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This medication has been associated with rare but serious liver complications, which can sometimes be fatal. These issues typically arise within the first six months of treatment. It is crucial to conduct laboratory tests before initiating therapy and at regular intervals during the first six months to monitor liver health.

• Increased Risk for Young Children: Children under two years old, particularly those with inherited metabolic disorders, severe seizure disorders accompanied by mental retardation, or organic brain diseases, are at a higher risk of developing severe liver problems. Concurrent use of multiple seizure medications also elevates this risk. Consult your doctor to weigh the risks and benefits of using this medication in such young patients.

• Contraindications: Individuals with certain inherited metabolic disorders, like Alpers-Huttenlocher syndrome, should not use this medication. Children under two suspected of having these conditions must avoid this medication, while older children should be carefully monitored if treatment is deemed necessary.

  This medication has also been linked to rare but potentially fatal pancreatitis, which can occur at any stage of treatment and may rapidly progress.

• Symptoms to Watch For: Immediately inform your healthcare provider if you experience persistent nausea or vomiting, unusual fatigue, weakness, facial swelling, stomach or abdominal pain, loss of appetite, dark urine, or yellowing of the eyes or skin, as these may indicate liver problems or pancreatitis.

During pregnancy, this medication poses risks of birth defects, may negatively impact a child’s IQ, and may increase the likelihood of certain neurological or mental conditions, such as autism or ADHD.

• Pregnancy Considerations: Both men and women using this medication should discuss potential risks, alternative treatments, and effective birth control methods with their doctor. If you are planning to become pregnant, or if pregnancy occurs or is suspected, contact your healthcare provider immediately. This medication should not be used during pregnancy for migraine prevention. For seizure or mood disorder treatments, do not cease use without medical guidance, as these conditions can pose significant risks to both the pregnant individual and the unborn child.

You may experience some mild side effects such as diarrhea, dizziness, drowsiness, hair loss, blurred or double vision, changes in menstrual periods, ringing in the ears, shakiness, unsteadiness, or fluctuations in weight. These are usually not a cause for concern, but if they persist or worsen, it’s important to inform your healthcare provider.

Occasionally, parts of the capsule may appear in your stool. Should this happen, notify your healthcare provider promptly. It's rare, but some individuals on anticonvulsants may develop mood changes, depression, or suicidal thoughts. Any unusual changes in mood or behavior should be reported to a healthcare professional immediately.

In very rare cases, a severe brain disorder known as encephalopathy may occur, particularly in those with metabolic disorders. Seek medical attention if you experience unexplained weakness, vomiting, or sudden mental changes. Serious side effects that require immediate medical attention include chest pain, unusual bruising or bleeding, irregular heartbeat, swelling of the extremities, uncontrolled eye movements, feeling cold or shivering, rapid breathing, or loss of consciousness.

A severe allergic reaction to this medication is rare, but should you notice symptoms such as fever, swollen lymph nodes, rash, severe dizziness, or difficulty breathing, seek emergency medical help. While these side effects cover a broad range, it’s crucial to consult with your healthcare provider if you notice any other unexpected effects.