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baloxavir marboxil

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Brand names: Xofluza

Endonuclease Inhibitor (Antiviral) Rx

Xofluza is an antiviral medicine that can treat the flu. It can also prevent the flu if you have been around someone who is sick.

Drug Pricing (NADAC)

Brand Price

$157.18/unit

Generic Available

No

GENENTECH INC

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

Xofluza is used to treat the flu in people 5 years and older.

Common side effects

Diarrhea, Bronchitis, Nausea

Key warnings

Xofluza can cause allergic reactions like anaphylaxis.

How It Works

Xofluza stops the flu virus from making more copies of itself in your body. It does this by blocking a protein the virus needs to grow. This helps you get better faster or prevents you from getting sick.

How to Take It

Take Xofluza as a single dose as soon as possible, but within 48 hours of when your flu symptoms started or after you were exposed to the flu. You can take Xofluza with or without food. The dose you need depends on your weight. If you weigh less than 80 kg (176 lbs), you will take one 40 mg tablet. If you weigh 80 kg (176 lbs) or more, you will take one 80 mg tablet.

Pregnancy & Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. The benefits of taking Xofluza should be weighed against any potential risks to the baby. It is not known if Xofluza passes into breast milk. Talk to your doctor about the best way to feed your baby if you take Xofluza.

Missed Dose

Xofluza is taken as a single dose, so you don't have to worry about missing a dose.

Storage

Store Xofluza tablets in their original blister package at room temperature, between 68°F and 77°F.

Side Effects (from patient reports)

Based on 1,855 FDA adverse event reports.

No Adverse Event
518
Off Label Use
419
Intentional Product Use Issue
283
Diarrhoea
129
Vomiting
120
Pneumonia
111
Drug Ineffective
86
Nausea
70
Rash
61
Headache
58

FDA Adverse Event Report Analysis

Detailed analysis of 2,164 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2017–2025.

Total Reports

2,164

Death-Related Reports

130

Hospitalization Reports

417

Top Indication

Influenza

Gender Distribution

Female 909 (54%)
Male 771 (46%)

Age Distribution

0–17 619
18–44 288
45–64 243
65–74 109
75+ 151

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 NO ADVERSE EVENT 518
2 OFF LABEL USE 419
3 INTENTIONAL PRODUCT USE ISSUE 283
4 DIARRHOEA 129
5 VOMITING 120
6 PNEUMONIA 111
7 DRUG INEFFECTIVE 86
8 NAUSEA 70
9 RASH 61
10 HEADACHE 58
11 INFLUENZA 57
12 COLITIS ISCHAEMIC 56
13 HYPERPYREXIA 54
14 PYREXIA 51
15 URTICARIA 42

Reactions in Death Reports

DEATH 32
PNEUMONIA 18
INFLUENZA 10
RESPIRATORY FAILURE 9
CARDIO-RESPIRATORY ARREST 7
MULTIPLE ORGAN DYSFUNCTION SYNDROME 7
ACUTE KIDNEY INJURY 6
DRUG INEFFECTIVE 6
OFF LABEL USE 6
ACUTE RESPIRATORY DISTRESS SYNDROME 5

Reactions in Hospitalization Reports

PNEUMONIA 52
DIARRHOEA 29
COLITIS ISCHAEMIC 25
VOMITING 24
RHABDOMYOLYSIS 17
OFF LABEL USE 16
ANAPHYLACTIC REACTION 14
PYREXIA 13
ABDOMINAL PAIN 12
DRUG ERUPTION 12

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Xofluza can cause allergic reactions like anaphylaxis. Get medical help right away if you have trouble breathing, hives, or swelling. Xofluza is not for children under 5 years old because it may not work as well in this age group. Xofluza does not prevent bacterial infections, which can happen with the flu. See a doctor if you think you have a bacterial infection.

Known Drug Interactions

7 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). 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).

Mechanism: Zinc can bind to this medicine in your stomach and prevent it from being absorbed into your body. This makes the medicine less effective at treating the flu.

What to do: Do not take this medicine at the same time as supplements containing zinc. Avoid these products during your treatment.

moderate selenium

7 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). 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).

Mechanism: Selenium can attach to the medicine in your digestive system and stop it from getting into your bloodstream. This prevents the drug from working correctly.

What to do: Avoid taking selenium supplements at the same time as this medication. Talk to your doctor about when it is safe to take your supplements.

Common Questions

How quickly does Xofluza work?
Xofluza starts working as soon as you take it, but it may take a day or two for you to feel better.
Can I take Xofluza if I'm allergic to eggs?
Yes, Xofluza does not contain eggs, so you can take it even if you have an egg allergy.
Can Xofluza prevent me from spreading the flu to others?
Xofluza can help you get better faster, which may reduce the time you are contagious. However, it's still important to practice good hygiene, like washing your hands, to avoid spreading the flu.
Can I take Xofluza with other medicines?
Avoid taking Xofluza with dairy products, calcium-fortified drinks, antacids, or supplements containing calcium, iron, magnesium, selenium, or zinc. These can make Xofluza less effective. Talk to your doctor or pharmacist about other medicines you are taking.
What if I start feeling worse after taking Xofluza?
If you start feeling worse or develop new symptoms after taking Xofluza, contact your doctor. It could be a sign of a bacterial infection.
Is there a generic version of Xofluza?
No, there is currently no generic version of Xofluza available.
How effective is Xofluza?
Xofluza has been shown to shorten the duration of flu symptoms by about one day in otherwise healthy people.
Can I get the flu again even if I take Xofluza?
Yes, it is possible to get the flu again, even if you have taken Xofluza. The flu virus can change, and Xofluza may not protect you from all strains.
Does Xofluza interact with the flu shot?
Using Xofluza with a live flu vaccine given through the nose (LAIV) is not recommended, as it may make the vaccine less effective. Interactions between inactivated flu vaccines and Xofluza have not been evaluated.
What should I do if someone in my family has the flu?
If someone in your family has the flu, talk to your doctor about whether Xofluza is right for you. It can be used to prevent the flu after exposure.
What are the common side effects of baloxavir marboxil?
The most commonly reported side effects of baloxavir marboxil include Diarrhea, Bronchitis, Nausea, Sinusitis, Vomiting (in children). Based on 1,855 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does baloxavir marboxil interact with other medications?
Yes, baloxavir marboxil has 2 known drug interactions. Notable interactions include zinc sulfate, selenium. Always inform your doctor about all medications you are taking.
What drug class is baloxavir marboxil?
baloxavir marboxil belongs to the Endonuclease Inhibitor (Antiviral) drug class. It requires a prescription (Rx). Xofluza is used to treat the flu in people 5 years and older.
Is baloxavir marboxil safe during pregnancy?
Tell your doctor if you are pregnant or plan to become pregnant. The benefits of taking Xofluza should be weighed against any potential risks to the baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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What the FDA Data Shows for baloxavir marboxil

The FDA label for baloxavir marboxil (sold under brand names such as Xofluza) classifies it as a prescription-only medication in the Endonuclease Inhibitor (Antiviral) class. Xofluza is used to treat the flu in people 5 years and older. Official labeling lists 6 commonly reported side effects, including Diarrhea, Bronchitis, Nausea.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 1,855 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: August 22, 2025

All federal data sources used on this page