Divalproex Sodium. Brand names differ between countries.

What are the side effects of Divalproex?

The official label lists: The following serious adverse reactions are described below and elsewhere in the labeling: Hepatic failure [see Warnings and Precautions (5.1) ] Birth defects [see Warnings and Precautions (5.2) ] Decreased IQ following in utero exposure [see Warnings and Precautions (5.3) ] Pancreatitis [see Warnings and Precautions (5.5) ] Hyperammonemic encephalopathy [see Warnings and Preca… Tell your doctor about any side effect that bothers you or does not go away.

Can children take Divalproex?

Experience has indicated that pediatric patients under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those with the aforementioned conditions [see Boxed Warning and Warnings and Precautions (5.1) ] . When divalproex sodium is used in this patient group, it should be used with extreme caution and as a sole agent. The ben… Always use the dose for the child's age or weight on the pack or prescription.

Can I take Divalproex when pregnant or breastfeeding?

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including divalproex sodium delayed-release tablets, during pregnancy. … Ask your doctor or midwife first.

What medicines interact with Divalproex?

Hepatic enzyme-inducing drugs (e.g., phenytoin, carbamazepine, phenobarbital, primidone, rifampin) can increase valproate clearance, while enzyme inhibitors (e.g., felbamate) can decrease valproate clearance. Therefore increased monitoring of valproate and concomitant drug concentrations and dosage adjustment are indicated whenever enzyme-inducing or inhibiting drugs are introd… Use the free interaction checker before combining medicines.

What happens if I take too much Divalproex?

Overdosage with valproate may result in somnolence, heart block, deep coma, and hypernatremia. Fatalities have been reported; however patients have recovered from valproate levels as high as 2,120 mcg/mL. In overdose situations, the fraction of drug not bound to protein is high and hemodialysis or t… Get medical help right away.

How should I store Divalproex?

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.

How can I check that my Divalproex is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.

Sources

This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.