Prescription medicine
Rivaroxaban Brand names: Xarelto
Rivaroxaban (Xarelto) is a prescription medicine with an FDA approval on record since 2011. FDA's NDC Directory lists it from 20 generic labelers, and pharmacies paid $0.650 per rivaroxaban 2.5 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $19.54 per Xarelto 20 mg tablet.
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the rivaroxaban FDA label on DailyMed (effective September 10, 2026, Janssen Pharmaceuticals, Inc.); the NDA 22406 record on Drugs@FDA; every rivaroxaban label on DailyMed.
Highlights of the record
FDA label of September 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
(A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS,; (B) SPINAL/EPIDURAL HEMATOMA A..
Premature discontinuation of XARELTO increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including XARELTO, increases the risk of thrombotic events. If anticoagulation with XARELTO is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.3 , 2.4), Warnings and Precautions (5.1), and Clinical Studies (14.1) ]. B. Spinal/epidural hematoma Epidural or spinal hematomas have occurred in patients treated with XARELTO who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. […]
Used for
From the label: indications and usageXARELTO is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1 ) for treatment of deep vein thrombosis (DVT) ( 1.2 ) for treatment of pulmonary embolism (PE) ( 1.3 ) for reduction in the risk of recurrence of DVT or PE ( 1.4 ) for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5 ) for prophyla
Forms and strengths
- 2.5 mg
- 10 mg
- 15 mg
- 20 mg
- 155 mg
Film-coated tablet; tablet; kit; granule for suspension; for suspension.
On the market
- Earliest approval on file
- July 1, 2011 Xarelto, Janssen Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 24 first March 3, 2025; 21 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 24 of which 20 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- August 17, 2034 Xarelto tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.650 per tablet Rivaroxaban 2.5 mg tablet
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest September 17, 2014; 1 more by firms not listed as its makers
- FAERS reports
- 206,938 through July 30, 2026
What is rivaroxaban used for?
From the label: indications and usageXARELTO is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1 ) for treatment of deep vein thrombosis (DVT) ( 1.2 ) for treatment of pulmonary embolism (PE) ( 1.3 ) for reduction in the risk of recurrence of DVT or PE ( 1.4 ) for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5 ) for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6 ) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) ( 1.7 ) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease […]
Conditions named in the indications of rivaroxaban's FDA labels, with every medicine labeled for each:
- Atrial fibrillation
- Heart attack and coronary artery disease
- Blood clots (DVT and PE)
- Stroke prevention
From other rivaroxaban labelsHeart attack and coronary artery disease: … patients ( 1.6 ) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) ( 1.7 ) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including …
FDA pharmacologic class: Factor Xa Inhibitor.
Source: FDA drug label (Xarelto), Janssen Pharmaceuticals, Inc., effective September 10, 2026 (SPL set 10db92f9-2300-4a80-836b-673e1ae91610), via openFDA; the full label on DailyMed
What does the patient leaflet for rivaroxaban say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about XARELTO?XARELTO may cause serious side effects, including: Increased risk of blood clots if you stop taking XARELTO. People with atrial fibrillation (a type of irregular heart beat) that is not caused by a heart valve problem (non-valvular) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO, you may have increased risk of forming a clot in your blood. Do not stop taking XARELTO without talking to the doctor who prescribes it for you. Stopping XARELTO increases your risk of having a stroke. If you have to stop taking XARELTO, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming. Increased risk of bleeding. XARELTO can cause bleeding which can be serious and may lead to death. […] Call your doctor or get medical help right away if you or your child develop any of these signs or symptoms of bleeding: unexpected bleeding or bleeding that lasts a long time, such as: nose bleeds that happen often unusual bleeding from the gums menstrual bleeding that is heavier than normal or vaginal bleeding bleeding that is severe or you cannot control red, pink or brown urine bright red or black stools (looks like tar) cough up blood or blood clots vomit blood or your vomit looks like "coffee grounds" headaches, feeling dizzy or weak pain, swelling, or new drainage at wound sites left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder or diffuse abdominal discomfort (these may be symptoms of rupture of the spleen) Spinal or epidural blood clots (hematoma). […]
From the patient leaflet: How should I store XARELTO?Store XARELTO tablets and suspension at room temperature between 68 °F to 77 °F (20 °C to 25 °C). Store syringes and bottle upright in the original carton for XARELTO suspension. Do not freeze XARELTO suspension. Keep XARELTO and all medicines out of the reach of children. Discard XARELTO suspension after "Discard after" date written on the bottle.
Source: FDA drug label (Xarelto), Janssen Pharmaceuticals, Inc., effective September 10, 2026 (SPL set 10db92f9-2300-4a80-836b-673e1ae91610), via openFDA; the full label on DailyMed
Is there a generic for rivaroxaban (Xarelto)?
The FDA approved the first generic rivaroxaban on March 3, 2025. 24 generic applications are approved; 21 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists rivaroxaban from 20 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Xarelto tablets, the last expiring on August 17, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2011 earliest approval on file
- 2025 first generic approved
- 2034 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for rivaroxaban (Xarelto)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.650 per Rivaroxaban 2.5 mg tablet, down 81% from $3.39 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Rivaroxaban 2.5 mg tablet (generic)
- Xarelto 20 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Rivaroxaban 1 mg/mL suspension | Generic | $1.79 per mL | n/a | n/a |
| Rivaroxaban 2.5 mg tablet | Generic | $0.650 per tablet | $19.49 | -81% |
| Xarelto 1 mg/mL suspension | Brand | $3.77 per mL | n/a | +2% |
| Xarelto 10 mg tablet | Brand | $19.52 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $585.67 | +2% |
| Xarelto 15 mg tablet | Brand | $19.54 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $586.06 | +2% |
| Xarelto 2.5 mg tablet | Brand | $9.77 per tablet | $293.24 | +2% |
| Xarelto 20 mg tablet | Brand | $19.54 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $586.26 | +2% |
| Xarelto DVT-PE treatment 30-day starter 15-20 mg pack | Brand | $19.47 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is rivaroxaban in shortage?
No rivaroxaban presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated September 18, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Xarelto, For Suspension, 155 mg (NDC 50458-575-01) | Janssen Pharmaceuticals | To Be Discontinued | September 18, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has rivaroxaban been recalled?
The FDA's Enforcement Report lists 2 recalls naming rivaroxaban since 2013: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of rivaroxaban and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 17, 2014 | Class II | Janssen Ortho L.L.C. | Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; RIVAROXABAN Tablet, 20 mg may be potentially mislabeled as VENLAFAXINE HCL, Tablet, 100 mg, NDC 00093738301, Pedigree: W002619, EXP … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the rivaroxaban label say about other medicines?
The rivaroxaban label names 13 other medicines in its interaction, contraindication or warning sections. The labels of 24 other medicines name rivaroxaban. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | drug interactions | Coadministration of enoxaparin, warfarin, aspirin, clopidogrel and chronic NSAID use may increase the risk of bleeding [see Clinical Pharmacology (12.3) ]. |
| Carbamazepine | drug interactions | Drugs that Induce Cytochrome P450 3A Enzymes and Drug Transport Systems Avoid concomitant use of XARELTO with drugs that are combined P-gp and strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's wort) [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3) ]. |
| Clarithromycin | drug interactions | Although clarithromycin is a combined P-gp and strong CYP3A inhibitor, pharmacokinetic data suggests that no precautions are necessary with concomitant administration with XARELTO as the change in exposure is unlikely to affect the bleeding risk [see Clinical Pharmacology (12.3) ]. |
| Clopidogrel | drug interactions | Coadministration of enoxaparin, warfarin, aspirin, clopidogrel and chronic NSAID use may increase the risk of bleeding [see Clinical Pharmacology (12.3) ]. |
| Enoxaparin | drug interactions | Coadministration of enoxaparin, warfarin, aspirin, clopidogrel and chronic NSAID use may increase the risk of bleeding [see Clinical Pharmacology (12.3) ]. |
| Erythromycin | drug interactions | Interaction with Combined P-gp and Moderate CYP3A Inhibitors in Patients with Renal Impairment XARELTO should not be used in patients with CrCl 15 to <80 mL/min who are receiving concomitant combined P-gp and moderate CYP3A inhibitors (e.g., erythromycin) unless the potential benefit justifies the potential risk [see … |
| Heparin | warnings and precautions | Patients or Patients Who Require Thrombolysis or Pulmonary Embolectomy Initiation of XARELTO is not recommended acutely as an alternative to unfractionated heparin in patients with pulmonary embolism who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy. |
| Ketoconazole | drug interactions | Drugs that Inhibit Cytochrome P450 3A Enzymes and Drug Transport Systems Interaction with Combined P-gp and Strong CYP3A Inhibitors Avoid concomitant administration of XARELTO with known combined P-gp and strong CYP3A inhibitors (e.g., ketoconazole and ritonavir) [see Warnings and Precautions (5.6) and Clinical … |
| Phenytoin | drug interactions | Drugs that Induce Cytochrome P450 3A Enzymes and Drug Transport Systems Avoid concomitant use of XARELTO with drugs that are combined P-gp and strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's wort) [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3) ]. |
| Protamine | warnings and precautions | Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban. |
| Rifampin | drug interactions | Drugs that Induce Cytochrome P450 3A Enzymes and Drug Transport Systems Avoid concomitant use of XARELTO with drugs that are combined P-gp and strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's wort) [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3) ]. |
| Ritonavir | drug interactions | Drugs that Inhibit Cytochrome P450 3A Enzymes and Drug Transport Systems Interaction with Combined P-gp and Strong CYP3A Inhibitors Avoid concomitant administration of XARELTO with known combined P-gp and strong CYP3A inhibitors (e.g., ketoconazole and ritonavir) [see Warnings and Precautions (5.6) and Clinical … |
| Warfarin | drug interactions | Coadministration of enoxaparin, warfarin, aspirin, clopidogrel and chronic NSAID use may increase the risk of bleeding [see Clinical Pharmacology (12.3) ]. |
Other labels that name rivaroxaban
Source: FDA drug label (Xarelto), Janssen Pharmaceuticals, Inc., effective September 10, 2026 (SPL set 10db92f9-2300-4a80-836b-673e1ae91610), via openFDA; the full label on DailyMed
What do FAERS reports show for rivaroxaban?
The FDA Adverse Event Reporting System holds 206,938 reports that list rivaroxaban among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 27,139 are coded as a death and 103,514 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as rivaroxaban?
4 other medicines are given the same way (oral) and in the same FDA class as rivaroxaban or labeled mainly for the same use (atrial fibrillation), the same class first. Atrial fibrillation lists all 17 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Apixaban | Atrial fibrillation, Blood clots (DVT and PE), Stroke prevention | 2 labelers | $5.52 per tablet 5 mg tablet | No current entry |
| Edoxaban | Atrial fibrillation, Blood clots (DVT and PE), Stroke prevention | none listed | $15.51 per tablet 60 mg tablet | No current entry |
| Warfarin | Atrial fibrillation, Blood clots (DVT and PE) | 19 labelers | $0.093 per tablet 2 mg tablet | No current entry |
| Dabigatran | Atrial fibrillation, Blood clots (DVT and PE), Stroke prevention | 16 labelers | $0.795 per capsule 150 mg capsule | No current entry |
Every medicine labeled for the same conditions as rivaroxaban
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does rivaroxaban compare with medicines for the same use?
6 side-by-side pages set rivaroxaban beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to rivaroxaban
- 4 medicines for the same use
- Other factor Xa inhibitors
- the pharmacologic class, with prices and generics
- Rivaroxaban side effects
- the label's list beside FAERS reports
- Rivaroxaban shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other