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 August 12, 2025)
Actemra (tocilizumab) Updated Kevzara (sarilumab)* Tofidence (tocilizumab-bavi)* Tyenne (tocilizumab-aazg)*	Drug reaction with eosinophilia and systemic symptoms	Updated The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling for Actemra, Tofidence, and Tyenne were updated in September 2024 to include information about Drug reaction with eosinophilia and systemic symptoms (DRESS). Example: Actemra labeling FDA determined that no action is necessary at this time for Kevzara based on available information. *FDA updated this signal for DRESS to include the products Kevzara, Tofidence, and Tyenne after the initial quarterly report was posted.
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) Updated Vivimusta (bendamustine hydrochloride)* Generic products containing bendamustine hydrochloride**	Nephrogenic diabetes insipidus	Updated The "Adverse Reactions" section of the labeling was updated between October 2022 and April 2024 to include nephrogenic diabetes insipidus. Example: Belrapzo labeling Vivimusta received FDA approval in December 2022 and was added to the list of product names after the initial quarterly report was posted. *An administrative error resulted in the omission of generic products containing bendamustine hydrochloride from the list of product names and was added after the initial quarterly report was posted.
Dantrium (dantrolene sodium) Ryanodex (dantrolene sodium) Generic products containing dantrolene sodium	Hepatotoxicity	Updated The "Adverse Reactions" section of the labeling of intravenous (IV) dantrolene products was updated in April 2024 to include information about hepatotoxicity. Example: Dantrium labeling FDA determined that the last approved labeling for oral dantrolene products is adequately labeled for hepatoxicity, and that no further regulatory action is needed.
Dupixent (dupilumab)	Psoriasis	Updated The "Warnings and Precautions" section of the labeling was updated in April 2025 to include information about the risk of new onset psoriasis. Dupixent labeling
Esbriet (pirfenidone) Generic products containing pirfenidone	Severe cutaneous adverse reactions	Updated The "Dosage and Administration", "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the labeling were updated in February 2023 to include information about severe cutaneous adverse reactions. Example: Esbriet labeling
Evenity (romosozumab-aqqg)	Injury associated with device	Updated FDA determined that no action is necessary at the time based on available information.
Ferrlecit (sodium ferric gluconate complex in sucrose injection) Venofer (iron sucrose injection) Generic products containing ferric oxyhydroxide; ferric carboxymaltose; iron sucrose Updated Injectafer (ferric carboxymaltose injection)*	Acute myocardial ischemia with or without myocardial infarction or with in-stent thrombosis in the context of a hypersensitivity reaction	Updated The "Adverse Reactions" section of the Ferrlecit and Venofer labeling was updated between March 2022 and August 2024 to include acute myocardial ischemia with or without myocardial infarction or with in-stent thrombosis in the context of a hypersensitivity reaction. Example: Ferrlecit labeling FDA determined that no action is necessary at this time for Injectafer based on available information. *An administrative error resulted in the omission of Injectafer from the list of product names and was added after the initial quarterly report was posted.
Hizentra Immune Globulin Subcutaneous (Human), 20% Liquid	Increased hypersensitivity reactions in patients receiving certain product lots	Updated Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions
Ilaris (canakinumab) Kineret (anakinra) Updated Arcalyst (rilonacept)*	Drug reaction with eosinophilia and systemic symptoms	Updated The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling for Ilaris and Kineret were updated between July 2024 and November 2024 to include drug reaction with eosinophilia and systemic symptoms. Example: Ilaris labeling FDA determined that no action is necessary for Arcalyst at the time based on available information. *Arcalyst was added to the list of product names after the initial quarterly report was posted.
Kyleena (levonorgestrel) Liletta (levonorgestrel) Mirena (levonorgestrel) Paragard (intrauterine copper contraceptive) Skyla (levonorgestrel)	Device breakage	Updated The "Dosage and Administration" sections of the Mirena, Skyla, and Kyleena labeling were updated between August 2022 and June 2024 to include information about the risk of device breakage during removal. Example: Mirena labeling FDA has determined that the last approved labeling for Paragard and Liletta is adequately labeled for risk of device breakage during removal, and that no further regulatory action is needed at this time.
Lutathera (lutetium Lu 177 dotatate)	Hypersensitivity	Updated The "Dosage and Administration", "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the labeling were updated in June 2022 to include information about hypersensitivity. Lutathera labeling
Privigen Immune Globulin Intravenous (Human), 10% Liquid	Increased hypersensitivity reactions in patients receiving certain product lots	Updated Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions
Proglycem (diazoxide) Generic products containing diazoxide	Necrotizing colitis	Updated The "Adverse Reactions" section of the labeling was updated in December 2022 to include information about necrotizing enterocolitis. Example: Proglycem labeling
Proton Pump Inhibitors Aciphex (rabeprazole sodium) Dexilant (dexlansoprazole) Nexium (esomeprazole magnesium) Omeprazole and clarithromycin and amoxicillin Pantoprazole Sodium Prevacid (lansoprazole) Prevacid SoluTab (lansoprazole) Prilosec (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) Generic products containing proton pump inhibitors	Erectile dysfunction	Updated The "Adverse Reactions" section of the labeling was updated between July 2023 and August 2023 to include erectile dysfunction. Example: Aciphex labeling An administrative error resulted in the inclusion of Esomeprazole magnesium, Esomeprazole strontium, Lansoprazole, Nexium 24HR, Nexium IV, Omeprazole, Prevacid 24HR, Prilosec OTC, and Zegerid OTC at the time of the initial quarterly posting.
Tagrisso (osimertinib mesylate)	Rhabdomyolysis	Updated The "Adverse Reactions" section of the labeling was updated in June 2023 to include increased blood creatine phosphokinase. Tagrisso labeling
Tecfidera (dimethyl fumarate) Generic products containing dimethyl fumarate	Pancreatitis acute	Updated The "Adverse Reactions" section of the labeling was updated in September 2022 to include acute pancreatitis. Example: Tecfidera labeling
Vfend (voriconazole) Voriconazole for injection Generic products containing voriconazole	Increased risk of photosensitivity reaction	Updated The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the labeling were updated in August 2022 to include information about increased risk of photosensitivity reaction with concomitant administration of voriconazole and methotrexate. Example: Vfend labeling
Xifaxan (rifaximin) Generic products containing rifaximin	Severe cutaneous adverse reactions	Updated The "Adverse Reactions" section of the labeling was updated in October 2022 to include information about severe cutaneous adverse reactions. Example: Xifaxan labeling
Xpovio (selinexor)	Tumour lysis syndrome	Updated FDA determined that no action is necessary at the time based on available information.

