XARELTO (rivaroxaban) Label - Food and Drug Administration
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceuticals, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT …
For current labeling information, please visit https://www.fda.gov/drugsatfda How should I store XARELTO? Store XARELTO at room temperature between 68 F to 77 F (20 to 25 C).
FDALabel - U.S. Food and Drug Administration
human prescription drug label: granule, for suspension; kit; tablet, film coated: oral: nda: 022406; 215859: xarelto; xarelto: rivaroxaban: 2024/10/29: 2011/07/01 ...
FDA Label for Xarelto Tablet, Film Coated Oral - NDC List
Mar 21, 2025 · The FDA product label includes the following information: other, 1.1 reduction of risk of stroke and systemic embolism in nonvalvular atrial fibrillation, 1.2 treatment
XARELTO® (rivaroxaban) | Official Patient Website
WHAT IS XARELTO (rivaroxaban)? XARELTO is a prescription medicine used to: reduce the risk of stroke and blood clots in adults who have a medical condition called atrial fibrillation that is …
FDA Label Search
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FDA approves drug to treat, help prevent types of blood clots
FDA has approved Xarelto (rivaroxaban) as tablets and an oral suspension to treat venous thromboembolism (VTE), or blood clots that form in the veins, and reduce the risk of VTE recurring in...
Xarelto: Package Insert / Prescribing Information - Drugs.com
Package insert / product label Generic name: rivaroxaban Dosage form: tablet, film coated Drug class: Factor Xa inhibitors. Medically reviewed by Drugs.com. Last updated on Apr 1, 2025.
U.S. FDA Approves XARELTO® (rivaroxaban) to Reduce the Risk …
Oct 11, 2018 · XARELTO® is now the only Factor Xa inhibitor approved for the treatment of more than 13 million Americans diagnosed with CAD and PAD. This label expansion adds to six existing XARELTO® indications granted since initial launch.
For patients currently taking XARELTO and transitioning to an anticoagulant with rapid onset, discontinue XARELTO and give the first dose of the other anticoagulant (oral or parenteral) at the...