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Side effects depakote er


Frequently asked questions (FAQs) | Depakote® (divalproex sodium)

A: Common side effects experienced with Depakote include drowsiness, nausea, abdominal pain, diarrhea, vomiting, low platelet count, tremors, tiredness, and hair loss. The side effects may be mild to moderate, but they may also be signs of a more serious condition. You should talk to your doctor about any side effects you may experience. Please see Full Prescribing Information with Medication Guide for the complete list of side effects.

A: The following serious side effects are associated with Depakote:

Serious liver damage that can cause death, especially in children younger than 2 years old. Risk of serious liver damage is more likely to occur within the first 6 months of treatment, and may continue despite discontinued use of the drug. Call your doctor right away if you experience any of the following symptoms:

  • 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

Inflammation of your pancreas that can cause death. Call your healthcare provider right away if you have any of these symptoms:

  • Severe stomach pain that you may also feel in your back
  • Nausea or vomiting that does not go away

Taking Depakote during pregnancy can harm your unborn baby; increasing the risk of serious birth defects [e.g. brain, spinal cord (spina bifida), heart, head, arms, legs and penis] and the risk of your child having a lower IQ. Call your doctor if you are pregnant or become pregnant.

Women taking Depakote should use an effective birth control and talk with their doctor about the best birth control method for them.

Suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

  • Thoughts about suicide or dying
  • Attempts to commit suicide
  • New or worse depression
  • New or worse anxiety
  • Feeling agitated or restless
  • Panic attacks
  • Trouble sleeping (insomnia)
  • New or worse irritability
  • Acting aggressive, being angry, or violent
  • Acting on dangerous impulses
  • An extreme increase in activity and talking (mania)
  • Other unusual changes in behavior or mood

Overall, pay attention to any symptom changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your doctor as scheduled, and call between visits as needed, especially if you are worried about symptoms. Please see Full Prescribing Information with Medication Guide for the complete list of side effects.

A: Depakote can have potentially important interactions with certain medicines. Talk to your doctor or pharmacist if you have concerns about Depakote and other medications you are currently taking, including those without a prescription, vitamins, and herbal products. Please see Full Prescribing Information with Medication Guide for the complete list of side effects.

A: As with all medications, Depakote should be kept in a safe place, tightly closed, and out of reach of children. Depakote should be stored at room temperature. Depakote should not be stored above 86° F. Do not keep it in the refrigerator. The pharmacy bottle or pillbox should be protected from light or moisture. Do not store it in a damp place like a bathroom medicine cabinet. Please see Full Prescribing Information with Medication Guide for the complete list of side effects.

A: If you forget to take your daily dose of medicine at the scheduled time, go ahead and take it as soon as you remember. However, if it’s almost time for you to take your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose. If you have any questions, please call your doctor. Please see Full Prescribing Information with Medication Guide for the complete list of side effects.

Depakote ER Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Warnings:

Rarely, this medication has caused serious (sometimes fatal) liver problems, usually within the first 6 months of starting treatment. Laboratory tests should be performed before you start treatment and periodically during treatment, especially within the first 6 months, to monitor this side effect.

The risk of serious liver problems is increased in children younger than 2 years, especially if they have an inherited metabolic disorder, severe seizure disorder with mental retardation, organic brain disease, or if they take more than one seizure medication. Talk with the doctor about the risks and benefits of using this medication in children younger than 2 years.

Due to an increased risk for liver problems, people with certain inherited metabolic disorders (such as Alpers-Huttenlocher syndrome) should not use this medication. Children younger than 2 years who might have these disorders should not use this medication. Children older than 2 years who might have these disorders should be closely monitored during treatment with divalproex sodium. Talk to your doctor for details.

This medication has rarely caused severe (sometimes fatal) disease of the pancreas (pancreatitis). This may occur at any time during treatment and can quickly worsen.

Tell your doctor right away if you develop symptoms of liver problems or pancreatitis such as nausea/vomiting that doesn't stop, unusual tiredness, weakness, swelling of the face, stomach/abdominal pain, loss of appetite, dark urine, or yellowing eyes/skin.

Taking this medication during pregnancy can cause birth defects, may lower your child's IQ, and may increase the risk of your child having certain brain/mental disorders (such as autism, attention deficit/hyperactivity disorder). Women of childbearing age should discuss the risks and benefits of this medication, other treatment options, and use of reliable forms of birth control with their doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor. If you are taking divalproex sodium only to prevent migraine headaches, this medication must not be used during pregnancy. If you are taking divalproex sodium to treat seizures or mental/mood problems (such as bipolar disorder), do not stop taking this medication unless directed by your doctor. Untreated seizures and mental/mood problems (such as bipolar disorder) are serious conditions that can harm both a pregnant woman and her unborn baby.

Warnings:

Rarely, this medication has caused serious (sometimes fatal) liver problems, usually within the first 6 months of starting treatment. Laboratory tests should be performed before you start treatment and periodically during treatment, especially within the first 6 months, to monitor this side effect.

The risk of serious liver problems is increased in children younger than 2 years, especially if they have an inherited metabolic disorder, severe seizure disorder with mental retardation, organic brain disease, or if they take more than one seizure medication. Talk with the doctor about the risks and benefits of using this medication in children younger than 2 years.

Due to an increased risk for liver problems, people with certain inherited metabolic disorders (such as Alpers-Huttenlocher syndrome) should not use this medication. Children younger than 2 years who might have these disorders should not use this medication. Children older than 2 years who might have these disorders should be closely monitored during treatment with divalproex sodium. Talk to your doctor for details.

This medication has rarely caused severe (sometimes fatal) disease of the pancreas (pancreatitis). This may occur at any time during treatment and can quickly worsen.

Tell your doctor right away if you develop symptoms of liver problems or pancreatitis such as nausea/vomiting that doesn't stop, unusual tiredness, weakness, swelling of the face, stomach/abdominal pain, loss of appetite, dark urine, or yellowing eyes/skin.

Taking this medication during pregnancy can cause birth defects, may lower your child's IQ, and may increase the risk of your child having certain brain/mental disorders (such as autism, attention deficit/hyperactivity disorder). Women of childbearing age should discuss the risks and benefits of this medication, other treatment options, and use of reliable forms of birth control with their doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor. If you are taking divalproex sodium only to prevent migraine headaches, this medication must not be used during pregnancy. If you are taking divalproex sodium to treat seizures or mental/mood problems (such as bipolar disorder), do not stop taking this medication unless directed by your doctor. Untreated seizures and mental/mood problems (such as bipolar disorder) are serious conditions that can harm both a pregnant woman and her unborn baby.

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Uses

This medication is used to treat seizure disorders, mental/mood conditions (such as manic phase of bipolar disorder), and to prevent migraine headaches. It works by restoring the balance of certain natural substances (neurotransmitters) in the brain.

How to use Depakote ER

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking divalproex sodium and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth once daily or as directed by your doctor. You may take it with food if stomach upset occurs. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

The dosage is based on your age, weight, medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day to keep the amount of medication in your blood constant.

If this medication is used for seizures, do not stop taking it without consulting your doctor. Your condition may become worse if the drug is suddenly stopped. Your dose may need to be gradually decreased.

Divalproex sodium does not relieve acute migraine headaches. Take other medications as directed by your doctor for acute attacks.

Inform your doctor if your condition does not improve.

Side Effects

See also Warning section.

Diarrhea, dizziness, drowsiness, hair loss, blurred/double vision, change in menstrual periods, ringing in the ears, shakiness (tremor), unsteadiness, weight changes may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

Severe (sometimes fatal) brain disorder (encephalopathy) has rarely occurred, particularly in patients with certain metabolic disorders (urea cycle disorders). Tell your doctor right away if you develop unexplained weakness, vomiting, or sudden mental/mood changes (such as confusion).

Get medical help right away if you have any very serious side effects, including: chest pain, easy bruising/unexplained bleeding, fast/slow/irregular heartbeat, swelling of hands/feet, uncontrolled eye movement (nystagmus), feeling cold/shivering, rapid breathing, loss of consciousness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

See also Warning section.

Before taking divalproex sodium, tell your doctor or pharmacist if you are allergic to it; or to valproic acid or valproate sodium; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, pancreatitis, certain metabolic disorders (such as urea cycle disorders, Alpers-Huttenlocher syndrome), alcohol abuse, bleeding problems, brain disease (dementia), kidney disease, dehydration, poor nutrition.

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Children younger than 6 years may be at greater risk for liver problems and pancreatitis.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, unsteadiness, or tremor. Drowsiness, dizziness, unsteadiness can increase the risk of falling.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using divalproex sodium. Divalproex sodium may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. See also Warning section.

This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: certain antidepressants (such as amitriptyline, nortriptyline, phenelzine), certain antibiotics (carbapenems such as imipenem), irinotecan, mefloquine, orlistat, other medications for seizure (such as ethosuximide, lamotrigine, phenytoin, rufinamide, topiramate), rifampin, vorinostat, warfarin, zidovudine.

Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually 81-162 milligrams a day), should be continued. Consult your doctor or pharmacist if you are using aspirin for any reason.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and opioid pain relievers (such as codeine, hydrocodone).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This drug may affect certain lab tests (such as urine ketones). Make sure laboratory personnel and your doctors know you use this medication.

Does Depakote ER interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: excessive drowsiness, coma, irregular/slow heartbeat.

Do not share this medication with others.

Laboratory and/or medical tests (such as drug levels, liver function tests, complete blood counts, clotting tests) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Valproic Acid and Derivatives: Pediatric Medication

Pediatric Medicine

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Provided by Lexicomp ® , this document contains all the information you need to know about this medicine, including indications, directions for use, side effects, and when your healthcare provider should be contacted.

Trade names: USA

Depacon [DSC]; Depakene [DSC]; Depakote; Depakote ER; Depakote Sprinkles nine0003

Trade names: Canada

APO-Divalproex; APO-Valproic Acid; Depakene; epival; MYLAN-Divalproex; PMS-Valproic; PMS-Valproic Acid; SANDOZ Valproic [DSC]; TEVA-Divalproex [DSC]

Warning

All Forms:
  • The use of this drug was accompanied by violations of the liver. In some cases, these violations have led to death. In most cases, liver problems occurred within the first 6 months after starting this drug. Call your child's doctor right away if your child shows signs of liver problems such as dark urine, fatigue, lack of appetite, nausea or abdominal pain, light-colored stools, vomiting, yellowing of the skin or eyes. In patients suffering from seizures, there may be a loss of control over seizures. Do your child's blood test as directed by their doctor. nine0006
  • The risk of life-threatening liver problems is increased in children under 2 years of age. The risk is highest in patients taking more than 1 anti-seizure drug or who have a metabolic disorder, severe epilepsy with mental retardation, or congenital brain disease. Consult your doctor.
  • Patients with a genetic liver disorder are at an increased risk of developing liver failure due to a mitochondrial disorder such as Alpers-Huttenlocher syndrome. Your child may need genetic testing to detect this disease. If a child has or may have a mitochondrial disorder, do not give this drug without consulting your doctor. nine0006
  • This drug can cause serious and sometimes deadly problems with the pancreas (pancreatitis). Such a violation can occur in children at any time during treatment with this drug. Symptoms of pancreatitis include abdominal pain, nausea, vomiting, or decreased appetite. If your child develops any of these symptoms, contact their doctor immediately.
If your child is or may be sexually active:
  • If your daughter is pregnant or may become pregnant, check with her doctor to make sure this drug is right for her. She must use birth control while taking this drug to prevent pregnancy. nine0006
If your daughter is pregnant or likely to be pregnant:
  • This drug can cause serious birth defects if taken during pregnancy. It can also lower a child's IQ and may increase the risk of autism or ADHD. If your daughter becomes pregnant while taking this drug, call her doctor right away.
  • Do not give this migraine prevention drug to your daughter if she is pregnant or not using birth control to prevent pregnancy. nine0006
All oral preparations:
  • This drug comes with a separate patient information leaflet called Patient Drug Information. Read it carefully each time you take this drug. If you have any questions about this drug, ask your doctor, pharmacist, or other health care professional.

What is this drug used for? nine0017

  • Used to treat seizures.
  • It is used to prevent migraine.
  • This medicine is used to treat bipolar disorder.
  • This drug can be given to children for other indications. Consult your doctor.

What do I need to tell the doctor BEFORE my child takes this drug?

  • If your child has an allergy to this drug, any of its ingredients, other drugs, foods, or substances. Tell the doctor about the allergy and how it manifested itself in the child. nine0006
  • If your child suffers from any of the following: liver disease or a urea cycle disorder.

This list of drugs and conditions that may interact with this drug is not exhaustive.

Talk to your doctor or pharmacist about all medicines your child is taking (prescription and over-the-counter, natural, and vitamins) and any health problems. You need to make sure that this drug is safe to use for your child's illnesses and in combination with other drugs he or she is already taking. Do not start, stop taking, or change the dosage of any drug your child is taking without the doctor's approval. nine0003

What do I need to know or do while my child is taking this drug?

For all uses of this drug:
  • Tell all health care providers who care for your child that your child is taking this drug. These are your child's doctors, nurses, pharmacists and dentists.
  • Have your child avoid tasks or activities that require attention until you see how this drug works for your child. This includes cycling, playing sports, or using items such as scissors, lawn mowers, electric scooters, toy cars, or motorized vehicles. nine0006
  • Perform blood tests as directed by your doctor. Consult with your doctor.
  • Alcohol can interact with this drug. Make sure your child does not drink alcohol.
  • Check with your child's doctor before using marijuana, other forms of cannabis, or prescription or over-the-counter drugs that may slow your child's progress.
  • This drug may affect the results of some lab tests. Tell all health care workers and laboratory workers who provide your child's health care that your child is taking this drug. nine0006
  • If your child is unable to eat or drink as usual, check with their healthcare provider. These situations include illness, fasting, certain procedures or surgery.
  • Some brands of this drug contain peanut butter. If your child is allergic to peanuts, ask your pharmacist to check the peanut butter content of your child's brand of peanut butter. nine0006
  • Your child may become more prone to bleeding. Make sure your child is careful to avoid injury. Make sure your child uses a soft toothbrush.
  • This drug has been associated with increased levels of ammonia in the blood. This can lead to certain brain disorders. Some fatalities. Consult your doctor.
  • In some individuals, certain brain disorders were not accompanied by an increase in the level of ammonia in the blood. In some cases, these brain disorders resolved after discontinuation of treatment with this drug. However, in some cases they did not go completely. Consult your doctor. nine0006
  • There was a serious reaction that could be deadly. In most cases, this reaction was accompanied by symptoms such as fever, rash, inflammation of the lymph nodes, and dysfunction of various organs such as the liver, kidneys, blood, heart, muscles, joints and lungs. If you have any questions, please consult your doctor.
  • This drug may affect a man's ability to have a child. Consult your doctor. nine0006
If your daughter is breastfeeding:
  • Tell your doctor if your daughter is breastfeeding. You will need to be counseled about the possible risks to the child.
Anti-seizure:
  • Talk to your doctor if your seizures change or get worse after you start taking this drug.

What side effects should I report to my child's doctor right away?

