January - March 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) |
|---|---|---|
| Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) | Weight increased |
Updated
The “Adverse Reactions” section of the labeling was updated in February 2024 to include weight increased. |
Braftovi (encorafenib) Tafinlar (dabrafenib) | Photosensitivity reaction |
Updated
The “Adverse Reactions” section of the labeling was updated between February 2024 and September 2024 to include photosensitivity. Example: Tafinlar labeling |
Brukinsa (zanubrutinib) Calquence (acalabrutinib) Imbruvica (ibrutinib) Jaypirca (pirtobrutinib) | Drug-induced liver injury |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Patient Information” sections of the labeling were updated between May 2024 and June 2024 to include information about drug-induced liver injury. Example: Imbruvica labeling |
Entyvio (vedolizumab) Tysabri (natalizumab) | Interstitial lung disease |
Updated
The “Adverse Reactions” section of the labeling for Entyvio was updated in April 2024 to include interstitial lung disease. FDA determined that no action was necessary for Tysabri at the time based on available information. |
Delsam Pharma’s Artificial Eye Ointment EzriCare Artificial Tears | Product contamination microbial | |
Droxia (hydroxyurea) Siklos (hydroxyurea)
Updated
Hydrea (hydroxyurea)*
| Drug-device interaction |
Updated
The “Warnings and Precautions”, “Drug Interactions”, “Medication Guide”, and “Patient Counseling Information” sections of the labeling were updated in November 2023 to include information about drug-device interaction. Example: Siklos labeling * An administrative error resulted in the omission of Hydrea from the list of product names and was added after the initial quarterly report was posted. |
Iclusig (ponatinib) Scemblix (asciminib)
| Panniculitis |
Updated
The “Adverse Reactions” section of the labeling was updated in March 2024 to include panniculitis. FDA determined that no action was necessary for Scemblix at the time based on available information. |
| Kineret (anakinra) | Amyloidosis |
Updated
The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in October 2025 to include information about amyloidosis. |
Local anesthetics
| Hepatic enzymes and function abnormalities | FDA is evaluating the need for regulatory action. |
| Mavenclad (cladribine) | Infections and infestations |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Medication Guide” sections of the labeling were updated in February 2024 to include information about infections. |
Mekinist (trametinib) Mektovi (binimetinib) | Photosensitivity reaction |
Updated
The “Adverse Reactions” section of the labeling was updated between February 2024 and September 2024 to include information about photosensitivity. Example: Mektovi labeling |
Diskets (methadone hydrochloride) Methadone Hydrochloride Methadose (methadone hydrochloride)
| Accidental exposure to product by child | FDA is evaluating the need for regulatory action. |
Nexletol (bempedoic acid)
Updated
Nexlizet (bempedoic acid and ezetimibe) *
| Hypersensitivity |
Updated
The “Adverse Reactions” section of the labeling was updated in September 2023 to include information about hypersensitivity. Example: Nexletol labeling *An administrative error resulted in the omission of Nexlizet from the list of product names and was added after the initial quarterly report was posted. |
| Norepinephrine Bitartrate in Dextrose Injection | Product label confusion contributing to medication error |
Updated
The container and overwrap labels were revised in November 2023 to mitigate the potential for medication errors. |
Opioids
Updated
| Hypoglycemia |
Updated
The “Adverse Reactions” and “Overdosage” sections of the labeling were updated in December 2023 to include information about hypoglycemia. Example: Oxycontin labeling Additional information is not provided for Fiorinal with Codeine and Kadian because approval of the marketing applications for these products was withdrawn by FDA, at the applicant’s request, prior to the labeling updates referenced above. * FDA updated this signal for Hypoglycemia to include the products Flowtuss, Hycodan, Hycofenix, Obredon, Promethazine HCl and Codeine Phosphate, Promethazine HCl Phenylephrine HCl and Codeine Phosphate, Tuxarin ER, Tuzistra XR, and Xtrelus after the initial quarterly report was posted. |
| Recothrom (thrombin topical recombinant) | Thrombosis due to inadvertent IV administration |
Updated
The "Warnings and Precautions" section of the labeling was updated in January 2024 to include information about the risk of thrombosis due to inadvertent IV administration. A warning that Recothrom is for topical use only was added to the syringes packaged with Recothrom in July 2024 to mitigate the risk of inadvertent IV administration. |
| Tepezza (teprotumumab-trbw) | Hearing impairment |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in July 2023 to include information about hearing impairment. |
| Turalio (pexidartinib) | Diarrhea |
Updated
FDA determined that no action was necessary at the time based on available information. |
| Turalio (pexidartinib) | Photosensitivity reaction |
Updated
The “Adverse Reactions”, “Patient Counseling Information”, and “Medication Guide” sections of the labeling were updated in November 2023 to include information about photosensitivity reaction. |