Product Name: Trade (Active Ingredient) or Product Class

Potential Signal of a Serious Risk / New Safety Information

Additional Information (as of August 12, 2025)

Actemra (tocilizumab)

Updated

Kevzara (sarilumab)*

Tofidence (tocilizumab-bavi)*

Tyenne (tocilizumab-aazg)*

Drug reaction with eosinophilia and systemic symptoms

Updated

The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling for Actemra, Tofidence, and Tyenne were updated in September 2024 to include information about Drug reaction with eosinophilia and systemic symptoms (DRESS).

Example: Actemra labeling

FDA determined that no action is necessary at this time for Kevzara based on available information.

*FDA updated this signal for DRESS to include the products Kevzara, Tofidence, and Tyenne after the initial quarterly report was posted.

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)

Updated

Vivimusta (bendamustine hydrochloride)*

Generic products containing bendamustine hydrochloride**

Nephrogenic diabetes insipidus

Updated

The "Adverse Reactions" section of the labeling was updated between October 2022 and April 2024 to include nephrogenic diabetes insipidus.

Example: Belrapzo labeling

*Vivimusta received FDA approval in December 2022 and was added to the list of product names after the initial quarterly report was posted.

**An administrative error resulted in the omission of generic products containing bendamustine hydrochloride from the list of product names and was added after the initial quarterly report was posted.

Dantrium (dantrolene sodium)

Ryanodex (dantrolene sodium)

Generic products containing dantrolene sodium

Hepatotoxicity

Updated

The "Adverse Reactions" section of the labeling of intravenous (IV) dantrolene products was updated in April 2024 to include information about hepatotoxicity.

Example: Dantrium labeling

FDA determined that the last approved labeling for oral dantrolene products is adequately labeled for hepatoxicity, and that no further regulatory action is needed.

Dupixent (dupilumab)

Psoriasis

Updated

The "Warnings and Precautions" section of the labeling was updated in April 2025 to include information about the risk of new onset psoriasis.

Dupixent labeling

Esbriet (pirfenidone)

Generic products containing pirfenidone

Severe cutaneous adverse reactions

Updated

The "Dosage and Administration", "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the labeling were updated in February 2023 to include information about severe cutaneous adverse reactions.

Example: Esbriet labeling

Evenity (romosozumab-aqqg)

Injury associated with device

Updated

FDA determined that no action is necessary at the time based on available information.