WARNING/CAUTION: Although rare, this drug can cause very serious and sometimes deadly side effects in some people. Call your child's doctor right away or get medical help if your child has any of the following signs or symptoms that could be associated with a very bad side effect:

  • Signs of an allergic reaction, such as rash, hives, itching, red and swollen skin with blisters or peeling, possibly accompanied by fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue or throat. nine0006
  • Signs of infection, such as fever, chills, very bad pain in the throat, ear, or sinuses, cough, more sputum or change in color, pain when urinating, mouth sores, or a sore that doesn't heal.
  • Signs of high ammonia levels such as irregular heartbeat, trouble breathing, confusion, pale skin, bradycardia, seizures, sweating, vomiting, or muscle twitches.
  • Chest pain. nine0006
  • Swelling of the hands or feet.
  • Vision change.
  • Impairment or loss of memory.
  • Balance change.
  • Difficulties with walking.
  • Any unexplained bruising or bleeding.
  • The appearance of purple spots on the skin or redness of the skin.
  • Difficulty urinating or a change in the amount of urine produced.
  • Swelling of the gland.
  • Muscle pain or weakness. nine0006
  • Pain or inflammation in the joints.
  • Shiver.
  • Loss of control over eye movements.
  • Tinnitus.
  • Chills.
  • Like other seizure medicines, this medicine can rarely increase the risk of suicidal ideation or behavior. This risk may be higher in people who have tried or had suicidal thoughts in the past. Call your doctor right away if you develop or worsen symptoms such as depression, nervousness, anxiety, irritability, panic attacks, or other mood or behavioral disturbances. If you have suicidal thoughts or attempted suicide, contact your doctor immediately. nine0006

What are some other side effects of this drug?

Any drug can cause side effects. However, for many people, side effects are either minor or non-existent. Contact your child's doctor or seek medical attention if any of these or other side effects bother your child or if they persist:

  • Headache.
  • Constipation, diarrhea, abdominal pain, nausea, vomiting, or decreased appetite. nine0006
  • Increased appetite.
  • Feeling dizzy, tired or weak.
  • Sleep disorders.
  • Weight gain or loss.
  • Hair loss.
  • Nervous tension and agitation.
  • Flu-like symptoms.

This list of possible side effects is not exhaustive. If you have any questions about side effects, ask your child's doctor. Talk to your child's doctor about side effects. nine0003

You can report side effects to the National Health Board.

What is the best way to give this drug?

Give this drug to your child as directed by your doctor. Read all the information provided to you. Strictly follow all instructions.

All oral preparations:
  • Give this drug with or without food. If the drug causes stomach upset, give it with food. nine0006
  • Keep giving this drug as directed by your child's doctor or other health care provider, even if your child is feeling well.
  • Do not stop giving this drug to your child abruptly without talking to the doctor. This can increase the risk of seizures. If needed, this drug should be stopped gradually for your child as directed by the doctor.
    • nine0005 If your child is taking cholestyramine, you may need to give it at a different time than this drug. Consult with a pharmacist.
Tablets and capsules:
  • Ask your child to swallow whole. Ask your child not to chew, break, or crush the tablet.
  • Give this drug with a full glass of water.
  • If your child has difficulty swallowing, check with your doctor. nine0006
Long acting tablets:
  • If you or your child see particles of this drug in your child's stool, contact your doctor.
Split capsule:
  • The child may swallow the capsule whole or mix the contents of the capsule with certain foods such as applesauce. Make sure the child takes the mixture immediately. Do not store for future use.
  • If you or your child see particles of this drug in your child's stool, contact your doctor. nine0006
Liquid:
  • Liquid doses should be measured with caution. Use the dispenser that comes with the medication. If the dispenser is not provided in the package, ask the pharmacist for a dosing agent for this drug.
Injection:
  • This drug is administered by infusion intravenously continuously for a certain time.

What if my child misses a dose of medication? nine0017

All oral preparations:
  • Give the missed dose as soon as possible.
  • If it is time for your child to take the next dose, do not take the missed dose and then go back to your child's normal schedule.
  • Do not give a double dose at the same time or additional doses.
Injection:
  • Contact your child's doctor to find out the next steps.

How do I store and/or discard this drug? nine0017

All oral preparations:
  • Store at room temperature in a dry place. Do not store in the bathroom.
Injection:
  • If you need to store this drug at home, check with your child's doctor, nurse, or pharmacist about how to store it.
All forms:
  • Keep all medicines in a safe place. Keep all medicines out of the reach of children and pets. nine0006
  • Dispose of unused or expired drugs. Do not empty into a toilet or sewer unless instructed to do so. If you have any questions about disposing of medicines, ask your pharmacist. Drug disposal programs may be in place in your area.

General information about medicines

  • If your child's symptoms or health problems do not improve, or worsen, contact your child's doctor. nine0006
  • Do not share your child's medicine with others and do not give anyone else's medicine to your child.
  • Some medicines may come with other patient information leaflets. If you have questions about this drug, talk with your child's doctor, nurse, pharmacist, or other health care professional.
  • If you think you have overdosed, call a poison control center or get medical help right away. Be prepared to tell or show what drug you took, how much, and when it happened. nine0006

Consumer Use of Information and Limitation of Liability

This summary information includes a summary of the diagnosis, treatment, and/or drug product. It is not intended to be a comprehensive source of data and should be used as a tool to help the user understand and/or evaluate potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a particular patient. It should not be considered medical advice or a substitute for medical advice, diagnosis or treatment provided by a physician based on a medical examination and assessment of the patient's specific and unique circumstances. Patients should consult with their physician for full information about their health, medical issues, and treatment options, including any risks or benefits regarding the use of medications. This information is not a guarantee that a treatment or drug is safe, effective, or approved for a particular patient. UpToDate, Inc. and its subsidiaries disclaim any warranties or liabilities related to this information or its use. The use of this information is subject to the Terms of Use found at https://www. wolterskluwer.com/en/know/clinical-effectiveness-terms. nine0003

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© UpToDate, Inc. and its affiliates and/or licensors, 2023. All rights reserved.

Depakote and Depakote ER side effects: what you need to know

Introduction

If you have epilepsy, migraine or bipolar disorder, your doctor may suggest Depakote or Depakote ER* (divalproex) as a treatment option. These prescription tablets are used for:

  • treatment of focal seizures and absences due to epilepsy in adults and children 10 years of age and older. nine0006
  • treat mania (episodes of high spirits, hyperactivity, and similar symptoms) in adults with bipolar disorder
  • helps prevent migraines in adults

Depakote is also available as powdered capsules. This form of the drug is indicated for the treatment of focal seizures and absences in adults and children aged 10 years and older with epilepsy.

For more information about Depakote and Depakote ER, including drug usage, see this detailed article. nine0003

Like other drugs, Depakote and Depakote ER can cause mild or serious side effects (also known as side effects). Keep reading to find out more.

What are the most common side effects of Depakote and Depakote ER?

Some people may experience mild or severe side effects while taking Depakote or Depakote ER.

More common side effects in people taking Depakote or Depakote ER include:

  • Headache
  • drowsiness
  • weakness
  • digestive side effects such as nausea, vomiting and diarrhea*
  • tremor (uncontrollable shaking)*

These are just some of the most common side effects reported people who have taken Depakote tablets, ER tablets, or powdered capsules in studies. These side effects may vary depending on the condition for which the medication is being taken. nine0003

What are the mild side effects of Depakote and Depakote ER?

Like most medicines, Depakote and Depakote ER treatment may cause mild side effects. Examples of mild side effects reported with Depakote and Depakote ER include:

  • abdominal pain
  • dizziness
  • headache
  • increased or decreased appetite
  • insomnia (sleep problems)
  • mild memory
  • problems with coordination or walking
  • drowsiness
  • weakness
  • vision problems such as blurred vision or double vision
  • digestive side effects such as nausea and constipation*
  • hair loss (tremor)
  • uncontrollable shaking)*
  • weight gain or loss†

In most cases, these side effects should be temporary. And some are easy to deal with. But if you have any symptoms that continue or bother you, talk to your doctor or pharmacist. And don't stop taking Depakote or Depakote ER unless your doctor tells you to. nine0003

Depakote and Depakote ER may cause mild side effects other than those listed above. For detailed information, see the prescribing information for Depakote Tablets, Depakote Spray Capsules and Depakote ER Tablets.

After the Food and Drug Administration (FDA) approves a drug, it monitors the drug's side effects. If you would like to notify the FDA of a side effect you have experienced while taking Depakote or Depakote ER, visit MedWatch. nine0003

What are the serious side effects of Depakote and Depakote ER?

Serious side effects reported with Depakote and Depakote ER include:

  • bleeding problems and low blood platelets
  • high blood ammonia
  • hypothermia (low body temperature)
  • and suicidal thoughts behavior
  • liver damage*†
  • pancreatitis (swelling and damage to the pancreas)*†
  • fetal harm if taken during pregnancy*‡
  • allergic reaction†

If you develop serious side effects while taking Depakote or Depakote ER, call your doctor right away. If the side effects seem life-threatening or if you think you need a medical emergency, call 911 or your local emergency number right away.

Suicide prevention

If you think someone is at immediate risk of harming themselves or harming another:

  • Call 911 or your local emergency number.
  • Stay with the person until help arrives.
  • Remove all weapons, knives, medicines, and other items that could cause harm.
  • Listen, but don't judge, argue, threaten or yell.

If you or someone you know is thinking about suicide, seek help from a crisis or suicide prevention hotline. Call the National Suicide Prevention Hotline at 800-273-8255.

Depakote and Depakote ER Side Effects Frequently Asked Questions

Get answers to some frequently asked questions about Depakote and Depakote ER side effects.

Are older people at a higher risk of side effects from Depakote and Depakote ER than younger people? nine0017

Yes, older people may have a higher risk of certain side effects of Depakote and Depakote ER. In studies of Depakote tablets, ER tablets, and powdered capsules, people aged 65 years and older were more likely to report:

  • accidental injury
  • infection
  • pain
  • drowsiness
  • tremor (uncontrollable shaking)*
    • 6 risk of side effects while taking Depakote or Depakote ER, talk to your doctor or pharmacist. They can tell you more about whether your medical history, including your age, puts you at a higher risk of side effects. nine0003

    Can Depakote and Depakote ER cause long-term side effects?

    Yes, Depakote and Depakote ER may cause long-term side effects.

    Liver damage, including liver failure, has been reported. Pancreatitis (swelling and damage to the pancreas) has also been reported, including in people who have taken Depakote for many years. Liver damage and pancreatitis are long-term side effects.

    Depakote and Depakote ER have a boxed warning for risk of liver damage and pancreatitis. The boxed warning is the most serious warning from the Food and Drug Administration (FDA). See "Explanation of Side Effects" below for more information. nine0003

    You can also talk to your doctor or pharmacist about the long-term side effects of Depakote and Depakote ER.

    If I take too much Depakote or Depakote ER, will I get overdose symptoms?

    Yes, taking too much Depakote or Depakote ER can cause overdose symptoms such as:

    • deep (severe) coma
    • heart block (irregular heart rhythm due to a problem with the heart's electrical signals)
    • low blood sodium
    • drowsiness

    In very rare cases, death has occurred due to an overdose of Depakote or Depakote ER.

