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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.

GIMERACIL\OTERACIL\TEGAFUR: 2,447 Adverse Event Reports & Safety Profile

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2,447
Total FAERS Reports
465 (19.0%)
Deaths Reported
906
Hospitalizations
2,447
As Primary/Secondary Suspect
201
Life-Threatening
31
Disabilities

First Report: 20021008 · Latest Report: 20250917

What Are the Most Common GIMERACIL\OTERACIL\TEGAFUR Side Effects?

#1 Most Reported
Myelosuppression
270 reports (11.0%)
#2 Most Reported
Diarrhoea
267 reports (10.9%)
#3 Most Reported
Decreased appetite
254 reports (10.4%)

All GIMERACIL\OTERACIL\TEGAFUR Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Myelosuppression 270 11.0% 8 131
Diarrhoea 267 10.9% 42 97
Decreased appetite 254 10.4% 40 90
Nausea 214 8.8% 16 49
Disease progression 199 8.1% 45 26
Neutropenia 173 7.1% 20 23
Anaemia 149 6.1% 20 27
Thrombocytopenia 129 5.3% 13 17
Neuropathy peripheral 128 5.2% 15 13
Drug ineffective 127 5.2% 36 33
Vomiting 125 5.1% 16 35
Malignant neoplasm progression 119 4.9% 53 41
Fatigue 111 4.5% 10 18
Febrile neutropenia 110 4.5% 32 42
Off label use 109 4.5% 15 40
Leukopenia 107 4.4% 6 8
Interstitial lung disease 94 3.8% 38 47
Death 89 3.6% 89 11
White blood cell count decreased 87 3.6% 9 36
Pyrexia 86 3.5% 18 57

Who Reports GIMERACIL\OTERACIL\TEGAFUR Side Effects? Age & Gender Data

Gender: 29.4% female, 70.6% male. Average age: 65.5 years. Most reports from: JP. View detailed demographics →

Is GIMERACIL\OTERACIL\TEGAFUR Getting Safer? Reports by Year

YearReportsDeathsHosp.
2002 1 1 0
2003 1 1 0
2004 1 0 1
2005 1 1 0
2006 2 1 1
2007 1 1 1
2008 1 0 1
2009 4 2 1
2010 4 2 3
2011 10 3 1
2012 9 5 3
2013 21 7 6
2014 34 10 18
2015 36 13 17
2016 66 23 34
2017 67 18 46
2018 54 9 38
2019 65 12 30
2020 68 15 38
2021 83 12 45
2022 137 15 96
2023 82 13 49
2024 172 14 103
2025 53 11 31

View full timeline →

What Is GIMERACIL\OTERACIL\TEGAFUR Used For?

IndicationReports
Gastric cancer 725
Pancreatic carcinoma 145
Gastric cancer stage iv 107
Adenocarcinoma gastric 91
Colon cancer 91
Colorectal cancer metastatic 80
Non-small cell lung cancer 73
Her2 positive gastric cancer 70
Metastases to liver 69
Rectal cancer 59

GIMERACIL\OTERACIL\TEGAFUR vs Alternatives: Which Is Safer?

GIMERACIL\OTERACIL\TEGAFUR vs GINKGO GIMERACIL\OTERACIL\TEGAFUR vs GIVINOSTAT GIMERACIL\OTERACIL\TEGAFUR vs GIVOSIRAN GIMERACIL\OTERACIL\TEGAFUR vs GLASDEGIB GIMERACIL\OTERACIL\TEGAFUR vs GLATIRAMER GIMERACIL\OTERACIL\TEGAFUR vs GLECAPREVIR\PIBRENTASVIR GIMERACIL\OTERACIL\TEGAFUR vs GLEEVEC GIMERACIL\OTERACIL\TEGAFUR vs GLICLAZIDE GIMERACIL\OTERACIL\TEGAFUR vs GLIMEPIRIDE GIMERACIL\OTERACIL\TEGAFUR vs GLIMEPIRIDE\ROSIGLITAZONE

Official FDA Label for GIMERACIL\OTERACIL\TEGAFUR

Official prescribing information from the FDA-approved drug label.