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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.

TIPIRACIL\TRIFLURIDINE: 10,250 Adverse Event Reports & Safety Profile

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10,250
Total FAERS Reports
4,127 (40.3%)
Deaths Reported
2,862
Hospitalizations
10,250
As Primary/Secondary Suspect
119
Life-Threatening
45
Disabilities

Active Ingredient: TIPIRACIL HYDROCHLORIDE\TRIFLURIDINE ·

First Report: 20041106 · Latest Report: 20250908

What Are the Most Common TIPIRACIL\TRIFLURIDINE Side Effects?

#1 Most Reported
Death
3,017 reports (29.4%)
#2 Most Reported
Disease progression
1,774 reports (17.3%)
#3 Most Reported
Fatigue
1,298 reports (12.7%)

All TIPIRACIL\TRIFLURIDINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Death 3,017 29.4% 3,013 197
Disease progression 1,774 17.3% 831 388
Fatigue 1,298 12.7% 197 335
Nausea 1,135 11.1% 172 335
Diarrhoea 965 9.4% 111 321
Decreased appetite 659 6.4% 105 216
Vomiting 628 6.1% 93 277
White blood cell count decreased 483 4.7% 49 202
Asthenia 472 4.6% 104 228
Anaemia 388 3.8% 76 183
Neutropenia 370 3.6% 53 127
Drug ineffective 361 3.5% 33 41
Constipation 322 3.1% 42 115
Dehydration 318 3.1% 41 249
Abdominal pain 313 3.1% 43 134
Weight decreased 302 3.0% 58 124
Inappropriate schedule of product administration 280 2.7% 109 72
Off label use 268 2.6% 114 77
Malaise 247 2.4% 49 119
Pain 240 2.3% 52 126

Who Reports TIPIRACIL\TRIFLURIDINE Side Effects? Age & Gender Data

Gender: 42.8% female, 57.2% male. Average age: 64.0 years. Most reports from: US. View detailed demographics →

Is TIPIRACIL\TRIFLURIDINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2004 1 0 0
2012 3 1 0
2014 7 2 4
2015 133 70 53
2016 1,417 403 321
2017 1,189 333 325
2018 990 350 282
2019 741 419 277
2020 685 407 219
2021 651 377 194
2022 495 329 124
2023 481 289 124
2024 298 149 106
2025 142 37 69

View full timeline →

What Is TIPIRACIL\TRIFLURIDINE Used For?

IndicationReports
Colon cancer 4,053
Colorectal cancer metastatic 1,320
Rectal cancer 1,297
Product used for unknown indication 811
Colorectal cancer 404
Colon cancer metastatic 370
Rectosigmoid cancer 263
Gastric cancer 171
Neoplasm malignant 147
Adenocarcinoma of colon 135

TIPIRACIL\TRIFLURIDINE vs Alternatives: Which Is Safer?

TIPIRACIL\TRIFLURIDINE vs TIPRANAVIR TIPIRACIL\TRIFLURIDINE vs TIRAGOLUMAB TIPIRACIL\TRIFLURIDINE vs TIRBANIBULIN TIPIRACIL\TRIFLURIDINE vs TIROFIBAN TIPIRACIL\TRIFLURIDINE vs TIRZEPATIDE TIPIRACIL\TRIFLURIDINE vs TISAGENLECLEUCEL TIPIRACIL\TRIFLURIDINE vs TISLELIZUMAB TIPIRACIL\TRIFLURIDINE vs TISOTUMAB VEDOTIN TIPIRACIL\TRIFLURIDINE vs TISOTUMAB VEDOTIN-TFTV TIPIRACIL\TRIFLURIDINE vs TITANIUM DIOXIDE\ZINC

Official FDA Label for TIPIRACIL\TRIFLURIDINE

Official prescribing information from the FDA-approved drug label.