Ferrlecit (sodium ferric gluconate complex in sucrose injection)

Venofer (iron sucrose injection)

Generic products containing ferric oxyhydroxide; ferric carboxymaltose; iron sucrose

Updated

Injectafer (ferric carboxymaltose injection)*

Acute myocardial ischemia with or without myocardial infarction or with in-stent thrombosis in the context of a hypersensitivity reaction

Updated

The "Adverse Reactions" section of the Ferrlecit and Venofer labeling was updated between March 2022 and August 2024 to include acute myocardial ischemia with or without myocardial infarction or with in-stent thrombosis in the context of a hypersensitivity reaction.

Example: Ferrlecit labeling

FDA determined that no action is necessary at this time for Injectafer based on available information.

*An administrative error resulted in the omission of Injectafer from the list of product names and was added after the initial quarterly report was posted.

Hizentra

Immune Globulin Subcutaneous (Human), 20% Liquid

Increased hypersensitivity reactions in patients receiving certain product lots

Updated

Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions

Ilaris (canakinumab)

Kineret (anakinra)

Updated

Arcalyst (rilonacept)*

Drug reaction with eosinophilia and systemic symptoms

Updated

The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling for Ilaris and Kineret were updated between July 2024 and November 2024 to include drug reaction with eosinophilia and systemic symptoms.

Example: Ilaris labeling

FDA determined that no action is necessary for Arcalyst at the time based on available information.

*Arcalyst was added to the list of product names after the initial quarterly report was posted.

Kyleena (levonorgestrel)

Liletta (levonorgestrel)

Mirena (levonorgestrel)

Paragard (intrauterine copper contraceptive)

Skyla (levonorgestrel)

Device breakage

Updated

The "Dosage and Administration" sections of the Mirena, Skyla, and Kyleena labeling were updated between August 2022 and June 2024 to include information about the risk of device breakage during removal.

Example: Mirena labeling

FDA has determined that the last approved labeling for Paragard and Liletta is adequately labeled for risk of device breakage during removal, and that no further regulatory action is needed at this time.

Lutathera (lutetium Lu 177 dotatate)

Hypersensitivity

Updated

The "Dosage and Administration", "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the labeling were updated in June 2022 to include information about hypersensitivity.

Lutathera labeling

Privigen

Immune Globulin Intravenous (Human), 10% Liquid

Increased hypersensitivity reactions in patients receiving certain product lots

Updated

Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions

Proglycem (diazoxide)

Generic products containing diazoxide

Necrotizing colitis

Updated

The "Adverse Reactions" section of the labeling was updated in December 2022 to include information about necrotizing enterocolitis.

Example: Proglycem labeling

Proton Pump Inhibitors

Aciphex (rabeprazole sodium)
Dexilant (dexlansoprazole)
Nexium (esomeprazole magnesium)
Omeprazole and clarithromycin and amoxicillin
Pantoprazole Sodium
Prevacid (lansoprazole)
Prevacid SoluTab (lansoprazole)
Prilosec (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)

Generic products containing proton pump inhibitors

Erectile dysfunction

Updated

The "Adverse Reactions" section of the labeling was updated between July 2023 and August 2023 to include erectile dysfunction.

Example: Aciphex labeling

An administrative error resulted in the inclusion of Esomeprazole magnesium, Esomeprazole strontium, Lansoprazole, Nexium 24HR, Nexium IV, Omeprazole, Prevacid 24HR, Prilosec OTC, and Zegerid OTC at the time of the initial quarterly posting.

Tagrisso (osimertinib mesylate)

Rhabdomyolysis

Updated

The "Adverse Reactions" section of the labeling was updated in June 2023 to include increased blood creatine phosphokinase.

Tagrisso labeling

Tecfidera (dimethyl fumarate)

Generic products containing dimethyl fumarate

Pancreatitis acute

Updated

The "Adverse Reactions" section of the labeling was updated in September 2022 to include acute pancreatitis.

Example: Tecfidera labeling

Vfend (voriconazole)

Voriconazole for injection

Generic products containing voriconazole

Increased risk of photosensitivity reaction

Updated

The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the labeling were updated in August 2022 to include information about increased risk of photosensitivity reaction with concomitant administration of voriconazole and methotrexate.

Example: Vfend labeling

Xifaxan (rifaximin)

Generic products containing rifaximin

Severe cutaneous adverse reactions

Updated

The "Adverse Reactions" section of the labeling was updated in October 2022 to include information about severe cutaneous adverse reactions.

Example: Xifaxan labeling

Xpovio (selinexor)

Tumour lysis syndrome

Updated

FDA determined that no action is necessary at the time based on available information.