Xarelto Side Effects

As of June 30, 2024, gastrointestinal bleeding was the most common Xarelto side effect reported to the Food and Drug Administration. There were also frequent reports of nose bleeds, blood in the urine, hemorrhage, stroke and deep vein thrombosis. DVT is when a clot forms in a deep vein, usually in the leg. It is the third most common cardiovascular cause of death.

Disclaimer: Reports sent to the FDA don’t necessarily mean the drug caused an adverse event. Consult a health care professional before stopping or changing medication.

FAERS data confirm study results showing that bleeding events are the most common side effects of Xarelto and similar drugs. The FDA considers the vast majority of reported adverse events as serious.

According to prescribing information, bleeding is the most common side effect observed in adults taking Xarelto. Among pediatric patients, the most common side effects are bleeding, cough, vomiting and stomach or gut inflammation.

Many Xarelto side effects are mild, resolve on their own and do not interfere with treatment. However, there is an increased risk of major bleeding. This can cause serious health consequences, including death.

Data from clinical studies presented in the drug’s prescribing information show that Xarelto has an increased risk of major bleeding events compared to several other similar medications.

Managing Minor Bleeding

Minor bleeding is among the most common side effects of Xarelto. This can manifest as nose bleeds, heavier-than-normal periods, prolonged bleeding after a minor cut and bleeding gums. Some patients also report bruising more easily or bruises that fade slowly.

In general, minor bleeding is not a serious health threat. Steps that can help you manage most minor bleeding include applying pressure to cuts, and using a soft toothbrush and waxed floss on teeth. Ice packs may help bruises fade more quickly. Pinching your nose and applying ice can help stop nosebleeds when they develop.

If any bleeding becomes excessive, discuss your options with your healthcare provider.

Major bleeding is the most common serious side effect for patients taking Xarelto. Other serious side effects linked to rivaroxaban, the active ingredient of Xarelto, include anaphylaxis caused by hypersensitivity and hematomas.

“Patients should monitor for signs and symptoms of major bleeding including blood in the urine, blood in the stool, severe bruising, prolonged nosebleeds, and vomiting blood,” clinical pharmacist Kenneth S. Fill told Drugwatch.

As with other direct oral anticoagulants, discontinuing Xarelto may lead to an increased risk of developing thrombosis. Therefore, the discontinuation of Xarelto should be done with a health care provider’s guidance.

Major bleeding events require immediate action. A 2024 study published in Fundamental & Clinical Pharmacology showed that both specific reversal agents that were designed as antidotes, and nonspecific treatments, such as activated charcoal, can serve as antidotes to bleeding caused by direct oral anticoagulants.

Abnormally High Risk of Internal Bleeding

Xarelto carries an abnormally high risk of bleeding. Taking Xarelto with certain other medications, including some common over-the-counter medications like nonsteroidal anti-inflammatory drugs and aspirin, magnifies the risk of bleeding.

Patients with a history of cancer, bleeding disorders, lung disease, lung cavities or bleeding in or around the lungs, also face a greater risk of severe bleeding when taking Xarelto.

Xarelto packaging contains a warning about the risk of serious and potentially fatal bleeding.

Multiple patients filed Xarelto lawsuits against the manufacturers Janssen Pharmaceuticals and Bayer Corp. These lawsuits largely claimed the companies failed to fully warn patients about the medication risks. Many of the plaintiffs were patients who experienced complications from serious internal bleeding. Others focused on wound leakage and infection after hip and knee replacement surgery.

Post-Surgical Wound Drainage and Infection

A 2021 study published in the British Journal of Clinical Pharmacology showed that patients taking rivaroxaban, the active ingredient in Xarelto, have a higher incidence of major or clinically relevant bleeding events after surgery than patients taking other types of medication.

Additionally, patients taking Xarelto have a higher incidence of post-surgical wound complications compared to those not using the medication. Infections and wound draining may contribute to the need for additional surgery on the affected joint.

The FDA requires two boxed warnings on Xarelto packaging. The first is the increased risk of thrombosis with premature discontinuation of Xarelto. The second is the possibility of developing hematomas during certain spinal procedures.

These side effects can cause severe, permanent health complications or death.

“[The boxed warning] emphasizes the need for careful monitoring of patients who are on Xarelto and are about to undergo a spinal puncture or epidural anesthesia, given the risk of spinal hematomas,” Fill said.

Because Xarelto prevents clotting, suddenly stopping the medication may cause excessive clotting. This can lead to thrombosis, which is when a clot becomes lodged in a vein. Severe blood clots may lead to stroke or death.

If you must stop taking Xarelto, only do so after consulting your healthcare provider. You may need to switch to another anticoagulant to limit the risk of a clotting event.

There are multiple classes of anticoagulants on the market today, so patients have plenty of alternatives.

Pradaxa and Eliquis are direct oral anticoagulants, which is the same class as Xarelto. These blood thinners typically cause side effects similar to those seen with Xarelto.

Warfarin is an older kind of blood thinner that blocks the body’s ability to synthesize Vitamin K for blood clotting purposes. Therefore, you may need to modify your diet when taking warfarin to moderate your Vitamin K intake.

Lovenox, Fragmin and Arixtra are low-molecular-weight heparin (LMWH) medications. Similar to Xarelto, they work by blocking factor Xa, an enzyme used for blood clotting. They have similar rates of wound complications compared to Xarelto.

“Xarelto’s risk of major bleeding compared to other DOACs such as apixaban, dabigatran, and edoxaban is similar, except when it comes to gastrointestinal bleeding, which is slightly higher,” Fill said.

“It is important to note that the risk of bleeding can vary depending on patient factors.”

Editor Lindsay Donaldson contributed to this article.