Depacon (Valproate Sodium) Side Effects
Depacon (valproate sodium) can cause numerous side effects ranging from common gastrointestinal issues to rare but serious complications including hepatotoxicity, thrombocytopenia, and hyperammonemia. Regular monitoring is essential for patients on this medication.
Common Side Effects
Gastrointestinal Effects
- Nausea (48% vs 14% placebo) 1
- Vomiting (27% vs 7% placebo) 1
- Abdominal pain (23% vs 6% placebo) 1
- Diarrhea (13% vs 6% placebo) 1
- Dyspepsia (indigestion) (8% vs 4% placebo) 1
- Constipation (5% vs 1% placebo) 1
- Anorexia (12% vs 0% placebo) 1
Neurological Effects
- Somnolence/drowsiness (27% vs 11% placebo) 1
- Tremor (25% vs 6% placebo) - may be dose-related 1
- Dizziness (25% vs 13% placebo) 1
- Diplopia (double vision) (16% vs 9% placebo) 1
- Blurred vision/amblyopia (12% vs 9% placebo) 1
- Ataxia (8% vs 1% placebo) 1
- Nystagmus (8% vs 1% placebo) 1
- Headache (31% vs 21% placebo) 1
Other Common Effects
- Hair loss/alopecia (6% vs 1% placebo) - typically diffuse and non-scarring 2
- Weight gain or loss 1
- Emotional lability (6% vs 4% placebo) 1
- Flu-like symptoms (12% vs 9% placebo) 1
Serious Side Effects
Hepatic Effects
- Liver toxicity - potentially fatal (overall incidence 1 in 20,000, but as high as 1 in 600-800 in high-risk groups such as infants under 2 years receiving polytherapy) 3
- Elevated liver enzymes (transaminases, LDH) - dose-related 1
- Abnormal changes in liver function tests 1
Hematologic Effects
- Thrombocytopenia (24% high dose vs 1% low dose) 1
- Altered bleeding time, petechiae, bruising, hematoma formation 1
- Relative lymphocytosis, macrocytosis, hypofibrinogenemia 1
- Leukopenia, eosinophilia, anemia 1
Metabolic Effects
- Hyperammonemia - can lead to encephalopathy 4, 1
- Hyponatremia 1
- Inappropriate ADH secretion 1
- Weight gain 1
Endocrine Effects
- Irregular menses, secondary amenorrhea 4, 1
- Polycystic ovary syndrome (PCOS) - especially in women of reproductive age 4, 5
- Breast enlargement, galactorrhea 1
- Abnormal thyroid function tests 1
Pancreatic Effects
- Acute pancreatitis - potentially fatal 1
Dermatologic Effects
- Transient hair loss 1, 2
- Skin rash, photosensitivity, pruritus 1
- Rare cases of severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis 1
Psychiatric Effects
Monitoring Requirements
Regular monitoring is essential for patients on valproate therapy:
- Liver function tests (ALT, AST, bilirubin, alkaline phosphatase) - baseline and every 3-6 months 5
- Complete blood counts - baseline and every 3-6 months 5
- Valproate serum levels - 2 weeks after initiation and dose changes (therapeutic range: 50-125 μg/mL) 5
- Pregnancy tests for women of childbearing potential (valproate is absolutely contraindicated in pregnancy due to high teratogenicity risk) 5
- Monitor for signs of hyperammonemia (lethargy, vomiting, mental status changes) 5
- Monitor for menstrual irregularities and signs of PCOS in women of reproductive age 5
Special Considerations
- Pregnancy: Valproate is absolutely contraindicated in pregnant women due to high teratogenicity risk (1-3% risk of neural tube defects) 5, 3
- Elderly: May experience extreme drowsiness that could affect eating and drinking habits 1
- Children under 2 years: Higher risk of hepatotoxicity, especially when on multiple antiepileptic drugs 3
- Women of reproductive age: Higher risk of reproductive endocrine disorders including PCOS 4
When to Discontinue
Valproate therapy should be discontinued if:
- Significant elevation in liver enzymes occurs 5
- Platelet count falls to ≤75 × 10^9/L 5
- Development of hyperammonemic encephalopathy 5
- Pregnancy is detected or planned 5
Recognizing these side effects early and implementing appropriate monitoring can significantly reduce morbidity and mortality associated with valproate therapy.