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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.

FOTEMUSTINE: 264 Adverse Event Reports & Safety Profile

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264
Total FAERS Reports
40 (15.2%)
Deaths Reported
79
Hospitalizations
264
As Primary/Secondary Suspect
44
Life-Threatening
2
Disabilities

First Report: 20051116 · Latest Report: 20230501

What Are the Most Common FOTEMUSTINE Side Effects?

#1 Most Reported
Off label use
66 reports (25.0%)
#2 Most Reported
Disease progression
38 reports (14.4%)
#3 Most Reported
Acute myeloid leukaemia
30 reports (11.4%)

All FOTEMUSTINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 66 25.0% 9 16
Disease progression 38 14.4% 8 0
Acute myeloid leukaemia 30 11.4% 4 8
Thrombocytopenia 29 11.0% 6 15
Mucosal inflammation 25 9.5% 5 10
Neutropenia 24 9.1% 6 10
Product use in unapproved indication 23 8.7% 1 12
Platelet count decreased 22 8.3% 1 1
Neutrophil count decreased 20 7.6% 0 1
Septic shock 20 7.6% 3 11
White blood cell count decreased 20 7.6% 1 0
Diffuse large b-cell lymphoma 17 6.4% 0 0
Diffuse large b-cell lymphoma recurrent 17 6.4% 0 0
Drug ineffective 17 6.4% 2 3
Vomiting 17 6.4% 6 8
Pancytopenia 15 5.7% 1 0
Pyrexia 15 5.7% 0 10
Anaemia 14 5.3% 7 3
Cytomegalovirus infection 14 5.3% 4 10
Haematotoxicity 13 4.9% 0 3

Who Reports FOTEMUSTINE Side Effects? Age & Gender Data

Gender: 48.0% female, 52.0% male. Average age: 52.0 years. Most reports from: IT. View detailed demographics →

Is FOTEMUSTINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 2 2 2
2010 2 1 1
2011 1 1 0
2012 4 2 3
2013 2 0 1
2014 4 0 3
2015 14 0 5
2016 16 1 14
2017 32 1 16
2018 5 0 4
2019 26 0 2
2020 7 0 2
2021 14 0 0
2022 6 0 6
2023 2 0 2

View full timeline →

What Is FOTEMUSTINE Used For?

IndicationReports
Diffuse large b-cell lymphoma 77
Bone marrow conditioning regimen 21
Non-hodgkin's lymphoma 20
Autologous bone marrow transplantation therapy 14
Glioblastoma 14
Diffuse large b-cell lymphoma stage iv 12
Metastatic malignant melanoma 10
Stem cell transplant 10
Intraocular melanoma 8
Product used for unknown indication 8

FOTEMUSTINE vs Alternatives: Which Is Safer?

FOTEMUSTINE vs FRAMYCETIN FOTEMUSTINE vs FREMANEZUMAB FOTEMUSTINE vs FREMANEZUMAB-VFRM FOTEMUSTINE vs FROVATRIPTAN FOTEMUSTINE vs FRUCTOSE FOTEMUSTINE vs FRUQUINTINIB FOTEMUSTINE vs FULVESTRANT FOTEMUSTINE vs FURAZOLIDONE FOTEMUSTINE vs FUROSEMIDE FOTEMUSTINE vs FUROSEMIDE\SPIRONOLACTONE

Official FDA Label for FOTEMUSTINE

Official prescribing information from the FDA-approved drug label.