Xofluza Side Effects
Generic name: baloxavir marboxil
Medically reviewed by Drugs.com. Last updated on Aug 7, 2024.
Note: This document provides detailed information about Xofluza.
Applies to baloxavir marboxil: oral tablet Side Effects associated with baloxavir marboxil. Some dosage forms listed on this page may not apply specifically to the brand name Xofluza.
Applies to baloxavir marboxil: oral tablet.
Precautions
It is very important that your doctor check your or your child's progress after treatment to make sure that the infection is cleared up completely, and to allow your doctor to check for any unwanted effects.
If your or your child's symptoms do not improve or if they become worse, check with your doctor.
This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.
This medicine is not a substitute for an annual flu shot. It also will not keep you or your child from getting a bacterial infection that starts with flu-like symptoms.
Serious side effects of Xofluza
Along with its needed effects, baloxavir marboxil (the active ingredient contained in Xofluza) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking baloxavir marboxil:
Less common side effects
Incidence not known
- blistering, peeling, or loosening of the skin
- bloody, black, or tarry stools
- chills
- cough
- diarrhea
- difficulty swallowing
- dizziness
- fast heartbeat
- hives, itching, skin rash
- hoarseness
- joint or muscle pain
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red, irritated eyes
- sores, ulcers, or white spots in the mouth or on the lips
- voice changes
Other side effects of Xofluza
Some side effects of baloxavir marboxil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common side effects
Incidence not known
- seeing, hearing, or feeling things that are not there
- vomiting
For healthcare professionals
Applies to baloxavir marboxil: oral granule for reconstitution, oral tablet.
Dermatologic adverse events
- Postmarketing reports: Angioedema (swelling of face, eyelids, tongue, and lips), rash, urticaria, erythema multiforme[Ref]
Gastrointestinal
- Common (1% to 10%): Diarrhea, nausea
- Postmarketing reports: Vomiting, hematochezia, bloody diarrhea, melena, colitis, ischemic colitis[Ref]
Nausea was reported in 6% of elderly subjects compared to 1% of younger subjects (aged 18 to 64 years).[Ref]
Hypersensitivity
- Postmarketing reports: Anaphylactic reactions, anaphylactic shock, anaphylactoid reactions, anaphylaxis, hypersensitivity reactions[Ref]
Nervous system
- Common (1% to 10%): Headache[Ref]
Psychiatric
- Postmarketing reports: Delirium, abnormal behavior, hallucinations
Respiratory
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References
1. (2021) "Product Information. Xofluza (baloxavir marboxil)." Roche Products Pty Ltd, Xofluza 20210527
2. (2022) "Product Information. Xofluza (baloxavir marboxil)." Genentech, SUPPL-9
3. (2022) "Product Information. Xofluza (baloxavir marboxil)." Roche Products Ltd
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Further information
Xofluza side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.