xospata
Pharmaranks rates Xospata 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Xospata (Gilteritinib Fumarate) is a medication used to treat Acute Myeloid Leukemia.
Gilteritinib Fumarate · by Astellas
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Gilteritinib Fumarate
- Form
- Tablet
- Strength
- Gilteritinib Fumarate EQ 40MG Base
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- acute myeloid leukemia
- Manufacturer
- Astellas
- FDA application
- NDA211349
May treat (source: NIH RxClass)
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Xospata treat?
- Xospata (Gilteritinib Fumarate) may be used to treat acute myeloid leukemia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Xospata rated?
- pharmaranks gives Xospata a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Xospata?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Xospata. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Xospata?
- Xospata is marketed by Astellas. You can see Astellas's full profile, rating, and other products on pharmaranks.
- Is Xospata a brand-name or generic drug?
- Xospata is a brand-name product with the active ingredient Gilteritinib Fumarate.
- Is Xospata available over the counter?
- No. Xospata is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Xospata come in?
- Xospata is currently marketed as tablet, per the FDA's National Drug Code Directory.
- Is Xospata FDA-registered?
- Xospata is on record with the U.S. FDA under application number NDA211349. You can verify this on its official FDA label.
- Has Xospata been recalled by the FDA?
- Xospata has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Xospata safe?
- There's no single safe-or-not verdict. pharmaranks gives Xospata a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
Information is sourced from public FDA regulatory data. Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
What people report to the FDA about GILTERITINIB FUMARATE
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 11 reports naming GILTERITINIB FUMARATE — the active ingredient in Xospata, 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 FUMARATE 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.
Reviews
No reviews yet. Be the first to write one.
People also viewed
idarubicin hydrochloride
Idarubicin Hydrochloride
idhifa
Enasidenib Mesylate
rydapt
Midostaurin
daunorubicin hydrochloride
Daunorubicin Hydrochloride
daurismo
Glasdegib Maleate
idamycin pfs
Idarubicin Hydrochloride
Compare Xospata head-to-head
Browse medications A–Z
Research products from A to Z, compare independent ratings, and find alternatives.
xospata
72/100