Prescription medicine
Divalproex Brand names: Depakote
Divalproex (Depakote) is a prescription medicine with an FDA approval on record since 1983. FDA's NDC Directory lists it from 44 generic labelers, and pharmacies paid $0.194 per divalproex sod ER 500 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the divalproex FDA label on DailyMed (effective March 31, 2026, AbbVie Inc.); the NDA 18723 record on Drugs@FDA; every divalproex label on DailyMed.
Highlights of the record
FDA label of March 31, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
LIFE THREATENING ADVERSE REACTIONS.
Hepatotoxicity General Population: Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting. In patients with epilepsy, a loss of seizure control may also occur. Patients should be monitored closely for appearance of these symptoms. Serum liver tests should be performed prior to therapy and at frequent intervals thereafter, especially during the first six months [see Warnings and Precautions ( 5.1 )]. Children under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those on multiple anticonvulsants, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease. When Depakote 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. The incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups. […]
Used for
From the label: indications and usageDepakote is 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;
Forms and strengths
- 125 mg
- 250 mg
- 500 mg
Delayed-release tablet; film-coated extended-release tablet; extended-release tablet; capsule (coated pellets); delayed-release capsule.
On the market
- Earliest approval on file
- March 10, 1983 Depakote, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 37 first July 29, 2008; 25 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 45 of which 44 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.194 per tablet Divalproex sod ER 500 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 16 since 2012 0 Class I among all firms' recalls; latest June 26, 2026
- FAERS reports
- 46,267 through July 30, 2026
What is divalproex used for?
From the label: indications and usageDepakote is 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 Depakote (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. […]
Conditions named in the indications of divalproex's FDA labels, with every medicine labeled for each:
From other divalproex labelsSeizures and epilepsy: Depakote is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures.
FDA pharmacologic class: Anti-epileptic Agent and Mood Stabilizer.
Source: FDA drug label (Depakote), AbbVie Inc., effective March 31, 2026 (SPL set 08a65cf4-7749-4ceb-6895-8f4805e2b01f), via openFDA; the full label on DailyMed
What does the patient leaflet for divalproex say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about DEPAKOTE ?Do not stop Depakote without first talking to a healthcare provider. Stopping Depakote suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). Depakote can cause serious side effects, including: 1. Serious liver damage that can cause death, especially in children younger than 2 years old and patients with mitochondrial disorders. The risk of getting this serious liver damage is more likely to happen within the first 6 months of treatment. Call your healthcare provider right away if you get any of the following symptoms: feeling very weak, tired, or uncomfortable (malaise) swelling of your face not feeling hungry nausea or vomiting that does not go away diarrhea pain on the right side of your stomach (abdomen) dark urine yellowing of your skin or the whites of your eyes loss of seizure control in people with epilepsy In some cases, liver damage may continue even though the medicine is stopped. Your healthcare provider will do blood tests to check your liver before and during treatment with DEPAKOTE. 2. Depakote may harm your unborn baby. If you take Depakote during pregnancy for any medical condition, your baby is at risk for serious birth defects that affect the brain and spinal cord (such as spina bifida or neural tube defects). These defects can begin in the first month, even before you know you are pregnant. Other birth defects that affect the structures of the heart, head, arms, legs, and the opening where the urine comes out (urethra) on the bottom of the penis can also happen. Decreased hearing or hearing loss can also happen. Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors. […]
From the patient leaflet: What should I avoid while taking Depakote?Do not drink alcohol while taking Depakote. Depakote and alcohol can affect each other causing side effects such as sleepiness and dizziness. Do not drive a car, operate dangerous machinery, or do dangerous activities until you know how Depakote affects you. Depakote can slow your thinking and motor skills and may affect your vision.
From the patient leaflet: How should I store Depakote?Store Depakote ER Tablets at room temperature between 68°F to 77°F (20°C to 25°C). Store Depakote delayed release tablets below 86°F (30°C). Store Depakote Sprinkle Capsules below 77°F (25°C). Keep Depakote and all medicines out of the reach of children.
Source: FDA drug label (Depakote), AbbVie Inc., effective March 31, 2026 (SPL set 08a65cf4-7749-4ceb-6895-8f4805e2b01f), via openFDA; the full label on DailyMed
Is there a generic for divalproex (Depakote)?
