Depakote ER Side Effects

Generic name: divalproex sodium

Note: This document contains side effect information about divalproex sodium. Some of the dosage forms listed on this page may not apply to the brand name Depakote ER.

Some side effects of Depakote ER may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to divalproex sodium: oral delayed release capsule, oral delayed release tablet, oral tablet extended release

Seek emergency medical attention if the person taking this medicine has nausea, vomiting, upper stomach pain, or loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). These symptoms may be early signs of liver damage or pancreatitis.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Get emergency medical help if you have any of these signs of an allergic reaction while taking divalproex sodium (the active ingredient contained in Depakote ER) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these other serious side effects:

• unexplained weakness with vomiting and confusion or fainting;

• easy bruising or bleeding, blood in your urine;

• fever, chills, body aches, swollen glands, flu symptoms;

• urinating less than usual;

• extreme drowsiness, lack of coordination, hallucinations;

• double vision or back-and-forth movements of the eyes; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects of divalproex sodium may include:

• mild drowsiness or weakness;

• diarrhea, constipation, upset stomach;

• changes in your menstrual periods;

• enlarged breasts, weight changes;

• tremor (shaking);

• hair loss;

• vision changes; or

• unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to divalproex sodium: oral delayed release capsule, oral delayed release tablet, oral tablet extended release

Gastrointestinal

Nausea, vomiting, and indigestion appear less frequently and less severely with divalproex sodium (the active ingredient contained in Depakote ER) than with valproic acid. These effects may be further attenuated by administering doses with food.

Gastrointestinal side effects related to gastritis are common and include nausea, vomiting, and indigestion, especially with the initiation of therapy and with rapid increases in dose. These effects are generally transient and rarely require the discontinuation of therapy. Life threatening pancreatitis has been reported to occur anywhere from shortly after initial use to occurring after several years of use. Some of the cases have been described as hemorrhagic with a rapid progression from initial symptoms to death. Hyperamylasemia occurs in up to 20% of patients and rarely presents as clinical pancreatitis (usually one to six months after initiation of therapy).

Hepatic

Hepatic side effects including transient dose-dependent elevations of serum transaminases, amylase, and ammonia have been reported to occur in up to 44% of treated patients. Mild elevations in transaminases and amylase may be managed by dose reductions. Dose-related hepatitis, which is occasionally fatal, has also been reported. Some clinicians recommend monitoring liver function tests at baseline, then monthly during the first 6 months of therapy and every 3 months thereafter. Prompt withdrawal of divalproex sodium (the active ingredient contained in Depakote ER) is recommended if significant hepatic dysfunction occurs.

Risk factors for valproate-associated hepatitis are young age (particularly age less than 2 years old), poor nutritional status, mental retardation, underlying metabolic disease, and concomitant use of other anticonvulsant medications. Characteristic pathological features include microvesicular steatosis.

Nervous system

Nervous system side effects including drowsiness, ataxia, and hand tremor have been reported. Cases of encephalopathy (manifested by stupor, coma, hallucinations or affective changes) and chorea have been reported. Reversible sensorineural hearing loss associated with valproate therapy has been reported rarely. Two cases of extrapyramidal disorders have been reported in association with valproate therapy. A case of pseudotumor cerebri has also been reported.

Divalproex sodium may inhibit urea synthesis resulting in hyperammonemia, which has been associated with encephalopathy, delirium, and ataxia in rare cases.

Loss of seizure control may indicate associated hepatitis.

Hematologic

Some clinicians recommend monitoring complete blood counts (including platelet counts) at baseline, then monthly for three months, and every three months thereafter.

Data from a study of 265 patients strongly suggests a causal relationship between rising plasma valproic acid levels and reduced platelet counts, with additional risk factors including female gender and lower baseline platelet counts.

Hematologic side effects including rare cases of reversible thrombocytopenia associated with antiplatelet antibodies and bone marrow suppression have been reported.

Respiratory

Respiratory side effects including a case of truncal weakness and respiratory failure has been associated with valproate therapy.

Renal

Renal side effects including several case reports which suggested that valproate acid may cause Fanconi's syndrome have been reported. Valproate-induced Fanconi's syndrome has been reported more often in children than in adults.

Cardiovascular

Cardiovascular side effects including vasodilation and peripheral edema have been reported.

Endocrine

Endocrine side effects including a variety of adverse reproductive endocrine disorders have been reported in epileptic women taking valproic acid.

Valproate therapy has been associated with polycystic ovaries, elevated serum testosterone concentrations and menstrual disturbance. One study has suggested that 80% of women treated with valproic acid before the age of 20 have polycystic ovaries or hyperandrogenism.

Dermatologic

Dermatologic side effects including transient alopecia and rare rashes have been reported.

Valproate therapy has been associated with stomatitis and cutaneous leukoclastic vasculitis. A case of psoriasiform eruption has been reported in a patient receiving valproic acid.

Musculoskeletal

Musculoskeletal side effects including a case of osteopenia have been reported.

General

General side effects including hypothermia have been reported.

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