January - March 2017 | 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 January 31, 2025)
Alli (orlistat) capsules Xenical (orlistat) capsules, for oral use	Orlistat and neuropsychiatric adverse events	Updated FDA decided that no action is necessary at this time based on available information.
Cubicin (daptomycin for injection) for intravenous use Cubicin RF (daptomycin for injection) for intravenous use	Medication error	The container labels and carton labeling were revised.  In addition, the “Dosage and Administration” section of the labeling was updated to better differentiate the two formulations. Cubicin labeling Cubicin RF labeling
Exjade (deferasirox) tablets, for oral suspension Jadenu (deferasirox) tablets, for oral use	Pediatric fever and dehydration	Updated The “Pediatric Use” and “Patient Counseling Information” sections of the Exjade and Jadenu labeling were updated in May 2018 to include pediatric fever and dehydration. Exjade labeling Jadenu labeling
Gonadotropin-releasing hormone (GnRH) Agonists Lupron (leuprolide acetate) injection Lupron Depot PED (leuprolide acetate for depot suspension), injection, powder, lyophilized, for suspension Supprelin LA (histrelin acetate) subcutaneous implant Synarel (nafarelin acetate) nasal solution	Musculoskeletal and connective tissue pain and discomfort	Updated The “Adverse Reactions” section of the labeling was updated for Lupron Depot-PED in April 2020 to include severe muscle pain. Lupron Depot-PED labeling FDA determined that no action is necessary at the time for Lupron (leuprolide acetate) injection, Supprelin LA (histrelin acetate) subcutaneous implant, and Synarel (nafarelin acetate) nasal solution based on available information.
Keppra (levetiracetam) tablets, for oral use Keppra (levetiracetam) extended-release tablets, for oral use Keppra (levetiracetam) oral solution Keppra (levetiracetam) injection, for intravenous use	Acute kidney injury and interstitial nephritis	The “Adverse Reactions; Postmarketing Experience” section of the labeling for Keppra and Keppra XR was updated to include acute kidney injury.  Keppra XR labeling  Keppra labeling (tablets & oral solution)  Keppra labeling (injection)
Keytruda (pembrolizumab) for injection, for intravenous use Opdivo (nivolumab) injection, for intravenous use Yervoy (ipilimumab) injection, for intravenous use	Ocular toxicities including vision loss and retinal detachment	Updated The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated for Opdivo in February 2018 to include Vogt-Koyanagi-Harada syndrome. Opdivo labeling The “Warnings and Precautions” section of the labeling was updated for Yervoy and Keytruda between December 2017 and November 2020 to include Vogt-Koyanagi-Harada syndrome. Yervoy labeling Keytruda labeling
Kybella (deoxycholic acid) injection, for subcutaneous use	Injection site infection and necrosis	Updated The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Information” sections of the Kybella labeling were updated in January 2018 to include injection site infection and necrosis. Kybella labeling
Methimazole tablets	Rhabdomyolysis in methimazole	FDA decided that no action is necessary at this time, based on available information.
Neulasta Onpro kit (pegfilgrastim) injection, for subcutaneous use	Device failure	Updated The “Warnings and Precautions” section of the Neulasta Onpro kit labeling was updated in December 2017 to include device failure. Neulasta Onpro kit labeling
Ofev (nintedanib) capsules, for oral use	Liver dysfunction	Updated The “Warnings and Precautions” and “Adverse Reactions” sections of the Ofev labeling were updated in August 2017 to include liver dysfunction. Ofev labeling
Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) tablets, for oral use Glyxambi (empagliflozin and linagliptin) tablets, for oral use Invokamet (canagliflozin and metformin hydrochloride) tablets, for oral use Invokamet XR (canagliflozin and metformin hydrochloride extended-release) tablets, for oral use Invokana (canagliflozin) tablets, for oral use Jardiance (empagliflozin) tablets, for oral use Synjardy (empagliflozin and metformin hydrochloride) tablets, for oral use Synjardy XR (empagliflozin and metformin hydrochloride extended-release) tablets, for oral use Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) tablets, for oral use	Nephrolithiasis	FDA decided that no action is necessary at this time, based on available information.
Stelara (ustekinumab) injection, for subcutaneous use	Interstitial pneumonia	Updated The “Warnings and Precautions” and “Adverse Reactions” sections of the Stelara labeling were updated in June 2018 to include interstitial pneumonia. Stelara labeling
Tanzeum (albiglutide) for injection, for subcutaneous use Trulicity (dulaglutide), injection, for subcutaneous use	Serious hypersensitivity reactions	Updated The “Contraindications”, “Warnings and Precautions”, “Adverse Reactions”, “Medication Guide”, and “Patient Counseling Information” sections of the Tanzeum and Trulicity labeling were updated in August 2017 to include serious hypersensitivity reactions. Tanzeum labeling Trulicity labeling
Uloric (febuxostat) tablets, for oral use	Drug reaction with Eosinophilia and Systemic Symptoms	Updated The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Patient Information” sections of the Uloric labeling were updated in February 2018 to include serious skin reactions. Uloric labeling