Futibatinib: uses, dosing, side effects & brands
Futibatinib is a medicine sold in the U.S. under one brand, for cholangiocarcinoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats (across its forms)
- Cholangiocarcinoma
- Available as
- Tablet · Kit
- Sold as
- Lytgobi
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How futibatinib is dosed
From the FDA label for Lytgobi (application NDA214801). Other futibatinib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Confirm the presence of an FGFR2 gene fusion or other rearrangement prior to initiation of treatment with LYTGOBI. ( 2.1 ) Recommended dose is 20 mg orally (five 4 mg tablets or one 16 mg tablet and one 4 mg tablet) once daily until disease progression or unacceptable toxicity occurs. ( 2.2 ) Swallow tablet whole, with or without food. ( 2.2 ) 2.1 Patient Selection Select patients for the treatment of unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma with LYTGOBI based on the presence of an FGFR2 gene fusion or rearrangement [see Clinical Studies (14.1) ]. An FDA-approved test for detection of FGFR2 gene fusions or other rearrangements in patients with unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma for selecting patients for treatment with LYTGOBI is not available. 2.2 Recommended Dosage The recommended dosage of LYTGOBI is 20 mg (five 4 mg tablets or one 16 mg and one 4 mg tablet) taken orally once daily until disease progression or unacceptable toxicity occurs. Take LYTGOBI with or without food at approximately the same time each day [see Clinical Pharmacology (12.3) ] . Swallow tablets whole. Do not crush, chew, split, or dissolve tablets. If the patient misses a dose of LYTGOBI for more than 12 hours or if vomiting occurs, resume dosing with the next scheduled dose. 2.3 Dosage Modification for Adverse Reactions The…
Futibatinib side effects
The following adverse reactions are discussed elsewhere in the labeling: Ocular Toxicity [see Warnings and Precautions (5.1) ] Hyperphosphatemia and Soft Tissue Mineralization [see Warnings and Precautions (5.2) ] Most common (≥20%) adverse reactions were nail toxicity, musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, dysgeusia, dry eye, nausea, decreased appetite, urinary tract infection, palmar-plantar erythrodysesthesia syndrome, and vomiting. ( 6.1 ) Most common laboratory abnormalities (≥20%) were increased phosphate, increased creatinine, decreased hemoglobin, increased glucose, increased calcium, decreased sodium, decreased phosphate, increased alanine aminotransferase, increased alkaline phosphatase, decreased lymphocytes, increased aspartate aminotransferase, decreased platelets, increased activated partial thromboplastin time, decreased leukocytes, decreased albumin, decreased neutrophils, increased creatine kinase, increased bilirubin, decreased glucose, increased prothrombin international normalized ratio, and decreased potassium. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Taiho Oncology Inc. at 1-844-878-2446 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse…
Who shouldn’t take futibatinib
None. None ( 4 )
Futibatinib drug interactions
Strong CYP3A inhibitors : Avoid concomitant use. ( 7.1 ) Strong CYP3A inducers : Avoid concomitant use. ( 7.1 ) 7.1 Effect of Other Drugs on LYTGOBI Strong CYP3A Inhibitors Avoid concomitant use of strong CYP3A inhibitors with LYTGOBI. Futibatinib is a CYP3A substrate [see Clinical Pharmacology (12.3) ] . Concomitant use of a strong CYP3A inhibitor increases futibatinib exposure [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions. Strong CYP3A Inducers Avoid concomitant use of strong CYP3A inducers with LYTGOBI. Futibatinib is a CYP3A substrate [see Clinical Pharmacology (12.3) ] . Concomitant use of a strong CYP3A inducer decreases futibatinib exposure [see Clinical Pharmacology (12.3) ] , which may reduce the effectiveness of LYTGOBI.
Every futibatinib 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: Lytgobi.
What futibatinib pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Can you crush or split futibatinib?
At least one futibatinibproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each futibatinib label says about crushing, splitting and chewingWhat people report to the FDA about futibatinib
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 40 reports naming futibatinib, and the FDA flagged 85% 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:
- hyperphosphataemia5 reports
- decreased appetite3 reports
- alanine aminotransferase increased2 reports
- dehydration2 reports
- drug effective for unapproved indication2 reports
- hypercalcaemia2 reports
- hypotension2 reports
- metastases to bone2 reports
Read these as a signal, not a rate. A report does not mean futibatinib 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.
Related calculators
Frequently asked questions
What is futibatinib?
Lytgobi (Futibatinib) is a medication used to treat Cholangiocarcinoma.
Can you take futibatinib 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 futibatinib 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 futibatinib come in?
Across the brands we track, futibatinib is currently marketed as tablet and kit, 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 futibatinib?
We do not currently list a generic-labelled futibatinib 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). Futibatinib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/futibatinib
- MLA
- “Futibatinib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/futibatinib.
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 futibatinib on DailyMed (NIH) ↗.