Note: This document contains side effect information about betrixaban. Some dosage forms listed on this page may not apply to the brand name Bevyxxa.
Applies to betrixaban: oral capsule.
Warning
- People who have any type of spinal or epidural procedure are more likely to have bleeding problems around the spine when already on this drug. This bleeding rarely happens, but can lead to not being able to move body (paralysis) long-term or paralysis that will not go away. The risk is raised in people who have problems with their spine, a certain type of epidural catheter, or have had spinal surgery. The risk is also raised in people who take any other drugs that may affect how the blood clots like blood-thinner drugs (like warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs). Talk with the doctor.
- Tell your doctor you use this drug before you have a spinal or epidural procedure. Call your doctor right away if you have any signs of nerve problems like back pain, numbness or tingling, muscle weakness, paralysis, or loss of bladder or bowel control.
- Talk with your doctor if you have recently had or will be having a spinal or epidural procedure. Some time may need to pass between the use of this drug and your procedure. Talk with your doctor.
Serious side effects of Bevyxxa
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Dizziness or passing out.
- Feeling tired or weak.
- Feeling confused.
- Headache.
- Joint pain or swelling.
Other side effects of Bevyxxa
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
For Healthcare Professionals
Applies to betrixaban: oral capsule.
General
The most common adverse events were related to bleeding.[Ref]
Hematologic
Common (1% to 10%): Clinically relevant non-major bleeding
Uncommon (0.1% to 1%): Major bleeding (gastrointestinal, intracranial, and fatal)
Cardiovascular
Common (1% to 10%): Hypertension[Ref]
Metabolic
Common (1% to 10%): Hypokalemia[Ref]
Gastrointestinal
Common (1% to 10%): Constipation, nausea, diarrhea[Ref]
Respiratory
Common (1% to 10%): Epistaxis[Ref]
Nervous system
Common (1% to 10%): Headache[Ref]
Hypersensitivity
Rare (less than 0.1%): Moderate hypersensitivity[Ref]
