In this study, FDA Adverse Event Reporting System (FAERS) data were retrospectively reviewed to analyze adverse event (AE) reporting for Sublocade® and Brixadi® during the 12-month periods following their commercial launches in the U.S. Overall, AEs associated with both products were infrequent during the first 12 months post-launch. These findings support a favorable overall safety profile for long-acting injectable buprenorphine in the treatment of moderate to severe opioid use disorder in the real-world setting.