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valproate

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Brand names: Depakote, Depakene

Anticonvulsant / Mood Stabilizer Rx

Valproate sodium injection is used when you cannot take valproate pills. It helps control seizures.

Drug Shortage Alert

valproate is currently listed as in shortage by the FDA. Affected manufacturer: Fresenius Kabi USA, LLC. Status: Available.

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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.

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.

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.

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.

Storage

This medicine should be stored at room temperature, between 68°F and 77°F.

Side Effects (from patient reports)

Based on 9,338 FDA adverse event reports.

The medicine is not working
1,403
The medicine is interacting with another medicine
1,187
Using the medicine for a condition it is not approved for
1,081
The baby was exposed to the medicine during pregnancy
1,043
Sleepiness
951
Seizures
813
Harmful effects from different substances
757
Seizure
754
Fever
738
Convulsion
611

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

Death-Related Reports

1,782

Hospitalization Reports

8,459

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 8,291 (47%)
Male 9,279 (53%)

Age Distribution

0–17 2,653
18–44 4,890
45–64 3,900
65–74 1,373
75+ 937

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 DRUG INEFFECTIVE 1,403
2 DRUG INTERACTION 1,185
3 OFF LABEL USE 1,081
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

Reactions in Death Reports

DEATH 237
SEPSIS 104
PNEUMONIA 101
CARDIAC ARREST 97
PYREXIA 88
TOXICITY TO VARIOUS AGENTS 87
DRUG INTERACTION 82
FOETAL EXPOSURE DURING PREGNANCY 82
OFF LABEL USE 80
MALAISE 73

Reactions in Hospitalization Reports

DRUG INEFFECTIVE 650
DRUG INTERACTION 595
PYREXIA 542
SOMNOLENCE 489
OFF LABEL USE 472
TOXICITY TO VARIOUS AGENTS 394
VOMITING 345
SUICIDE ATTEMPT 308
PNEUMONIA 304
EPILEPSY 297

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, ifos...

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.

moderate risperidone

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.

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Common Questions

Can I take valproate if I have liver problems?
No, you should not take valproate if you have liver disease or liver problems.
Can valproate affect my unborn baby?
Yes, valproate can cause serious birth defects and lower IQ in children exposed to it during pregnancy.
How often will I get this medicine?
The frequency will be the same as when you take the oral form.
What should I do if I experience nausea or vomiting?
Tell your doctor if you experience nausea or vomiting, as it could be a sign of a serious problem.
Can I take valproate if I have a urea cycle disorder?
No, you should not take valproate if you have a urea cycle disorder.
What if I am taking other medicines?
Tell your doctor about all the medicines you take, including over-the-counter drugs and supplements, as they may interact with valproate.
Will valproate cure my seizures?
Valproate helps control seizures, but it may not cure the underlying condition.
Can valproate cause pancreatitis?
Yes, valproate can cause pancreatitis, which can be serious.
What are the symptoms of liver problems I should watch out for?
Watch for symptoms like weakness, tiredness, swelling of the face, loss of appetite, and vomiting.
Is it okay to stop taking this medicine on my own?
No, do not stop taking this medicine without talking to your doctor first.
What are the common side effects of valproate?
The most commonly reported side effects of valproate include Headache, Dizziness, Nausea, Pain at the injection site. Based on 9,338 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does valproate interact with other medications?
Yes, valproate has 41 known drug interactions. Notable interactions include ranitidine, cimetidine, clarithromycin. Always inform your doctor about all medications you are taking.
What drug class is valproate?
valproate belongs to the Anticonvulsant / Mood Stabilizer drug class. It requires a prescription (Rx). This medicine treats certain types of seizures.
Is valproate safe during pregnancy?
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. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Is valproate currently in shortage?
Yes, valproate is currently listed as in shortage by the FDA. Affected manufacturer: Fresenius Kabi USA, LLC. Status: Available. Visit the FDA Drug Shortages database for the latest updates.

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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 9,338 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

All federal data sources used on this page