Use and Important Safety Information You Should Know About Depakote Products

Use^1,2

Depakote and Depakote ER are used to treat acute manic episodes associated with bipolar disorder.

IMPORTANT SAFETY INFORMATION^1,2

Depakote and Depakote ER are medicines prescribed by your doctor as part of your treatment plan. Serious side effects can occur during treatment. It is very important that you know about these serious side effects and talk about them with your doctor.

The following serious side effects can occur with Depakote or Depakote ER:

Some people have experienced serious liver problems, including death, while taking valproic acid.* Children under the age of 2 are at much greater risk than adults of experiencing fatal liver problems. Your doctor should check your liver function before you start this medication and at frequent intervals thereafter. You will also be monitored for symptoms that lead to liver toxicity. Before taking this medication, tell your doctor if you have liver disease. Depakote or Depakote ER should not be taken if you have liver disease. Notify your doctor immediately if you develop symptoms of feeling ill, weakness, tiredness, facial swelling, and loss of appetite or vomiting.

Before taking valproate,* women who could become pregnant should talk with their doctor, as valproic acid has been associated with birth defects in children of women who have taken it while pregnant. If you become pregnant while taking this medication, contact your doctor immediately. Your doctor should advise you of the risk and alternative treatment options. Be sure to read the Patient Information Leaflet, which appears as the last section of the full Prescribing Information.

Some children and adults taking valproate have experienced a serious, life-threatening problem called pancreatitis, which means that the pancreas has become inflamed. Call your doctor immediately if you experience stomach pain, nausea, vomiting, and/or loss of appetite, as these can be symptoms of pancreatitis.

You should not take this medication if you are allergic to it, if you have liver disease, or if you have a condition called urea cycle disorder, which may cause too much ammonia to build up in your body. Let your doctor know if you have been diagnosed with these conditions.

There have been reports of developmental delay, autism and/or autism spectrum disorder in some children of women who took this medicine while pregnant.

Taking this medication may increase the risk of thoughts or behaviors of suicide in patients taking it for any illness or disorder. Patients, their caregivers and family need to be alert for new or worsening signs or symptoms of depression, thoughts or behaviors of suicide, or for any unusual changes in behavior or mood. Behaviors of concern should be immediately reported to a health care professional.

Some people taking Depakote or Depakote ER may experience low blood platelet counts. Your doctor should order blood tests to check your platelets while you are taking this medication, as well as prior to surgery. Tell your doctor if you have any unexplained bleeding or bruising.

Elevated ammonia levels and hypothermia (an unintentional drop in body temperature) have been reported in some patients receiving valproate. Contact your doctor immediately if you experience abnormal drowsiness and vomiting or changes in mental status.

A fever associated with other symptoms such as rash or enlargement of the lymph nodes should be reported to your doctor immediately, as this may be a sign of a serious reaction.

Depakote and Depakote ER can affect other medications. Your doctor may need to perform certain blood tests while taking this medication. Tell your doctor about all medicines you are taking or planning to take, including those without a prescription, vitamins and herbal products.

Some older patients with dementia have experienced extreme drowsiness. Let your doctor know if you become too tired or if your appetite changes.

You may experience drowsiness when you start this medication. You should not drive or operate dangerous machinery until you know how this medication will affect you.

Side Effects

The most common side effects reported in clinical studies were nausea, vomiting, extreme drowsiness, dizziness, weakness, abdominal pain, stomach upset, rash, diarrhea, increased appetite, pain, tremor, weight gain, back pain, hair loss, headache, fever, loss of appetite, constipation, double/blurred vision, side-to-side eye movements, staggering, emotional upset, abnormal thinking, amnesia, flu syndrome, infection, bronchitis, runny nose, bruising, swelling of the arms or legs, insomnia, nervousness, depression, sore throat, shortness of breath, and ringing of the ears.

This is not a complete list of reported side effects.

Dosing Considerations

Depakote and Depakote ER should be swallowed whole and should not be crushed or chewed.

Keep Depakote and Depakote ER and all other medication where children cannot reach them.

This is the most important information to know about Depakote and Depakote ER. For more information, talk with your health care provider.

*Divalproex sodium is a compound that contains sodium valproate and valproic acid.

References: 1. Depakote [package insert]. North Chicago, IL: Abbott Laboratories.
2. Depakote ER [package insert]. North Chicago, IL: Abbott Laboratories.