Valproate (Formulary: CNS)

Valproate is the first choice of the antiepileptics used to treat bipolar disorder. In acute mania valproic acid is licensed; sodium valproate is a cost-effective alternative to valproic acid but is off-label for this indication. Both drugs are used for maintenance treatment but both are off-label for this indication.

Valproate medicines are contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met (MHRA advice April 2018)

• MHRA advice: Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell): updated safety and educational materials to support patient discussion on reproductive risks (June 2025) (www.gov.uk).
• MHRA advice: Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell): review by two specialists is required for initiating valproate but not for male patients already taking valproate (February 2025) (www.gov.uk).
• MHRA advice: Valproate use in men: as a precaution, men and their partners should use effective contraception (September 2024) (www.gov.uk).
• MHRA advice: Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell): new safety and educational materials to support regulatory measures in men and women under 55 years of age (January 2024) (www.gov.uk).
• National Patient Safety Alert: Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients (November 2023) (www.gov.uk).
• MHRA advice: Valproate: dispense full packs of valproate-containing medicines (October 2023) (www.gov.uk).
• MHRA advice: Valproate: reminder of current Pregnancy Prevention Programme requirements; information on new safety measures to be introduced in the coming months (December 2022) (www.gov.uk).
• MHRA advice: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review (January 2021) (www.gov.uk).
• MHRA advice: Valproate (Epilim▼, Depakote▼) pregnancy prevention programme: updated educational materials (May 2020) (www.gov.uk).
• MHRA advice: Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19) (February 2020) (www.gov.uk).
• MHRA advice: Antiepileptic drugs: updated advice on switching between different manufacturers’ products (November 2018) (www.gov.uk).
• Risk Minimisation Materials
• MHRA Drug Safety Update articles