Rivaroxaban 2.5 mg Tablet, Film Coated, 180-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Factor Xa Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Rivaroxaban is used to: prevent and treat deep vein thrombosis (DVT; a blood clot) and pulmonary embolism (PE; a blood clot in the lung). lower the risk of a heart attack, stroke, or death in people with coronary artery disease (narrowing of the blood vessels that bring blood to the heart) or peripheral arterial disease (poor blood flow to the arms and legs). Rivaroxaban is in a class of medications called factor Xa inhibitors. It works by blocking a natural substance that helps blood clots to form.
Read the full MedlinePlus article ↗- Yes, rivaroxaban is a blood thinner, but it covers a pretty wide range of conditions. It's used to treat blood clots in the legs (DVT) and lungs (pulmonary embolism), prevent those...
- What exactly is rivaroxaban used for — is it just a blood thinner?
- It depends on the strength you've been prescribed. Certain higher-strength tablets need to be taken with food — food helps your body absorb enough of the medication. Lower-strength...
- Do I need to take rivaroxaban with food?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Rivaroxaban — tap one for details:
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.656 | $118.08 / 180 tablets |
| Medicaid paysCMS SDUD · 12 mo | $2.31 | $414.90 / 180 tablets |
| Medicare drug plans payPart D · Q2 2026 | $4.05 | $728.60 / 180 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Rivaroxaban 2.5 mgthis 33342-0488-57 | Macleods | 180 tablets | $0.656 | AB | Availability likely | — |
| Rivaroxaban 2.5 mg 43598-0981-18 | Dr.Reddy's | 180 tablets | $0.656 | AB | Availability likely | — |
| Rivaroxaban 2.5 mg 50228-0513-18 | ScieGen | 180 tablets | $0.656 | AB | Availability likely | — |
| Rivaroxaban 2.5 mg 51672-4228-04 | Sun | 60 tablets | $0.656 | AB | Availability likely | — |
| Rivaroxaban 2.5 mg 59651-0849-18 | Aurobindo | 180 tablets | $0.656 | AB | Availability likely | — |
| Rivaroxaban 2.5 mg 68180-0709-06 | Lupin | 30 tablets | $0.656 | AB | Availability likely | — |
| rivaroxaban 2.5 mg 71921-0405-06 | Florida | 60 tablets | $0.656 | AB | Availability likely | — |
| Rivaroxaban 2.5 mg 72205-0416-02 | Novadoz | 10 tablets | $0.656 | AB | Availability likely | — |
| Rivaroxaban 2.5 mg 76282-0774-18 | Exelan | 180 tablets | $0.656 | AB | Availability likely | — |
| Xarelto 2.5 mg 50458-0577-10 | Janssen | 10 tablets | $9.779 | AB | Availability likely | +1391% |
| Rivaroxaban 2.5 mg 14445-0147-10 | Indoco | 10 tablets | — | AB | FDA listed | — |
| Rivaroxaban 2.5 mg 31722-0496-18 | Camber | 180 tablets | — | AB | FDA listed | — |
| Rivaroxaban 2.5 mg 46708-0683-10 | Alembic | 10 tablets | — | AB | FDA listed | — |
| Rivaroxaban 2.5 mg 60505-6256-05 | Apotex | 500 tablets | — | AB | FDA listed | — |
| Rivaroxaban 2.5 mg 62332-0683-10 | Alembic | 10 tablets | — | AB | FDA listed | — |
| Rivaroxaban 2.5 mg 72603-0890-01 | NorthStar | 60 tablets | — | AB | FDA listed | — |
| Rivaroxaban 2.5 mg 72865-0321-18 | XLCare | 180 tablets | — | AB | FDA listed | — |
| Rivaroxaban 2.5 mg 42571-0345-05 | Micro | 500 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 33342-0488-09 | 60 TABLET, FILM COATED in 1 BOTTLE (33342-488-09) | $0.6560 / ea | $39.36 | 2025-05-14 | Active |
| 33342-0488-57 You're viewing this | 180 TABLET, FILM COATED in 1 BOTTLE (33342-488-57) | $0.6560 / ea | $118.08 | 2025-05-14 | Active |
| 33342-0488-98 | 10 BLISTER PACK in 1 CARTON (33342-488-98) / 6 TABLET, FILM COATED in 1 BLISTER PACK | — | — | 2025-05-14 | Active |
This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.6560 NADAC).
This pack accounts for about 25% of this product's recent Medicaid fills; most go to the 60 tablets pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 33342-0488-57?