The FDA approved the first generic divalproex on July 29, 2008. 37 generic applications are approved; 25 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists divalproex from 44 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1983 earliest approval on file
- 2008 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for divalproex (Depakote)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.194 per Divalproex sod ER 500 mg tablet, up 3% from $0.188 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Divalproex sod ER 500 mg tablet (generic)
- Depakote DR 125 mg sprinkle capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Divalproex DR 125 mg capsule sprnk | Generic | $0.201 per capsule | $6.02 | -9% |
| Divalproex sod DR 125 mg tablet | Generic | $0.0549 per tablet | $1.65 | -1% |
| Divalproex sod DR 250 mg tablet | Generic | $0.0856 per tablet | $2.57 | -8% |
| Divalproex sod DR 500 mg tablet | Generic | $0.161 per tablet | $4.82 | -1% |
| Divalproex sod ER 250 mg tablet | Generic | $0.130 per tablet | $3.90 | -10% |
| Divalproex sod ER 500 mg tablet | Generic | $0.194 per tablet | $5.83 | +3% |
| Depakote DR 125 mg sprinkle capsule | Brand | $1.97 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $59.09 | +5% |
| Depakote DR 125 mg tablet | Brand | $2.06 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $61.66 | +5% |
| Depakote DR 250 mg tablet | Brand | $4.05 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $121.37 | +5% |
| Depakote DR 500 mg tablet | Brand | $7.46 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $223.67 | +5% |
| Depakote ER 250 mg tablet | Brand | $3.69 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $110.61 | +5% |
| Depakote ER 500 mg tablet | Brand | $6.49 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $194.76 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has divalproex been recalled?
The FDA's Enforcement Report lists 16 recalls naming divalproex since 2012: 0 Class I (the most serious), 14 Class II, 2 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 26, 2026 | Class II | Bionpharma Inc. | Presence of Foreign Tablets/Capsules |
| December 26, 2023 | Class II | Amneal Pharmaceuticals of New York, LLC | Failed dissolution specifications |
| July 27, 2022 | Class II | Amneal Pharmaceuticals of New York, LLC | Failed dissolution specifications. |
| June 27, 2022 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test. |
| April 24, 2019 | Class II | MAJOR PHARMACEUTICALS | cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations. |
| April 11, 2019 | Class II | Dr. Reddy's Laboratories, Inc. | cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations. |
| January 31, 2019 | Class II | Dr. Reddy's Laboratories, Inc. | Failed Dissolution Specifications: Out of specification results observed for high dissolution. |
| December 19, 2017 | Class II | Unichem Pharmaceuticals Usa Inc | Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the divalproex label say about other medicines?
The divalproex label names 24 other medicines in its interaction, contraindication or warning sections. The labels of 38 other medicines name divalproex. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amitriptyline | drug interactions | … begin valproate therapy at a low dose, and titrate to clinically effective dose ( 7.2 ) Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with Depakote ( 7.2 ) Topiramate: |
| Aspirin | drug interactions | 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: |
| Cannabidiol | drug interactions | Hyperammonemia and encephalopathy ( 5.10 , 7.3 ) Cannabidiol: ALT and/or AST elevation |
| Carbamazepine | drug interactions | DRUG INTERACTIONS 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. |
| Clonazepam | drug interactions | Clonazepam The concomitant use of valproate and clonazepam may induce absence status in patients with a history of absence type seizures. |
| Diazepam | drug interactions | Monitoring of valproate concentrations is recommended ( 7.1 ) Co-administration of valproate can affect the pharmacokinetics of other drugs (e.g., diazepam, ethosuximide, lamotrigine, phenytoin) by inhibiting their metabolism or protein binding displacement ( 7.2 ) Patients stabilized on rufinamide should begin … |
| Ertapenem | drug interactions | Carbapenem Antibiotics A clinically significant reduction in serum valproic acid concentration has been reported in patients receiving carbapenem antibiotics (for example, ertapenem, imipenem, meropenem; this is not a complete list) and may result in loss of seizure control. |
| Ethosuximide | drug interactions | Monitoring of valproate concentrations is recommended ( 7.1 ) Co-administration of valproate can affect the pharmacokinetics of other drugs (e.g., diazepam, ethosuximide, lamotrigine, phenytoin) by inhibiting their metabolism or protein binding displacement ( 7.2 ) Patients stabilized on rufinamide should begin … |
| Felbamate | drug interactions | DRUG INTERACTIONS 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. |
| Glutamine | warnings and precautions | 1) those with a history of unexplained encephalopathy or coma, encephalopathy associated with a protein load, pregnancy-related or postpartum encephalopathy, unexplained mental retardation, or history of elevated plasma ammonia or glutamine; |
