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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

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:

Change in appetite; constipation; diarrhea; dizziness; drowsiness; hair loss; headache; indigestion; nausea; stomach pain; trouble sleeping; vomiting; weight changes.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abdominal cramps; abnormal thinking; change in menstrual period; changes in behavior; chest pain; confusion; dark urine; difficulty speaking; difficulty urinating or other urination problems; extreme tiredness; fast or irregular heartbeat; fever; general body discomfort; hallucinations; hearing loss; involuntary movements of the arms and legs; involuntary movements or chewing movements of face, jaw, mouth, or tongue; joint pain; lack of energy; loss of appetite; loss of coordination; loss of seizure control; memory loss; mental or mood changes; nosebleed; pounding in the chest; severe or persistent nausea, vomiting, or stomach pain; sore throat; suicidal thoughts or actions; swelling of the arms or legs; tremor; unusual bleeding or bruising; unusual weakness; vision changes; yellowing of skin or eyes.

Divalproex Extended-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 Extended-Release Tablets:

Change in appetite; constipation; diarrhea; dizziness; drowsiness; hair loss; headache; indigestion; nausea; stomach pain; trouble sleeping; vomiting; weight changes.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abdominal cramps; abnormal thinking; change in menstrual period; changes in behavior; chest pain; confusion; dark urine; difficulty speaking; difficulty urinating or other urination problems; extreme tiredness; fast or irregular heartbeat; fever; general body discomfort; hallucinations; hearing loss; involuntary movements of the arms and legs; involuntary movements or chewing movements of face, jaw, mouth, or tongue; joint pain; lack of energy; loss of appetite; loss of coordination; loss of seizure control; memory loss; mental or mood changes; nosebleed; pounding in the chest; severe or persistent nausea, vomiting, or stomach pain; sore throat; suicidal thoughts or actions; swelling of the arms or legs; tremor; unusual bleeding or bruising; unusual weakness; vision changes; yellowing of skin or eyes.

Divalproex Sprinkle Capsules

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 Sprinkle Capsules:

Change in appetite; constipation; diarrhea; dizziness; drowsiness; hair loss; headache; indigestion; nausea; stomach pain; trouble sleeping; vomiting; weight changes.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abdominal cramps; abnormal thinking; change in menstrual period; changes in behavior; chest pain; confusion; dark urine; difficulty speaking; difficulty urinating or other urination problems; extreme tiredness; fast or irregular heartbeat; fever; general body discomfort; hallucinations; hearing loss; involuntary movements of the arms and legs; involuntary movements or chewing movements of face, jaw, mouth, or tongue; joint pain; lack of energy; loss of appetite; loss of coordination; loss of seizure control; memory loss; mental or mood changes; nosebleed; pounding in the chest; severe or persistent nausea, vomiting, or stomach pain; sore throat; suicidal thoughts or actions; swelling of the arms or legs; tremor; unusual bleeding or bruising; unusual weakness; vision changes; yellowing of skin or eyes.

Divalproex Side Effects - for the Professional

Divalproex

• Most common adverse reactions (reported > 5%) reported in adult studies are nausea, somnolence, dizziness, vomiting, asthenia, abdominal pain, dyspepsia, rash, diarrhea, increased appetite, tremor, weight gain, back pain, alopecia, headache, fever, anorexia, constipation, diplopia, amblyopia/blurred, ataxia, nystagmus, emotional lability, thinking abnormal, amnesia, flu syndrome, infection, bronchitis, rhinitis, ecchymosis, peripheral edema, insomnia, nervousness, depression, pharyngitis, dyspnea, tinnitus (6.1, 6.2, 6.3, 6.4).
• Most common, drug-related adverse reactions (reported > 5% and twice the rate of placebo) reported in the controlled pediatric mania study are nausea, upper abdominal pain, somnolence, increased ammonia, gastritis and rash.

  To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-888-838-2872, X6351 or drug.safety@tevausa.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Side Effects by Body System

Gastrointestinal

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

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

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

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.

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