Prescription medicine
Valproic acid First approved as Depakene
Valproic acid (Depakene) is a prescription medicine with an FDA approval on record since 1978. FDA's NDC Directory lists it from 22 generic labelers, and pharmacies paid $0.243 per valproic acid 250 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the valproic acid FDA label on DailyMed (effective January 24, 2025, PAI Holdings, LLC dba PAI Pharma); the NDA 18082 record on Drugs@FDA; every valproic acid label on DailyMed.
Highlights of the record
FDA label of January 24, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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. Monitor patients closely, and perform serum liver testing prior to therapy and at frequent intervals thereafter ( 5.1 ) Fetal Risk, particularly neural tube defects, other major malformations, and decreased IQ ( 5.2 , 5.3 , 5.4 ) Pancreatitis, including fatal hemorrhagic cases ( 5.5 ) 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) ]. […]
Used for
From the label: indications and usageValproic acid is indicated for: Monotherapy and adjunctive therapy of complex partial seizures;
Forms and strengths
- 250 mg
- 100 mg/ml
- 250 mg/5ml
- 500 mg/10ml
- 500 mg/5ml
Solution; liquid-filled capsule; capsule; injection (solution); injection.
On the market
- Earliest approval on file
- February 28, 1978 Depakene, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 19 first February 28, 1986; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 22 of which 22 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.243 per capsule Valproic acid 250 mg capsule
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- 2 since 2021 0 Class I among all firms' recalls; latest September 15, 2021; 1 more by firms not listed as its makers
- FAERS reports
- 51,380 through July 30, 2026
What is valproic acid used for?
From the label: indications and usageValproic acid is indicated for: Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy of simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1 ) 1.1 Epilepsy Valproic acid 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. Valproic acid is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures. […]
Conditions named in the indications of valproic acid's FDA labels, with every medicine labeled for each:
From other valproic acid labelsMigraine: For prophylaxis of migraine headaches, valproate is contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception [see Contraindications (4) ].
FDA pharmacologic class: Anti-epileptic Agent and Mood Stabilizer.
Source: FDA drug label (VALPROIC ACID), PAI Holdings, LLC dba PAI Pharma, effective January 24, 2025 (SPL set 7d5cb52e-37dd-4dfa-a6f4-09f9548846c6), via openFDA; the full label on DailyMed
What does the patient leaflet for valproic acid 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 valproic acid?Do not stop taking valproic acid without first talking to your healthcare provider. Stopping valproic acid suddenly can cause serious problems. Valproic acid can cause serious side effects, including: 1. Serious liver damage that can cause death, especially in children younger than 2 years old. 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: In some cases, liver damage may continue despite stopping the drug. nausea or vomiting that does not go away loss of appetite pain on the right side of your stomach (abdomen) dark urine swelling of your face yellowing of your skin or the whites of your eyes 2. Valproic acid may harm your unborn baby. If you take valproic acid during pregnancy for any medical condition, your baby is at risk for serious birth defects that affect the brain and spinal cord and are called spina bifida or neural tube defects. These defects occur in 1 to 2 out of every 100 babies born to mothers who use this medicine during pregnancy. 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. Taking folic acid supplements before getting pregnant and during early pregnancy can lower the chance of having a baby with a neural tube defect. […]
From the patient leaflet: What should I avoid while taking valproic acid?Valproic acid can cause drowsiness and dizziness. Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking valproic acid, until you talk with your doctor. Taking valproic acid with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse. Do not drive a car or operate dangerous machinery until you know how valproic acid affects you. Valproic acid can slow your thinking and motor skills.
From the patient leaflet: How should I store Valproic Acid Oral Solution USP?Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep valproic acid and all medicines out of the reach of children.
Source: FDA drug label (VALPROIC ACID), PAI Holdings, LLC dba PAI Pharma, effective January 24, 2025 (SPL set 7d5cb52e-37dd-4dfa-a6f4-09f9548846c6), via openFDA; the full label on DailyMed
Is there a generic for valproic acid (Depakene)?
The FDA approved the first generic valproic acid on February 28, 1986. 19 generic applications are approved; 9 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 valproic acid from 22 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1978 earliest approval on file
- 1986 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 valproic acid (Depakene)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.243 per Valproic acid 250 mg capsule, down 4% from $0.252 on October 8, 2025. 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.
- Valproic acid 250 mg/5 mL solution (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Valproic acid 250 mg capsule | Generic | $0.243 per capsule | $7.28 | -4% |
| Valproic acid 250 mg/5 mL solution | Generic | $0.0332 per mL | n/a | +0.2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is valproic acid in shortage?
No valproic acid presentation is listed as limited or unavailable in the FDA Drug Shortage Database (read October 8, 2026); it keeps 2 current entries listed as available (updated September 18, 2026). ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Valproate Sodium, Injection, 100 mg/1 mL (NDC 63323-494-05) | Fresenius Kabi USA, LLC | Current | September 15, 2026 |
| Valproate Sodium, Injection, 500 mg/5 mL (NDC 0143-9785-10) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
Every valproic acid presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has valproic acid been recalled?
The FDA's Enforcement Report lists 3 recalls naming valproic acid since 2021: 0 Class I (the most serious), 3 Class II, 0 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of valproic acid and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 26, 2023 | Class II | Akorn, Inc. not a listed maker | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| September 15, 2021 | Class II | American Health Packaging | CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. |
| September 3, 2021 | Class II | Morton Grove Pharmaceuticals, Inc. | CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the valproic acid label say about other medicines?
