Divalproex Side Effects
Please note - some side effects for Divalproex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Divalproex - for the Consumer
Divalproex Delayed-release tablets
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Divalproex Delayed-release tablets:
Seek medical attention right away if any of these SEVERE side effects occur when using Divalproex Delayed-release tablets:
Change in appetite; constipation; diarrhea; dizziness; drowsiness; hair loss; headache; indigestion; nausea; stomach cramps or pain; trouble sleeping; vomiting; weakness; weight changes.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; change in menstrual period; changes in behavior; chest pain; confusion; dark, tarry, or bloody stools; dark urine; difficulty speaking; difficulty urinating or other urination problems; extreme tiredness; fast or irregular heartbeat; hallucinations; hearing loss; involuntary movements of the arms and legs; involuntary movements or chewing movements of the face, jaw, mouth, or tongue; joint pain; lack of energy; loss of appetite; loss of coordination; loss of seizure control; memory loss; new or worsening mental or mood changes (eg, aggressiveness, agitation, anxiety, depression, exaggerated feeling of well-being, hostility, impulsiveness, inability to sit still, irritability, panic attacks, restlessness); nosebleed; pounding in the chest; red, swollen, blistered, or peeling skin; severe or persistent nausea, vomiting, or stomach pain; shortness of breath; suicidal thoughts or actions; swelling of the arms or legs; symptoms of infection (eg, fever, chills, sore throat); tremor; unusual bleeding or bruising; unusual weakness; vision changes or blurred vision; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.Top
Side Effects by Body System - for Healthcare Professionals
Applies to: oral delayed release capsule; oral delayed release tablet; oral tablet, extended release
Nausea, vomiting, and indigestion appear less frequently and less severely with divalproex sodium 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 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 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 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.
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 side effects including a case of truncal weakness and respiratory failure has been associated with valproate therapy.
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 side effects including vasodilation and peripheral edema have been reported.
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 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 side effects including a case of osteopenia have been reported.
General side effects including hypothermia have been reported.Top
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