Rivaroxaban

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• CAD or PAD:
• 2.5 mg orally twice daily with or without food, in combination with aspirin (75 to 100 mg) once daily ( 2.1 )
• Recommended Dosage in
• Adults Table 1:
• Recommended Dosage in
• Adults Indication Renal Considerations* Dosage Food/Timing † Re duction 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 to 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 doseadjustment neededbased on CrCl 2.5 mg twice daily , plus aspirin (75 to 100 mg) once daily.
• When starting therapy after asuccessful lower extremityrevascularization procedure,initiate once hemostasis has beenestablished.
• 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 )]
• 2.2 Recommended Dosage in Pediatric Patients Rivaroxaban 2.5 mg tablets are not recommended for use in pediatric patients [see Use in Specific Populations ( 8.4 )] .
• 2.3 Switching 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 in
• adults and below 2.5 in pediatric patients 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 - 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 tablet dose would have been taken [see Drug Interactions ( 7.4 )].
• Switching from Anticoagulants other than Warfarin to Rivaroxaban Tablets - 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.
• 2.4 Discontinuation 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.
• Missed Dose
• Adults For patients receiving 2.5 mg twice daily:
• if a dose is missed, the patient should take a single 2.5 mg rivaroxaban tablet dose as recommended at the next scheduled time.
• On the following day, the patient should continue with their regular regimen.
• 2.6 Administration Options For adult patients who are unable to swallow whole tablets, rivaroxaban tablets (all strengths) may be crushed and mixed with applesauce immediately prior to use and administered orally.
• Administration with food is not required for the 2.5 mg tablets [see Clinical Pharmacology ( 12.3 )].
• Administration of rivaroxaban tablets via nasogastric (NG) tube or gastric feeding tube :
• After confirming gastric placement of the tube, rivaroxaban tablets may be crushed and suspended in 50 mL of water and administered via an NG tube or gastric feeding tube.
• Since rivaroxaban absorption is dependent on the site of drug release,
• avoid administration of rivaroxaban tablets distal to the stomach which can result in reduced absorption and thereby, reduced drug exposure.
• Enteral feeding is not required following administration of the 2.5 mg tablets [see Clinical Pharmacology ( 12.3 )].
• Crushed rivaroxaban tablets (all strengths) are stable in water and in applesauce for up to 4 hours.
• An in vitro compatibility study indicated that there is no adsorption of rivaroxaban from a water suspension of a crushed rivaroxaban tablets to PVC or silicone nasogastric (NG) tubing.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