What is the difference between NDC 33342-0488-57 and NDC 33342-0488-09?
What NDC number is used to bill for this package of Rivaroxaban 2.5 mg Tablet, Film Coated?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING:(A) PREMATURE DISCONTINUATION OF RIVAROXABAN TABLETS INCREASES THE RISK OF THROMBOTIC EVENTS,(B) SPINAL/EPIDURAL HEMATOMA A. Premature discontinuation of rivaroxaban tablets increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including rivaroxaban tablets, increases the risk of thrombotic events. If anticoagulation with rivaroxaban tablets 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 rivaroxaban tablets 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. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: • use of indwelling epidural catheters • concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants • a history of traumatic or repeated epidural or spinal punctures • a history of spinal deformity or spinal surgery • optimal timing between the administration of rivaroxaban tablets and neuraxial procedures is not known [see Warnings and Precautions ( 5.2 , 5.3 ) and Adverse Reactions ( 6.2 )].
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions ( 5.3 )]. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions ( 5.3 )].
WARNING: (A) PREMATURE DISCONTINUATION OF RIVAROXABAN TABLETS INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning. (A) Premature discontinuation of rivaroxaban tablets increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including rivaroxaban tablets, increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if rivaroxaban tablets are discontinued for a reason other than pathological bleeding or completion of a course of therapy.
( 2.2 , 2.3 , 5.1 , 14.1 ) (B) Spinal/epidural hematoma Epidural or spinal hematomas have occurred in patients treated with rivaroxaban tablets who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. ( 5.2 , 5.3 , 6.2 ) Monitor patients frequently for signs and symptoms of neurological impairment and if observed, treat urgently.
Consider the benefits and risks before neuraxial intervention in patients who are or who need to be anticoagulated. ( 5.3 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Rivaroxaban tablets are a factor Xa inhibitor indicated: • 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 patients after recent lower extremity revascularization due to symptomatic PAD ( 1.8 )
1.7Reduction of Risk of Major Cardiovascular Events in Patients with Coronary Artery Disease (CAD) Rivaroxaban tablets, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in adult patients with coronary artery disease.
1.8Reduction of Risk of Major Thrombotic Vascular Events in Patients with Peripheral Artery Disease (PAD), Including Patients after Lower Extremity Revascularization due to Symptomatic PAD Rivaroxaban tablets, in combination with aspirin, is indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology) in adult patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • CAD or PAD: 2.5 mg orally twice daily with or without food, in combination with aspirin (75-100 mg) once daily ( 2.1 )
2.1Recommended Dosage in Adults Table 1: Recommended Dosage in Adults Indication Renal Considerations * Dosage Food/Timing † Reduction of Risk of Major Cardiovascular Events (CV Death, MI, and Stroke) in CAD No dose adjustment needed based on CrCl 2.5 mg twice daily , plus aspirin (75- 100 mg) once daily Take with or without food Reduction of Risk of Major Thrombotic Vascular Events in PAD, Including Patients after Lower Extremity Revascularization due to Symptomatic PAD No dose adjustment needed based on CrCl 2.5 mg twice daily , plus aspirin (75-100 mg) once daily.
When starting therapy after a successful lower extremity revascularization procedure, initiate once hemostasis has been established. Take with or without food * Calculate CrCl based on actual weight. [see Warnings and Precautions (5.4) and Use in Specific Populations (8.6)]. † [See Clinical Pharmacology (12.3)].
2.2Recommended Dosage in Pediatric Patients Rivaroxaban 2.5 mg tablets are not recommended for use in pediatric patients [see Use in Specific Populations ( 8.4 )].
2.3Switching to and from Rivaroxaban Tablets Switching from Warfarin to rivaroxaban tablets - When switching patients from warfarin to rivaroxaban tablets, discontinue warfarin and start rivaroxaban tablets as soon as the International Normalized Ratio (INR) is below 3.0 in adults to avoid periods of inadequate anticoagulation. Switching from rivaroxaban tablets to Warfarin – • Adults: No clinical trial data are available to guide converting patients from rivaroxaban tablets to warfarin. rivaroxaban tablets affects INR, so INR measurements made during coadministration with warfarin may not be useful for determining the appropriate dose of warfarin.
One approach is to discontinue rivaroxaban tablets and begin both a parenteral anticoagulant and warfarin at the time the next dose of rivaroxaban tablets would have been taken. Once rivaroxaban tablets are discontinued, INR testing may be done reliably 24 hours after the last dose. Switching from rivaroxaban tablets to Anticoagulants other than Warfarin - For adult and pediatric patients currently taking rivaroxaban tablets and transitioning to an anticoagulant with rapid onset, discontinue rivaroxaban tablets and give the first dose of the other anticoagulant (oral or parenteral) at the time that the next rivaroxaban tablets dose would have been taken [see Drug Interactions ( 7.4 )].
