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Depakote Side Effects

Side effects of Depakote and Depakote ER can be serious and sometimes deadly. Depakote side effects include liver damage, life-threatening pancreatitis, suicidal thoughts, and blood and metabolic disorders. When women take Depakote during pregnancy, their children have a higher risk of birth defects.

Depakote
Depakote Side Effects
  1. Birth Defects spina bifida, lower intelligence
  2. Liver Problems Liver damage can be fatal
  3. Pancreas Damage Enzymes in the pancreas consume the organ
  4. Suicidal Thoughts Risk greatest for epilepsy patients
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Depakote side effects can be serious and potentially deadly. Most Depakote and Depakote ER side effects are associated with the ingredient valproate.

The World Health Organization (WHO) considers valproate among the medicines needed by a basic health care system. The international agency included the ingredient on its Model List of Essential Medicines.

But, valproate is associated with liver problems. It requires regular monitoring of liver function. Doctors must also watch patients for life-threatening pancreatitis, birth defects and suicidal thoughts.

What Are the Side Effects of Depakote?

Studies link Depakote and Depakote ER to serious side effects. These side effects can cause permanent disability and even death.

Common side effects of Depakote can happen any time during treatment. Some Depakote side effects are specific to certain populations, such as pregnant women.

The drug’s label warns of several serious Depakote side effects, including:
  • Liver damage
  • Pancreatitis
  • Birth defects such as spina bifida
  • Suicidal thoughts and actions
  • Blood disorders
  • Metabolic disorders such as hyperammonemia

Like many drugs, Depakote also comes with several less-serious, but more common, side effects. Depakote users should tell their doctor if they experience any side effects while taking Depakote or Depakote ER.

Less serious Depakote and Depakote ER side effects include:
  • Nausea
  • Diarrhea
  • Vomiting
  • Abdominal pain
  • Weight gain
  • Drowsiness
  • Dizziness
  • Insomnia
  • Hair loss

Long-Term Side Effects of Depakote

Many of the serious side effects from taking Depakote are lifelong.

For example, damage done to the unborn when their mothers take the drug can affect the child for his or her life. Also, liver damage cannot be cured or reversed.

Depakote and Pregnancy

Pregnant women or women who may become pregnant should not take Depakote. Depakote and Depakote ER have the potential to cause birth defects. These include neural-tube defects and other risks of fetal harm, such as lower intelligence.

In 2009, the U.S. Food and Drug Administration urged health care providers and women who may be pregnant to consider other options before Depakote. The FDA directed this warning especially for treating non-life-threatening conditions, such as migraines.

Neural-Tube Defects: Spina Bifida & Anencephaly

Neural-tube defects are birth defects that affect the brain, spine or spinal cord. They occur within the first month of pregnancy, often before a woman knows she’s pregnant.

A baby’s neural tube starts out as a tiny, flat ribbon and then turns into a tube at the end of the first month of pregnancy. It normally develops into the brain and spinal cord.

Without maternal use of Depakote, the general population risk of children being born with spina bifida is 6 to 7 in 10,000 births. When Depakote is taken during pregnancy, the risk is estimated at 1 to 2 per 100 births.

Pregnancy and Depakote
When women take Depakote during pregnancy, the chances their babies will be born with spina bifida are more than 30 times the chances of the condition without the drug.

In pregnant women with epilepsy, Depakote was linked to a four-fold higher rate of major fetal malformations than other epilepsy medications.

The two most common neural-tube defects are spina bifida and anencephaly. Spina bifida is the result of the fetal spinal column not closing completely. It causes part of the spinal cord to stick out through the spine.

Anencephaly is one of the most severe neural-tube defects. It happens when the upper part of the neural tube that forms the brain does not close completely.

In this deadly condition, most of the baby’s brain, skull and scalp do not develop. Infants born with anencephaly do not live long after they are born, typically just for a few hours.

Families of children who suffered birth defects after their mothers took Depakote during pregnancy sued AbbVie. More than 600 Depakote lawsuits remained pending in early 2018.

Depakote and Liver Damage

Depakote can cause liver failure. The drug label carries a boxed warning regarding liver failure, or hepatotoxicity.

Doctor performing a liver biopsy
Doctors may perform a liver biopsy to detect liver damage.

Hepatoxicity is an inflammation of the liver. It is a serious condition that can be fatal.

There is no treatment, cure or reversal for liver damage. The primary treatment is to discontinue any medications processed through the liver and to avoid alcohol.

Doctors may prescribe medications that help to reduce the symptoms of liver damage. One medication might be a diuretic to reduce fluid accumulation and swelling (edema).

