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rivaroxaban

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Brand names: Xarelto

Direct Oral Anticoagulant (Factor Xa Inhibitor) Rx

Rivaroxaban (Xarelto) is a drug that helps to prevent blood clots from forming. It is used to lower the risk of stroke and treat or prevent dangerous clots in your veins and lungs.

Drug Pricing (NADAC)

Brand Price

$18.21/unit

Generic Available

Yes (13 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

This medicine can help prevent strokes in people with an irregular heartbeat called atrial fibrillation.

Common side effects

Bleeding, Cough, Vomiting

Key warnings

This medicine has two important warnings.

How It Works

Rivaroxaban is a factor Xa inhibitor. It blocks a substance in your blood called factor Xa. By blocking factor Xa, the medicine helps to prevent blood clots from forming.

How to Take It

Take this medicine exactly as your doctor tells you. The dose depends on what condition you have. Some doses should be taken with food, while others can be taken with or without food. If you have trouble swallowing pills, talk to your doctor about the oral suspension form.

Pregnancy & Breastfeeding

Talk to your doctor if you are pregnant or plan to become pregnant. This medicine may cause bleeding problems during pregnancy and delivery. It is not known if this medicine passes into breast milk, so talk to your doctor about the risks and benefits of breastfeeding.

Missed Dose

If you miss a dose, take it as soon as you remember. If you take it twice a day, take both doses at once to make up for the missed dose.

Storage

Store at room temperature between 68°F to 77°F. Keep out of the reach of children.

Side Effects (from patient reports)

Based on 81,250 FDA adverse event reports.

Bleeding in the stomach or intestines
21,559
Using the medicine for something it's not approved for
7,808
Bleeding
7,713
Shortness of breath
7,149
Nosebleed
6,698
Tiredness
6,546
Death
6,030
Fall
6,003
Blood clot in the lungs
5,962
The medicine is not working
5,782

FDA Adverse Event Report Analysis

Detailed analysis of 203,269 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2007–2025.

Total Reports

203,269

Death-Related Reports

26,830

Hospitalization Reports

102,060

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 91,224 (50%)
Male 91,403 (50%)

Age Distribution

0–17 2,873
18–44 8,377
45–64 32,734
65–74 39,786
75+ 56,115

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 GASTROINTESTINAL HAEMORRHAGE 21,559
2 OFF LABEL USE 7,808
3 HAEMORRHAGE 7,714
4 DYSPNOEA 7,149
5 EPISTAXIS 6,698
6 FATIGUE 6,546
7 DEATH 6,030
8 FALL 6,003
9 PULMONARY EMBOLISM 5,962
10 DRUG INEFFECTIVE 5,782
11 ANAEMIA 5,590
12 CEREBROVASCULAR ACCIDENT 5,543
13 DIARRHOEA 5,496
14 DIZZINESS 5,364
15 NAUSEA 5,235

Reactions in Death Reports

DEATH 6,020
GASTROINTESTINAL HAEMORRHAGE 4,743
CEREBRAL HAEMORRHAGE 1,638
ACUTE KIDNEY INJURY 1,448
FALL 1,173
HAEMORRHAGE 1,142
UPPER GASTROINTESTINAL HAEMORRHAGE 988
HAEMORRHAGE INTRACRANIAL 986
EPISTAXIS 973
INTERNAL HAEMORRHAGE 964

Reactions in Hospitalization Reports

GASTROINTESTINAL HAEMORRHAGE 18,375
ACUTE KIDNEY INJURY 4,523
FALL 4,303
UPPER GASTROINTESTINAL HAEMORRHAGE 4,289
ANAEMIA 4,247
DYSPNOEA 4,166
RECTAL HAEMORRHAGE 4,053
EPISTAXIS 3,970
OFF LABEL USE 3,554
HAEMATURIA 3,456

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

This medicine has two important warnings. First, stopping this medicine too early can increase your risk of blood clots. Do not stop taking it without talking to your doctor first. Second, if you receive spinal anesthesia or have a spinal puncture while taking this medicine, you have a risk of a blood clot forming around your spine, which can cause long-term paralysis.

Known Drug Interactions

moderate clopidogrel

7.4 Anticoagulants and NSAIDs/Aspirin Coadministration of enoxaparin, warfarin, aspirin, clopidogrel and chronic NSAID use may increase the risk of bleeding [see Clinical Pharmacology (12.3) ].

Mechanism: Both drugs work to prevent blood clots, so taking them together makes it much easier for you to bleed.

