April - June 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
The drug product(s) included in any of the potential signals of serious risks/new safety information listed below may also include the generic version of the drug product(s), if there are generic versions approved for use by the FDA at the time of this publication.
| Product Name: Trade (Active Ingredient) or Product Class | Potential Signal of a Serious Risk / New Safety Information | Additional Information (as of October 24, 2025) |
|---|---|---|
Afinitor (everolimus) Afinitor Disperz (everolimus) Rapamune (sirolimus) Zortress (everolimus)
| Drug interaction | FDA is evaluating the need for regulatory action. |
Bavencio (avelumab) Imfinzi (durvalumab) Jemperli (dostarlimab-gxly) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab)
| Keratoacanthoma |
Updated
FDA determined that no action was necessary at the time based on available information. |
Cabometyx (cabozantinib) Cometriq (cabozantinib)
| Bradyarrhythmia (including conduction defects and disorders of sinus node function) |
Updated
FDA determined that no action was necessary at the time based on available information. |
| Calquence (acalabrutinib) | Pneumonitis |
Updated
FDA determined that no action was necessary at the time based on available information. |
| Calquence (acalabrutinib) | Tumor lysis syndrome |
Updated
FDA determined that no action was necessary at the time based on available information. |
| Elzonris (tagraxofusp-erzs) | Tumor lysis syndrome |
Updated
The “Adverse Reactions” section of the labeling was updated in July 2023 to include information about tumor lysis syndrome. |
| Certain everolimus product (generic product for the trade name Afinitor) | Product packaging confusion |
Updated
The container labeling was revised in February 2023 to address product packaging confusion. |
Glucagon-like peptide 1 (GLP-1) receptor agonists
| Intestinal obstruction |
Updated
The “Adverse Reactions” section of the labeling was updated between November 2022 and September 2023 to include information about ileus. Example: Adlyxin labeling |
| Proglycem (diazoxide) | Pericardial effusion |
Updated
The “Adverse Reactions” section of the labeling was updated in December 2022 to include information about pericardial effusion. |
| Reblozyl (luspatercept-aamt) | Sickle cell anemia with crisis |
Updated
FDA determined that no action was necessary at the time based on available information. |
Saxenda (liraglutide recombinant) Victoza (liraglutide recombinant) Xultophy 100/3.6 (insulin degludec and liraglutide) injection Generic products containing liraglutide | Cutaneous amyloidosis | The “Postmarketing Experience” section of the labeling was updated to include the risk of cutaneous amyloidosis. |
| Scenesse (afamelanotide) | Hypersensitivity |
Updated
The “Contraindications”, “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in August 2024 to include information about hypersensitivity. |
| Talzenna (talazoparib) | Thrombotic microangiopathy | FDA decided that no action is necessary at this time based on available information. |
| Tazverik (tazemetostat) | Blood bromide increased |
Updated
FDA determined that no action was necessary at the time based on available information. |
| Tezspire (tezepelumab-ekko) | Anaphylactic reaction |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in February 2023 to include information about anaphylaxis. |
Tyvaso (treprostinil) Tyvaso DPI (treprostinil)
| Bronchospasm | The “Warnings and Precautions” section of the labeling was updated May 2022 to include bronchospasm.
|
Zolgensma (onasemnogene abeparvovec-xioi)
| Hepatotoxicity-associated fatality | The “Boxed Warning”, “Warnings and Precautions”, “Postmarketing Experience” and “Patient Counseling Information” sections of the labeling were updated in February 2023 to include fatal cases of acute liver failure.
|