Switching from Anticoagulants other than Warfarin to rivaroxaban tablets -For adult and pediatric patients currently receiving an anticoagulant other than warfarin, start rivaroxaban tablets 0 to 2 hours prior to the next scheduled administration of the drug (e.g., low molecular weight heparin or non-warfarin oral anticoagulant) and omit administration of the other anticoagulant. For unfractionated heparin being administered by continuous infusion, stop the infusion and start rivaroxaban tablets at the same time.
2.4Discontinuation for Surgery and other Interventions If anticoagulation must be discontinued to reduce the risk of bleeding with surgical or other procedures, rivaroxaban tablets should be stopped at least 24 hours before the procedure to reduce the risk of bleeding [see Warnings and Precautions ( 5.2 )] . In deciding whether a procedure should be delayed until 24 hours after the last dose of rivaroxaban tablets, the increased risk of bleeding should be weighed against the urgency of intervention. rivaroxaban tablets should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established, noting that the time to onset of therapeutic effect is short [see Warnings and Precautions ( 5.1 )].
If oral medication cannot be taken during or after surgical intervention, consider administering a parenteral anticoagulant.
2.5Missed Dose Adults • For patients receiving 2.5 mg twice…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS • 2.5 mg tablets are Light yellow colour, circular, biconvex, film coated tablets debossed with “J 7” on one side and plain on the other side. Tablets: 2.5 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Rivaroxaban tablets is contraindicated in patients with: • active pathological bleeding [see Warnings and Precautions ( 5.2 )] • severe hypersensitivity reaction to rivaroxaban tablets (e.g., anaphylactic reactions) [see Adverse Reactions ( 6.2 )] • Active pathological bleeding ( 4 ) • Severe hypersensitivity reaction to rivaroxaban tablets ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Risk of bleeding: Rivaroxaban tablets can cause serious and fatal bleeding ( 5.2 ) • Pregnancy-related hemorrhage: Use rivaroxaban tablets with caution in pregnant women due to the potential for obstetric hemorrhage and/or emergent delivery ( 5.7 , 8.1 ) • Prosthetic heart valves: rivaroxaban tablets use not recommended ( 5.8 ) • Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome: Rivaroxaban tablets use not recommended ( 5.10 )
5.1Increased Risk of Thrombotic Events after Premature Discontinuation Premature discontinuation of any oral anticoagulant, including rivaroxaban tablets, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from rivaroxaban tablets to warfarin in clinical trials in atrial fibrillation patients. If rivaroxaban tablets 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 ) and Clinical Studies (14.1)].
5.2Risk of Bleeding Rivaroxaban tablets increases the risk of bleeding, including in any organ, and can cause serious or fatal bleeding. In deciding whether to prescribe rivaroxaban tablets to patients at increased risk of bleeding, the risk of thrombotic events should be weighed against the risk of bleeding. Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement.
Discontinue rivaroxaban tablets in patients with active pathological hemorrhage. The terminal elimination half-life of rivaroxaban is 5 to 9 hours in healthy subjects aged 20 to 45 years. Concomitant use of other drugs that impair hemostasis increases the risk of bleeding.
These include aspirin, P2Y 12 platelet inhibitors, dual antiplatelet therapy, other antithrombotic agents, fibrinolytic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) [see Drug Interactions ( 7.4 )], selective serotonin reuptake inhibitors, and serotonin norepinephrine reuptake inhibitors. Concomitant use of drugs that are known combined P-gp and strong CYP3A inhibitors increases rivaroxaban exposure and may increase bleeding risk [see Drug Interactions ( 7.2 )]. Risk of Hemorrhage in Acutely III Medical Patients at High Risk of Bleeding Acutely ill medical patients with the following conditions are at increased risk of bleeding with the use of rivaroxaban tablets for primary VTE prophylaxis: history of bronchiectasis, pulmonary cavitation, or pulmonary hemorrhage, active cancer (i.e., undergoing acute, in-hospital cancer treatment), active gastroduodenal ulcer in the three months prior to treatment, history of bleeding in the three months prior to treatment, or dual antiplatelet therapy.
