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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.

GEDATOLISIB: 43 Adverse Event Reports & Safety Profile

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43
Total FAERS Reports
0
Deaths Reported
29
Hospitalizations
43
As Primary/Secondary Suspect
1
Life-Threatening

First Report: 20130421 · Latest Report: 20230321

What Are the Most Common GEDATOLISIB Side Effects?

#1 Most Reported
Pyrexia
7 reports (16.3%)
#2 Most Reported
Hyperglycaemia
7 reports (16.3%)
#3 Most Reported
Embolism
5 reports (11.6%)

All GEDATOLISIB Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Hyperglycaemia 7 16.3% 0 1
Pyrexia 7 16.3% 0 3
Anaemia 5 11.6% 0 1
Embolism 5 11.6% 0 5

Who Reports GEDATOLISIB Side Effects? Age & Gender Data

Gender: 94.9% female, 5.1% male. Average age: 59.2 years. Most reports from: US. View detailed demographics →

Is GEDATOLISIB Getting Safer? Reports by Year

YearReportsDeathsHosp.
2013 1 0 1
2014 3 0 3
2015 2 0 1
2016 3 0 2
2017 2 0 2
2018 6 0 6
2019 4 0 4
2020 3 0 3
2021 3 0 3
2022 2 0 2
2023 2 0 1

View full timeline →

What Is GEDATOLISIB Used For?

IndicationReports
Breast cancer metastatic 15
Breast cancer 13

Official FDA Label for GEDATOLISIB

Official prescribing information from the FDA-approved drug label.