Rivaroxaban
Rivaroxaban is a blood thinner (factor Xa inhibitor) used to prevent and treat dangerous blood clots, lower stroke risk in atrial fibrillation, and reduce heart and artery events in coronary artery disease and peripheral artery disease.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 27 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Rivaroxaban (Xarelto) blocks factor Xa, a clotting protein, and is one of the most prescribed newer blood thinners, used for leg and lung clots, stroke prevention in atrial fibrillation, and coronary or peripheral artery disease; on the market since about 2011, it is available as a generic. Most people tolerate it well, though bruising and minor bleeding are common, and bleeding that will not stop needs urgent care. The boxed warning says stopping early raises clot and stroke risk, and a spinal tap or epidural can cause a bleed near the spine and lasting paralysis. Never stop it on your own, and tell every provider about it before any procedure.
Clinical pearls
- Some strengths absorb properly only with food, so check whether your label says to take it with a meal.
- Avoid ibuprofen and naproxen for pain; acetaminophen is usually the safer choice alongside rivaroxaban.
- Ketoconazole and ritonavir raise rivaroxaban levels and should be avoided, while SSRI and SNRI antidepressants add to bleeding risk.
- Unlike warfarin, it needs no routine clotting blood tests, but periodic kidney checks matter because kidney function guides the dose.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Stopping rivaroxaban early can raise your risk of dangerous blood clots and stroke. If you must stop for a reason other than bleeding or finishing treatment, your doctor may switch you to another blood thinner.
Rivaroxaban can also cause a spinal or epidural hematoma (a blood collection near the spine) in people having epidural or spinal anesthesia or a spinal puncture. This can cause long-term or permanent paralysis. Risk is higher with epidural catheters, NSAIDs, platelet inhibitors or other blood thinners, past spinal procedures or surgery, or spinal deformity. Report back pain, numbness, tingling, leg weakness, or bowel or bladder problems immediately.
Patient information guide A plain-language walkthrough of Rivaroxaban, written from its FDA label.
What Rivaroxaban is used for
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Rivaroxaban is used to prevent and treat blood clots and related events. Uses vary by product.
- Lowers stroke and systemic embolism risk in adults with nonvalvular atrial fibrillation (Xarelto and Rivaroxaban tablets)
- Treats deep vein thrombosis (DVT) and pulmonary embolism (PE)
- Reduces the risk of DVT or PE coming back in adults at continued risk
- Prevents DVT after hip or knee replacement surgery
- Prevents VTE in acutely ill medical patients
- With aspirin, reduces major cardiovascular events (cardiovascular death, heart attack, stroke) in adults with CAD
- With aspirin, reduces major thrombotic vascular events in adults with PAD, including after recent lower extremity revascularization
- Treats VTE and reduces recurrence in patients from birth to under 18 years (tablets and oral suspension)
- Prevents clots in children 2 and older with congenital heart disease after the Fontan procedure (tablets and oral suspension)
How Rivaroxaban works
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Rivaroxaban selectively blocks factor Xa, a key clotting protein. It works on its own and does not need a helper such as antithrombin III. Blocking factor Xa reduces thrombin production, which makes clots form less readily.
Rivaroxaban dosage
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Rivaroxaban is taken by mouth. Adults take tablets. Children may take tablets or an oral suspension, with doses based on weight.
- Frequency ranges from once to twice daily, depending on the condition.
- Some tablet strengths must be taken with food; others can be taken with or without.
- Follow your prescriber and label instructions, and do not stop without medical advice.
Dosing details from the FDA-approved label
From the Rivaroxaban prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Nonvalvular Atrial Fibrillation (Reduction in Risk of Stroke)
- 15 or 20 mg, once daily with food
- CrCl >50 mL/min: 20 mg once daily
- Take with evening meal; CrCl >50 mL/min: 20 mg once daily; CrCl ≤50 mL/min text is truncated in the provided label
- Treatment of DVT and/or PE
- 15 mg orally twice daily with food for the first 21 days followed by 20 mg orally once daily with food for the remaining treatment
- Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE
- 10 mg once daily with or without food, after at least 6 months of standard anticoagulant treatment
- Prophylaxis of DVT Following Hip or Knee Replacement Surgery
- 10 mg orally once daily with or without food
- Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding
- 10 mg once daily, with or without food, in hospital and after hospital discharge for a total recommended duration of 31 to 39 days
- CAD or PAD
- 2.5 mg orally twice daily with or without food, in combination with aspirin (75–100 mg) once daily
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • Nonvalvular Atrial Fibrillation : 15 or 20 mg, once daily with food ( 2.1 ) • Treatment of DVT and/or PE : 15 mg orally twice daily with food for the first 21 days followed by 20 mg orally once daily with food for the remaining treatment ( 2.1 ) • Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE : 10 mg once daily with or without food, after at least 6 months of standard anticoagulant treatment ( 2.1 ) • Prophylaxis of DVT Following Hip or Knee Replacement Surgery : 10 mg orally once daily with or without food ( 2.1 ) • Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding : 10 mg once daily, with or without food, in hospital and after hospital discharge for a total recommended duration of 31 to 39 days ( 2.1 ) • CAD or PAD : 2.5 mg orally twice daily with or without food, in combination with aspirin (75–100 mg) once daily ( 2.1 ) • Pediatric Patients: See dosing recommendations in the Full Prescribing Information ( 2.2 ) 2.1 Recommended Dosage in Adults Table 1:Recommended Dosage in Adults Indication Renal Considerations Calculate CrCl based on actual weight [see Warnings and Precautions (5.4) and Use in Specific Populations (8.6) ] . Dosage Food/Timing [See Clinical Pharmacology (12.3) ] . Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation CrCl >50 mL/min 20 mg once daily Take with evening meal CrCl ≤50 mL/min Patients with CrCl <30 mL/min were not studied, but administration of XARELTO is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) [see Use in Specific Populations (8.6) ] . 15 mg once daily Take with evening meal Treatment of DVT and/or PE CrCl ≥15 mL/min 15 mg twice daily ▼ after 21 days, transition to ▼ 20 mg once daily Take with food, at the same time each day CrCl <15 mL/min Avoid Use Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE CrCl ≥15 mL/min 10 mg once daily, after at least 6 months of standard anticoagulant treatment Take with or without food CrCl <15 mL/min Avoid Use Prophylaxis of DVT Following: • Hip Replacement Surgery [See Dosage and Administration (2.4) ] .
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Rivaroxaban side effects
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Bleeding is the most common side effect in adults.
Common side effects
- Bleeding (the most common side effect in adults)
- Bleeding in children, plus cough
- Vomiting in children
- Gastroenteritis (stomach flu-type illness) in children
- Bleeding of various kinds
When to get medical help
- Call your doctor right away for signs of serious bleeding, such as bleeding that won't stop or signs of blood loss.
- Get urgent help if you have back pain, numbness, tingling, or weakness in your legs, or bowel or bladder problems after a spinal procedure or epidural.
- Seek emergency care for signs of a severe allergic reaction, such as anaphylaxis.
- Tell your doctor before stopping rivaroxaban for any reason, since stopping early raises clot and stroke risk.
Get medical help for signs of serious bleeding, spinal hematoma symptoms, or a severe allergic reaction.
Rivaroxaban warnings and precautions
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- Bleeding: Rivaroxaban can cause serious or fatal bleeding.
- Stopping early: raises the risk of clots and stroke.
- Spinal or epidural hematoma: can cause permanent paralysis after spinal procedures.
- Pregnancy: use with caution because of possible hemorrhage and emergency delivery.
- Not recommended: with prosthetic heart valves or triple positive antiphospholipid syndrome.
Rivaroxaban interactions
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Several drugs can raise bleeding risk or change rivaroxaban levels.
- Other anticoagulants: avoid combining.
- Aspirin, NSAIDs, and platelet inhibitors: more bleeding.
- SSRIs and SNRIs: more bleeding.
- Ketoconazole and ritonavir: raise levels, so avoid.
- Combined P-gp and strong CYP3A inducers: lower levels and may raise clot risk.
Interactions listed in the FDA-approved label
From the Rivaroxaban prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Combined P-gp and strong CYP3A inhibitors (e.g., ketoconazole and ritonavir): Increase exposure to rivaroxaban and may increase the risk of bleeding. Avoid concomitant administration.
- Combined P-gp and strong CYP3A inducers: Decrease exposure to rivaroxaban and may increase the risk of thromboembolic events. Avoid combined P-gp and strong CYP3A inducers.
- Clarithromycin: Although a combined P-gp and strong CYP3A inhibitor, the change in exposure is unlikely to affect the bleeding risk. No precautions are necessary with concomitant administration.
Read the label’s full interactions text
7 DRUG INTERACTIONS Avoid combined P-gp and strong CYP3A inhibitors and inducers ( 7.2 , 7.3 ) Anticoagulants: Avoid concomitant use ( 7.4 ) 7.1 General Inhibition and Induction Properties Rivaroxaban is a substrate of CYP3A4/5, CYP2J2, and the P-gp and ATP-binding cassette G2 (ABCG2) transporters, the latter also known as breast cancer resistance protein (BCRP). Combined P-gp and strong CYP3A inhibitors increase exposure to rivaroxaban and may increase the risk of bleeding. Combined P-gp and strong CYP3A inducers decrease exposure to rivaroxaban and may increase the risk of thromboembolic events. 7.2 Drugs that Inhibit Cytochrome P450 3A Enzymes and Drug Transport Systems Interaction with Combined P-gp and Strong CYP3A Inhibitors Avoid concomitant administration of rivaroxaban tablets with known combined P-gp and strong CYP3A inhibitors (e.g., ketoconazole and ritonavir) [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3)] . Although clarithromycin is a combined P-gp and strong CYP3A inhibitor, pharmacokinetic data suggests that no precautions are necessary with concomitant administration with rivaroxaban tablets as the change in exposure is unlikely to affect the bleeding risk [see Clinical Pharmacology (12.3)] . Interaction with Combined P-gp and Moderate CYP3A Inhibitors in Patients with Renal Impairment Rivaroxaban tablets 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 Warnings and Precautions (5.4) and Clinical Pharmacology (12.3)] . 7.3 Drugs that Induce Cytochrome P450 3A Enzymes and Drug Transport Systems Avoid concomitant use of rivaroxaban tablets 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)] .
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Rivaroxaban
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- Don't use with active bleeding or a past severe allergic reaction to rivaroxaban.
- Tell your doctor if you are pregnant or breastfeeding.
- Kidney problems may require dose changes or avoiding it.
- Avoid with moderate to severe liver impairment.
- Older adults had more clots and bleeding in trials.
- Children's dosing depends on weight and age; 2.5 mg tablets are not recommended for children.
Rivaroxaban overdose
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Too much rivaroxaban may cause bleeding. The label advises stopping it and treating bleeding appropriately. Activated charcoal may be considered, and it cannot be removed by dialysis.
What Rivaroxaban does in the body
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Rivaroxaban reduces factor Xa activity in proportion to the dose, and clotting tests such as PT and aPTT become longer. Routine monitoring with these tests is not recommended. No effect on heart rhythm (QTc) was seen in a study of healthy adults.
How your body processes Rivaroxaban
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Rivaroxaban peaks about 2 to 4 hours after a tablet. Higher-strength tablets are absorbed better with food. It is processed by the liver and cleared through urine and feces. Its half-life is 5 to 9 hours in younger adults and 11 to 13 hours in older adults.
How to store Rivaroxaban
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of tablets, granules and reconstituted suspension: Store at room temperature between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) . Do not freeze the granules or reconstituted suspension. Keep out of the reach of children.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Rivaroxaban
285 supplements and herbal products have documented interactions with Rivaroxaban in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 5
- Moderate · 240
- Minor · 40
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Rivaroxaban: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Rivaroxaban — the kind of thing our pharmacy team would talk through with you at the counter.
What is rivaroxaban for?
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Should I take it with food?
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Can I stop it if I feel fine?
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What side effects should I watch for?
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What should I avoid taking with it?
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Is it safe in pregnancy?
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Is Rivaroxaban available over the counter?
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When was Rivaroxaban first available?
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Who makes Rivaroxaban?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Rivaroxaban on HelloPharmacist
Rivaroxaban forms and strengths (how it comes)
Rivaroxaban is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Xarelto and Rivaroxaban tablets are used for stroke prevention in nonvalvular atrial fibrillation, DVT and PE treatment, and lowering risk of recurrence.
- Xarelto and Rivaroxaban tablets are used to prevent DVT after hip or knee replacement and VTE in acutely ill medical patients.
- Rivaroxaban tablets taken with aspirin reduce cardiovascular events in CAD and PAD.
- Xarelto and Rivaroxaban tablets: some strengths must be taken with food, while others can be taken with or without food, as directed on your label.
Oral suspension
How this form is used
- Rivaroxaban for oral suspension is used to treat VTE and reduce recurrent VTE in children from birth to under 18 years, after at least 5 days of initial injected anticoagulant treatment.
- Rivaroxaban for oral suspension is used for clot prevention in children 2 years and older with congenital heart disease after the Fontan procedure.
- Rivaroxaban for oral suspension dosing in children depends on body weight and is given by mouth once, twice, or three times daily; follow your prescriber.
Rivaroxaban on the U.S. market: products, makers and brands
How Rivaroxaban appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
23 companies list 46 Rivaroxaban product records with the FDA, mostly as tablet, oral suspension; the earliest marketing or approval year on record is 2011. Brand names on the directory include Xarelto, rivaroxaban granule; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (38) · Kit (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Rivaroxaban is used (Medicaid data)
A general measure of how commonly Rivaroxaban is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Rivaroxaban is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Rivaroxaban prescribed? Of the 1,601 medications we measure, Rivaroxaban ranks #228 by Medicaid prescriptions — more than 86% of them.
Utilization by Rivaroxaban product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
rivaroxaban 20 MG Oral Tablet Most dispensed
Summed across the 4 of 25 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1232086
rivaroxaban 10 MG Oral Tablet
Summed across the 3 of 24 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1114198
rivaroxaban 2.5 MG Oral Tablet
Summed across the 14 of 52 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2059015
rivaroxaban 15 MG Oral Tablet
Summed across the 3 of 21 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1232082
rivaroxaban 1 MG/ML Oral Suspension
Summed across the 3 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2588062
Other Rivaroxaban products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 1 of 102 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Rivaroxaban, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 28 of 227 listed Rivaroxaban NDCs with Medicaid activity.
Compare Rivaroxaban products
A representative set of FDA-listed product records for Rivaroxaban — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Oral suspension | ||||
| 155 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 155 mg | Oral | Janssen Pharmaceuticals, Inc. | NDA | View NDC → |
| 155 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 💊Tablet | ||||
| 10 mg | Oral | A-S Medication Solutions × 2 listings | NDA | View NDC → |
| 20 mg | Oral | A-S Medication Solutions × 2 listings | NDA | View NDC → |
| 2.5 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 10 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 15 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 20 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 10 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 15 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 20 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 10 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC | NDA | View NDC → |
| 2.5 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 2.5 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 2.5 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 15 mg | Oral | Cardinal Health 107, LLC | NDA | View NDC → |
| 20 mg | Oral | Cardinal Health 107, LLC | NDA | View NDC → |
| 10 mg | Oral | Changzhou Pharmaceutical Factory | ANDA | View NDC → |
| 15 mg | Oral | Changzhou Pharmaceutical Factory | ANDA | View NDC → |
| 20 mg | Oral | Changzhou Pharmaceutical Factory | ANDA | View NDC → |
| 2.5 mg | Oral | Dr.Reddy's Laboratories, Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Exelan pharmaceuticals,Inc | ANDA | View NDC → |
| 2.5 mg | Oral | Florida Pharmaceutical Products, LLC | ANDA | View NDC → |
| 2.5 mg | Oral | Indoco Remedies Limited | ANDA | View NDC → |
| 10 mg | Oral | Indoco Remedies Limited | ANDA | View NDC → |
| 15 mg | Oral | Indoco Remedies Limited | ANDA | View NDC → |
| 20 mg | Oral | Indoco Remedies Limited | ANDA | View NDC → |
| 2.5 mg | Oral | Janssen Pharmaceuticals, Inc. | NDA | View NDC → |
| 10 mg | Oral | Janssen Pharmaceuticals, Inc. | NDA | View NDC → |
| 15 mg | Oral | Janssen Pharmaceuticals, Inc. | NDA | View NDC → |
| 20 mg | Oral | Janssen Pharmaceuticals, Inc. | NDA | View NDC → |
| 2.5 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 2.5 mg | Oral | Micro Labs Limited | ANDA | View NDC → |
| 2.5 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 2.5 mg | Oral | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| 2.5 mg | Oral | ScieGen pharmaceuticals,Inc | ANDA | View NDC → |
| 2.5 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | XLCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| 💊Kits | ||||
| — | — | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| — | — | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| — | — | Janssen Pharmaceuticals, Inc. | NDA | View NDC → |
Showing 46 of 46 products — FDA National Drug Code Directory. See every product, package size and price: browse all 46 Rivaroxaban NDCs →
Rivaroxaban side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Rivaroxaban — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Rivaroxaban in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Rivaroxaban FDA approval history
How Rivaroxaban went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Rivaroxaban recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Rivaroxaban recalls since July 2021.
✅No Rivaroxaban recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1114195 2 dose forms · 5 strengths
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Dose form (SCDF) Oral Suspension RxCUI 2589626In current FDA listingsClinical drug / strength (SCD) 1 MG/MLRxCUI 2588062 -
Dose form (SCDF) Oral Tablet RxCUI 1114197In current FDA listings
Look up RxCUI 1114195 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Rivaroxaban supply and shortage status
Whether Rivaroxaban is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Rivaroxaban costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Granule, For Suspension · Oral | 155 mg | $3.77 per mL | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Rivaroxaban brand names
Rivaroxaban is sold under 2 brand names in the FDA directory — Xarelto, rivaroxaban granule. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Rivaroxaban: manufacturers and labelers
23 companies list Rivaroxaban products with the FDA. By number of product records, the largest are Janssen Pharmaceuticals, Inc., Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Rivaroxaban drug class (RxNorm)
Rivaroxaban belongs to the Factor Xa Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Rivaroxaban page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Cardinal Health 107, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →