Skip to content
ppharmaranks
Menu

Pemigatinib: uses, dosing, side effects & brands

Pemigatinib 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.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Treats
Cholangiocarcinoma
Available as
Tablet
Sold as
Pemazyre
Prescription?
Prescription only
Generic available?
Not in our catalog

How pemigatinib is dosed

From the FDA label for Pemazyre (application NDA213736). Other pemigatinib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Cholangiocarcinoma: Confirm the presence of an FGFR2 fusion or rearrangement prior to initiation of treatment with PEMAZYRE. ( 2.1 ) Recommended dosage is 13.5 mg orally once daily for 14 consecutive days followed by 7 days off therapy in 21-day cycles. Continue treatment until disease progression or unacceptable toxicity occurs. ( 2.2 ) Myeloid/lymphoid neoplasms with FGFR1 rearrangement: Recommended dosage is 13.5 mg orally once daily. Continue treatment until disease progression or unacceptable toxicity. ( 2.2 ) All patients treated with PEMAZYRE: Swallow tablet whole, with or without food. ( 2.2 ) Severe Renal Impairment: the recommended dosage of PEMAZYRE is 9 mg with the schedule (intermittent or continuous) designated for the indication. ( 2.5 , 8.6 , 12.3 ) Severe Hepatic Impairment: the recommended dosage of PEMAZYRE is 9 mg with the schedule (intermittent or continuous) designated for the indication. ( 2.6 , 8.7 , 12.3 ) 2.1 Patient Selection Select patients for the treatment of locally advanced or metastatic cholangiocarcinoma with PEMAZYRE based on the presence of an FGFR2 fusion or rearrangement as detected by an FDA-approved test [see Clinical Studies ( 14.1 )]. Information on FDA-approved test(s) for the detection of an FGFR2 fusion or rearrangement in cholangiocarcinoma is available at http://www.fda.gov/CompanionDiagnostics . Select patients for the treatment…

Pemigatinib 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 )] Cholangiocarcinoma: The most common adverse reactions (incidence ≥ 20%) are hyperphosphatemia, alopecia, diarrhea, nail toxicity, fatigue, dysgeusia, nausea, constipation, stomatitis, dry eye, dry mouth, decreased appetite, vomiting, arthralgia, abdominal pain, hypophosphatemia, back pain, and dry skin. ( 6.1 ) Myeloid/lymphoid neoplasms with FGFR1 rearrangement: The most common (≥ 20%) adverse reactions are hyperphosphatemia, nail toxicity, alopecia, stomatitis, diarrhea, dry eye, fatigue, rash, abdominal pain, anemia, constipation, dry mouth, epistaxis, serous retinal detachment, extremity pain, decreased appetite, dry skin, dyspepsia, back pain, nausea, blurred vision, peripheral edema, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Incyte Corporation at 1-855-463-3463 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 pooled safety population…

Who shouldn’t take pemigatinib

None. None. ( 4 )

Pemigatinib drug interactions

Strong and Moderate CYP3A Inducers: Avoid concomitant use of PEMAZYRE. ( 7.1 ) Strong and Moderate CYP3A Inhibitors: Avoid concomitant use. If concomitant use cannot be avoided, reduce PEMAZYRE dosage. ( 2.4 , 7.1 ) 7.1 Effect of Other Drugs on PEMAZYRE Strong and Moderate CYP3A Inducers Concomitant use of PEMAZYRE with a strong or moderate CYP3A inducer decreases pemigatinib plasma concentrations [ see Clinical Pharmacology ( 12.3 )], which may reduce the efficacy of PEMAZYRE. Avoid concomitant use of strong and moderate CYP3A inducers with PEMAZYRE. Strong and Moderate CYP3A Inhibitors Concomitant use of a strong or moderate CYP3A inhibitor with PEMAZYRE increases pemigatinib plasma concentrations [see Clinical Pharmacology ( 12.3 )], which may increase the incidence and severity of adverse reactions. Avoid concomitant use of strong and moderate CYP3A inhibitors with PEMAZYRE. Reduce PEMAZYRE dosage if concomitant use of strong and moderate CYP3A inhibitors cannot be avoided [see Dosage and Administration ( 2.4 )] .

Every pemigatinib 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: Pemazyre.

What pemigatinib pills look like

Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.

Pemigatinib pill imprints
ImprintStrengthColourShape
I;454.5 mgwhiteround
I;99 mgwhiteoval
I;13513.5 mgwhiteround

Can you crush or split pemigatinib?

At least one pemigatinibproduct 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 pemigatinib label says about crushing, splitting and chewing

What people report to the FDA about pemigatinib

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 209 reports naming pemigatinib, and the FDA flagged 43% 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:

  • fatigue43 reports
  • alopecia28 reports
  • decreased appetite26 reports
  • nausea25 reports
  • stomatitis21 reports
  • constipation20 reports
  • diarrhoea19 reports
  • dry mouth18 reports

Read these as a signal, not a rate. A report does not mean pemigatinib 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 pemigatinib?

Pemazyre (Pemigatinib) is a medication used to treat Cholangiocarcinoma.

Can you take pemigatinib 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 pemigatinib 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 pemigatinib come in?

Across the brands we track, pemigatinib 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 pemigatinib?

We do not currently list a generic-labelled pemigatinib 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). Pemigatinib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/pemigatinib
MLA
“Pemigatinib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/pemigatinib.

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 pemigatinib on DailyMed (NIH) ↗.