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Divalproex Sodium Safety and Warning Information

Divalproex sodium can pose significant health risks if not used cautiously. Below are important safety warnings and precautions to consider while using this medication. It is crucial to review these details carefully and discuss any concerns with your healthcare provider.

• Liver Concerns: This medication may lead to severe, potentially life-threatening liver issues, particularly within the first six months of treatment. The risk is heightened for those with a history of liver problems, children under two years old, multiple anti-seizure medications, severe seizure disorders, or specific genetic metabolic conditions. Regular lab tests are recommended to monitor liver function.

• Pancreatitis Risk: Rare cases of pancreatitis, an inflammation of the pancreas, have been reported. Symptoms may include persistent nausea, vomiting, abdominal pain, and fever. Seek immediate medical attention if these symptoms occur.

• Pregnancy Warnings: Divalproex sodium can cause serious birth defects and developmental issues in an unborn child. Women who are pregnant or may become pregnant should avoid this medication unless necessary. Discuss alternative treatments and effective birth control options with your healthcare provider. Participation in the North American Antiepileptic Drug (NAAED) Pregnancy Registry is encouraged for pregnant individuals on this medication.

• Suicidal Thoughts and Behavior: As with other anti-epileptic drugs, there is an increased risk of suicidal thoughts or actions. This risk is greater if there is a personal history of depression or suicidal behavior. Inform family and friends to monitor for any mood changes or new symptoms, and contact your healthcare provider immediately if they occur.

• Blood Cell Count Issues: Though rare, divalproex sodium can lead to lower platelet counts, increasing bleeding risk. Regular blood tests may be necessary to ensure safety. Report any unusual bruising or bleeding to your healthcare provider.

• High Ammonia Levels: This medication may cause elevated ammonia levels in the blood, especially when combined with topiramate. Symptoms include fatigue, confusion, vomiting, and decreased body temperature. These can lead to severe brain damage if untreated. Avoid this medication if you have metabolic disorders known to raise ammonia levels.

• Severe Allergic Reactions: Severe skin and allergic reactions, such as DRESS syndrome, might occur. Symptoms include skin rash, blisters, peeling, mouth sores, and fever. Immediate medical attention is required if these symptoms develop.

• Drug Interactions: Certain medications can affect how divalproex sodium is metabolized, altering its effectiveness and side effect profile. Discuss all current medications with your healthcare provider to avoid potential interactions.

Contraindications:

• History of liver disease or specific liver conditions (e.g., urea cycle disorders).
• Certain genetic disorders (e.g., Alpers-Huttenlocher Syndrome).
• Children under two years with a risk of genetic disorders (e.g., POLG disorder).
• Pregnancy or potential for pregnancy without proper contraceptive use.
• Use for migraine treatment during pregnancy.

Consult your healthcare provider before starting or stopping divalproex sodium to ensure it is a safe option for you.

When taking this medication, it's possible to encounter some common side effects. These may include nausea, dizziness, drowsiness, headache, vomiting, and stomach pain. These effects are generally mild, but if they persist or worsen, it's important to consult your healthcare provider for guidance.

Some individuals might also experience changes in weight, hair loss, tremors, blurred or double vision, changes in menstrual periods, ringing in the ears, or feelings of low energy and unsteadiness. While these effects can be concerning, they often do not require immediate medical attention unless they become severe or persistent.

It's crucial to be aware of more serious side effects, which are rare but require immediate medical intervention. These include chest pain, easy bruising or unexplained bleeding, irregular heartbeat, swelling of the hands or feet, uncontrolled eye movements, and loss of consciousness. Additionally, severe allergic reactions, such as fever, swollen lymph nodes, rash, or difficulty breathing, necessitate urgent care.

In rare cases, mental health changes like depression or suicidal thoughts may occur, particularly in individuals using anticonvulsants for conditions like seizures or bipolar disorder. If you or your loved ones notice sudden mood changes or thoughts of self-harm, seek help without delay. Also, be vigilant for signs of encephalopathy, a serious brain disorder, especially if you experience unexplained weakness, vomiting, or confusion.

While this list covers many potential side effects, it's not exhaustive. If you observe any unusual symptoms, it's best to discuss them with your healthcare provider to ensure your well-being.

When taking Divalproex (Depakote), it's important to be aware of its potential interactions with other medications and substances. Inform your doctor and pharmacist about all other medicines and supplements you are using, whether they are prescription, over-the-counter, vitamins, or herbal supplements.

Certain medications can interact with Divalproex and are usually not recommended to be used together unless necessary. If they are prescribed together, your doctor may adjust the dosage or frequency. These include certain antibiotics (such as imipenem), seizure medications (like Lamotrigine), and others such as Orlistat, Warfarin, and vorinostat.

Additionally, some medicines may increase the risk of side effects when used with Divalproex. This includes antidepressants (such as Nortriptyline), antibiotics like Erythromycin, and seizure medications such as Ethosuximide, Topiramate, and Rufinamide. If both medicines are necessary, your doctor may change how you use them.

Divalproex may also cause drowsiness. Be cautious when using other products that cause drowsiness, like alcohol, antihistamines, sleep or anxiety medications, muscle relaxants, and opioid pain relievers. Always check the labels of your medicines for ingredients that may cause drowsiness and consult your pharmacist for safe use.

Lastly, Divalproex can interfere with certain lab tests, such as urine ketone tests, so ensure that your healthcare providers are informed about your medication use.