January - March 2026 | New Safety Information or Potential Signals of Serious Risks Identified by the FDA Adverse Event Monitoring System (AEMS)

_{The drug product(s) included in any of the new safety information or potential signals of serious risks listed below may also include generic drug product(s) and biosimilar or interchangeable biosimilar biological product(s), as appropriate.}

Product Name: Trade (Active Ingredient) or Product Class	New Safety Information or Potential Signal of a Serious Risk	Additional Information (as of June 4, 2026)
Acthar Gel (repository corticotropin injection) Corticotrophin (sterile corticotropin zinc hydroxide suspension injection) Purified Cortrophin Gel (repository corticotropin injection)	Drug hypersensitivity	FDA is evaluating the need for regulatory action.
Beyfortus (nirsevimab-alip) injection	Immune thrombocytopenia	FDA is evaluating the need for regulatory action.
Beyfortus (nirsevimab-alip) injection	Seizure	FDA determined that no action was needed at the time based on available information.
Braftovi (encorafenib) capsules Ojemda (tovorafenib) tablets; for oral suspension	Severe cutaneous adverse reaction	FDA is evaluating the need for regulatory action.
Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Ocrevus (ocrelizumab) injection Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) injection	Pneumocystis jirovecii infection	FDA determined that no action was needed at the time based on available information.
Depakote (divalproex sodium) delayed-release tablets Depakote ER (divalproex sodium) extended-release tablets Depakote Sprinkle Capsules (divalproex sodium delayed release capsules) Stavzor (valproic acid) delayed released capsules Generic products containing valproate sodium	Pleural effusion	FDA is evaluating the need for regulatory action.
Elahere (mirvetuximab soravtansine-gynx) injection	Extravasation	FDA is evaluating the need for regulatory action.
Elrexfio (elranatamab-bcmm) injection Tecvayli (teclistamab-cqyv) injection	Uveitis	FDA is evaluating the need for regulatory action.
Elucirem (gadopiclenol) injection	Anaphylactic reaction	FDA is evaluating the need for regulatory action.
Gadolinium-based contrast agents	Angioedema	FDA is evaluating the need for regulatory action.
Gomekli (mirdametinib) capsules; tablets Koselugo (selumetinib) capsules; oral granules Mektovi (binimetinib) tablets	Severe cutaneous adverse reaction	FDA is evaluating the need for regulatory action.
Gonadotropin-releasing hormone (GnRH) agonists Camcevi (leuprolide) injectable emulsion Eligard (leuprolide acetate) for injectable suspension Fensolvi (leuprolide acetate) for injectable suspension Leuprolide Acetate for Depot Suspension Lupron (leuprolide acetate) injection Lupron Depot (leuprolide acetate for depot suspension) Lupron Depot-Ped (leuprolide acetate for depot suspension) Trelstar (triptorelin pamoate for injectable suspension) Triptodur (triptorelin) for extended-release injectable suspension	Injection site reaction	FDA is evaluating the need for regulatory action.
Injectafer (ferric carboxymaltose injection)	Hypophosphatemia	FDA is evaluating the need for regulatory action.
Qelbree (viloxazine extended-release capsules)	Seizure	FDA is evaluating the need for regulatory action.
Rinvoq (upadacitinib) extended-release tablets	Semen discoloration	FDA is evaluating the need for regulatory action.
Teflaro (ceftaroline fosamil) for injection	Severe cutaneous adverse reactions	FDA is evaluating the need for regulatory action.
Tepezza (teprotumumab-trbw) for injection	Hypertension	FDA is evaluating the need for regulatory action.
Tepezza (teprotumumab-trbw) for injection	Encephalopathy	FDA is evaluating the need for regulatory action.
Tepezza (teprotumumab-trbw) for injection	Hypersensitivity	FDA is evaluating the need for regulatory action.
Vistogard (uridine triacetate) oral granules Xuriden (uridine triacetate) oral granules	Device occlusion	FDA is evaluating the need for regulatory action.