Gilteritinib: uses, dosing, side effects & brands
Gilteritinib 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
- Tablet
- Sold as
- Xospata
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
Every gilteritinib 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: Xospata.
Gilteritinib and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for gilteritinib: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on gilteritinib during breastfeeding. It is 94% bound to plasma proteins, so amounts in milk are likely to be low; however, it has a long half-life of about 113 hours. The manufacturer recommends that breastfeeding be discontinued during gilteritinib therapy and for 2 months after the last dose.
National Institute of Child Health and Human Development, record revised February 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about gilteritinib
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 11 reports naming gilteritinib, and the FDA flagged 91% 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:
- myelosuppression4 reports
- pyrexia3 reports
- acute myeloid leukaemia recurrent2 reports
- c-reactive protein increased2 reports
- diarrhoea2 reports
- full blood count decreased2 reports
- immunodeficiency2 reports
- nausea2 reports
Read these as a signal, not a rate. A report does not mean gilteritinib 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.
Source: openFDA drug/event (FAERS), retrieved September 25, 2026.
Related calculators
Frequently asked questions
Can you take gilteritinib 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 gilteritinib 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 gilteritinib come in?
Across the brands we track, gilteritinib is currently marketed as 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 gilteritinib?
We do not currently list a generic-labelled gilteritinib 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). Gilteritinib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/gilteritinib
- MLA
- “Gilteritinib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/gilteritinib.
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 gilteritinib on DailyMed (NIH) ↗.