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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.

FUTIBATINIB: 161 Adverse Event Reports & Safety Profile

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161
Total FAERS Reports
38 (23.6%)
Deaths Reported
60
Hospitalizations
161
As Primary/Secondary Suspect
2
Life-Threatening
Jul 28, 2025
FDA Approved
TAIHO PHARMACEUTICAL CO., LTD.
Manufacturer
Prescription
Status

Drug Class: Breast Cancer Resistance Protein Inhibitors [MoA] · Manufacturer: TAIHO PHARMACEUTICAL CO., LTD. · FDA Application: 214801 ·

Patent Expires: Nov 5, 2039 · First Report: 20200101 · Latest Report: 20250623

What Are the Most Common FUTIBATINIB Side Effects?

#1 Most Reported
Death
30 reports (18.6%)
#2 Most Reported
Diarrhoea
29 reports (18.0%)
#3 Most Reported
Hyperphosphataemia
22 reports (13.7%)

All FUTIBATINIB Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Death 30 18.6% 30 9
Diarrhoea 29 18.0% 4 13
Hyperphosphataemia 22 13.7% 6 6
Nausea 21 13.0% 9 12
Disease progression 20 12.4% 5 6
Dry mouth 18 11.2% 4 9
Fatigue 18 11.2% 6 8
Off label use 16 9.9% 5 4
Vomiting 15 9.3% 5 11
Dry eye 13 8.1% 0 5
Constipation 12 7.5% 2 8
Decreased appetite 12 7.5% 1 7
Neuropathy peripheral 12 7.5% 1 7
Asthenia 11 6.8% 4 7
Dehydration 11 6.8% 5 8
Blood phosphorus increased 10 6.2% 2 6
Dry skin 10 6.2% 0 5
Onychomadesis 10 6.2% 0 4
Pain in extremity 10 6.2% 1 4
Stomatitis 10 6.2% 3 5

Who Reports FUTIBATINIB Side Effects? Age & Gender Data

Gender: 51.3% female, 48.7% male. Average age: 61.8 years. Most reports from: US. View detailed demographics →

Is FUTIBATINIB Getting Safer? Reports by Year

YearReportsDeathsHosp.
2020 1 1 1
2021 3 0 3
2022 14 2 10
2023 25 9 16
2024 22 10 10
2025 8 1 3

View full timeline →

What Is FUTIBATINIB Used For?

IndicationReports
Cholangiocarcinoma 77
Product used for unknown indication 23
Oesophageal carcinoma 11
Bile duct cancer 10

FUTIBATINIB vs Alternatives: Which Is Safer?

FUTIBATINIB vs GABAPENTIN FUTIBATINIB vs GABAPENTIN ENACARBIL FUTIBATINIB vs GADAVIST FUTIBATINIB vs GADOBENATE DIMEGLUMINE FUTIBATINIB vs GADOBUTROL FUTIBATINIB vs GADODIAMIDE FUTIBATINIB vs GADOLINIUM FUTIBATINIB vs GADOPENTETATE DIMEGLUMINE FUTIBATINIB vs GADOPICLENOL FUTIBATINIB vs GADOTERATE MEGLUMINE

Other Drugs in Same Class: Breast Cancer Resistance Protein Inhibitors [MoA]

Official FDA Label for FUTIBATINIB

Official prescribing information from the FDA-approved drug label.