What to do: Your doctor should monitor you closely for any signs of bleeding while taking these medicines.

moderate aspirin

7.4 Anticoagulants and NSAIDs/Aspirin Coadministration of enoxaparin, warfarin, aspirin, clopidogrel and chronic NSAID use may increase the risk of bleeding [see Clinical Pharmacology (12.3) ]. 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) ] .

Mechanism: Using these two medicines at the same time increases the risk of bleeding because they both interfere with how blood clots.

What to do: Seek medical help immediately if you notice signs of blood loss, like coughing up blood or black stools.

moderate warfarin

7.4 Anticoagulants and NSAIDs/Aspirin Coadministration of enoxaparin, warfarin, aspirin, clopidogrel and chronic NSAID use may increase the risk of bleeding [see Clinical Pharmacology (12.3) ].

Mechanism: These are both powerful blood thinners, and using them together significantly raises the chance of dangerous bleeding.

What to do: This combination should generally be avoided unless specifically directed and monitored by your healthcare provider.

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 XARELTO 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) ] .

Mechanism: Ketoconazole stops your body from breaking down rivaroxaban, which can cause the medicine to build up to unsafe levels.

What to do: Do not take these two medications together as it can increase your risk of side effects.

7.3 Drugs that Induce Cytochrome P450 3A Enzymes and Drug Transport Systems Avoid concomitant use of XARELTO with drugs that are combined P-gp and strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin, St.

Mechanism: Carbamazepine causes your body to process rivaroxaban too quickly, which may prevent the drug from protecting you against blood clots.

What to do: Avoid taking these drugs together to ensure your blood thinner stays at the right level in your body.

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Common Questions

What should I do if I experience heavy bleeding?
Contact your doctor immediately. Rivaroxaban can increase your risk of bleeding, and you may need medical attention.
Can I take aspirin or ibuprofen with rivaroxaban?
Talk to your doctor before taking aspirin, ibuprofen, or other pain relievers with rivaroxaban, as they can increase your risk of bleeding.
Will I need regular blood tests while taking rivaroxaban?
Your doctor may order blood tests to monitor your kidney and liver function, as well as your blood counts.
Can I drink alcohol while taking rivaroxaban?
Talk to your doctor about alcohol consumption while taking rivaroxaban, as it may increase your risk of bleeding.
What if I need surgery or a dental procedure?
Tell your doctor or dentist that you are taking rivaroxaban before any surgery or dental procedure. You may need to stop taking it temporarily.
Are there any foods I should avoid while taking rivaroxaban?
There are no specific foods you need to avoid while taking rivaroxaban.
How long will I need to take rivaroxaban?
The length of treatment with rivaroxaban depends on your condition and your doctor's recommendations.
Can I crush or chew the tablets?
Swallow the tablets whole. If you have trouble swallowing, talk to your doctor about the oral suspension form.
What are the symptoms of a blood clot?
Symptoms of a blood clot in the leg (DVT) include pain, swelling, redness, and warmth. Symptoms of a blood clot in the lung (PE) include shortness of breath, chest pain, and coughing up blood.
Is there an antidote for rivaroxaban?
Yes, there is an agent to reverse the activity of rivaroxaban if needed.
What are the common side effects of rivaroxaban?
The most commonly reported side effects of rivaroxaban include Bleeding, Cough, Vomiting, Gastroenteritis (inflammation of the stomach and intestines). Based on 81,250 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does rivaroxaban interact with other medications?
Yes, rivaroxaban has 14 known drug interactions. Notable interactions include clopidogrel, aspirin, warfarin. Always inform your doctor about all medications you are taking.
What drug class is rivaroxaban?
rivaroxaban belongs to the Direct Oral Anticoagulant (Factor Xa Inhibitor) drug class. It requires a prescription (Rx). This medicine can help prevent strokes in people with an irregular heartbeat called atrial fibrillation.
Is rivaroxaban safe during pregnancy?
Talk to your doctor if you are pregnant or plan to become pregnant. This medicine may cause bleeding problems during pregnancy and delivery. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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What the FDA Data Shows for rivaroxaban

The FDA label for rivaroxaban (sold under brand names such as Xarelto) classifies it as a prescription-only medication in the Direct Oral Anticoagulant (Factor Xa Inhibitor) class. This medicine can help prevent strokes in people with an irregular heartbeat called atrial fibrillation. Official labeling lists 4 commonly reported side effects, including Bleeding, Cough, Vomiting.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 81,250 voluntary reports. The database also lists 14 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: January 16, 2026

All federal data sources used on this page