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 |
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) |
FDA determined that no action was necessary at the time based on available information. |
| Calquence (acalabrutinib) | Pneumonitis |
FDA determined that no action was necessary at the time based on available information. |
| Calquence (acalabrutinib) | Tumor lysis syndrome |
FDA determined that no action was necessary at the time based on available information. |
| Elzonris (tagraxofusp-erzs) | Tumor lysis syndrome |
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 |
The container labeling was revised in February 2023 to address product packaging confusion. |
|
Glucagon-like peptide 1 (GLP-1) receptor agonists
|
Intestinal obstruction |
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 |
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 |
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 |
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 |
FDA determined that no action was necessary at the time based on available information. |
| Tezspire (tezepelumab-ekko) | Anaphylactic reaction |
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.
|
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Content current as of:
04/13/2026
