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) |
|---|---|---|
|
Alecensa (alectinib) capsules Alunbrig (brigatinib) tablets Xalkori (crizotinib) capsules Xalkori (crizotinib) oral pellets |
Severe cutaneous adverse reaction | FDA is evaluating the need for regulatory action. |
|
Cardene IV (nicardipine hydrochloride) in sodium chloride injection Certain vasopressin in sodium chloride injection Myxredlin (human insulin) in sodium chloride injection Nexterone (amiodarone hydrochloride) Premixed Injection Zosyn (piperacillin sodium and tazobactam sodium) injection |
Look alike container labels or carton labeling that may contribute to wrong drug errors |
The carton and container labeling were updated between November 2024 and March 2025 to minimize the risk of wrong drug errors. Example: Nexterone labeling |
|
Cubicin (daptomycin for injection) Cubicin RF (daptomycin for injection) Dapzura RT (daptomycin for injection) |
Hyperkalemia |
The “Adverse Reactions” section of the labeling was updated in April and May 2025 to include information about hyperkalemia. Example: Cubicin labeling |
| Entyvio (vedolizumab) injection | Infections and infestations | FDA is evaluating the need for regulatory action. |
| Generic products available in oral dosage form containing dapsone | Glycosylated hemoglobin decreased |
The “Precautions” and “Adverse Reactions” sections of the labeling were updated in April 2025 to include information about the risk of falsely low glycated hemoglobin (HbA1c). |
|
Kalydeco (ivacaftor) tablets
Kalydeco (ivacaftor) oral granules
Orkambi (lumacaftor and ivacaftor) tablets
Orkambi (lumacaftor and ivacaftor) oral granules
Symdeko (tezacaftor/ivacaftor) tablets; (ivacaftor) tablets
Trikafta (elexacaftor, tezacaftor, and ivacaftor tablets; ivacaftor tablets), co-packaged Trikafta (elexacaftor, tezacaftor, and ivacaftor oral granules; ivacaftor oral granules), co-packaged |
Drug-induced liver injury |
The “Dosage and Administration”, “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in December 2024 for Trikafta to include information about drug-induced liver injury and liver failure. In addition, FDA added a Boxed Warning and approved a new Medication Guide. FDA determined that no action was necessary at the time for Kalydeco, Orkambi, and Symdeko based on available information. |
|
Lenvima (lenvatinib) capsules Nexavar (sorafenib) tablets |
Tumor lysis syndrome |
FDA determined that no action was necessary at the time based on available information. |
| Syfovre (pegcetacoplan injection) | Hypersensitivity |
The “Contraindications” and “Adverse Reactions” sections of the labeling were updated in December 2024 to include information about hypersensitivity. |
| Zolgensma (onasemnogene abeparvovec-xioi) suspension | Hypersensitivity including anaphylaxis |
The “Warnings and Precautions,” “Postmarketing Experience,” and “Patient Counseling Information” sections of the labeling for Zolgensma were updated in February 2025 to include Infusion-related Reactions. |
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Content current as of:
04/13/2026
