OBJECTIVE To explore the risk factors for the occurrence of adverse event(AE), signal mining of ocular toxicity associated with trigeminal neuralgia(TN) therapeutics in elderly patients was performed based on the FAERS database.

METHODS The reported data of lamotrigine, pregabalin, gabapentin, carbamazepine, oxcarbazepine-related ocular toxicity in elderly patients from the FAERS database for a total of 22 quarters from first quarter of 2019 to second quarter of 2024 were extracted, and data mining were carried out by utilizing reporting odds ratio(ROR) and healthcare products regulatory agency(MHRA). After obtaining signaled preferred terms(PT), the Chinese language and high level term(HLT) were classified by the International Medical Dictionary for Regularly Activities(MedDRA).

RESULTS Among reports of ocular toxicity occurring in elderly patients in the FAERS database, 92 cases were reported with lamotrigine as the primary suspect drug(PS), with a total of 8 signaling PT involving 7 HLT; 1149 cases were reported with pregabalin as the PS, with a total of 19 signaling PT involving 13 HLT; 405 cases were reported with gabapentin as the PS, with a total of 10 signaling PT involving 6 HLT; 83 cases were reported with carbamazepine as the PS, with a total of 6 signaling PT involving 4 HLT; and 17 cases were reported with oxcarbazepine as the PS, with a total of 1 signaling PT. The top two reported HLT were visual impairment and blindness(excl colour blindness) and visual disorders(no separate classification). Reports of ophthalmotoxicity with all five TN therapeutic agents were higher in female elderly patients than in males, with most of the reports coming from consumers and most of the routes of administration being oral, with a trend towards a gradual decrease in the number of reports in recent years. The onset of adverse events was mostly in the first month after drug administration.

CONCLUSION Older women may be a risk factor for the occurrence of ophthalmotoxicity, and focused monitoring of the first month after drug administration may be key to preventing the occurrence of ophthalmotoxicity in elderly patients using 5 TN therapeutic agents. The occurrence of ophthalmotoxicity involving HLT in elderly patients using the 5 TN therapeutic agents has a differential effect, which may provide a reference for clinical drug selection and help to promote the rational use of drugs.