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The following safety information is crucial for understanding the risks and precautions associated with the use of valproic acid. Please review these details carefully and consult your healthcare provider if you have any questions or concerns.

• Liver Problems: Valproic acid can lead to serious and potentially fatal liver issues, especially within the first six months of treatment. Children under 2 years, those on multiple seizure medications, and individuals with severe seizure disorders or genetic metabolic disorders are at higher risk. Regular lab tests are necessary to monitor liver function.

• Pancreatitis: Rare but severe inflammation of the pancreas can occur at any time during treatment. Symptoms include persistent nausea, vomiting, abdominal pain, and fever. Immediate medical attention is required if these symptoms appear.

• Pregnancy Risks: Valproic acid can cause birth defects and developmental issues in unborn babies. Pregnant individuals or those planning to become pregnant should discuss alternative treatments and contraception options with their doctor. Participation in the North American Antiepileptic Drug (NAAED) Pregnancy Registry is encouraged.

• Suicidal Thoughts: The medication may increase the risk of suicidal thoughts or behaviors, particularly in individuals with a history of depression. It's important for patients and their families to monitor mood changes and seek medical advice if necessary.

• Blood Cell Counts: In rare cases, valproic acid can lead to reduced platelet counts, increasing bleeding risks. Regular blood tests are recommended to monitor these levels.

• Ammonia Levels: The drug can elevate ammonia levels, potentially causing fatigue, concentration difficulties, vomiting, and hypothermia. This is particularly concerning for individuals with certain metabolic disorders.

• Severe Skin Reactions: Rare but severe skin and allergic reactions, including DRESS syndrome, can occur. Immediate cessation of the drug and medical consultation are advised if symptoms like rash, peeling skin, or mouth sores develop.

• Excessive Sleepiness in Older Adults: Older adults may experience increased drowsiness, dehydration, and weight loss. Dose adjustments by a healthcare provider are necessary to mitigate these effects.

• Drug Interactions: Other medications may affect the efficacy and safety of valproic acid. It's important to inform your healthcare provider about all medications you are taking.

Contraindications:

• History of liver problems or specific liver diseases.
• Known genetic disorders like Alpers-Huttenlocher Syndrome.
• Children under 2 years at risk of certain genetic disorders.
• Pregnant individuals or those who can become pregnant without using contraception.

Please ensure to discuss any concerns or questions with your healthcare provider for personalized advice and guidance.

Common side effects:

• Tremors
• Nausea
• Headaches
• Excess sleepiness
• Vomiting
• Weakness
• Dizziness
• Hair loss
• Diarrhea
• Stomach pain

Less common but important to monitor:

• Infections
• Double or blurry vision
• Trouble sleeping
• Changes in appetite
• Flu-like symptoms
• Feeling nervous
• Fever
• Indigestion

Serious side effects:

• Suicidal thoughts or behaviors
• Severe allergic reactions
• Serious liver issues
• Extremely high blood ammonia levels
• Severe pancreatitis
• Significant bleeding
• Extreme drowsiness
• Severe drops in body temperature
• Encephalopathy

Interactions with high risk of serious adverse effects and should be avoided:

• Imipenem
• Lamotrigine
• Orlistat
• Warfarin
• Vorinostat
• Carbapenems such as imipenem
• Carvedilol
• Doripenem
• Ertapenem
• Meropenem
• Potassium Oxybate
• Sodium Oxybate
• Magnesium Oxybate
• Calcifediol

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Amitriptyline
• Nortriptyline
• Mefloquine
• Ethosuximide
• Rufinamide
• Topiramate
• Zidovudine
• Cannabidiol
• Estradiol
• Ethinyl Estradiol
• Lumateperone
• Mestranol
• Pexidartinib
• Primidone
• Propofol
• Acyclovir
• Aspirin
• Betamipron
• Carbamazepine
• Cholestyramine
• Clomipramine
• Erythromycin
• Felbamate
• Fosphenytoin
• Ginkgo
• Lopinavir
• Lorazepam
• Nimodipine
• Olanzapine
• Oxcarbazepine
• Panipenem
• Phenobarbital
• Phenytoin
• Rifampin
• Rifapentine
• Risperidone
• Ritonavir
• Valacyclovir

Interactions with low risk that usually do not require a change in therapy:

• Alcohol
• Marijuana (cannabis)
• Antihistamines (such as cetirizine, diphenhydramine)
• Drugs for sleep or anxiety (such as alprazolam, zolpidem)
• Muscle relaxants (such as carisoprodol, cyclobenzaprine)
• Opioid pain relievers (such as codeine, hydrocodone)