Valproic Acid

DRUG INFORMATION

  ADULT
    - (2.1) Simple and Complex Absence Seizures: Start at 10 to 15 mg/kg/day, increasing
      at 1 week intervals by 5 to 10 mg/kg/week until seizure control or limiting side
      effects (2.1) Safety of doses above 60 mg/kg/day is not established (2.1, 2.2) 2.1
      Epilepsy Valproic acid oral solution is intended for oral administration.
      Source: US FDA label for valproic acid (VALPROIC ACID), section 'dosage and
      administration', retrieved 2026-08-29
    - Patients should initiate therapy at 10 to 15 mg/kg/day.
      Source: US FDA label for valproic acid (VALPROIC ACID), section 'dosage and
      administration', retrieved 2026-08-29
    - Ordinarily, optimal clinical response is achieved at daily doses below 60
      mg/kg/day.
      Source: US FDA label for valproic acid (VALPROIC ACID), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Experience has indicated that pediatric patients under the age of two years are at
      a considerably increased risk of developing fatal hepatotoxicity, especially those
      with the aforementioned conditions [see Boxed Warning ]. When valproic acid oral
      solution is used in this patient group, it should be used with extreme caution and
      as a sole agent. The benefits of therapy should be weighed against the risks.
      Source: US FDA label for valproic acid (VALPROIC ACID), section 'pediatric use',
      retrieved 2026-08-29
    - Valproic acid oral solution is intended for oral administration. (2.1) Simple and
      Complex Absence Seizures: Start at 10 to 15 mg/kg/day, increasing at 1 week
      intervals by 5 to 10 mg/kg/week until seizure control or limiting side effects
      (2.1) Safety of doses above 60 mg/kg/day is not established (2.1, 2.2) 2.1
      Epilepsy Valproic acid oral solution is intended for oral administration.
      Source: US FDA label for valproic acid (VALPROIC ACID), section 'dosage and
      administration', retrieved 2026-08-29
    - Epilepsy Valproic acid oral solution is intended for oral administration. Patients
      should be informed to take valproic acid oral solution every day as prescribed. If
      a dose is missed it should be taken as soon as possible, unless it is almost time
      for the next dose. If a dose is skipped, the patient should not double the next
      dose.
      Source: US FDA label for valproic acid (VALPROIC ACID), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No kidney-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for valproic acid (VALPROIC ACID),
      retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Valproate-induced acute liver failure and liver-related deaths have been reported
      in patients with hereditary neurometabolic syndromes caused by mutations in the
      gene for mitochondrial DNA polymerase γ (POLG) (e.g., Alpers- Huttenlocher
      Syndrome) at a higher rate than those without these syndromes.
      Source: US FDA label for valproic acid (VALPROIC ACID), section 'warnings and
      cautions', retrieved 2026-08-29
    - Most of the reported cases of liver failure in patients with these syndromes have
      been identified in children and adolescents.
      Source: US FDA label for valproic acid (VALPROIC ACID), section 'warnings and
      cautions', retrieved 2026-08-29

  PREGNANCY
    - Pregnancy Category D for epilepsy [see Warnings and Precautions (5.2 , 5.3) ].
      Source: US FDA label for valproic acid (VALPROIC ACID), section 'pregnancy',
      retrieved 2026-08-29
    - Pregnancy Registry To collect information on the effects of in utero exposure to
      valproic acid oral solution, physicians should encourage pregnant patients taking
      valproic acid oral solution to enroll in the North American Antiepileptic Drug
      (NAAED) Pregnancy Registry.
      Source: US FDA label for valproic acid (VALPROIC ACID), section 'pregnancy',
      retrieved 2026-08-29
    - This can be done by calling toll free 1-888-233-2334, and must be done by the
      patients themselves.
      Source: US FDA label for valproic acid (VALPROIC ACID), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING   [ CAUTION ]
    The label allows it only when the benefit is judged to outweigh the risk. Read the
      quote below.
    - Caution should be exercised when valproate is administered to a nursing woman.
      Source: US FDA label for valproic acid (VALPROIC ACID), section 'nursing mothers',
      retrieved 2026-08-29
    - Behavioral abnormalities (including cognitive, locomotor, and social interaction
      deficits) and brain histopathological changes have also been reported in mice and
      rat offspring exposed prenatally to clinically relevant doses of valproate. 8.3
      Nursing Mothers Valproate is excreted in human milk.
      Source: US FDA label for valproic acid (VALPROIC ACID), section 'use in specific
      populations', retrieved 2026-08-29
    - Caution should be exercised when valproate is administered to a nursing woman. 8.4
      Pediatric Use Experience has indicated that pediatric patients under the age of
      two years are at a considerably increased risk of developing fatal hepatotoxicity,
      especially those with the aforementioned conditions [see Boxed Warning ].
      Source: US FDA label for valproic acid (VALPROIC ACID), section 'use in specific
      populations', retrieved 2026-08-29