Valproic acid may cause serious or life-threatening damage to the liver that is most likely to occur within the first 6 months of therapy. The risk of developing liver damage is greater in children who are younger than 2 years of age and are also taking more than one medication to prevent seizures, have certain inherited diseases that may prevent the body from changing food to energy normally, or any condition that affects the ability to think, learn, and understand. Tell your doctor if you have a certain inherited condition that affects the brain, muscles, nerves, and liver (Alpers Huttenlocher Syndrome), urea cycle disorder (an inherited condition that affects the ability to metabolize protein), or liver disease. Your doctor will probably tell you not to take valproic acid. If you notice that your seizures are more severe or happen more often or if you experience any of the following symptoms, call your doctor immediately: excessive tiredness, lack of energy, weakness, pain on the right side of your stomach, loss of appetite, nausea, vomiting,, dark urine, yellowing of your skin or the whites of your eyes, or swelling of the face.

Valproic acid can cause serious birth defects (physical problems that are present at birth), especially affecting the brain and spinal cord and can also cause lower intelligence and problems with movement and coordination, learning, communication, emotions, and behavior in babies exposed to valproic acid before birth. Tell your doctor if you are pregnant or plan to become pregnant. Women who are pregnant or who are able to become pregnant and are not using effective birth control must not take valproic acid to prevent migraine headaches. Women who are pregnant should only take valproic acid to treat seizures or bipolar disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods) if other medications have not successfully controlled their symptoms or cannot be used. Talk to your doctor about the risks of using valproic acid during pregnancy. If you are a woman of childbearing age, including girls from the start of puberty, talk to your doctor about using other possible treatments instead of valproic acid. If the decision is made to use valproic acid, you must use effective birth control during your treatment. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking valproic acid, call your doctor immediately. Valproic acid can harm the fetus.

Valproic acid may cause serious or life-threatening damage to the pancreas. This may occur at any time during your treatment. If you experience any of the following symptoms, call your doctor immediately: ongoing pain that begins in the stomach area but may spread to the back nausea, vomiting, or loss of appetite.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to valproic acid.

Talk to your doctor about the risks of taking valproic acid or of giving valproic acid to your child.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with valproic acid and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.