Depakote Side Effects
Common Depakote side effects include nausea, hair loss and weight gain. Serious risks involve liver damage, pancreatitis and birth defects. It carries a boxed warning for hepatic failure and teratogenicity. Depakote is primarily used for treating bipolar disorder and epilepsy.
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- Last Modified: August 7, 2024
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- Common Side Effects
- Alopecia, blurred/double vision, diarrhea, dizziness, drowsiness, menstrual period changes, ringing in the ears, tremors, unsteadiness and weight changes
- Serious Side Effects
- Depression, fetal risk, mental or mood problems, pancreatitis, seizures and suicidal thoughts/attempts
- Boxed Warning
- Increased risk of hepatotoxicity (liver damage), fetal harm and pancreatitis
Latest Depakote Side Effects Information
As of June 30, 2024, the Food and Drug Administration’s Adverse Event Reporting System data on Depakote (divalproex sodium) shows commonly reported side effects like alopecia (7.9%), seizure (7.5%), weight gain (5.4%) and tremors (4.6%) from three different types of Depakote.
| FDA Adverse Events Reporting System (FAERS) Data for Depakote Side Effects | |
|---|---|
| Total cases reported | 25,423 |
| Serious cases (including deaths) | 20,067 |
| Deaths | 975 |
Disclaimer: Reports sent to the FDA don’t necessarily mean the drug caused an adverse event. Consult a health care professional before stopping or changing medication.
Neurological side effects such as tremors and increased seizures are crucial to be aware of for an anticonvulsant medication. Another serious side effect is thrombocytopenia (4.35%), which is a condition marked by low blood platelet counts. This condition can cause excessive bleeding.
Newest Depakote Boxed Warning Updates
The label carries a boxed warning of hepatotoxicity, meaning toxic liver disease. Patients who develop hepatotoxicity are at the highest risk for fatality during the first six months of treatment. Children under 2 and those with mitochondrial disorders are particularly vulnerable. It also carries risks for fetal harm, such as neural tube defects, which are defects of the brain and spine, and decreased IQ. Additionally, Depakote has been linked to potentially fatal pancreatitis.
Recent Depakote FDA Warnings
On Feb. 26, 2016, the FDA released a warning against taking valproate medications while pregnant. The warning cites a study published in Lancelot Neurology. According to this study, children exposed to Depakote during their fetal development had an average IQ score that was 9 points lower than children who were exposed to similar drugs during their fetal development. As of June 30, 2024, there have been 677 reported cases of fetal exposure during pregnancy.
Case Study: Baby Born With Birth Defects After Mother Was Prescribed Depakote
Court documents claim that Janija James, a resident of Toledo, Ohio, was born with multiple congenital malformations due to her mother’s ingestion of Depakote during the first trimester of pregnancy.
Drug Information
Legal documents claim that Abbott Laboratories, the makers of Depakote, promoted the drug as an effective anti-epileptic drug (AED). However, its main component, divalproex sodium, is known to cause serious birth defects if taken during pregnancy, especially during the first trimester when the embryo is undergoing critical development, according to the complaint.
Side Effects
Court documents say that medical research has found that Depakote can cause serious birth defects like spina bifida, cleft palate, limb and finger malformations, developmental delays, genitourinary issues and heart defects.
The documents also say that even though Depakote is effective for controlling seizures, it carries a higher risk of causing severe birth defects compared to other similar medications for pregnant women or those who may become pregnant.
Consequences
The complaint claims that because of her mother’s use of Depakote, Janija was born with leg deformities and other congenital malformations. Her mother claimed Janija will continue to face physical and mental impairments, requiring ongoing medical treatment and support.
Common Depakote Side Effects
Hair loss, gastrointestinal disturbances and weight gain are among Depakote’s commonly reported side effects.
- Abdominal pain
- Diarrhea
- Drowsiness
- Hair loss
- Mood changes
- Nausea and vomiting
- Tremors
- Low platelet count
- Weight gain
Patients and health care providers should know of these side effects during treatment. Prompt management can minimize the impact on patients while helping them maintain their regimen.
Alopecia
Alopecia, or hair loss, is the most common side effect of treatments involving valproate drugs such as Depakote. Studies show varying degrees of alopecia among users, but according to a study published in the Indian Journal of Pharmacology, about 6% of patients taking valproate for any reason experience hair loss.
When exposed to high concentrations of valproate, this study found that up to 28% of patients experienced significant hair loss. This suggests that higher levels of valproate in the blood increase the likelihood of experiencing alopecia.
Fortunately, the alopecia resolved in all patients after decreasing the dose or discontinuing the medication.
Serious Depakote Side Effects
As of June 30, 2024, Depakote has several serious side effects.
- Liver damage
- Pancreatitis
- Teratogenicity (birth defects)
The highest risk factors are for children under 2 or for unborn babies exposed through their pregnant parent. Patients and their doctors must ensure the advantages of taking Depakote outweigh the dangers.
Teratogenicity
Valproate use during pregnancy is linked to significant fetal malformations, including craniofacial defects, cardiovascular malformations and, most notably, neural tube defects. Neural tube defects include conditions such as spina bifida, in which the spinal column doesn’t close completely and anencephaly, in which the skull and brain are underdeveloped.
