What the label lists and what reports show
Pemigatinib side effects
Pemigatinib's FDA label: “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 …” FAERS holds 821 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (79 reports).
- No generic listed
Check it at the source: the pemigatinib FDA label on DailyMed (effective June 9, 2026, Incyte Corporation); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of PEMAZYRE?PEMAZYRE may cause serious side effects, including: Eye problems. Certain eye problems are common with PEMAZYRE but can also be serious. Eye problems include dry eye or inflamed eyes, inflamed cornea (front part of the eye), increased tears, and a disorder of the retina (an internal part of the eye). You will need to see an eye specialist for a complete eye exam before you begin treatment with PEMAZYRE, every 2 months for the first 6 months, and then every 3 months during treatment with PEMAZYRE. You should use artificial tears or substitutes, hydrating or lubricating eye gels as needed, to help prevent or treat dry eyes. Tell your healthcare provider right away if you develop any changes in your vision during treatment with PEMAZYRE, including: blurred vision, flashes of light, or see black spots. You may need to see an eye specialist right away. […]
Source: FDA drug label, Incyte Corporation, effective June 9, 2026 (SPL set 9e1f2222-1d89-4e63-989c-ccebe2ab1eb4), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe 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.
Table 3: Adverse Reactions (≥ 15%) in Patients Receiving PEMAZYRE in FIGHT-202
| Reaction | Adverse Reaction All Grades Graded per NCI CTCAE 4.03. (%) | PEMAZYRE N=146 Grades 3 or 4 (%) |
|---|---|---|
| Hyperphosphatemia Includes hyperphosphatemia and blood phosphorous increased; graded… | 60 | 0 |
| Decreased appetite | 33 | 1.4 |
| Hypophosphatemia Includes hypophosphatemia and blood phosphorous decreased. | 23 | 12 |
| Dehydration | 15 | 3.4 |
| Alopecia | 49 | 0 |
| Nail toxicity Includes nail toxicity, nail disorder, nail discoloration, nail dystrophy,… | 43 | 2.1 |
| Dry skin | 20 | 0.7 |
| Palmar-plantar erythrodysesthesia syndrome | 15 | 4.1 |
| Diarrhea | 47 | 2.7 |
| Nausea | 40 | 2.1 |
| Constipation | 35 | 0.7 |
| Stomatitis | 35 | 5 |
| Dry mouth | 34 | 0 |
| Vomiting | 27 | 1.4 |
| Abdominal pain | 23 | 4.8 |
| Fatigue | 42 | 4.8 |
| Edema peripheral | 18 | 0.7 |
| Dysgeusia | 40 | 0 |
| Headache | 16 | 0 |
| Dry eye Includes dry eye, keratitis, lacrimation increased, pinguecula, and punctate… | 35 | 0.7 |
| Arthralgia | 25 | 6 |
| Back pain | 20 | 2.7 |
| Pain in extremity | 19 | 2.1 |
| Urinary tract infection | 16 | 2.7 |
| Weight loss | 16 | 2.1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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.
Source: FDA drug label, Incyte Corporation, effective June 9, 2026 (SPL set 9e1f2222-1d89-4e63-989c-ccebe2ab1eb4), via openFDA; the full label on DailyMed
What do FAERS reports show?
821 reports list pemigatinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 144 are coded as a death and 197 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 15 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Pemigatinib: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions