What the label lists and what reports show
Rivaroxaban side effects
Rivaroxaban's FDA label: “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 Janssen …” FAERS holds 206,938 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is gastrointestinal haemorrhage (21,636 reports).
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the rivaroxaban FDA label on DailyMed (effective September 10, 2026, Janssen Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of XARELTO?XARELTO may cause serious side effects: See " What is the most important information I should know about XARELTO? " The most common side effect of XARELTO in adults was bleeding. The most common side effects of XARELTO in children include: bleeding vomiting cough inflamed stomach and gut Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800-FDA-1088.
Source: FDA drug label, Janssen Pharmaceuticals, Inc., effective September 10, 2026 (SPL set 10db92f9-2300-4a80-836b-673e1ae91610), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe 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 Janssen Pharmaceuticals, Inc.
Table 8: Bleeding Events Bleeding events occurring any time following the first dose of double-blind study medication (which may have been prior to administration of active drug) until two days after the last dose of…
| Total treated patients | XARELTO 10 mg N=4487 n (%) | Enoxaparin Includes the placebo-controlled period for RECORD 2, enoxaparin dosing was 40… N=4524 n (%) |
|---|---|---|
| Major bleeding event | 14 (0.3) | 9 (0.2) |
| Fatal bleeding | 1 (<0.1) | 0 |
| Bleeding into a critical organ | 2 (<0.1) | 3 (0.1) |
| Bleeding that required re-operation | 7 (0.2) | 5 (0.1) |
| Extra-surgical site bleeding requiring transfusion of >2 units of whole blood or packed… | 4 (0.1) | 1 (<0.1) |
| Any bleeding event Includes major bleeding events | 261 (5.8) | 251 (5.6) |
| Major bleeding event | 7 (0.2) | 3 (0.1) |
| Fatal bleeding | 1 (<0.1) | 0 |
| Bleeding into a critical organ | 1 (<0.1) | 1 (<0.1) |
| Bleeding that required re-operation | 2 (0.1) | 1 (<0.1) |
| Extra-surgical site bleeding requiring transfusion of >2 units of whole blood or packed… | 3 (0.1) | 1 (<0.1) |
| Any bleeding event | 201 (6.1) | 191 (5.8) |
| Major bleeding event | 7 (0.6) | 6 (0.5) |
| Fatal bleeding | 0 | 0 |
| Bleeding into a critical organ | 1 (0.1) | 2 (0.2) |
| Bleeding that required re-operation | 5 (0.4) | 4 (0.3) |
| Extra-surgical site bleeding requiring transfusion of >2 units of whole blood or packed… | 1 (0.1) | 0 |
| Any bleeding event | 60 (5.0) | 60 (4.9) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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 Janssen Pharmaceuticals, Inc. at 1-800-526-7736 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 XARELTO. Hemorrhage The most common adverse reactions with XARELTO were bleeding complications [see Warnings and Precautions (5.2) ]. …
Source: FDA drug label, Janssen Pharmaceuticals, Inc., effective September 10, 2026 (SPL set 10db92f9-2300-4a80-836b-673e1ae91610), via openFDA; the full label on DailyMed
What do FAERS reports show?
206,938 reports list rivaroxaban among the medicines taken, each a report of something that happened, not proof the medicine caused it; 27,139 are coded as a death and 103,514 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Rivaroxaban: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions