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  6. April - June 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
  1. FDA's Adverse Event Reporting System (FAERS)

April - June 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 ClassPotential Signal of a Serious Risk / New Safety InformationAdditional Information
(as of August 12, 2025)
Adcetris (brentuximab vedotin)Guillain-Barre syndrome

Updated

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

Arzerra (ofatumumab)
Gazyva (obinutuzumab)
Riabni (rituximab-arrx)
Rituxan (rituximab)
Rituxan Hycela (rituximab and hyaluronidase human)
Ruxience (rituximab-pvvr)
Truxima (rituximab-abbs)		Colitis

Updated

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

Balversa (erdafitinib)Calciphylaxis

Updated

The "Warnings and Precautions", "Patient Counseling Information", and the "Patient Information" sections of the labeling were updated in April 2022 to include information about soft tissue mineralization, including calciphylaxis.

Balversa labeling

Bavencio (avelumab)
Keytruda (pembrolizumab)
Opdivo (nivolumab)
Yervoy (ipilimumab)

Updated

Imfinzi (durvalumab) *

Necrotizing fasciitis

Updated

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

*An administrative error resulted in the omission of Imfinzi (durvalumab) from the list of product names. Imfinzi was added after the initial quarterly report was posted.

Beta-blockers

  • Betapace (sotalol hydrochloride)
  • Brevibloc (esmolol hydrochloride)
  • Bystolic (nebivolol)
  • Byvalson (nebivolol and valsartan)
  • Coreg (carvedilol)
  • Coreg CR (carvedilol)
  • Corgard (nadolol)
  • Corzide (nadolol and bendroflumethiazide)
  • Dutoprol (metoprolol succinate and hydrochlorothiazide)
  • Kapspargo Sprinkle (metoprolol succinate)
  • Lopressor HCT  (metoprolol tartrate and hydrochlorothiazide)
  • Sectral (acebutolol hydrochloride)
  • Sotylize (sotalol hydrochloride)
  • Tenoretic (atenolol and chlorthalidone)
  • Toprol XL (metoprolol succinate)
  • Trandate (labetalol hydrochloride)
  • Ziac (bisoprolol fumarate and hydrochlorothiazide)

Generic products containing beta-blockers

Updated

  • Hemangeol (Propranolol Hydrochloride)*
  • Inderal LA (Propranolol Hydrochloride)*
  • Innopran XL (Propranolol hydrochloride)*
  • Lopressor (metoprolol tartrate)*
  • Tenormin (Atenolol)*
Hypoglycemia in pediatric patients

Updated

The "Warnings and Precautions" and "Patient Counseling Information" sections of the labeling were updated between March 2023 and June 2024 to add additional information regarding hypoglycemia.

Example: Coreg labeling

An administrative error resulted in the inclusion of Betapace AF, Levatol, and Zebeta in the list of product names at the time of the initial quarterly posting.

*An administrative error resulted in the omission of Hemangeol, Inderal LA, Innopran XL, Lopressor, and Tenormin from the list of product names and was added after the initial quarterly report was posted.

Bosulif (bosutinib monohydrate)
Gleevec (imatinib mesylate)
Iclusig (ponatinib)
Sprycel (dasatinib)
Tasigna (nilotinib)		Osteonecrosis

Updated

The "Adverse Reactions" section of the Tasigna labeling was updated in February 2024 to include information about osteonecrosis.

Tasigna labeling

FDA determined that Gleevec and Sprycel are adequately labeled for osteonecrosis, and that no further regulatory action is needed at this time.

FDA determined no action is necessary at this time for Iclusig and Bosulif based on available information.

Cablivi (caplacizumab-yhdp)Hemorrhage

Updated

The "Warnings and Precautions", "Drug Interactions", and "Patient Counseling Information" sections of the labeling were updated in February 2022 to include information about life-threatening and fatal bleeding.

Cablivi labeling

Cyramza (ramucirumab)Cardiac failure

Updated

The "Adverse Reactions" section of the labeling was updated in March 2022 to include information about heart failure.

Cyramza labeling

Doxil (doxorubicin hydrochloride)Acute interstitial pneumonitis

Updated

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

Gleevec (imatinib mesylate)
Tasigna (nilotinib)		Myasthenia gravis

Updated

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

Ibrance (palbociclib)
Kisqali (ribociclib)
Kisqali Femara Co-Pack (ribociclib; letrozole)
Verzenio (abemaciclib)		Radiation recall phenomenon 

Updated

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

Lokelma (sodium zirconium cyclosilicate)Gastrointestinal disorders

Updated

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

Padcev (enfortumab vedotin-ejfv)Pancreatitis

Updated

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

Padcev (enfortumab vedotin-ejfv)Pneumonitis

Updated

The "Adverse Reactions", "Warnings and Precautions", and "Patient Counseling Information" sections of the labeling were updated in July 2021 to include information about pneumonitis.

Padcev labeling

Poteligeo (mogamulizumab-kpkc)Cytomegalovirus viraemia

Updated

The "Adverse Reactions" section of the labeling was updated in March 2022 to include cytomegalovirus infection.

Poteligeo labeling

Procysbi (cysteamine bitartrate)
Generic products containing cysteamine bitartrate		Fibrosing colonopathy

Updated

The "Warnings and Precautions", "Adverse Reactions", "Patient Information", and "Patient Counseling Information" sections of the labeling were updated in February 2022 to include information about fibrosing colonopathy.

Example: Procysbi labeling

Sarclisa (isatuximab-irfc)Herpes zoster

Updated

The "Dosage and Administration", "Adverse Reactions", and "Patient Information" sections of the labeling were updated in July 2022 to include information about herpes zoster.

Sarclisa labeling

Sprycel (dasatinib)Drug-induced liver injury

Updated

The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information” and “Patient Information” sections of the labeling were updated in February 2023 to include information about hepatotoxicity.

Sprycel labeling

Taxotere (docetaxel)Rhabdomyolysis

Updated

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

Veklury (remdesivir)Bradycardia

Updated

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

Zepzelca (lurbinectedin)Extravasation

Updated

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

Zepzelca labeling

Zepzelca (lurbinectedin)Tumor lysis syndrome

Updated

The “Adverse Reactions” section of the labeling was updated in April 2022 to include tumor lysis syndrome.

Zepzelca labeling

Zepzelca (lurbinectedin)Rhabdomyolysis

Updated

The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Patient Information” sections of the labeling were updated in April 2022 to include rhabdomyolysis.

Zepzelca labeling

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