Safety of Gadoterate Meglumine: A Review of 35 Years of Clinical Use and More Than 170 Million Doses.

AIM: The aim of this review was to evaluate the safety profile of gadoterate meglumine from published literature and pharmacovigilance reports of adverse drug reactions (ADRs) encompassing 35 years of clinical use and more than 170 million administered doses.

MATERIALS AND

METHODS

A review of published literature up to December 31, 2024 was performed through a search in Embase and PubMed databases. The analysis focused on current safety concerns associated with gadolinium-based contrast agents, the hypersensitivity reactions (HSRs), nephrogenic systemic fibrosis (NSF), gadolinium accumulation, and symptoms associated with gadolinium exposure.

RESULTS

A total of 62 publications reporting safety results for gadoterate meglumine were included. Age ranged from a few weeks to 103 years, including patients with all stages of renal impairment. The incidence of HSRs was reported in 17 studies and ranged from <0.01% to 0.58%. Occurrence of NSF was analyzed in 9 studies; to date, no confirmed unconfounded case of NSF diagnosis has been associated with gadoterate meglumine use. Regarding gadolinium presence in the body, 17 studies did not show any significant signal intensity increase in the deep brain in patients after up to 53 exposures, while 4 showed some signal intensity increase in specific subgroups after repeated exposure, but without any clinical symptoms. Symptoms associated with gadolinium exposure have been described in 8 studies, although no causal relationship with gadolinium deposition was established. Safety data obtained from pharmacovigilance monitoring showed an incidence of adverse reactions in 8 cases per 100,000 patients exposed. The most frequently reported adverse reactions were urticaria, nausea, and vomiting (0.001% each), while the incidence of HSRs was less than 0.00035%. No unconfounded NSF reports were received.

CONCLUSIONS

Clinical evidence from the published data and pharmacovigilance monitoring demonstrated that gadoterate meglumine is a safe magnetic resonance imaging contrast agent for all age groups in a variety of approved indications throughout the whole body, including in patients with renal impairment.