OBJECTIVES : This study estimated and characterized the frequency of AEs attributable to AOMs between January 2013 and March 2020.

METHODS : Using the US FDA Adverse Event Reporting System (FAERS) between January 01, 2013, and March 31, 2020, a retrospective, descriptive analysis was conducted to analyze all major reported AEs including (death, life-threatening, initial or prolonged hospitalization, persistent or significant disability, and required intervention, or congenital anomaly) related to AOMs. The total numbers of reports, cases, adverse reactions, and outcomes were calculated for each study drug, and the mean age and gender of patients were compared among drugs.

RESULTS : We found a total of 18,675 unique AEs reports associated with antiobesity medications use for 15,143 patients. The mean age was 49.8 years [SD 1.83], while most patients were female adults (73.4 %). The main themes of safety reports were nausea, headache, cardiovascular diseases, dizziness, drug ineffective, acute kidney failure/ kidney injury, and dry mouth. The FAERS database had 21,229 unique outcomes involving anti-obesity medication use, including 1,039 deaths (fatality ratio of 4.9%), 1,613 (7.6%) life-threatening events, 7,426 (35%) hospitalizations, and 1,249 (5.9%) disability cases. Phentermine/topiramate fatal cases represent 6% of the overall medication's reported AEs. The cardiovascular AEs were sizable, including 542 reports (31%) for phentermine, 402 reports (23%) for liraglutide, 381 reports (22%) for phentermine/topiramate. Naltrexone/bupropion use has the lowest share of the reported serious AEs.

CONCLUSIONS : Although several antiobesity medications have been withdrawn from the market and replaced with new ones, the utilization of the AOMs is widespread, and the FAERS database's analysis revealed many serious AEs attributable to AOMs. Therefore, it is necessary to continue and systematically monitor AOMs' safety to help to optimize their use.