Rivaroxaban tablets are not for use for primary VTE prophylaxis in these hospitalized, acutely ill medical patients at high risk of bleeding. Reversal of Anticoagulant Effect A specific agent to reverse the anti-factor Xa activity of rivaroxaban is not available. Because of high plasma protein binding, rivaroxaban is not dialyzable [see Clinical Pharmacology ( 12.3 )].
Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban. Use of procoagulant reversal agents, such as prothrombin complex concentrate (PCC), activated prothrombin complex concentrate or recombinant factor VIIa, may be considered but has not been evaluated in clinical efficacy and safety studies. Monitoring for the anticoagulation effect of rivaroxaban using a clotting test (PT, INR or aPTT) or anti-factor Xa (FXa) activity is not recommended.
5.3Spinal/Epidural Anesthesia or Puncture When neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture is employed, patients treated with anticoagulant agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can resul…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are also discussed in other sections of the labeling: • Increased Risk of Stroke After Discontinuation in Nonvalvular Atrial Fibrillation [see Boxed Warning and Warnings and Precautions ( 5.1 )] • Bleeding Risk [see Warnings and Precautions ( 5.2 , 5.4, 5.5 , 5.6 , 5.7 )] • Spinal/Epidural Hematoma [see Boxed Warning and Warnings and Precautions ( 5.3 )] • The most common adverse reaction (>5%) in adult patients was bleeding ( 6.1 ) • The most common adverse reactions (>10%) in pediatric patients were bleeding, cough, vomiting, and gastroenteritis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact contact Macleods Pharma USA, Inc., at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. During clinical development for the approved indications, 34,947 adult patients were exposed to rivaroxaban tablets. Hemorrhage The most common adverse reactions with rivaroxaban tablets were bleeding complications [see Warnings and Precautions ( 5.2 )].
Reduction of Risk of Major Cardiovascular Events in Patients with CAD In the COMPASS trial overall, the most frequent adverse reactions associated with permanent drug discontinuation were bleeding events, with incidence rates of 2.7% for rivaroxaban 2.5 mg twice daily vs. 1.2% for placebo on background therapy for all patients with aspirin 100 mg once daily. The incidences of important bleeding events in the CAD and PAD populations in COMPASS were similar.
Table 10 shows the number of patients experiencing various types of major bleeding events in the COMPASS trial. Table 10: Major Bleeding Events in COMPASS - On Treatment Plus 2 Days* Parameter Rivaroxaban † N=9134 n (%/year) Placebo † N=9107 n (%/year) Rivaroxaban vs. Placebo HR (95 % CI) Modified ISTH Major Bleeding ‡ 263 (1.6) 144 (0.9) 1.8 (1.5, 2.3) - Fatal bleeding event Intracranial hemorrhage (ICH) Non-intracranial 12 (<0.1) 6 (<0.1) 6 (<0.1) 8 (<0.1) 3 (<0.1) 5 (<0.1) 1.5 (0.6, 3.7) 2.0 (0.5, 8.0) 1.2 (0.4, 4.0) -Symptomatic bleeding in critical organ (non-fatal) -ICH (fatal and non-fatal) Hemorrhagic Stroke Other ICH 58 (0.3) 23 (0.1) 18 (0.1) 6 (<0.1) 43 (0.3) 21 (0.1) 13 (<0.1) 9 (<0.1) 1.4 (0.9, 2.0) 1.1 (0.6, 2.0) 1.4 (0.7, 2.8) 0.7 (0.2, 1.9) - Bleeding into the surgical site requiring reoperation (non-fatal, not in critical organ) 7 (<0.1) 6 (<0.1) 1.2 (0.4, 3.5) - Bleeding leading to hospitalization (non-fatal, not in critical organ, not requiring reoperation) 188 (1.1) 91 (0.5) 2.1 (1.6, 2.7) Major GI bleeding 117 (0.7) 49 (0.3) 2.4 (1.7, 3.4) * Major bleeding events within each subcategory were counted once per patient, but patients may have contributed events to multiple subcategories.
These events occurred during treatment or within 2 days of stopping treatment in the safety analysis set in COMPASS patients. † Treatment schedule: rivaroxaban 2.5 mg twice daily or placebo. All patients received background therapy with aspirin 100 mg once daily. ‡ Defined as i) fatal bleeding, or ii) symptomatic bleeding in a critical area or organ, such as intraarticular, intramuscular with compartment syndrome, intraspinal, intracranial, intraocular, respiratory, pericardial, liver, pancreas, retroperitoneal, adrenal gland or kidney; or iii) bleeding into the surgical site requiring reoperation, or iv) bleeding leading to hospitalization.
