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CAS Registry Number 99-66-1
This medication has rarely caused serious (sometimes fatal) liver problems.
Children less than 2 years old are more likely to develop severe liver
problems, especially if they have metabolic problems, severe seizures with
mental retardation, brain disease (organic) or if they take more than one
drug for seizures. If valproic acid is being used in patients with these
conditions, then it should not be taken with additional anti-seizure
medications. Liver function tests should be performed before and during
Early signs of serious liver problems include vomiting, unusual tiredness,
swelling of the face or loss of seizure control in patients with seizure
disorder. Tell your doctor immediately if you develop any of these symptoms.
This medication is used to treat seizure disorders. It works by restoring
the balance of certain natural substances (neurotransmitters) in the brain.
This drug may also be used for the prevention of migraine headaches and
treatment of certain psychiatric conditions (e.g., manic phase of bipolar
Diarrhea, dizziness, drowsiness, hair loss, blurred/double vision, change in
menstrual periods, ringing in the ears, shakiness (tremor), unsteadiness,
weight changes may occur. If any of these effects persist or worsen, notify
your doctor or pharmacist promptly.
This medication rarely may cause mood or behavior changes, such as anxiety,
agitation, hostility, pressured/rapid speech, or thoughts of suicide. Tell
your doctor immediately if you develop unusual (possibly sudden) mood
Tell your doctor immediately if any of these highly unlikely but very
serious side effects occur: dark urine, persistent nausea/vomiting, severe
stomach/abdominal pain, yellowing eyes or skin.
Severe (sometimes fatal) brain disorder (encephalopathy) has rarely
occurred, particularly in patients with certain metabolic disorders (urea
cycle disorders). Tell your doctor immediately if you develop unexplained
weakness and vomiting or sudden mental changes.
A serious allergic reaction to this drug is unlikely, but seek immediate
medical attention if it occurs. Symptoms of a serious allergic reaction
include: rash, itching/swelling (especially of the face/tongue/throat),
severe dizziness, trouble breathing.
This medication should not be used if you have certain medical conditions.
Before using this drug, consult your doctor or pharmacist if you have: liver
disease, pancreatitis, certain metabolic disorders (urea cycle disorders).
Before using this medication, tell your doctor or pharmacist your medical
history, especially of: alcohol abuse, bleeding problems, brain disease
(dementia), kidney disease, low body water (dehydration), poor nutrition.
Before having surgery, tell your doctor or dentist that you are taking
This drug may make you dizzy, drowsy, or cause blurred vision. Use caution
engaging in activities requiring alertness or clear vision such as driving
or using machinery. Do not engage in such activities until you know how this
medication affects you. Limit alcoholic beverages.
Caution is advised when using this drug in the elderly because they may be
more sensitive to its side effects, especially drowsiness or tremor.
This medication is not recommended for use during pregnancy due to the
possible risk of birth defects and harm to an unborn baby. Do not suddenly
stop taking this medication unless directed by your doctor. Suddenly
stopping your medication could cause a severe, possibly fatal, seizure.
Before using this medication, tell your doctor or pharmacist of all
prescription and nonprescription/herbal products you may use, especially of:
certain antidepressants , certain benzodiazepines certain antibiotics
other medications for seizure rifampin, vorinostat, warfarin,
Low-dose aspirin, as prescribed by your doctor for specific medical reasons
such as heart attack or stroke prevention (usually these dosages are 81-325
milligrams per day), should be continued. Consult your doctor or pharmacist
if you are using aspirin for any reason.
Tell your doctor or pharmacist if you also take drugs that cause drowsiness
such as: antihistamines that cause drowsiness ( medicine for sleep , muscle
relaxants, narcotic pain relievers , psychiatric medicines such as
This drug may affect certain lab tests (e.g., urine ketones). Make sure
laboratory personnel and your doctors know you use this medication.