July - September 2023 | 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 March 13, 2026) |
|---|---|---|
| Allergenic Extract – Peanut (Arachis hypogaea) - For Diagnostic Use Only, manufactured by ALK-Abelló, Inc. | Certain product lots were associated with increased reports of false negative skin test results, with some cases of anaphylaxis from subsequent peanut exposure. | The Package Insert - Allergenic Extracts was revised in February 2023 to include a Warning for Anaphylaxis Following False Negative Food Allergen Skin Test Results. |
Amoxil (amoxicillin) Augmentin (amoxicillin and clavulanate potassium) Augmentin ES-600 (amoxicillin and clavulanate potassium) Augmentin XR (amoxicillin and clavulanate potassium) Moxatag (amoxicillin extended-release tablets) Omeclamox-Pak (omeprazole delayed-release capsules; clarithromycin tablets; amoxicillin capsules) Talicia (omeprazole magnesium, amoxicillin and rifabutin delayed-release capsules) Voquezna Dual Pak (vonoprazan tablets; amoxicillin capsules) Voquezna Triple Pak (vonoprazan tablets; amoxicillin capsules; clarithromycin tablets) | Drug-Induced Enterocolitis Syndrome |
The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in May 2024 to include information about drug-induced enterocolitis syndrome (DIES). Example: Amoxil labeling |
Bactrim (sulfamethoxazole and trimethoprim) Bactrim DS (sulfamethoxazole and trimethoprim) Septra (sulfamethoxazole and trimethoprim) Septra DS (sulfamethoxazole and trimethoprim) Sulfatrim (sulfamethoxazole and trimethoprim) Sulfamethoxazole and Trimethoprim
| Hemophagocytic lymphohistiocytosis |
The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in February 2025 to include information about hemophagocytic lymphohistiocytosis (HLH). Example: Sulfatrim labeling |
BCMA- or CD19-directed genetically modified autologous T-cell immunotherapies
| Post-treatment T-cell malignancy | FDA issued a Safety Communication on April 18, 2024: FDA Requires Boxed Warning for T cell Malignancies Following Treatment with BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies. The Boxed Warning was updated and related changes were made to other sections of the labels (Warnings and Precautions, Postmarketing Experience, Patient Counseling Information and Medication Guide) to include the serious risk of T cell malignancies following treatment with BCMA-directed or CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies as class safety labeling changes: |
Cabometyx (cabozantinib) Cometriq (cabozantinib) | Rhabdomyolysis |
FDA determined that no action was necessary at the time based on available information. |
Elepsia XR (levetiracetam) Keppra (levetiracetam) Keppra XR (levetiracetam) Levetiracetam in Sodium Chloride Spritam (levetiracetam) | Drug reaction with eosinophilia and systemic symptoms | An FDA Drug Safety Communication was issued on November 28, 2023. The FDA is requiring applicants of these medicines to add new warnings about drug reaction with eosinophilia and systemic symptoms to the prescribing information and the Medication Guide for patients and caregivers.
|
Gemcitabine Infugem (gemcitabine in sodium chloride injection) | Drug reaction with eosinophilia and systemic symptoms |
The “Dosage and Administration”, “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated between May 2024 and September 2024 to include information about Severe Cutaneous Adverse Reactions (SCARs). Example: Gemcitabine labeling |
Gilenya (fingolimod) Mayzent (siponimod) Ponvory (ponesimod) Tascenso ODT (fingolimod) Zeposia (ozanimod)
| Progressive multifocal leukoencephalopathy |
The “Warnings and Precautions” section of the labeling was updated in June 2024 to include information about progressive multifocal leukoencephalopathy (PML). Example: Tascenso ODT labeling FDA required a postmarketing requirement (PMR) study in December 2024 for sphingosine 1-phosphate (S1P) receptor modulators to assess risk factors for the development of PML among patients with multiple sclerosis exposed to S1P receptor modulators. Potential risk factors to be assessed include age, duration of exposure to the therapy, prior immunosuppressant use, lymphopenia, and anti-JCV antibody status. |
Glucagon-like peptide-1 (GLP-1) receptor agonists
| Alopecia |
The “Adverse Reactions” section of the labeling for Adlyxin, Saxenda, Soliqua 100/33, Trulicity, Victoza, Mounjaro, Ozempic, Rybelsus, and Xultophy 100/3.6 was updated between December 2024 and May 2025 to include alopecia. Example: Xultophy 100/3.6 labeling FDA has determined that the last approved labeling is adequate for Byetta, Bydureon, Bydureon BCise, Wegovy, and Zepbound and that no further regulatory action is needed at the time. *An administrative error resulted in the omission of Zepbound from the list of product names and was added after the initial quarterly report was posted. |
Glucagon-like peptide-1 (GLP-1) receptor agonists
| Aspiration |
The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated between October 2024 and November 2024 to include information about aspiration during general anesthesia or deep sedation. Example: Adlyxin labeling FDA required a postmarketing requirement (PMR) trial in November 2024 to measure the effects of temporary withholding of GLP-1 receptor agonists and fasting duration on retained gastric contents to evaluate delayed gastric emptying associated with GLP-1 receptor agonist use and inform potential recommendations to mitigate the serious risk of pulmonary aspiration. |
Glucagon-like peptide-1 (GLP-1) receptor agonists
| Suicidal ideation | FDA is evaluating the need for regulatory action. |
Kyprolis (carfilzomib) Ninlaro (ixazomib) | Anaphylactic reaction |
The “Adverse Reactions” and “Patient Information” sections of the labeling for Ninlaro were updated in July 2024 to include information about angioedema. FDA determined that no action was necessary at the time for Kyprolis based on available information. |
Lupkynis (voclosporin)
| Nausea and vomiting symptoms |
The “Adverse Reactions” section of the labeling was updated in October 2025 to include nausea and vomiting. |
| Ocrevus (ocrelizumab) | Drug-induced liver injury |
|
Onfi (clobazam) Sympazan (clobazam)
| Drug reaction with eosinophilia and systemic symptoms | An FDA Drug Safety Communication was issued on November 28, 2023. The FDA is requiring applicants of these medicines to add new warnings about drug reaction with eosinophilia and systemic symptoms to the prescribing information and the Medication Guide for patients and caregivers.
|
Phyrago (dasatinib) Sprycel (dasatinib) | Chylothorax |
The “Adverse Reactions” section of the labeling was updated in July 2024 to include chylothorax. Example: Phyrago labeling |
Sodium-glucose cotransporter-2 (SGLT2) inhibitors
| Diabetic ketoacidosis | The “Warnings and Precautions” section of the SGLT2 inhibitors product labeling was updated in September 2023 to include prolonged diabetic ketoacidosis and glucosuria. Example: Farxiga labeling |
| Stivarga (regorafenib) | Thrombotic microangiopathy |
FDA determined that no action was necessary at the time based on available information. |
| Syfovre (pegcetacoplan injection) | Retinal vasculitis | The “Warnings and Precautions”, “Postmarketing Experience”, and “Patient Counseling Information” sections of the labeling were updated in November 2023 to include retinal vasculitis and/or retinal vascular occlusion.
|
Topical corticosteroids
| Skin reaction | FDA is evaluating the need for regulatory action. |