Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: • Hepatic failure [see Warnings and Precautions ( 5.1 )] • Birth defects [see Warnings and Precautions ( 5.2 )] • Decreased IQ following in utero exposure [see Warnings and Precautions ( 5.3 )] • Pancreatitis [see Warnings and Precautions ( 5.5 )] • Hyperammonemic encephalopathy [see Warnings and Precautions ( 5.6 , 5.8 , 5.9 )] • Bleeding and other hematopoietic disorders [see Warnings and Precautions ( 5.7 )] • Hypothermia [see Warnings and Precautions ( 5.10 )] • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan hypersensitivity reactions [see Warnings and Precautions ( 5.11 )] • Somnolence in the elderly [see Warnings and Precautions ( 5.13 )] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The adverse reactions that can result from valproate sodium use include all of those associated with oral forms of valproate.
The following describes experience specifically with valproate sodium.
Valproate sodium has been generally well tolerated in clinical trials involving 111 healthy adult male volunteers and 352 patients with epilepsy, given at doses of 125 to 6,000 mg (total daily dose).
A total of 2% of patients discontinued treatment with valproate sodium due to adverse reactions.
The most common adverse reactions leading to discontinuation were 2 cases each of nausea/vomiting and elevated amylase.
Other adverse reactions leading to discontinuation were hallucinations, pneumonia, headache, injection site reaction, and abnormal gait.
Dizziness and injection site pain were observed more frequently at a 100 mg/min infusion rate than at rates up to 33 mg/min.
At a 200 mg/min rate, dizziness and taste perversion occurred more frequently than at a 100 mg/min rate.
The maximum rate of infusion studied was 200 mg/min.
5 WARNINGS AND PRECAUTIONS • Hepatotoxicity;
evaluate high risk populations and monitor serum liver tests ( 5.1 ) • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure;
should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable ( 5.2 , 5.3 , 5.4 ) • Pancreatitis;
valproate sodium should ordinarily be discontinued ( 5.5 ) • Bleeding and other hematopoietic disorders;
monitor platelet counts and coagulation tests ( 5.7 ) • Hyperammonemia and hyperammonemic encephalopathy;
Like all medications, Valproate Sodium can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: