Xarelto Side Effects FAQs
Created by FindLaw's team of legal writers and editors | Last reviewed December 03, 2018
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Q: What is Xarelto?
Xarelto is a brand name version of the generic anticoagulant (blood thinner) medication rivaroxaban. Manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (J&J), Xarelto decreases the blood's clotting ability, thus preventing the formation of harmful clots in the blood vessels. The U.S. Food and Drug Administration (FDA) approved Xarelto for use in 2011.
Q: What does Xarelto specifically treat?
Xarelto is a multipurpose medication that has received FDA approval to treat several conditions. Xarelto was first approved to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism in patients undergoing hip and knee replacement surgeries.
DVT is a blood clot that forms deep in the veins. They typically develop in the lower leg or thigh area, which explains their tendency to emerge after operations on the hips and knees. The clot can break off into the blood stream and travel to the lungs, potentially blocking blood flow and developing into a pulmonary emobilism. Thus, pulmonary embolism is a condition where the pulmonary arteries in the lungs become blocked, usually caused by DVT.
In 2012, the FDA broadened the use of Xarelto as a treatment for DVT and pulmonary embolism. The FDA approved Xarelto for general use, meaning that doctors can prescribe Xarelto to any patient vulnerable to DVT or pulmonary embolism whether or not they have undergone an operation. The FDA also approved Xarelto to treat recurrent DVT and pulmonary embolism following initial formation.
In addition, Xarelto has been approved by the FDA to prevent blood clots and strokes in patients with an irregular heart condition called atrial fibrillation.
Q: What are common Xarelto side effects?
As with any medication, Xarelto can present certain complications. Some common Xarelto side effects include:
- Headache
- Bladder or bowel issues
- Back pain
- Itching or burning sensations
- Black or red-colored stools
- Dark brown or red urine
- Respiratory issues (trouble breathing and swallowing)
Q: Are there any serious Xarelto side effects?
Unfortunately, Xarelto can have an unintentionally severe impact on blood proteins, causing the blood to become extremely thin and leaving the patient susceptible to internal or external bleeding. As Xarelto is designed to prevent clotting, there is a risk that excessive bleeding may continue until Xarelto has exited the patient's system.
Bleeding can cause serious health issues or even become fatal. For example, if there is bleeding near a vital organ such as the brain, lungs, or kidneys, then the normal blood flow to that organ may be interrupted. This disruption in the delivery of oxygen and vital nutrients could cause the organ to fail or otherwise lose some of its function.
The FDA advises that Xarelto patients tell their health care professionals if they have any signs of serious bleeding including:
- Prolonged bleeding from wounds or gums
- Unusual bruising
- Frequent nosebleeds
- Coughing blood
- Abnormal menstrual flow - prolonged/heavy
Q: Does Xarelto carry a boxed warning?
A boxed warning, also known as a black box warning, is the strongest type of FDA warning that can appear on prescription drug labels. A boxed warning usually indicates that medical studies have concluded a particular medication poses a serious health risk or life-threatening complications.
Xarelto carries a boxed warning stating that early/premature discontinuation of Xarelto increases the risk of thrombotic events. If use of Xarelto is discontinued for any reason besides problematic bleeding or the completion of treatment, patients are advised to strongly consider using a different anticoagulant medication.
Q: What are the benefits of filing a lawsuit?
Patients who believe they have been harmed by Xarelto side effects can elect to file a lawsuit against J&J. A successful plaintiff can be compensated for injuries such as lost wages, medical expenses, and pain and suffering.
Any Xarelto lawsuits will likely be based on product liability law, which imposes a duty on manufacturers and sellers to ensure that their products are free from any unexpected defects or dangers. A successful plaintiff in a product liability case must show that the product was defective and that this defect caused his or her injuries.
Q: Where can I get expert legal advice about my claim?
If you've been injured by Xarelto and believe you have a valid injury claim, it may be a good idea to seek professional legal advice. Contact an experienced drugs and medical devices attorney near you today to learn more about your potential legal claim for suffering side effects from Xarelto.
Next Steps
Contact a qualified product liability attorney to make sure your rights are protected.