CI: confidence interval; HR: hazard ratio; ISTH: International Society on Thrombosis and Hemostasis Reduction of Risk of Major Thrombotic Vascular Events in Patients with Peripheral Artery Disease (PAD), Including Patients after Lower Extremity Revascularization due to Symptomatic PAD The incidence o…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Avoid combined P-gp and strong CYP3A inhibitors and inducers ( 7.2 , 7.3 ) • Anticoagulants: Avoid concomitant use ( 7.4 )
7.1General 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.
7.2Drugs 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 )].
7.3Drugs 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 )].
7.4Anticoagulants and NSAIDs/Aspirin Coadministration of enoxaparin, warfarin, aspirin, clopidogrel and chronic NSAID use may increase the risk of bleeding [see Clinical Pharmacology ( 12.3 )]. Avoid concurrent use of rivaroxaban tablets with other anticoagulants due to increased bleeding risk unless benefit outweighs risk. Promptly evaluate any signs or symptoms of blood loss if patients are treated concomitantly with aspirin, other platelet aggregation inhibitors, or NSAIDs [see Warnings and Precautions ( 5.2 )].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Renal impairment: Avoid or adjust dose ( 8.6 ) • Hepatic impairment: Avoid use in Child-Pugh B and C hepatic impairment or hepatic disease associated with coagulopathy ( 8.7 )
8.1Pregnancy Risk Summary The limited available data on rivaroxaban tablets in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. Use rivaroxaban tablets with caution in pregnant patients because of the potential for pregnancy related hemorrhage and/or emergent delivery. The anticoagulant effect of rivaroxaban tablets cannot be reliably monitored with standard laboratory testing.
Consider the benefits and risks of rivaroxaban tablets for the mother and possible risks to the fetus when prescribing rivaroxaban tablets to a pregnant woman [see Warnings and Precautions ( 5.2 , 5.7 )]. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnancy is a risk factor for venous thromboembolism and that risk is increased in women with inherited or acquired thrombophilias. Pregnant women with thromboembolic disease have an increased risk of maternal complications including pre-eclampsia.
Maternal thromboembolic disease increases the risk for intrauterine growth restriction, placental abruption and early and late pregnancy loss. Fetal/Neonatal Adverse Reactions Based on the pharmacologic activity of Factor Xa inhibitors and the potential to cross the placenta, bleeding may occur at any site in the fetus and/or neonate. Labor or Delivery All patients receiving anticoagulants, including pregnant women, are at risk for bleeding and this risk may be increased during labor or delivery [see Warnings and Precautions (5.7)].
The risk of bleeding should be balanced with the risk of thrombotic events when considering the use of rivaroxaban tablets in this setting. Data Human Data There are no adequate or well-controlled studies of rivaroxaban tablets in pregnant women, and dosing for pregnant women has not been established. Post-marketing experience is currently insufficient to determine a rivaroxaban-associated risk for major birth defects or miscarriage.
In an in vitro placenta perfusion model, unbound rivaroxaban was rapidly transferred across the human placenta. Animal Data Rivaroxaban crosses the placenta in animals. Rivaroxaban increased fetal toxicity (increased resorptions, decreased number of live fetuses, and decreased fetal body weight) when pregnant rabbits were given oral doses of ≥10 mg/kg rivaroxaban during the period of organogenesis.
This dose corresponds to about 4 times the human exposure of unbound drug, based on AUC comparisons at the highest recommended human dose of 20 mg/day. Fetal body weights decreased when pregnant rats were given oral doses of 120 mg/kg during the period of organogenesis. This dose corresponds to about 14 times the human exposure of unbound drug.
In rats, peripartal maternal bleeding and maternal and fetal death occurred at the rivaroxaban dose of 40 mg/kg (about 6 times maximum human exposure of the unbound drug at the human dose of 20 mg/day).
8.2Lactation Risk Summary Rivaroxaban has been detected in human milk. There are insufficient data to determine the effects of rivaroxaban on the breastfed child or on milk production. Rivaroxaban and/or its metabolites were present in the milk of rats.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for rivaroxaban tablets and any potential adverse effects on the breastfed infant from rivaroxaban tablets or from the underlying maternal condi…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary The limited available data on rivaroxaban tablets in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. Use rivaroxaban tablets with caution in pregnant patients because of the potential for pregnancy related hemorrhage and/or emergent delivery. The anticoagulant effect of rivaroxaban tablets cannot be reliably monitored with standard laboratory testing.