The valproic acid label names 33 other medicines in its interaction, contraindication or warning sections. The labels of 38 other medicines name valproic acid. 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 |
|---|---|---|
| Acetaminophen | drug interactions | Drugs for which either no interaction or a likely clinically unimportant interaction has been observed Acetaminophen Valproate had no effect on any of the pharmacokinetic parameters of acetaminophen when it was concurrently administered to three epileptic patients. |
| 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 Valproic acid ( 7.2 ) Topiramate: Hyperammonemia and encephalopathy |
| 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: |
| 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. |
| Chlorpromazine | drug interactions | Chlorpromazine A study involving the administration of 100 to 300 mg/day of chlorpromazine to schizophrenic patients already receiving valproate (200 mg BID) revealed a 15% increase in trough plasma levels of valproate. |
| Cholestyramine | drug interactions | Cholestyramine Cholestyramine, when concurrently administered with valproic acid, led to, on average, a 14% decrease in plasma levels of valproic acid in a study conducted in 6 healthy subjects administered valproic acid and cholestyramine. |
| Cimetidine | drug interactions | Cimetidine and Ranitidine Cimetidine and ranitidine do not affect the clearance of valproate. |
| Clonazepam | drug interactions | Clonazepam The concomitant use of valproate and clonazepam may induce absence status in patients with a history of absence type seizures. |
| Clozapine | drug interactions | Clozapine In psychotic patients (n = 11), no interaction was observed when valproate was co-administered with clozapine. |
| 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; |
Every other medicine the valproic acid label names
| Medicine named | Section | What the label says |
|---|---|---|
| Haloperidol | drug interactions | Haloperidol A study involving the administration of 6 to 10 mg/day of haloperidol to schizophrenic patients already receiving valproate (200 mg BID) revealed no significant changes in valproate … |
| Lamotrigine | drug interactions | … 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 … |
| Levonorgestrel | drug interactions | Oral Contraceptive Steroids Administration of a single-dose of ethinyloestradiol (50 mcg)/levonorgestrel (250 mcg) to 6 women on valproate (200 mg BID) therapy for 2 months did not reveal any … |
| Lithium | drug interactions | Lithium Co-administration of valproate (500 mg BID) and lithium carbonate (300 mg TID) to normal male volunteers (n = 16) had no effect on the steady-state kinetics of lithium. |
| Lorazepam | drug interactions | Lorazepam Concomitant administration of valproate (500 mg BID) and lorazepam (1 mg BID) in normal male volunteers (n = 9) was accompanied by a 17% decrease in the plasma clearance of lorazepam. |
| Meropenem | drug interactions | … receiving carbapenem antibiotics (for example, ertapenem, imipenem, meropenem; this is not a complete list) and may result in loss of seizure control. |
| Nortriptyline | drug interactions | … clinically effective dose ( 7.2 ) Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with Valproic acid ( 7.2 ) Topiramate … |
| Olanzapine | drug interactions | Olanzapine No dose adjustment for olanzapine is necessary when olanzapine is administered concomitantly with valproate. |
| 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 Valproic acid ( 7.2 ) Topiramate … |
| Ranitidine | drug interactions | Cimetidine and Ranitidine Cimetidine and ranitidine do not affect the clearance of valproate. |
| 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 | … may be necessary if used concomitantly with Valproic acid ( 7.2 ) Topiramate: Hyperammonemia and encephalopathy |
| Warfarin | drug interactions | … 7.2 ) Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with Valproic acid ( 7.2 ) Topiramate: Hyperammonemia and … |
| Zidovudine | drug interactions | … adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with Valproic acid ( 7.2 ) Topiramate: Hyperammonemia and encephalopathy |
Other labels that name valproic acid
- Aripiprazole
- Cilastatin and imipenem
- Cilastatin and imipenem and relebactam
- Drospirenone and ethinyl estradiol and levomefolate
- Ganaxolone
- Glycerol phenylbutyrate
- Nifedipine
- Pentobarbital
- Pivmecillinam
- Probenecid and sulopenem etzadroxil
- Risperidone
- Sapropterin
- Sodium benzoate and sodium phenylacetate
- Sodium phenylbutyrate
- Vorinostat
- Zonisamide
Source: FDA drug label (VALPROIC ACID), PAI Holdings, LLC dba PAI Pharma, effective January 24, 2025 (SPL set 7d5cb52e-37dd-4dfa-a6f4-09f9548846c6), via openFDA; the full label on DailyMed
What do FAERS reports show for valproic acid?
The FDA Adverse Event Reporting System holds 51,380 reports that list valproic acid among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,386 are coded as a death and 21,799 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 valproic acid?
21 other medicines are given the same way (oral) and in the same FDA class as valproic acid or labeled mainly for the same use (seizures and epilepsy), the same class first. Seizures and epilepsy lists all 27 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 | Seizures and epilepsy | 50 labelers | $0.0268 per tablet 25 mg tablet | A presentation being discontinued |
| Divalproex | Seizures and epilepsy, Migraine | 44 labelers | $0.194 per tablet 500 mg tablet | No current entry |
| Carbamazepine | 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 |
| Zonisamide | Seizures and epilepsy | 20 labelers | $0.106 per capsule 100 mg capsule | No current entry |
| Phenytoin | Seizures and epilepsy | 23 labelers | $0.145 per capsule 100 mg capsule | No current entry |
| Primidone | Seizures and epilepsy | 21 labelers | $0.0914 per tablet 50 mg tablet | No current entry |
Every medicine labeled for the same conditions as valproic acid
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does valproic acid compare with medicines for the same use?
7 side-by-side pages set valproic acid beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to valproic acid
- 21 medicines for the same use
- Other anti-seizure medicines
- the pharmacologic class, with prices and generics
- Valproic acid side effects
- the label's list beside FAERS reports
- Valproic acid shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other