October - December 2022 | 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 October 24, 2025) |
|---|---|---|
Apretude (cabotegravir extended-release injectable suspension) Cabenuva (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension), co-packaged for intramuscular use Vocabria (cabotegravir)
| Anaphylactic reaction | The “Adverse Reactions: Postmarketing Experience” subsection of the labeling was updated in February 2023 to include hypersensitivity reactions (including angioedema and urticaria).
|
Atypical antipsychotics
| Fecal incontinence |
Updated
The “Adverse Reactions” section of the labeling for the aripiprazole, clozapine, olanzapine, pimavanserin, and quetiapine-containing products was updated in January 2025 to include information about the risk of fecal incontinence. Example: Abilify labeling FDA determined that no action was necessary at the time based on available information for the other listed products. |
Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (peginterferon beta-1a) Rebif (interferon beta-1a)
| Pulmonary hypertension |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Medication Guide” sections of the labeling were updated in July 2023 to include information about the risk of pulmonary arterial hypertension. Example: Betaseron labeling |
Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Prepopik (sodium picosulfate, magnesium oxide, and anhydrous citric acid)
| Syncope |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, and “Drug Interactions” sections of the labeling were updated in August 2023 to include information about syncope. Example: Clenpiq labeling |
Definity (perflutren lipid microsphere) Lumason (sulfur hexafluoride lipid-type A microspheres) Optison (perflutren protein-type A microspheres) | Sickle cell anemia with crisis |
Updated
The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling for Definity were updated in June 2023 to include information about the risk of inducing severe, acute pain episodes in patients with sickle cell disease. FDA determined that no action was necessary at the time based on available information for Optison and Lumason. |
Eliquis (apixaban) Savaysa (edoxaban) Pradaxa (dabigatran etexilate mesylate) Xarelto (rivaroxaban)
| Acute kidney injury |
Updated
The “Adverse Reactions” section of the Savaysa, Pradaxa, and Xarelto labeling were updated between February 2023 and November 2023 to include information about anticoagulant-related nephropathy. Example: Pradaxa labeling FDA determined that no action was necessary at the time based on available information for Eliquis. |
Certain glipizide extended-release product (generic product for the trade name Glucotrol XL) Certain chlorpromazine hydrochloride product (generic product)
| Similar tablet appearance that may contribute to wrong drug errors |
Updated
The code imprint on a certain glipizide extended-release product was revised in March 2023 to minimize the risk of wrong drug errors. |
Hydroxychloroquine sulfate Plaquenil (hydroxychloroquine sulfate) | Hepatotoxicity |
Updated
The “Warnings and Precautions”, “Adverse Reactions” and “Patient Counseling Information” sections of the labeling were updated between July 2023 and December 2023 to include information about the risk of hepatotoxicity in patients with porphyria cutanea tarda. Example: Plaquenil labeling |
Hydroxychloroquine sulfate Primaquine (primaquine phosphate) Plaquenil (hydroxychloroquine sulfate)
| Neuropsychiatric symptoms |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in July and August 2023 to include information about neuropsychiatric symptoms. Example: Plaquenil labeling FDA determined that no action is necessary for Primaquine at the time based on available information. |
Kalydeco (ivacaftor) Orkambi (lumacaftor and ivacaftor) Symdeko (tezacaftor/ivacaftor) Trikafta (elexacaftor, tezacaftor, and ivacaftor) | Acute pancreatitis |
Updated
FDA determined that no action was necessary at the time based on available information. |
Nexletol (bempedoic acid) Nexlizet (bempedoic acid and ezetimibe) | Rhabdomyolysis |
Updated
FDA determined that no action was necessary at the time based on available information. |
Non-steroidal anti-inflammatory drugs (NSAIDs)
| Generalized bullous fixed drug eruption |
Updated
The “Warnings and Precautions” and “Adverse Reactions” sections of the prescription NSAID product labeling was updated in November 2024 to include information about fixed drug eruption, including generalized bullous fixed drug eruption. Example: Feldene labeling FDA determined that no action was necessary at the time based on available information for the nonprescription NSAID products. |
| Prolia (denosumab) | Hypocalcemia |
Updated
Drug Safety Communication (01/19/2024): FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab). The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Medication Guide” sections of the labeling were updated in January 2024 to include information about severe hypocalcemia. In addition, FDA added a new “Boxed Warning”, and updated “Dosage and Administration” sections of the labeling to include information about severe hypocalcemia in patients with advanced chronic kidney disease and recommendations for laboratory testing prior to initiation of Prolia in these patients. |
| Semglee (insulin glargine) | Device malfunction | FDA is evaluating the need for regulatory action. |
| Spravato (esketamine) | Respiratory depression |
Updated
The “Boxed Warning”, “Warnings and Precautions”, “Adverse Reactions”, “Postmarketing Experience” sections of the labeling and Medication Guide were updated in October 2023 to include information about respiratory depression. |
| Tivdak (tisotumab vedotin-tftv) | Stevens-Johnson syndrome |
Updated
The “Warnings and Precautions” and “Patient Counseling Information” sections of the labeling were updated in July 2023 to include information about severe cutaneous adverse reactions (including Stevens-Johnson syndrome). |