April - June 2025 | 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 September 4, 2025) |
|---|---|---|
| Acetaminophen-containing products | Anaphylactic reaction | FDA is evaluating the need for regulatory action. |
Aptryxol (desvenlafaxine) DaTscan (ioflupane I 123 injection) Desvenlafaxine extended-release tablets Effexor XR (venlafaxine extended-release) capsules Pristiq (desvenlafaxine) extended-release tablets Venlafaxine (venlafaxine hydrochloride) extended-release tablets
| False positive radioisotope investigation test result potentially secondary to a drug interaction with venlafaxine
| FDA is evaluating the need for regulatory action. |
Barium sulfate-containing products
| Anaphylactic reaction | FDA is evaluating the need for regulatory action. |
Blincyto (blinatumomab) for injection Columvi (glofitamab-gxbm) injection Elrexfio (elranatamab-bcmm) injection Epkinly (epcoritamab-bysp) injection Imdelltra (tarlatamab-dlle) for injection Kimmtrak (tebentafusp-tebn) injection Lunsumio (mosunetuzumab-axgb) injection Talvey (talquetamab-tgvs) injection Tecvayli (teclistamab-cqyv) injection
| Progressive multifocal leukoencephalopathy | FDA is evaluating the need for regulatory action. |
BRAF kinase inhibitors
| Gingival hypertrophy | FDA is evaluating the need for regulatory action. |
Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection | Acute hepatic failure | The "Warnings and Precautions" section of the labeling was updated in August 2025 to include information about liver injury. Example: Briumvi labeling
|
Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Ocrevus (ocrelizumab) injection Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) injection | Central nervous system infection | FDA is evaluating the need for regulatory action. |
Crexont (carbidopa and levodopa) extended-release capsules Dhivy (carbidopa and levodopa) tablets Duopa (carbidopa and levodopa) enteral suspension Rytary (carbidopa and levodopa) extended-release capsules Sinemet (carbidopa and levodopa) tablets Sinemet CR (carbidopa and levodopa) sustained-release tablets Stalevo (carbidopa, levodopa and entacapone) tablets Vyalev (foscarbidopa and foslevodopa) injection | Seizure | FDA is evaluating the need for regulatory action. |
| Crysvita (burosumab-twza) injection | Hypercalcemia | The "Dosage and Administration", "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in August 2025 to include information about hypercalcemia.
|
Dexmedetomidine-containing products
| Diabetes insipidus | FDA is evaluating the need for regulatory action. |
| Dupixent (dupilumab) injection | Ocular infections, irritations, and inflammation | FDA is evaluating the need for regulatory action. |
Eprontia (topiramate) oral solution Qudexy XR (topiramate) extended-release capsules Qsymia (phentermine and topiramate) extended-release capsules Topamax (topiramate) tablets Topamax Sprinkle (topiramate) capsules Trokendi XR (topiramate) extended-release capsules | Hypersensitivity | FDA is evaluating the need for regulatory action. |
| Gavreto (pralsetinib) capsules | Chylothorax | FDA is evaluating the need for regulatory action. |
Glucagon-like peptide-1 (GLP-1) receptor agonists
| Intestinal obstruction and fecal impaction | FDA is evaluating the need for regulatory action. |
Imbruvica (ibrutinib) capsules; tablets; oral suspension
| Nail and nail bed conditions (excluding infections and infestations) | FDA is evaluating the need for regulatory action. |
MEK inhibitors
| Gingival hypertrophy | FDA is evaluating the need for regulatory action. |
| Neffy (epinephrine nasal spray) | Product storage error | FDA is evaluating the need for regulatory action. |
Nurtec ODT (rimegepant) orally disintegrating tablets Zavzpret (zavegepant) nasal spray | Anaphylactic reaction | The "Contraindications" and "Warnings and Precautions" sections of the labeling were updated in August 2025 to include information about hypersensitivity reactions, including anaphylaxis. Example: Nurtec ODT labeling
|
| Rozlytrek (entrectinib) capsules; oral pellets | Brugada syndrome | FDA is evaluating the need for regulatory action. |
Sodium-glucose cotransporter-2 (SGLT2) inhibitors
| Fournier's gangrene | FDA is evaluating the need for regulatory action. |
| Teriparatide injection (a particular generic product) | Device malfunction | FDA is evaluating the need for regulatory action. |
| Vizamyl (flutemetamol F18 injection) | Anaphylactic reaction | The "Warnings and Precautions" section of the labeling was updated in June 2025 to include information about anaphylaxis and other serious hypersensitivity reactions. |