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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

INFIGRATINIB: 67 Adverse Event Reports & Safety Profile

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67
Total FAERS Reports
11 (16.4%)
Deaths Reported
32
Hospitalizations
67
As Primary/Secondary Suspect
1
Life-Threatening
May 28, 2021
FDA Approved
Discontinued
Status

FDA Application: 214622 ·

Patent Expires: Dec 11, 2034 · First Report: 20160610 · Latest Report: 20221118

What Are the Most Common INFIGRATINIB Side Effects?

#1 Most Reported
Fatigue
16 reports (23.9%)
#2 Most Reported
Stomatitis
12 reports (17.9%)
#3 Most Reported
Off label use
11 reports (16.4%)

All INFIGRATINIB Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fatigue 16 23.9% 3 7
Stomatitis 12 17.9% 0 4
Off label use 11 16.4% 3 2
Alopecia 10 14.9% 2 4
Decreased appetite 10 14.9% 4 4
Diarrhoea 10 14.9% 0 7
Nausea 9 13.4% 2 4
Blood phosphorus increased 8 11.9% 3 2
Skin exfoliation 8 11.9% 1 3
Vomiting 8 11.9% 0 4
Death 7 10.5% 7 1
Malignant neoplasm progression 7 10.5% 1 1
Onychomadesis 7 10.5% 0 2
Vision blurred 7 10.5% 0 2
Constipation 6 9.0% 0 4
Dehydration 6 9.0% 1 5
Dry eye 6 9.0% 1 1
Dry mouth 6 9.0% 1 3
Pain in extremity 6 9.0% 1 3
Arthralgia 5 7.5% 0 2

Who Reports INFIGRATINIB Side Effects? Age & Gender Data

Gender: 58.3% female, 41.7% male. Average age: 54.2 years. Most reports from: US. View detailed demographics →

Is INFIGRATINIB Getting Safer? Reports by Year

YearReportsDeathsHosp.
2016 1 0 1
2018 2 0 1
2019 1 0 1
2020 5 0 4
2021 13 2 7
2022 28 7 15

View full timeline →

What Is INFIGRATINIB Used For?

IndicationReports
Cholangiocarcinoma 42

Official FDA Label for INFIGRATINIB

Official prescribing information from the FDA-approved drug label.