Consider the benefits and risks of rivaroxaban tablets for the mother and possible risks to the fetus when prescribing rivaroxaban tablets to a pregnant woman [see Warnings and Precautions ( 5.2 , 5.7 )]. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnancy is a risk factor for venous thromboembolism and that risk is increased in women with inherited or acquired thrombophilias. Pregnant women with thromboembolic disease have an increased risk of maternal complications including pre-eclampsia.
Maternal thromboembolic disease increases the risk for intrauterine growth restriction, placental abruption and early and late pregnancy loss. Fetal/Neonatal Adverse Reactions Based on the pharmacologic activity of Factor Xa inhibitors and the potential to cross the placenta, bleeding may occur at any site in the fetus and/or neonate. Labor or Delivery All patients receiving anticoagulants, including pregnant women, are at risk for bleeding and this risk may be increased during labor or delivery [see Warnings and Precautions (5.7)].
The risk of bleeding should be balanced with the risk of thrombotic events when considering the use of rivaroxaban tablets in this setting. Data Human Data There are no adequate or well-controlled studies of rivaroxaban tablets in pregnant women, and dosing for pregnant women has not been established. Post-marketing experience is currently insufficient to determine a rivaroxaban-associated risk for major birth defects or miscarriage.
In an in vitro placenta perfusion model, unbound rivaroxaban was rapidly transferred across the human placenta. Animal Data Rivaroxaban crosses the placenta in animals. Rivaroxaban increased fetal toxicity (increased resorptions, decreased number of live fetuses, and decreased fetal body weight) when pregnant rabbits were given oral doses of ≥10 mg/kg rivaroxaban during the period of organogenesis.
This dose corresponds to about 4 times the human exposure of unbound drug, based on AUC comparisons at the highest recommended human dose of 20 mg/day. Fetal body weights decreased when pregnant rats were given oral doses of 120 mg/kg during the period of organogenesis. This dose corresponds to about 14 times the human exposure of unbound drug.
In rats, peripartal maternal bleeding and maternal and fetal death occurred at the rivaroxaban dose of 40 mg/kg (about 6 times maximum human exposure of the unbound drug at the human dose of 20 mg/day).
🧒 Pediatric Use ▾
8.4Pediatric Use For the rivaroxaban tablets 2.5 mg tablets, there are no safety, efficacy, pharmacokinetic and pharmacodynamic data to support the use in pediatric patients. Therefore, rivaroxaban tablets 2.5 mg tablets are not recommended for use in pediatric patients. Although not all adverse reactions identified in the adult population have been observed in clinical trials of children and adolescent patients, the same warnings and precautions for adults should be considered for children and adolescents.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of adult patients in clinical trials for the approved indications of rivaroxaban tablets (N=64,943 patients), 64 percent were 65 years and over, with 27 percent 75 years and over. In clinical trials the efficacy of rivaroxaban tablets in the elderly (65 years or older) was similar to that seen in patients younger than 65 years. Both thrombotic and bleeding event rates were higher in these older patients [see Clinical Pharmacology ( 12.3 ) and Clinical Studies ( 14 )].
🆘 Overdosage ▾
10 OVERDOSAGE Overdose of Rivaroxaban tablets may lead to hemorrhage. Discontinue rivaroxaban tablets and initiate appropriate therapy if bleeding complications associated with overdosage occur. Rivaroxaban systemic exposure is not further increased at single doses >50 mg due to limited absorption.
The use of activated charcoal to reduce absorption in case of rivaroxaban tablets overdose may be considered. Due to the high plasma protein binding, rivaroxaban is not dialyzable [see Warnings and Precautions ( 5.2 ) and Clinical Pharmacology ( 12.3 )] . Partial reversal of laboratory anticoagulation parameters may be achieved with use of plasma products.
A specific agent to reverse the anti-factor Xa activity of rivaroxaban is not available.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Rivaroxaban is a selective inhibitor of FXa. It does not require a cofactor (such as Anti-thrombin III) for activity. Rivaroxaban inhibits free FXa and prothrombinase activity. Rivaroxaban has no direct effect on platelet aggregation, but indirectly inhibits platelet aggregation induced by thrombin. By inhibiting FXa, rivaroxaban decreases thrombin generation.
12.2Pharmacodynamics Rivaroxaban produces dose-dependent inhibition of FXa activity. Clotting tests, such as prothrombin time (PT), activated partial thromboplastin time (aPTT) and HepTest®, are also prolonged dose-dependently. In children treated with rivaroxaban, the correlation between anti-factor Xa to plasma concentrations is linear with a slope close to 1.