    Do not take more Depakote or Depakote ER than your doctor has told you to. If you think you have taken too much Depakote or Depakote ER, call your doctor right away. You can also call 800-222-1222 to contact the American Association of Poison Control Centers or use their online resource. nine0420 If you have severe symptoms, call 911 or your local emergency number immediately. Or go to the nearest emergency room.

    Can Depakote and Depakote ER cause sexual side effects in men and women?

    It is possible. Studies have shown that valproic acid can interfere with sex hormones and cause certain sexual side effects. The active drug* in Depakote and Depakote ER, divalproex sodium, is a form of valproic acid. nine0003

    Sexual side effects of valproic acid may include erectile dysfunction in men† and menstrual irregularities in women. †Valproic acid may also decrease libido (sex drive).

    If you are concerned about the sexual side effects of Depakote or Depakote ER, talk to your doctor. They can recommend treatment for any sexual problems you have. They may also suggest stopping Depakote or Depakote ER and trying another medicine for your condition. nine0003

    Does the risk of side effects increase with higher doses of Depakote or Depakote ER (125 mg, 250 mg, 500 mg)?

    It is possible. But in most of the studies on Depakote tablets, ER tablets, and powdered capsules, researchers did not compare how different doses might affect side effects. Thus, it is not known whether the risk of most side effects increases at higher doses.

    If you take Depakote or Depakote ER during pregnancy, the risk of fetal harm is known to increase with higher doses. Depakote and Depakote ER have a warning in the box about the risk of fetal harm. For details, see "Pregnancy and lactation while taking Depakote or Depakote ER" in the "Warnings regarding Depakote and Depakote ER" section below. nine0003

    You can also talk to your doctor or pharmacist for more information.

    Can Depakote and Depakote ER cause weight gain?

    Taking Depakote and Depakote ER may cause weight gain. This side effect has been reported in studies of Depakote tablets, ER tablets, and powdered capsules.

    Weight loss, increased appetite and decreased appetite have also been reported. Changes in appetite can affect your weight.

    Be aware that loss of appetite may be a sign of serious side effects from Depakote or Depakote ER. These include liver damage and pancreatitis (swelling and damage to the pancreas). Depakote and Depakote ER have boxed warnings for these side effects.*

    If you are concerned about weight gain while taking Depakote or Depakote ER, talk to your doctor. They can suggest ways to maintain a healthy weight for you.

    Will I get withdrawal symptoms if I stop taking Depakote or Depakote ER? nine0317

    No, no withdrawal symptoms have been reported with Depakote tablets, ER tablets or powder capsules. These are the side effects that can occur when you stop taking medications that your body depends on. Depakote and Depakote ER are not known to cause addiction or withdrawal symptoms.

    But stopping Depakote or Depakote ER may cause symptoms of your condition to return. For example, if you are taking a medication to prevent migraine headaches, stopping the medication may cause your migraine headaches to return. nine0003

    Talk to your doctor if you are interested in stopping Depakote or Depakote ER. They can advise you on how to do it safely. They can also discuss other treatment options for your condition.

    Side effects explained

    Find out more about some of the side effects Depakote and Depakote ER may cause.

    Hair loss

    Hair loss may be a side effect of taking Depakote or Depakote ER. This side effect has been reported by people taking the medicine to treat seizures or prevent migraines. Although this was not common. nine0003

    People taking Depakote or Depakote ER to treat bipolar mania have not reported hair loss. (Mania refers to episodes of intense elation, hyperactivity, and similar symptoms.)

    Hair shed during treatment usually grows back after Depakote or Depakote ER is stopped.

    What can help

    Call your doctor if you are concerned about hair loss while taking Depakote or Depakote ER. They may recommend treatment for this side effect. Or they may recommend trying a different treatment for your condition. nine0003

    Tremors

    Tremor is a possible side effect of Depakote and Depakote ER. Having a tremor means that you have shaking that you cannot control and that may affect one part of your body (such as one arm).

    This side effect has been most commonly seen in people taking medicine to treat seizures. Also, people aged 65 and older may have a higher risk of tremor than younger people.

    What can help

    If you have tremors that bother you while taking Depakote or Depakote ER, talk to your doctor. They may rate your symptoms for reasons other than Depakote. If they decide that stopping Depakote is best for you, they may also recommend other treatments for your condition.

    Digestive side effects such as nausea and constipation

    Digestive side effects are possible with Depakote and Depakote ER. These may include:

    • abdominal pain
    • constipation
    • diarrhea
    • nausea
    • upset stomach
    • vomiting

    Nausea, vomiting and diarrhea were among the most common side effects of Depako Depako ER.

    What can help

    Call your doctor if you have any digestive side effects while taking Depakote or Depakote ER. They may suggest treatment depending on the symptoms you have. If you have symptoms that bother you or don't go away, your doctor may suggest other treatments for your condition. nine0003

    Liver damage

    Liver damage is a rare side effect of Depakote or Depakote ER. These drugs have a warning in the box about the risk of liver damage.

    Boxed warnings are the most severe FDA warnings. They warn doctors and patients about drug side effects that can be dangerous.

    Liver damage from Depakote or Depakote ER may cause liver failure. In extreme cases, it can be life-threatening. But liver damage and liver failure were not common in studies of Depakote tablets, ER tablets, or powdered capsules. nine0003

    Liver damage is likely to occur during the first 6 months of taking Depakote or Depakote ER. But this side effect can happen at any time during treatment. And the liver damage caused by Depakote can be long term.

