valproate sodium syrup-oral (cont.)
SIDE EFFECTS: See also Warning section. 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. Tell your doctor immediately if any of these serious side effects occur: mental/mood changes, signs of infection (e.g., fever, persistent sore throat). Tell your doctor immediately if any of these unlikely but serious side effects occur: chest pain, easy bruising/unexplained bleeding, fast/irregular heartbeat, swelling of hands/feet, uncontrolled eye movement (nystagmus). 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, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: See also Warning section. Before taking valproate sodium, tell your doctor or pharmacist if you are allergic to it; or to valproic acid or divalproex sodium; or if you have any other allergies. 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 medication. 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. Valproate sodium can cause birth defects. This medication is not recommended for use during pregnancy. Discuss the risks and benefits with your doctor. If you become pregnant while taking this drug, contact your doctor immediately. If you are pregnant, prenatal care including tests for spinal cord defects is recommended. This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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