Monitoring for anticoagulation effect of rivaroxaban using anti-FXa activity or a clotting test is not recommended. Specific Populations Renal Impairment The relationship between systemic exposure and pharmacodynamic activity of rivaroxaban was altered in adult subjects with renal impairment relative to healthy control subjects [see Use in Specific Populations ( 8.6 )]. Table 18: Percentage Increase in Rivaroxaban PK and PD Measures in Adult Subjects with Renal Impairment Relative to Healthy Subjects from Clinical Pharmacology Studies Measure Parameter Creatinine Clearance (mL/min) 50-79 30-49 15-29 ESRD (on dialysis)* ESRD (post-dialysis)* Exposure AUC 44 52 64 47 56 FXa Inhibition AUEC 50 86 100 49 33 PT Prolongation AUEC 33 116 144 112 158 *Separate stand-alone study.
PT = Prothrombin time; FXa = Coagulation factor Xa; AUC = Area under the plasma concentration-time curve; AUEC = Area under the effect-time curve Hepatic Impairment Anti-Factor Xa activity was similar in adult subjects with normal hepatic function and in mild hepatic impairment (Child-Pugh A class). There is no clear understanding of the impact of hepatic impairment beyond this degree on the coagulation cascade and its relationship to efficacy and safety.
12.3Pharmacokinetics Absorption The absolute bioavailability of rivaroxaban is dose-dependent. For the 2.5 mg dose, it is estimated to be 80% to 100% and is not affected by food. Rivaroxaban 2.5 mg tablets can be taken with or without food .[see Dosage and Administration ( 2.1 )].
The maximum concentrations (C max ) of rivaroxaban appear 2 to 4 hours after tablet intake. The pharmacokinetics of rivaroxaban were not affected by drugs altering gastric pH. Coadministration of rivaroxaban (30 mg single dose) with the H2-receptor antagonist ranitidine (150 mg twice daily), the antacid aluminum hydroxide/magnesium hydroxide (10 mL) or rivaroxaban (20 mg single dose) with the PPI omeprazole (40 mg once daily) did not show an effect on the bioavailability and exposure of rivaroxaban (see Figure 3).
Absorption of rivaroxaban is dependent on the site of drug release in the GI tract. A 29% and 56% decrease in AUC and C max compared to tablet was reported when rivaroxaban granulate is released in the proximal small intestine. Exposure is further reduced when drug is released in the distal small intestine, or ascending colon.
Avoid administration of rivaroxaban distal to the stomach which can result in reduced absorption and related drug exposure. Distribution Protein binding of rivaroxaban in human plasma is approximately 92% to 95%, with albumin being the main binding component. The steady-state volume of distribution in healthy subjects is approximately 50 L.
Metabolism Approximately 51% of an orally administered [ 14 C]-rivaroxaban dose was recovered as inactive metabolites in urine (30%) and feces (21%). Oxidative degradation catalyzed by CYP3A4/5 and CYP2J2 and hydrolysis are the major sites of biotransformation. Unchanged rivaroxaban was the predominant moiety in plasma with no major or active circulating metabolites.
Excretion In a Phase 1 study, following the administration of [ 14 C]-rivaroxaban, approximately one-third (36%) was recovered as unch…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Rivaroxaban is a selective inhibitor of FXa. It does not require a cofactor (such as Anti-thrombin III) for activity. Rivaroxaban inhibits free FXa and prothrombinase activity. Rivaroxaban has no direct effect on platelet aggregation, but indirectly inhibits platelet aggregation induced by thrombin. By inhibiting FXa, rivaroxaban decreases thrombin generation.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Rivaroxaban Tablets, USP are available in the strengths and packages listed below: • 2.5 mg tablets are Light yellow colour, circular, biconvex, film coated tablets debossed with “J 7” on one side and plain on the other side. The tablets are supplied in the packages listed: NDC 33342-488-09 Bottle containing 60 tablets NDC 33342-488-57 Bottle containing 180 tablets NDC 33342-488-98 Blister package containing 60 tablets (10 blister cards containing 6 tablets each) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Keep out of the reach of children.
📋 Description ▾
11 DESCRIPTION Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in Rivaroxaban Tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C 19 H 18 ClN 3 O 5 S and the molecular weight is 435.89. The structural formula is: Rivaroxaban USP is a pure (S)-enantiomer.
It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban USP is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each Rivaroxaban tablets, USP contains 2.5 mg of rivaroxaban.
