Maideen, Naina Mohamed Pakkir2025-10-022025-10-022025-07-2440716154https://repository.mbru.ac.ae/handle/1/1811Background: Topiramate (TPM) is a new-generation, broad-spectrum anti-seizure drug with a unique structure compared to other anti-epileptic medications. It is widely used for epilepsy treatment, migraine prevention, and weight management in overweight or obese individuals. Additionally, it has off-label applications in conditions such as alcohol use disorder, binge eating disorder, and neuropathic pain. TPM exerts its therapeutic effects through multiple mechanisms, including the inhibition of voltage-gated ion channels and the enhancement of GABAergic neurotransmission.Method: This review examines the potential risks associated with TPM use during pregnancy by analyzing a comprehensive range of existing studies on fetal growth, congenital malformations, and neurodevelopmental disabilities linked to prenatal exposure.Results: Research indicates that prenatal exposure to TPM significantly increases the risk of intellectual disability, cleft lip/cleft palate, attention-deficit/hyperactivity disorder, and autism spectrum disorder in offspring. These risks are influenced by dosage, co-administration with other medications, and the timing of exposure, with the first trimester being the most critical period for risk.Conclusion: Due to its potential teratogenic effects, TPM has been classified as a pregnancy category D drug by major regulatory bodies, including the US FDA, EMA, TGA, and UK MHRA. Given the serious risks to fetal development, healthcare professionals must exercise careful consideration and diligent monitoring when prescribing TPM to women of childbearing age.enAttention-deficit/hyperactivity disorderAutism spectrum disorderCleft lipCleft palateCongenital malformationsFetal growth restrictionsIntellectual disabilityNeurodevelopmental disabilitiesPharmacovigilancePregnancyPrenatal exposureTopiramate