| Lamotrigine | drug interactions | Monitoring of valproate concentrations is recommended ( 7.1 ) Co-administration of valproate can affect the pharmacokinetics of other drugs (e.g., diazepam, ethosuximide, lamotrigine, phenytoin) by inhibiting their metabolism or protein binding displacement ( 7.2 ) Patients stabilized on rufinamide should begin … |
| Meropenem | drug interactions | Carbapenem Antibiotics A clinically significant reduction in serum valproic acid concentration has been reported in patients receiving carbapenem antibiotics (for example, ertapenem, imipenem, meropenem; this is not a complete list) and may result in loss of seizure control. |
| Methotrexate | drug interactions | 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: |
| Nortriptyline | drug interactions | … therapy at a low dose, and titrate to clinically effective dose ( 7.2 ) Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with Depakote ( 7.2 ) Topiramate: |
Every other medicine the divalproex label names
| Medicine named | Section | What the label says |
|---|---|---|
| Phenobarbital | drug interactions | DRUG INTERACTIONS Hepatic enzyme-inducing drugs (e.g., phenytoin, carbamazepine, phenobarbital, primidone, rifampin) can increase valproate clearance, while enzyme inhibitors (e.g., felbamate) can … |
| Phenytoin | drug interactions | DRUG INTERACTIONS Hepatic enzyme-inducing drugs (e.g., phenytoin, carbamazepine, phenobarbital, primidone, rifampin) can increase valproate clearance, while enzyme inhibitors (e.g., felbamate) can … |
| Primidone | drug interactions | DRUG INTERACTIONS Hepatic enzyme-inducing drugs (e.g., phenytoin, carbamazepine, phenobarbital, primidone, rifampin) can increase valproate clearance, while enzyme inhibitors (e.g., felbamate) can … |
| Propofol | drug interactions | … effective dose ( 7.2 ) Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with Depakote ( 7.2 ) Topiramate: |
| Rifampin | drug interactions | DRUG INTERACTIONS Hepatic enzyme-inducing drugs (e.g., phenytoin, carbamazepine, phenobarbital, primidone, rifampin) can increase valproate clearance, while enzyme inhibitors (e.g., felbamate) can … |
| Ritonavir | drug interactions | … particularly those that elevate levels of glucuronosyltransferases (such as ritonavir), may increase the clearance of valproate. |
| Rufinamide | drug interactions | … metabolism or protein binding displacement ( 7.2 ) Patients stabilized on rufinamide should begin valproate therapy at a low dose, and titrate to clinically effective dose ( 7.2 ) Dosage adjustment … |
| Topiramate | drug interactions | … zidovudine may be necessary if used concomitantly with Depakote ( 7.2 ) Topiramate: |
| Warfarin | drug interactions | … 7.2 ) Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with Depakote ( 7.2 ) Topiramate: |
| Zidovudine | drug interactions | … adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with Depakote ( 7.2 ) Topiramate: |
Other labels that name divalproex
Source: FDA drug label (Depakote), AbbVie Inc., effective March 31, 2026 (SPL set 08a65cf4-7749-4ceb-6895-8f4805e2b01f), via openFDA; the full label on DailyMed
What do FAERS reports show for divalproex?
The FDA Adverse Event Reporting System holds 46,267 reports that list divalproex among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,570 are coded as a death and 15,090 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as divalproex?
15 other medicines are given the same way (oral) and in the same FDA class as divalproex or labeled mainly for the same use (bipolar disorder), the same class first. Bipolar disorder lists all 17 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Gabapentin | Seizures and epilepsy | 87 labelers | $0.0218 per capsule 100 mg capsule | No current entry |
| Lamotrigine | Bipolar disorder, Seizures and epilepsy | 50 labelers | $0.0268 per tablet 25 mg tablet | A presentation being discontinued |
| Carbamazepine | Bipolar disorder, Seizures and epilepsy | 42 labelers | $0.119 per tablet 200 mg tablet | A presentation being discontinued |
| Oxcarbazepine | Seizures and epilepsy | 43 labelers | $0.167 per tablet 300 mg tablet | No current entry |
| Lithium | Bipolar disorder | 24 labelers | $0.104 per capsule 300 mg capsule | No current entry |
| Zonisamide | Seizures and epilepsy | 20 labelers | $0.106 per capsule 100 mg capsule | No current entry |
| Valproic acid | Seizures and epilepsy, Migraine | 19 labelers | $0.243 per capsule 250 mg capsule | Listed; available |
| Phenytoin | Seizures and epilepsy | 23 labelers | $0.145 per capsule 100 mg capsule | No current entry |
Every medicine labeled for the same conditions as divalproex
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does divalproex compare with medicines for the same use?
4 side-by-side pages set divalproex beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to divalproex
- 15 medicines for the same use
- Other anti-seizure medicines
- the pharmacologic class, with prices and generics
- Divalproex side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other