    Symptoms of liver damage may include:

    • loss of appetite
    • extreme tiredness or tiredness (low energy)
    • feeling generally unwell
    • jaundice (yellowing of the skin or whites of the eyes)
    • pain in your upper right abdomen
    • swelling on your face
    • weakness
    • vomiting

    Because of the risk of liver damage, doctors usually do not prescribe Depakote or Depakote ER if you have liver problems. They will also not prescribe Depakote or Depakote ER to people with certain mitochondrial disorders.*

    While taking Depakote or Depakote ER, your doctor will closely monitor your liver health with blood tests. Your doctor can tell you more about how often you will have these tests while taking Depakote. nine0003

    What can help

    If you notice symptoms of liver damage, contact your doctor immediately. Most likely, they will want to examine you. If they determine that you may have liver damage, they will likely force you to stop taking Depakote.

    Pancreatitis

    Pancreatitis is a rare possible side effect of Depakote or Depakote ER. These drugs have a warning in the box about this side effect.

    Pancreatitis refers to inflammation (swelling and damage) of the pancreas. Symptoms of this condition may include:

    • nausea or vomiting that does not go away
    • severe abdominal pain that may radiate to the back
    • loss of appetite

    This side effect was very rare in studies of Depakote tablets, ER tablets, and powder capsules. It can be life-threatening or fatal in extreme cases.

    What can help

    Call your doctor right away if you notice symptoms of pancreatitis. Or call your local emergency number or go to the nearest emergency room. nine0003

    If your doctor confirms that you have pancreatitis, you will need to stop taking Depakote or Depakote ER. They also treat pancreatitis. This may require hospital treatment.

    Allergic reaction

    Like most medicines, Depakote and Depakote ER may cause an allergic reaction in some people. This side effect was not common in studies of Depakote tablets, ER tablets, or powdered capsules.

    Symptoms may be mild or severe and may include:

    • skin rash
    • itching
    • redness (temporary warmth, redness, or increased skin color)
    • swelling under the skin, usually on the eyelids, lips, arms, or legs
    • swelling of the mouth, tongue, or throat that causes difficulty breathing

    Rarely, Depakote and Depakote ER can also cause a kind of allergic reaction called drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS most often occurs within 2 to 6 weeks of starting treatment. DRESS can be life-threatening or fatal in very rare cases. nine0003

    DRESS often starts with a red rash on the face and upper body. Other symptoms may include:

    • burning pain in the skin
    • swelling on your face
    • fever
    • itching
    • swelling in the lymph nodes (such as in the armpits or neck)
    • damage to an organ

    If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may offer an over-the-counter antihistamine that you take by mouth, such as Benadryl (diphenhydramine). Or they may suggest a product that you apply topically (to the skin), such as a hydrocortisone cream. nine0003

    If your doctor confirms that you had a mild allergic reaction to Depakote or Depakote ER, they will decide whether you should continue using it.

    If you have symptoms of a severe allergic reaction, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms can be life threatening and require immediate medical attention.

    If your doctor confirms that you have had a severe allergic reaction to Depakote or Depakote ER, they may ask you to switch to another treatment. nine0003

    Tracking side effects

    While on Depakote or Depakote ER, consider keeping a record of any side effects you experience. You can then share this information with your doctor. This is especially helpful when you first start taking new medications or using a combination of treatments.

    Your side effect notes may include things like:

    • what dose you were taking when you had the side effect
    • how soon after starting this dose did you experience a side effect
    • what were your symptoms
    • how did your symptoms affect your daily activities
    • what other medications did you also take
    • any other information you think is important

    Taking notes and sharing them with your doctor will help him learn more about how Depakote or Depakote ER is affecting you. And your doctor can use this information to adjust your treatment plan if necessary. nine0003

    Warnings for Depakote and Depakote ER

    There are certain warnings to consider before taking Depakote or Depakote ER.

    Boxed Warnings

    Depakote and Depakote ER have several boxed warnings. Boxed warnings are the most severe warnings from the Food and Drug Administration (FDA). Depakote and Depakote ER warnings in the boxes refer to risks:

    • Liver injury. Depakote or Depakote ER can cause life-threatening liver damage.
    • Pancreatitis (swelling and damage to the pancreas). Depakote or Depakote ER may cause life-threatening pancreatitis.
    • Fetal harm. Taking Depakote or Depakote ER during pregnancy may harm the fetus.

    For more information about liver damage and pancreatitis, see the "Explanation of side effects" section above. And for more information about harm to the fetus, see "Pregnancy and lactation while taking Depakote or Depakote ER" below. nine0003

    Other warnings

    Depakote and Depakote ER may not be right for you if you have certain medical conditions or other health conditions. Talk to your doctor about your medical history before taking Depakote or Depakote ER. The list below includes factors to consider.

    Mitochondrial disorder. The presence of certain mitochondrial disorders may increase the risk of serious side effects, including liver damage, when taking Depakote or Depakote ER. Mitochondrial disorders are rare conditions caused by genetic changes that affect the mitochondria (energy-producing structures within cells). Due to the risk of liver damage, doctors usually do not prescribe Depakote if you have certain mitochondrial disorders, such as Alpers-Guttenlocher syndrome. Your doctor can tell you about other treatment options that may be safer for you. nine0003

    Mood problems, including depression or suicidal thoughts. As with all drugs prescribed for the treatment of epilepsy, Depakote and Depakote ER may increase the risk of suicidal thoughts or behavior. They can also cause or worsen depression. If you have mood problems or have had them in the past, be sure to tell your doctor. They can help decide if it is safe for you to take Depakote or Depakote ER.

