Note: This document contains side effect information about baloxavir marboxil. Some dosage forms listed on this page may not apply to the brand name Xofluza.
Applies to baloxavir marboxil: oral tablet.
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
- Chest tightness
- cough producing mucus
- difficulty breathing
- fever
- headache
- muscle aches
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
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
- Nausea
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
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
Common (1% to 10%): Bronchitis, sinusitis, nasopharyngitis
Frequency not reported: Dysphonia[Ref]
