Abstract: Objective To explore the characteristics and profiles of adverse drug reactions (ADRs) related to antiepileptic drugs (AEDs) used in monotherapies, and explore the method of post-marketing safety surveillance of drugs, so as to guide the rational use of AEDs in clinic. Methods We reviewed the data of ADRs related to AEDs used in monotherapies, which came from the database of outpatients with epilepsy in our hospital from January 2003 to December 2015. Totally, 1 170 cases were included, involving 2 461 ADRs. Data of cases and ADRs was analyzed. Results Among 1 170 cases with ADRs caused by AEDs used in monotherapy, women accounted for 51.03%, and 731 (62.48%) cases aged 21 to 40 years old. The system-organs of nervous system, mental system and digestive system were mainly involved. Carbamazepine, valproate, lamotrigine, oxcarbazepine, topiramate, and levetiracetam could all cause amnesia (poor memory), dizziness, headache, and insomnia. Low, medium and high doses could lead to ADRs. In the 2 461 ADRs, the proportion of ADRs appeared within one month and one year after taking AEDs was 33.08% and 29.46%, respectively. The outcomes of most ADRs came out well. Serious adverse reactions were mainly allergy, fetal abnormalities and renal calculus. Conclusion Clinicians should be alert of ADRs related to AEDs used in monotherapies, especially serious adverse reactions such as hypersensitivity and fetal abnormalities. The post-marketing monitoring system of drugs should be improved gradually to pay attention to ADRs and ensure patients' safety.

Key words: antiepileptic drugs, monotherapy, adverse drug reaction, safety surveillance of post-marketing drugs