The inactive ingredients of Rivaroxaban tablets, USP are: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for Rivaroxaban Tablet, USP 2.5 mg is Instacoat@ Yellow and containing Hypromellose, polyethylene glycol, Titanium dioxide, yellow iron oxide. USP Dissolution test pending. str
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION For the tablets, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide). Bleeding Risks • Advise patients to report any unusual bleeding or bruising to their physician. Inform patients that it might take them longer than usual to stop bleeding, and that they may bruise and/or bleed more easily when they are treated with rivaroxaban [see Warnings and Precautions ( 5.2 )]. • If patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDs or platelet inhibitors, advise patients to watch for signs and symptoms of spinal or epidural hematoma, such as back pain, tingling, numbness (especially in the lower limbs), muscle weakness, and stool or urine incontinence.
If any of these symptoms occur, advise the patient to contact his or her physician immediately [see Boxed Warning]. Invasive or Surgical Procedures Instruct patients to inform their healthcare professional that they are taking rivaroxaban tablets before any invasive procedure (including dental procedures) is scheduled. Concomitant Medication and Herbals Advise patients to inform their physicians and dentists if they are taking, or plan to take, any prescription or over-the-counter drugs or herbals, so their healthcare professionals can evaluate potential interactions [see Drug Interactions ( 7 )].
Pregnancy and Pregnancy-Related Hemorrhage • Advise patients to inform their physician immediately if they become pregnant or intend to become pregnant during treatment with rivaroxaban [see Use in Specific Populations ( 8.1 )]. • Advise pregnant women receiving rivaroxaban to immediately report to their physician any bleeding or symptoms of blood loss [see Warnings and Precautions ( 5.7 )]. Lactation Advise patients to discuss with their physician the benefits and risks of rivaroxaban for the mother and for the child if they are nursing or intend to nurse during anticoagulant treatment [see Use in Specific Populations ( 8.2 )].
Females and Males of Reproductive Potential Advise patients who can become pregnant to discuss pregnancy planning with their physician [see Use in Specific Populations ( 8.3 )]. Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufactured by: Macleods Pharmaceuticals Ltd.
Baddi, Himachal Pradesh- 174101, INDIA All trademarks are the property of their respective owners. Dispense with Medication Guide available at: www.macleodspharma.com/usa Revised: 04/2026
💬 Medication Guide ▾
SPL MEDGUIDE SECTION MEDICATION GUIDE Rivaroxaban (RIV a ROX a ban) Tablets Dispense with Medication Guide available at: www.macleodspharma.com/usa What is the most important information I should know about rivaroxaban Tablets? Rivaroxaban Tablets may cause serious side effects, including: • Increased risk of blood clots if you stop taking rivaroxaban tablets. 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.
Rivaroxaban tablets lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking rivaroxaban tablets, you may have increased risk of forming a clot in your blood. Do not stop taking rivaroxaban tablets without talking to the doctor who prescribes it for you.
Stopping rivaroxaban tablets increases your risk of having a stroke. If you have to stop taking rivaroxaban tablets, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming. • Increased risk of bleeding . Rivaroxaban tablets can cause bleeding which can be serious and may lead to death.
This is because rivaroxaban tablets is a blood thinner medicine (anticoagulant) that lowers blood clotting. During treatment with rivaroxaban tablets you are likely to bruise more easily, and it may take longer for bleeding to stop. You may have a higher risk of bleeding if you take rivaroxaban tablets and have certain other medical problems.
You may have a higher risk of bleeding if you take rivaroxaban tablets and take other medicines that increase your risk of bleeding, including: o aspirin or aspirin containing products o long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs) o warfarin sodium (Coumadin®, Jantoven®) o any medicine that contains heparin o clopidogrel (Plavix®) o selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) o other medicines to prevent or treat blood clots Tell your doctor if you take any of these medicines.
Ask your doctor or pharmacist if you are not sure if your medicine is one listed above. Call your doctor or get medical help right away if you or your child develop any of these signs or symptoms of bleeding: o 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 o bleeding that is severe or you cannot control o red, pink or brown urine o bright red or black stools (looks like tar) o cough up blood or blood clots o vomit blood or your vomit looks like “coffee grounds” o headaches, feeling dizzy or weak o pain, swelling, or new drainage at wound sites o 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).
People who take a blood thinner medicine (anticoagulant) like rivaroxaban tablets, and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if: o a thin tube called an epidural catheter is placed in your back to give you certain medicine o you take NSAIDs or a medicine to prevent blood from clotting o you have a history of difficult or repeated epidural or spinal punctures o you have a history of problems with your spine or have had surgery on your spine If you take rivaroxaban tablets and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots.
Tell your doctor right away if you have: back pain m…