Prescription medication · Anticonvulsant / Mood Stabilizer
valproate
Also sold as Depakote, Depakene. This medicine treats certain types of seizures.
Data updated 2026-05-15
- 19,772
- FDA reportsModerately reported
- 41
- InteractionsMany interactions
- In shortage
- FDA status
What the data shows
valproate (Depakote) is a prescription Anticonvulsant / Mood Stabilizer, reported at a middle-of-the-pack volume (19,772 FDA reports), with 41 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
valproate (Depakote) is a prescription Anticonvulsant / Mood Stabilizer. This medicine treats certain types of seizures.
Valproate sodium injection is used when you cannot take valproate pills. It helps control seizures.
Verify with FDA → · CMS NADAC pricing →
Drug Shortage Alert
valproate is currently listed as in shortage by the FDA. Affected manufacturer: Fresenius Kabi USA, LLC. Status: Available.
View all drug shortages →What it does
This medicine treats certain types of seizures.
Common side effects
Headache, Dizziness, Nausea
Key warnings
Valproate can cause life-threatening liver problems, especially in the first 6 months of treatment.
The sections below are summarized in plain English from valproate's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Valproate affects the levels of certain chemicals in your brain. These chemicals help to control seizures. This medicine helps to reduce the frequency of seizures.
How to Take It
This medicine is given into a vein (IV). It is usually given over 60 minutes. You will likely switch to oral valproate as soon as you can take pills. Your doctor will monitor your blood levels and adjust your dose as needed.
This is a plain-language summary of valproate's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Valproate can cause serious birth defects if taken during pregnancy. Do not take this medicine if you are pregnant or plan to become pregnant unless other medicines don't work for you. There is a pregnancy registry for women who take valproate during pregnancy; call 1-888-233-2334 to enroll.
This is a plain-language summary of valproate's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
Since this medicine is given in a hospital or clinic, you are not likely to miss a dose. Contact your doctor if you have concerns.
This is a plain-language summary of valproate's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
This medicine should be stored at room temperature, between 68°F and 77°F.
Side Effects (from patient reports)
Based on 19,772 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for valproate, by number of reports
- The medicine is interacting with another medicine
The medicine is interacting with another medicine
1,187 reports
- The baby was exposed to the medicine during pregnancy
The baby was exposed to the medicine during pregnancy
1,043 reports
- Sleepiness
Sleepiness
951 reports
- Seizures
Seizures
813 reports
- Harmful effects from different substances
Harmful effects from different substances
757 reports
- Seizure
Seizure
754 reports
- Fever
Fever
738 reports
- Convulsion
Convulsion
611 reports
- Throwing up
Throwing up
599 reports
- Low white blood cell count
Low white blood cell count
521 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for valproate each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where valproate sits
valproate has more FDA adverse-event reports than 54% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is valproate; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 19,772 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2001–2025.
Total Reports
19,772
Reports Mentioning Death
1,782
9.0% of reports — not proof of cause
Hospitalization Reports
8,459
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | DRUG INTERACTION | 1,185 |
| 4 | FOETAL EXPOSURE DURING PREGNANCY | 1,043 |
| 5 | SOMNOLENCE | 950 |
| 6 | EPILEPSY | 813 |
| 7 | TOXICITY TO VARIOUS AGENTS | 757 |
| 8 | SEIZURE | 754 |
| 9 | PYREXIA | 738 |
| 10 | CONVULSION | 612 |
| 11 | VOMITING | 598 |
| 12 | NEUTROPENIA | 521 |
| 13 | DIARRHOEA | 520 |
| 14 | WEIGHT INCREASED | 502 |
| 15 | CONDITION AGGRAVATED | 500 |
| 16 | NAUSEA | 498 |
| 17 | FATIGUE | 489 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Valproate can cause life-threatening liver problems, especially in the first 6 months of treatment. Children under 2 and people with mitochondrial disorders have a higher risk. Valproate can also harm an unborn baby, causing birth defects and lower IQ. It can also cause pancreatitis, which can be fatal.