Side effects

• 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 wasbleeding.
• ( 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 Dr.
• Reddy’s Laboratories, Inc. at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
• 6.1 Clinical 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.
• Hemorrhage The most common adverse reactions with rivaroxaban 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=9,134 n (%/year) Placebo † N=9,107 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 tablets 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 of premature permanent discontinuation due to bleeding events for rivaroxaban 2.5 mg twice daily vs. placebo on background therapy with aspirin 100 mg once daily in VOYAGER was 4.1% vs. 1.6% and in COMPASS PAD was 2.7% vs. 1.3%, respectively.
• Table 11 shows the number of patients experiencing various types of TIMI (Thrombolysis inMyocardial Infarction) major bleeding events in the VOYAGER trial.
• The most common site of bleeding was gastrointestinal.
• Table 11:
• Major Bleeding Events* in VOYAGER - On Treatment Plus 2 D ays Rivaroxaban † N=3,256 Placebo † N=3,248 Rivaroxaban vs.
• Placebo HR (95 % CI) Parameter n (%) Event rate %/year n (%) Event rate %/year TIMI Major Bleeding (CABG/non-CABG) 62 (1.9) 0.96 44 (1.4) 0.67 1.4 (1.0, 2.1) Fatal bleeding 6 (0.2) 0.09 6 (0.2) 0.09 1.0 (0.3, 3.2) Intracranial bleeding 13 (0.4) 0.20 17 (0.5) 0.26 0.8 (0.4, 1.6) Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL or drop in hematocrit of ≥15% 46 (1.4) 0.71 24 (0.7) 0.36 1.9 (1.2, 3.2) * Major bleeding events within each subcategory were counted once per patient, but patients may have contributed events to multiple subcategories. † Treatment schedule:
• Rivaroxaban tablets 2.5 mg twice daily or placebo.
• All patients received background therapy with aspirin 100 mg once daily.
• CABG: Coronary artery bypass graft;
• CI: confidence interval;
• HR: hazard ratio;
• TIMI:
• Thrombolysis in Myocardial Infarction Bleeding Criteria Other Adverse Reactions Non-hemorrhagic adverse reactions reported in ≥1% of rivaroxaban-treated patients in the EINSTEIN DVT and EINSTEIN PE studies are shown in Table 12.
• Table 12:
• Other Adverse Reactions * Reported by ≥1% of Rivaroxaban -Treated Patients in EINSTEIN DVT and EINSTEIN PE Studies Body System Adverse Reaction EINSTEIN DVT Study Rivaroxaban 20 mg N=1,718 n (%) Enoxaparin/VKA N=1,711 n (%) Gastrointestinal disorders Abdominal pain 46 (2.7) 25 (1.5) General disorders and administration site conditions Fatigue 24 (1.4) 15 (0.9) Musculoskeletal and connective tissue disorders Back pain 50 (2.9) 31 (1.8) Muscle spasm 23 (1.3) 13 (0.8) Nervous system disorders Dizziness 38 (2.2) 22 (1.3) Psychiatric disorders Anxiety 24 (1.4) 11 (0.6) Depression 20 (1.2) 10 (0.6) Insomnia 28 (1.6) 18 (1.1) EINSTEIN PE Study Rivaroxaban 20 mg N=2,412 n (%) Enoxaparin/VKA N=2,405 n (%) Skin and subcutaneous tissue disorders Pruritus 53 (2.2) 27 (1.1) * Adverse reaction with Relative Risk >1.5 for rivaroxaban versus comparator Non-hemorrhagic adverse reactions reported in ≥1% of rivaroxaban-treated patients in RECORD 1 to 3 studies are shown in Table 13.
• Table 13:
• Other Adverse Drug Reactions * Reported by ≥1% of Rivaroxaban -Treated Patients in RECORD 1 to 3 Studies Body System Adverse Reaction Rivaroxaban 10 mg N=4,487 n (%) Enoxaparin † N=4,524 n (%) Injury, poisoning and procedural complications Wound secretion 125 (2.8) 89 (2.0) Musculoskeletal and connective tissue disorders Pain in extremity 74 (1.7) 55 (1.2) Muscle spasm 52 (1.2) 32 (0.7) Nervous system disorders Syncope 55 (1.2) 32 (0.7) Skin and subcutaneous tissue disorders Pruritus 96 (2.1) 79 (1.8) Blister 63 (1.4) 40 (0.9) * Adverse reaction occurring any time following the first dose of double-blind medication, which may have been prior to administration of active drug, until two days after the last dose of double-blind study medication † Includes the placebo-controlled period of RECORD 2, enoxaparin dosing was 40 mg once daily (RECORD 1 to 3) Non-bleeding adverse reactions reported in ≥5% of rivaroxaban-treated patients are shown in Table 17.
• Table 17:
• Other Adverse Reactions * Reported by ≥5% of Rivaroxaban-Treated Patients in UNIVERSE Study (Part B) Adverse Reaction Rivaroxaban N=64 n (%) Aspirin N=34 n (%) Cough 10 (15.6) 3 (8.8) Vomiting 9 (14.1) 3 (8.8) Gastroenteritis † 8 (12.5) 1 (2.9) Rash † 6 (9.4) 2 (5.9) * Adverse reaction with Relative Risk >1.5 for rivaroxaban versus aspirin. † The following terms were combined:Gastroenteritis:
• gastroenteritis, gastroenteritis viralRash:
• rash, rash maculo-papular, viral rash
• 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of rivaroxaban.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Blood and lymphatic system disorders:
• agranulocytosis, thrombocytopenia Hepatobiliary disorders:
• jaundice, cholestasis, hepatitis (including hepatocellular injury) Immune system disorders:
• hypersensitivity, anaphylactic reaction, anaphylactic shock, angioedema Nervous system disorders:
• hemiparesis Renal disorders:
• Anticoagulant-related nephropathy Respiratory, thoracic and mediastinal disorders:
• Eosinophilic pneumonia Skin and subcutaneous tissue disorders :
• Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS) Injury, poisoning and procedural complications:
• Atraumatic splenic rupture

Quoted from the official label, section “Adverse Reactions”.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

32 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Rivaroxaban