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  6. October - December 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
  1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)

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 March 23, 2022)

Actemra (tocilizumab)

Drug reaction with eosinophilia and systemic symptoms

FDA is evaluating the need for regulatory action.

Aliqopa (copanlisib)

Cytomegalovirus infection

FDA is evaluating the need for regulatory action.

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.

 
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