Baloxavir Marboxil: uses, dosing, side effects & brands
Baloxavir Marboxil is a medicine sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Available as
- Powder · Tablet
- Sold as
- Xofluza
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How baloxavir marboxil is dosed
From the FDA label for Xofluza (application NDA214410). Other baloxavir marboxil products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Treatment and Post-Exposure Prophylaxis of Influenza Take XOFLUZA as a single dose as soon as possible and within 48 hours of influenza symptom onset for treatment of acute uncomplicated influenza or following contact with an individual who has influenza. XOFLUZA may be taken with or without food. ( 2.1 , 2.2 ) Patient Body Weight Recommended Single Oral Dose in Patients 5 Years of Age and Older (Tablets) 20 kg to less than 80 kg One 40 mg tablet (blister card contains one 40 mg tablet) At least 80 kg One 80 mg tablet (blister card contains one 80 mg tablet) Patient Body Weight Recommended Single Oral Dose in Patients 5 Years of Age and Older For Oral Suspension (Packets) 15 kg to less than 20 kg One 30 mg packet 20 kg to less than 80 kg One 40 mg packet At least 80 kg 80 mg (two 40 mg packets) Patient Body Weight Recommended Single Oral Dose in Patients 5 Years of Age and Older For Oral Suspension (Bottles) Less than 20 kg 2 mg/kg 20 kg to less than 80 kg 40 mg (20 mL) At least 80 kg 80 mg (40 mL) Refer to the Full Prescribing Information for additional information on the recommended dosage and preparation of XOFLUZA for oral suspension (bottles) or for oral suspension (packets) for both for oral or enteral use in patients 5 years of age and older. ( 2.2 , 2.3 ) 2.1 Dosage and Administration Overview XOFLUZA is available in two dosage forms: XOFLUZA tablets (40 mg and 80 mg).…
Baloxavir Marboxil side effects
Adverse events reported in at least 1% of adult and adolescent influenza subjects treated with XOFLUZA included diarrhea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%). ( 6.1 ) Adverse events reported in at least 5% of pediatric subjects (5 to < 12 years) treated with XOFLUZA included vomiting (5%) and diarrhea (5%). To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The overall safety profile of XOFLUZA is based on data from 2,079 subjects, 5 years of age and older in 5 controlled clinical trials who received XOFLUZA. Of these subjects, 1,943 were adults and adolescents (≥ 12 years of age) and 136 were in the pediatric age group (5 to < 12 years of age) [see Clinical Studies (14) ] . Treatment of Acute Uncomplicated Influenza Adult and Adolescent Subjects (≥ 12 Years of Age): The safety of XOFLUZA in adult and adolescent subjects is based on data from 3 placebo-controlled trials in which a total of 1,640 subjects received XOFLUZA: 1,334 (81%) subjects were 18 to 64 years of age, 209 (13%)…
Who shouldn’t take baloxavir marboxil
XOFLUZA is contraindicated in patients with a history of hypersensitivity to baloxavir marboxil or any of its ingredients. Serious allergic reactions have included anaphylaxis, angioedema, urticaria, and erythema multiforme [see Warnings and Precautions (5.1) ]. XOFLUZA is contraindicated in patients with a history of hypersensitivity to baloxavir marboxil or any of its ingredients. ( 4 )
Baloxavir Marboxil drug interactions
Avoid coadministration of XOFLUZA with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc). ( 2.1 , 7.1 ) Live attenuated influenza vaccines may be affected by antivirals. ( 7.2 ) 7.1 Effect of Other Drugs on XOFLUZA Baloxavir may form a chelate with polyvalent cations such as calcium, aluminum, or magnesium. Coadministration with polyvalent cation-containing products may decrease plasma concentrations of baloxavir [see Clinical Pharmacology (12.3) ], which may reduce XOFLUZA efficacy. Avoid coadministration of XOFLUZA with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc). 7.2 Vaccines The concurrent use of XOFLUZA with intranasal live attenuated influenza vaccine (LAIV) has not been evaluated. Concurrent administration of antiviral drugs may inhibit viral replication of LAIV and thereby decrease the effectiveness of LAIV vaccination. Interactions between inactivated influenza vaccines and XOFLUZA have not been evaluated.
Every baloxavir marboxil product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Xofluza.
What baloxavir marboxil pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
What people report to the FDA about baloxavir marboxil
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 129 reports naming baloxavir marboxil, and the FDA flagged 96% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- hyperpyrexia19 reports
- vomiting15 reports
- rash11 reports
- diarrhoea10 reports
- nausea8 reports
- abdominal pain6 reports
- acute kidney injury6 reports
- acute respiratory distress syndrome6 reports
Read these as a signal, not a rate. A report does not mean baloxavir marboxil caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
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Frequently asked questions
What is baloxavir marboxil?
Baloxavir marboxil is an influenza virus PA endonuclease inhibitor. The active component of XOFLUZA is baloxavir marboxil.
Can you take baloxavir marboxil with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run baloxavir marboxil against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does baloxavir marboxil come in?
Across the brands we track, baloxavir marboxil is currently marketed as powder and tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic baloxavir marboxil?
We do not currently list a generic-labelled baloxavir marboxil product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Baloxavir Marboxil: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/baloxavir-marboxil
- MLA
- “Baloxavir Marboxil: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/baloxavir-marboxil.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for baloxavir marboxil on DailyMed (NIH) ↗.