The average chance of being born with a neural tube defect in the United States is roughly .08% or 1 in 1,200 births, according to the Cleveland Clinic. However, according to a 2005 study published in the Journal of the American Academy of Neurology, the malformation rate of newborns who had fetal exposure to valproate was 10.7%, compared to only 2.9% among the newborns who were exposed to other antiepileptic drugs. While most anti-seizure medications come with fetal risk, the rate is almost four times higher with valproate.
As of 2018, plaintiffs filed hundreds of Depakote lawsuits against the drug’s maker AbbVie Inc., a biopharmaceutical company spun off from Abbott Laboratories in 2013. Plaintiffs alleged that taking Depakote during pregnancy led to their children suffering from birth defects. These legal actions held that AbbVie failed to adequately warn about the potential risks of taking the drug during pregnancy.
Liver Damage
Depakote can lead to different types of liver damage, some of which can be serious or even fatal. According to clinical research published by the National Library of Medicine, about 5% to 10% of individuals on long-term valproate therapy may experience an increase in the liver enzymes alanine aminotransferase (ALT), which can be an indicator of liver disease. However, these are typically mild elevations that resolve even if they continue taking the medication.
- Hyperammonemia
- This condition occurs when there are elevated levels of ammonia in the blood, often because the liver did not filter it out correctly. Hyperammonemia can cause confusion, significant lethargy and coma. It typically occurs within a few weeks of starting Depakote or increasing its dose. However, some people with hyperammonemia are asymptomatic.
- Acute Hepatocellular Injury
- The liver damage appears 1 to 6 months after starting valproate. This condition is when liver cells, called hepatocytes, become damaged. It can cause jaundice and is also associated with microvesicular steatosis, a potentially fatal condition in which fat accumulates within liver cells. It is also associated with centrilobular necrosis, which is cell death within the liver.
- Reye-like Syndrome
- Particularly prevalent in children, this severe condition mimics Reye's syndrome with symptoms like fever, lethargy, confusion, stupor and coma, alongside high ammonia levels and significant ALT elevations. Viral infections like influenza or varicella are the common triggers in the presence of valproate. This syndrome can quickly turn fatal.
Depakote can cause serious liver damage in children under 2, those with neurological problems and people on multiple anticonvulsants.
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).
When To Seek Medical Attention
It’s vital to know when to seek emergency medical attention while taking Depakote. You should not ignore the following symptoms that require immediate intervention.
- Signs of Liver Problems
- Symptoms such as jaundice (yellowing of the skin or eyes), severe fatigue, abdominal pain (especially on the upper right side), dark urine and unusually pale stools require urgent medical evaluation.
- Pancreatitis Symptoms
- If you experience severe abdominal pain that may radiate to your back, nausea, vomiting and fever, these could be signs of pancreatitis.
- Mental Status Changes
- While taking Depakote or any seizure medication, watch for changes in mood or behavior. Seek immediate help if you experience new or worsening depression or anxiety.
- Severe Allergic Reactions
- Signs of a serious allergic reaction include difficulty breathing; swelling of the face, lips, tongue or throat and severe rash or hives.
- Symptoms of Bleeding or Blood Clotting Disorders
- Unexplained bruising, nosebleeds, bleeding gums or any signs of non-stop bleeding may indicate a serious blood disorder linked to valproate use.
Contacting a doctor immediately can be crucial in preventing the development of more serious conditions. Prompt medical evaluation can help diagnose the severity of the situation and provide the necessary treatments to mitigate health risks.
Is There a Depakote Recall?
While there have been no mandatory recalls for the brand Depakote, Amneal Pharmaceuticals initiated a voluntary Class II recall on December 26, 2023 for their Divalproex Sodium Extended-release Tablets (250 mg), which uses the same active ingredient Depakote uses. The Amneal product did not meet dissolution specifications, which could affect how the body absorbs the medication. This recall is still ongoing.
Depakote Alternatives
Depakote alternatives include lithium for bipolar disorder, lamotrigine for bipolar disorder and epilepsy and topiramate for seizures and migraines.
- Lithium (Priadel)
- Often used for bipolar disorder, lithium can help manage mood swings effectively. Currently, doctors do not fully understand its mechanisms, but researchers believe it increases dopamine and serotonin levels.
- Lamotrigine (Lamictal)
- This treatment for bipolar disorder and epilepsy has mood-stabilizing properties. It slows excessive electrical activity in the brain by suppressing glutamate, a neurotransmitter. Unlike other anticonvulsants, lamotrigine has not been associated with adverse fetal development.
- Topiramate (Topamax)
- Topiramate is used to treat seizures and migraines. It is beneficial for those who need a medication that also aids in weight loss. While its exact mechanisms are unknown, it likely reduces excess bursts of electrical activity in the brain.
Depakote is commonly used to treat various conditions, including bipolar disorder, epilepsy and migraine headaches. It works by increasing the levels of gamma-aminobutyric acid (GABA) in the brain. These chemicals help calm excessive electrical impulses, which can help prevent seizures and stabilize your mood.
Because Depakote is used for various conditions, the best alternative depends on your condition. Your health care provider can help guide you in choosing the right medication.
Editor Lindsay Donaldson contributed to this article.
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