Actemra (tocilizumab)
Drug reaction with eosinophilia and systemic symptoms
FDA is evaluating the need for regulatory action.
Aliqopa (copanlisib)
Cytomegalovirus infection
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.
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.
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.
Tumour lysis syndrome
FDA is evaluating the need for regulatory action.