Known Drug Interactions
Cimetidine and Ranitidine Cimetidine and ranitidine do not affect the clearance of valproate.
Mechanism: Ranitidine does not change how the body processes or removes valproate from your system. There is no known interaction between these two drugs based on the provided information.
What to do: These medications can be taken together as prescribed. No dosage adjustments are usually necessary.
Cimetidine and Ranitidine Cimetidine and ranitidine do not affect the clearance of valproate.
Mechanism: Cimetidine does not interfere with how the body breaks down or clears valproate. This means the amount of valproate in your blood should remain stable.
What to do: You can take these medications together without needing to change your dose. Your doctor will continue to monitor you as usual.
Other Drugs Metabolized by CYP450 Isoforms Other than CYP3A: Hexobarbital Phenytoin Valproate Use With Caution There have been postmarketing reports of interactions of clarithromycin with drugs not thought to be metabolized by CYP3A, including hexobarbital, phenytoin, and valproate.
Mechanism: Clarithromycin can change how your body processes valproate, which might lead to higher levels of the medicine in your system.
What to do: Use this combination with caution. Your doctor should monitor you for any signs of valproate toxicity.
Drugs That May Cause Methemoglobinemia When Used with LIDODERM Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Examples of Drugs Associated with Methemoglobinemia : Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea,...
Mechanism: These medications can both lead to a rare blood disorder that prevents oxygen from moving through your body. Taking them at the same time makes this side effect more likely.
What to do: Watch for symptoms like headache or dizziness and tell your doctor if they occur. Your healthcare provider may need to check your blood more often.
Valproate Repeated oral doses of risperidone tablets (4 mg once daily) did not affect the pre-dose or average plasma concentrations and exposure (AUC) of valproate (1000 mg/day in three divided doses) compared to placebo (n=21). However, there was a 20% increase in valproate peak plasma concentration (C max) after concomitant administration of risperidone tablets. Dose adjustment for valproate is not recommended.
Mechanism: Risperidone can cause the peak amount of valproate in your blood to increase by a small amount.
What to do: A dose adjustment for valproate is not typically required when these drugs are used together.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I take valproate if I have liver problems?
Can valproate affect my unborn baby?
How often will I get this medicine?
What should I do if I experience nausea or vomiting?
Can I take valproate if I have a urea cycle disorder?
What if I am taking other medicines?
Will valproate cure my seizures?
Can valproate cause pancreatitis?
What are the symptoms of liver problems I should watch out for?
Is it okay to stop taking this medicine on my own?
What are the common side effects of valproate?
Does valproate interact with other medications?
What drug class is valproate?
Is valproate safe during pregnancy?
Is valproate currently in shortage?
Related Medications in Anticonvulsant / Mood Stabilizer
Other drugs grouped near valproate - same-class peers and common alternatives.
brivaracetam
Briviact
Brivaracetam is a medicine used to treat partial-onset seizures.
Compare with valproate →
cannabidiol
Epidiolex
Epidiolex is a medicine that contains cannabidiol.
Compare with valproate →
carbamazepine
Tegretol
Carbamazepine is a medicine used to control seizures and treat nerve pain.
Compare with valproate →
cenobamate
Xcopri
Xcopri is a medicine used to treat partial-onset seizures in adults.
Compare with valproate →
clobazam
Onfi, Sympazan
Clobazam oral suspension is a medicine used with other medicines to treat seizures caused by Lennox-Gastaut syndrome.
Compare with valproate →
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for valproate
The FDA label for valproate (sold under brand names such as Depakote, Depakene) classifies it as a prescription-only medication in the Anticonvulsant / Mood Stabilizer class. This medicine treats certain types of seizures. Official labeling lists 4 commonly reported side effects, including Headache, Dizziness, Nausea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 19,772 voluntary reports. The database also lists 41 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: December 15, 2024
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages