October - December 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Product Name: Trade (Active Ingredient) or Product Class	Potential Signal of a Serious Risk / New Safety Information	Additional Information (as of January 31, 2025)
Actemra (tocilizumab)	Drug reaction with eosinophilia and systemic symptoms	FDA is evaluating the need for regulatory action.
Aliqopa (copanlisib)	Cytomegalovirus infection	Updated The “Warnings and Precautions”, “Dosage and Administration”, and “Patient Information” sections of the labeling were updated in September 2023 to include information about cytomegalovirus infection. Aliqopa labeling
Belrapzo (bendamustine hydrochloride) Bendeka (bendamustine hydrochloride) Treanda (bendamustine hydrochloride)	Nephrogenic diabetes insipidus	FDA is evaluating the need for regulatory action.
Dantrium (dantrolene sodium) Ryanodex (dantrolene sodium) Generic products containing dantrolene sodium	Hepatotoxicity	FDA is evaluating the need for regulatory action.
Dupixent (dupilumab)	Psoriasis	FDA is evaluating the need for regulatory action.
Esbriet (pirfenidone) Generic products containing pirfenidone	Severe cutaneous adverse reactions	FDA is evaluating the need for regulatory action.
Evenity (romosozumab-aqqg)	Injury associated with device	FDA is evaluating the need for regulatory action.
Ferrlecit (sodium ferric gluconate complex in sucrose injection) Venofer (iron sucrose injection) Generic products containing ferric oxyhydroxide; ferric carboxymaltose; iron sucrose	Acute myocardial ischemia with or without myocardial infarction or with in-stent thrombosis in the context of a hypersensitivity reaction	FDA is evaluating the need for regulatory action.
Hizentra Immune Globulin Subcutaneous (Human), 20% Liquid	Increased hypersensitivity reactions in patients receiving certain product lots	FDA is evaluating the need for regulatory action.
Ilaris (canakinumab) Kineret (anakinra)	Drug reaction with eosinophilia and systemic symptoms	FDA is evaluating the need for regulatory action.
Kyleena (levonorgestrel) Liletta (levonorgestrel) Mirena (levonorgestrel) Paragard (intrauterine copper contraceptive) Skyla (levonorgestrel)	Device breakage	FDA is evaluating the need for regulatory action.
Lutathera (lutetium Lu 177 dotatate)	Hypersensitivity	FDA is evaluating the need for regulatory action.
Privigen Immune Globulin Intravenous (Human), 10% Liquid	Increased hypersensitivity reactions in patients receiving certain product lots	FDA is evaluating the need for regulatory action.
Proglycem (diazoxide) Generic products containing diazoxide	Necrotising colitis	FDA is evaluating the need for regulatory action.
Proton Pump Inhibitors Aciphex (rabeprazole sodium) Dexilant (dexlansoprazole) Esomeprazole magnesium Esomeprazole strontium Lansoprazole Nexium (esomeprazole magnesium) Nexium 24 HR (esomeprazole magnesium) Nexium IV (esomeprazole sodium) Omeprazole and clarithromycin and amoxicillin Omeprazole Pantoprazole Sodium Prevacid (lansoprazole) Prevacid 24 HR (lansoprazole) Prevacid (lansoprazole) Prilosec (omeprazole magnesium) Prilosec OTC (omeprazole magnesium) Protonix (pantoprazole sodium) Protonix IV (pantoprazole sodium) Talicia (amoxicillin; omeprazole magnesium; rifabutin Yosprala (aspirin and omeprazole) Vimovo (esomeprazole magnesium; naproxen) Zegerid (omeprazole; sodium bicarbonate) Zegerid OTC (omeprazole; sodium bicarbonate) Generic products containing proton pump inhibitors	Erectile dysfunction	FDA is evaluating the need for regulatory action.
Tagrisso (osimertinib mesylate)	Rhabdomyolysis	FDA is evaluating the need for regulatory action.
Tecfidera (dimethyl fumarate) Generic products containing dimethyl fumarate	Pancreatitis acute	FDA is evaluating the need for regulatory action.
Vfend (voriconazole) Voriconazole for injection Generic products containing voriconazole	Increased risk of photosensitivity reaction	FDA is evaluating the need for regulatory action.
Xifaxan (rifaximin) Generic products containing rifaximin	Severe cutaneous adverse reactions	FDA is evaluating the need for regulatory action.
Xpovio (selinexor)	Tumour lysis syndrome	FDA is evaluating the need for regulatory action.