The Topamax® (topiramate) product information has recently been updated. When used for migraine prophylaxis, this medicine is now contraindicated in pregnancy and in women of childbearing potential unless a highly effective method of contraception is used.

Topiramate belongs to category D in the Australian categorisation system for prescribing medicines in pregnancy. Studies suggest that topiramate significantly increases the risk of overall major congenital malformations, foetal loss, prenatal growth retardation, and cleft lip/palate. However, some evidence suggests that the risks associated with topiramate may be disproportionately higher when used for the treatment of epilepsy compared to other indications.

If migraine prophylaxis is required during pregnancy, a beta blocker or tricyclic antidepressant is considered safer.


  1. Castilla-Puentes R, Ford L, Manera L, Kwarta RF, Ascher S, Li Q. Topiramate monotherapy use in women with and without epilepsy: Pregnancy and neonatal outcomes. Epilepsy Res. 2014; 108(4): 717-24.
  2. Migraine [published 2017 Nov]. In: Therapeutic Guidelines. Melbourne: Therapeutic Guidelines Limited; accessed 27 June 2023.
  3. Topamax® (Topiramate) Australian approved product information. Macquarie Park: Janssen-Cilag. Approved May 2023.
  4. Veroniki AA, Cogo E, Rios P, Straus SE, Finkelstein Y, Kealey R, et al. Comparative safety of anti-epileptic drugs during pregnancy: A systematic review and network meta-analysis of congenital malformations and prenatal outcomes. BMC Med. 2017; 15: 95.

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