Depakote and Pancreas Damage

Life-threatening pancreatitis has been reported in children and adults taking Depakote. Pancreatitis is inflammation of the pancreas. It occurs when digestive enzymes start digesting the pancreas itself.

Some cases have even been described as hemorrhagic. Initial symptoms progress rapidly to death, according to the boxed warning on the drug’s label. This deadly condition can occur shortly after initial use of Depakote or after several years of use.

Blood and Metabolic Disorders with Depakote Use

Depakote is associated with bleeding and other hematopoietic disorders. Hematopoietic disorders pertain to the formation of blood cells.

Bleeding and other hematopoietic disorders associated with Depakote include:
  • Abnormal/low platelet counts (thrombocytopenia)
  • Decreases in other blood cells
  • Poorly formed or dysfunctional blood cells (myelodysplasia)
  • Hemorrhage, bruising or a disorder of blood clotting

Depakote and Suicidal Thoughts

Taking certain anti-seizure medications, including Depakote ER, can increase a patient’s risk of suicidal thoughts and behaviors, according to drug labeling. Clinical trials showed patients taking the medication for epilepsy were at the greatest risk.

Signs and symptoms of suicidal thoughts and behaviors as a side effect of taking Depakote can be observed as early as one week after starting treatment, labels say. Once these signs become apparent, they can continue for the duration of treatment.

“Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior.”

A doctor from the FDA's Center for Drug Evaluation and Research told Fierce Biotech

However, clinical trials have not studied this effect beyond 24 weeks of treatment. Patients’ risk of suicidal thoughts and actions with treatment lasting longer than 24 weeks is unknown.

Effects of Long-Term Use of Depakote

Doctors prescribe Depakote for epilepsy, migraines or mania associated with bipolar disorder. AbbVie Inc. makes Depakote.

The drugmaker says clinical trials have not shown valproate is effective for long-term use in patients with mania. This refers to use longer than three weeks.

AbbVie recommends that doctors who give patients Depakote or Depakote ER for extended periods continually evaluate the risks and benefits of the drug.

People who take Depakote for years, rather than months, may have trouble stopping. This is because their bodies may become dependent on the medication.

Possible Depakote withdrawal symptoms include:
  • Anger
  • Relapse of bipolar disorder
  • Depression
  • Trouble concentrating
  • Dizziness
  • Headache
  • Insomnia
  • Nausea
  • Seizures

Please seek the advice of a medical professional before making health care decisions.

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10 Cited Research Articles

  1. Mental Health Daily (n.d.). Depakote (Valproic Acid) Withdrawal Symptoms + How Long They Last. Retrieved from https://mentalhealthdaily.com/2014/07/15/depakote-valproic-acid-withdrawal-symptoms-how-long-they-last/
  2. U.S. Food and Drug Administration. (2011, June 30). FDA drug safety podcast for healthcare professionals: children born to mothers who took valproate products while pregnant may have impaired cognitive development. Retrieved https://www.fda.gov/Drugs/DrugSafety/ucm261543.htm
  3. Epilepsy Foundations of Connecticut. (2010, June 11). Anticonvulsant Valproic Acid Increases Risk of Congenital Disorders. Retrieved from https://www.epilepsyct.com/article.php?id=37
  4. Ornoy, A. (2009 July). Valproic acid in pregnancy: how much are we endangering the embryo and fetus? Reproductive Toxicology, 28:1. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/19490988
  5. Smith, M. (2010, June 10). Antiseizure Drug Increases Birth Defect Risk. ABC News. Retrieved from http://abcnews.go.com/Health/MindMoodNews/depakote-antiseizure-drug-increase-birth-defect-risk/story?id=10871067
  6. Joffe, H. et al. (2006, January 31). Valproate is associated with new-onset oligoamenorrhea with hyperandrogenism in women with bipolar disorder. Biological Psychiatry, 59:11. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/16448626
  7. Myers, C. (2008, December 17). FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications. Retrieved from https://www.fiercebiotech.com/biotech/fda-requires-warnings-about-risk-of-suicidal-thoughts-and-behavior-for-antiepileptic
  8. PubMed Health. (n.d.). Valproic Acid (By mouth). Retrieved from https://www.ncbi.nlm.nih.gov/pubmedhealth/PMHT0012594/
  9. Underwood, T.W. & Frye, C.B. (1993, June). Drug-induced pancreatitis. Clinical Pharmacology 12:6. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/8403815
  10. U.S. Food and Drug Administration. (2009 January). Depakene (valproic acid) Solution; Depakene (valproic acid) Capsule, Liquid Filled. Retrieved from http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018081s047,018082s032lbl.pdf
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