Depakote Side Effects

For most people, Depakote side effects are mild, but research has linked the drug to some serious side effects including liver problems, birth defects and suicidal thoughts. 

The World Health Organization 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.

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.

Common side effects of Depakote can happen any time during treatment.

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.

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 2 to 3 in 10,000 births. When Depakote is taken during pregnancy, the risk is estimated at 1 to 2 per 100 births.

In pregnant women with epilepsy, Depakote was linked to a higher rate of major fetal malformations than with the use of newer generation 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, parts 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 filed Depakote lawsuits. In June 2022, an Illinois appellate panel ruled that Abbott could not dismiss a birth defect lawsuit that claimed the drug company failed to warn physicians about birth defect risks.

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

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).

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.

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
• Hemorrhage, bruising or a disorder of blood clotting
• Poorly formed or dysfunctional blood cells (myelodysplasia)

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.

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.

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

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

The drugmaker says that clinical trials have not shown valproate to be 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.