July - September 2017 | Potential Signals of Serious Risks/New Safety Information Identified from 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)
Actemra (tocilizumab) injection, for intravenous and subcutaneous use	Tocilizumab and pancreatitis	Updated The “Adverse Reactions” section of the Actemra labeling was updated in March 2018 to include pancreatitis. Actemra labeling
Actemra (tocilizumab) injection, for intravenous or subcutaneous use	Tocilizumab and hepatotoxicity	Updated The “Warnings and Precautions”, “Adverse Reactions”, and  “Medication Guide” sections of the Actemra labeling were updated in June 2019 to include hepatotoxicity. Actemra labeling
Antara (fenofibrate) capsules, for oral use Fenoglide (fenofibrate) tablets, for oral use Fibricor (fenofibric acid) tablets, for oral use Lipofen (fenofibrate capsules, USP) for oral use Tricor (fenofibrate) tablet, for oral use Triglide (fenofibrate) tablets, for oral use Trilipix (fenofibric acid) capsule, delayed release for oral use	Serious skin reactions	Updated The “Warnings and Precautions” and “Adverse Reactions sections of the fenofibrate product labeling were updated in May 2018 to include hypersensitivity reactions and photosensitivity reactions. Example: Antara labeling
Certain antidepressants amitriptyline         bupropion         citalopram         duloxetine         escitalopram         fluoxetine         paroxetine         sertraline         venlafaxine	Drug reaction with eosinophilia and systemic symptoms (DRESS)	Updated The “Adverse Reactions” section of the labeling was updated for amitriptyline, bupropion, escitalopram, fluoxetine, and paroxetine in August 2023 to include DRESS. Example: Paxil CR labeling FDA determined that no action is necessary at this time for citalopram, duloxetine, sertraline, and venlafaxine based on available information.
Avelox (moxifloxacin hydrochloride) injection, for intravenous use Avelox (moxifloxacin hydrochloride) tablets, for oral use Cipro (ciprofloxacin hydrochloride), for oral suspension Cipro IV (ciprofloxacin) injection, for intravenous use Cipro (ciprofloxacin hydrochloride) tablet, for oral use Cipro XR (ciprofloxacin) extended-release tablets, for oral use Factive (gemifloxacin mesylate) tablets Levaquin (levofloxacin) injection, solution for intravenous use Levaquin (levofloxacin), solution for oral use Levaquin (levofloxacin) tablet, film coated for oral use Moxifloxacin injection, for intravenous use	Hypoglycemic coma	Updated The “Warnings and Precautions”, “Adverse Reactions”, “Drug Interactions”, and “Patient Counseling Information” sections of the fluoroquinolone product labeling were updated in October 2018 to include blood glucose disturbances. Example: Avelox labeling Fluoroquinolone Drug Safety Communication, July 10, 2018 FDA Response to a Citizen Petition Submitted by the Southern Network on Adverse Reactions, Docket No. FDA-2014-P-1611, July 10, 2018
Xyzal (levocetirizine) Cetirizine hydrochloride Hydroxyzine Levocetirizine dihydrochloride	Rebound Pruritis	Updated The “Adverse Reactions” section of the prescription Xyzal (levocetirizine) labeling was updated in April 2018 to include rebound pruritis. Xyzal (levocetirizine) labeling
Pseudoephedrine	Acute generalized exanthematous pustulosis	Updated The “Adverse Reactions” and “Patient Information” sections of the prescription pseudoephedrine product labeling were updated in February 2018 to include acute generalized exanthematous pustulosis. Example: Clarinex-D 12-Hour Extended Release Tablets (desloratadine/pseudoephedrine sulfate) labeling
Imbruvica (ibrutinib) capsules, for oral use	Hepatotoxicity	Updated FDA decided that no action is necessary at this time based on available information.
Imbruvica (ibrutinib) capsules, for oral use	Ventricular arrhythmia	The “Warnings and Precautions” section of the labeling for Imbruvica was updated to include ventricular arrhythmia. Imbruvica labeling
Methotrexate injection, USP Xatmep (methotrexate) oral solution	Drug interaction with nitrous oxide - potentiated effect of methotrexate on folate metabolism, resulting in increased toxicity (severe myelosuppression, stomatitis, and neurotoxicity)	Updated The “Precautions: Drug Interactions” section of the methotrexate product labeling was updated in March 2018 to include a drug interaction with nitrous oxide. Example: Methotrexate injection, USP labeling
Nafcillin Injection, USP, for intravenous use only	Acute renal failure	Updated The “Adverse Reactions” section of the nafcillin labeling was updated in April 2018 to include nephrotoxicity. Nafcillin injection, USP labeling
Ocaliva (obeticholic acid) tablets, for oral use	Liver injury	Updated The Boxed Warning, “Warnings and Precautions”, “Adverse Reactions”, “Use in Specific Populations”, and “Patient Counseling Information” sections of the labeling were updated in February 2018 to include information about hepatic impairment. Specifically, guidance was added on proper dosing to avoid hepatic decompensation, failure, or death in the patient population with decompensated cirrhosis or Child-Pugh Class B or C. Ocaliva labeling FDA Drug Safety Communications were issued September 21, 2017 and February 1, 2018.
Rheumatrex (methotrexate sodium) tablets Methotrexate tablets, USP	Wrong dosing frequency errors (once daily administration instead of intended once weekly schedule)	Updated The “Warnings and Precautions” section of the labeling was updated in May 2020 to include information about the risk of serious adverse reactions with medication error. Example: Methotrexate labeling
Soliris (eculizumab) injection, for intravenous use	Nongroupable meningitis infections and Neisseria (other than N. meningitides) infections	Updated The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the Soliris labeling were updated in July 2018 to include serious meningococcal infections. Soliris labeling
Uptravi (selexipag) tablets, for oral use	Hypotension	The “Adverse Reactions: Postmarketing Experience” section of the labeling for Uptravi was updated to include hypotension. Uptravi labeling
Vraylar (cariprazine) capsules, for oral use	Stevens-Johnson syndrome (SJS)	Updated The “Postmarketing Experience” section of the Vraylar labeling was updated in November 2017 to include Stevens-Johnson syndrome. Vraylar labeling
Xarelto (rivaroxaban) tablets, for oral use	Liver injury	FDA decided that no action is necessary at this time based on available information.