    Urea cycle disorder. nine0422 If you have a urea cycle disorder, your doctor will not usually prescribe Depakote or Depakote ER. In rare cases, life-threatening or fatal levels of ammonia in the blood have been reported when people with this condition have taken Depakote tablets, ER tablets, or powdered capsules. Talk to your doctor about other treatments for your condition that may be safer for you.

    Allergic reaction. If you have had an allergic reaction to Depakote or Depakote ER or any of their ingredients, your doctor will likely not prescribe you any form of Depakote. Ask your doctor what other medicines are the best options. nine0003

    Alcohol, Depakote and Depakote ER

    It is best to avoid or minimize alcohol while taking Depakote and Depakote ER.

    Alcohol may aggravate some of the side effects of Depakote and Depakote ER. These include dizziness, drowsiness, and liver damage. It is important to note that Depakote and Depakote ER have a boxed warning for liver damage.*

    If you drink alcohol, talk to your doctor about how much (if any) is safe for you to drink while you are taking Depakote or Depakote ER. nine0003

    Pregnancy and breastfeeding while taking Depakote or Depakote ER

    Below is information about taking Depakote and Depakote ER during pregnancy and breastfeeding.

    pregnancy

    Depakote and Depakote ER have a boxed warning about harm to the fetus (commonly known as birth defects) if the drug is taken during pregnancy.

    Studies of Depakote tablets, ER tablets and powder capsules have shown that taking these drugs during pregnancy can cause serious problems for the fetus. These problems may include problems with the brain and spinal cord, as well as physical abnormalities of the heart, head, arms, or legs. It can also increase a child's risk of developmental disorders, including autism. nine0003

    Your doctor will likely tell you not to take Depakote or Depakote ER if you are pregnant or planning to become pregnant. If you can become pregnant, your doctor will recommend that you use effective birth control while you are taking Depakote or Depakote ER.

    If Depakote or Depakote ER are the only drugs that help control your seizures, your doctor may prescribe the drug even if you are pregnant or planning to become pregnant. In this case, you and your doctor will discuss your treatment plan and the risks and benefits of Depakote treatment. nine0003

    If you become pregnant while taking Depakote or Depakote ER, you may consider enrolling in the pregnancy registry for antiepileptic drugs. And the pregnancy register helps to collect information about how the medicine can affect the pregnancy.

    For more information about the North American Pregnancy Antiepileptic Drug Registry, talk to your doctor. You can also call 888-233-2334 or visit the registry website. nine0003

    Talk to your doctor if you have questions about Depakote or Depakote ER and pregnancy.

    Breastfeeding

    Depakote and Depakote ER are known to pass into breast milk if taken during breastfeeding. These drugs can cause side effects in a breastfed baby. Side effects may include unusual bruising or bleeding, and jaundice (yellowing of the skin or whites of the eyes).

    Talk to your doctor about feeding options for your child if you have been prescribed Depakote or Depakote ER. Together you can discuss the risks and benefits of Depakote treatment while breastfeeding. If you are breastfeeding while taking Depakote or Depakote ER, be sure to monitor your baby for any side effects. nine0003

    What to ask your doctor

    Like most medicines, taking Depakote or Depakote ER can cause side effects. In most cases, side effects are mild. But serious side effects are possible.

    If you are considering treatment with Depakote or Depakote ER, talk to your doctor. Ask questions that will help you feel comfortable with your choice of treatment. Here are some examples to help you get started:

    • Can Depakote or Depakote ER cause nervous system side effects such as hallucinations or tardive dyskinesia?
    • Are there treatments for common side effects of Depakote or Depakote ER?
    • How do the side effects of Depakote and Depakote ER compare to other medicines that may treat my condition?
    • If I get side effects while taking Depakote or Depakote ER, will I need to stop taking them? nine0006

    If you have bipolar disorder, consider subscribing to the Drink-Drink newsletter for advice on mood management and mental health.

    Drink-Drink also has a Migraine Fact Sheet, which has treatment recommendations delivered to your mailbox. You can also find support and advice in our Bezzy migrain community.

    Ask a pharmacist

    Q:

    Are there blood tests to check for side effects of Depakote or Depakote ER? nine0003

    Anonymous

    A:

    Yes, your doctor will likely recommend certain blood tests during treatment. You will have liver function tests to monitor liver damage. Your doctor may also order blood cell count tests to determine your risk of bleeding while taking Depakote or Depakote ER.

    You may also have tests to check your blood levels of valproic acid and ammonia. (The active drug in Depakote and Depakote ER, divalproex sodium, is a form of valproic acid). Your doctor may recommend this if you become ill or have serious side effects during treatment. nine0003

    Your doctor or pharmacist can tell you more about the blood tests you can expect while taking Depakote or Depakote ER.

    Beverage Pharmacy Team Answers represent the opinions of our medical experts. All content is for informational purposes only and should not be considered medical advice.

    Registration data: Drink-Drink has made every effort to ensure that all information is accurate, complete and up to date. However, this article should not be used as a substitute for the knowledge and experience of a licensed healthcare professional.

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