January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
| Product Name: Trade (Active Ingredient) or Product Class | Potential Signal of a Serious Risk / New Safety Information | Additional Information (as of August 12, 2025) |
|---|---|---|
| Addyi (flibanserin) | Drug hypersensitivity |
Updated
The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions. |
Glucagon-like peptide-1 (GLP-1) analogues
| Drug-induced liver injury |
Updated
The "Adverse Reactions" section of the liraglutide and dulaglutide labeling was updated in June 2022 to include information about elevations of liver enzymes. Example: Trulicity labeling FDA determined that no action is necessary at the time for lixisenatide, exenatide, and semaglutide based on available information. |
| Alcohol-based hand sanitizers | Exposure via inhalation |
Updated
FDA determined that no action is necessary at the time based on available information. A FDA Drug Safety Communication was issued on June 16, 2021. |
Amlodipine and Levamlodipine Products
| Non-cardiogenic pulmonary edema |
Updated
FDA determined that no action is necessary at the time based on available information. |
| Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (pegylated interferon beta-1a) Rebif (interferon beta-1a) | Injection site abscess | FDA is evaluating the need for regulatory action. |
| Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) | Scleroderma |
Updated
FDA determined that no action is necessary at the time based on available information. |
| Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) | Cholangitis sclerosing |
Updated
The "Adverse Reactions" section of the Keytruda (pembrolizumab) labeling was updated in August 2021 to include sclerosing cholangitis. Example: Keytruda labeling FDA determined that no action is necessary at the time for Bavencio (avelumab), Imfinzi (durvalumab), Libtayo (cemiplimab-rwlc), Opdivo (nivolumab), and Tecentriq (atezolizumab) based on available information. |
Chloroquine Generic products containing chloroquine | Phospholipidosis |
Updated
The “Warnings” section of the labeling was updated in May 2022 to include information about phospholipidosis. |
| Eliquis (apixaban) Pradaxa (dabigatran etexilate mesylate) Savaysa (edoxaban tosylate) Xarelto (ribaroxaban) Generic products containing dabigatran etexilate mesylate Generic products containing ribaroxaban | Menorrhagia | The “Use in Specific Populations” section was updated April 2021 to add language to describe the risk of clinically significant uterine bleeding in females of reproductive potential. Eliquis label Pradaxa label Savaysa label Xarelto label |
| Depakote (divalproex sodium) Depakote ER (divalproex sodium) Stavzor (valproic acid) Generic products containing divalproex sodium Generic products containing valproic acid | Tubulointerstitial nephritis |
Updated
The "Adverse Reactions" section of the labeling was updated in November 2021 to include tubulointerstitial nephritis. Example: Depakote labeling |
| Dupixent (dupilumab) | Alopecias | FDA is evaluating the need for regulatory action. |
| H.P. Acthar Gel (corticotropin) | Anaphylactic and anaphylactoid responses |
Updated
The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include anaphylaxis. |
| H.P. Acthar Gel (corticotropin) | Cardiac arrhythmias |
Updated
The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include atrial fibrillations and palpitations. |
| Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Verzenio (abemaciclib) | Second primary malignancy |
Updated
FDA determined that no action is necessary at the time based on available information. |
| Lynparza (olaparib) | Drug-induced liver injury |
Updated
FDA determined that no action is necessary at the time based on available information. |
| Ocrevus (ocrelizumab) | Autoimmune colitis |
Updated
The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Medication Guide" sections of the labeling were updated in August 2022 to include colitis. |
| Poteligeo (mogamulizumab-kpkc) | Acute kidney injury |
Updated
The "Warnings and Precautions" section of the labeling was updated in March 2022 to include glomerulonephritis. |
| Ravicti (glycerol phenylbutyrate) | Product labeling issue regarding stability and instructions for administration |
Updated
The container label, carton label, "Medication Guide", and sections of the Prescribing Information ("Dosage and Administration" and "Patient Counseling Information") were updated in September 2021 to enhance the instructions for administration. |
| Spravato (esketamine) | Hypertensive crisis |
Updated
FDA determined that no action is necessary at the time based on available information. |
| Tremfya (guselkumab) | Device use errors resulting in possible missed or partial doses |
Updated
The Tremfya One Press Instructions for Use (IFU) and carton labeling was updated in June 2023 to mitigate medication errors, such as underdose or no dose delivered. |
| Trulance (plecanatide) | Drug hypersensitivity | The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include skin itching, hives, and rash. Trulance Label |
| Trulance (plecanatide) | Vomiting | The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include vomiting. Trulance Label |