85/100 · Critical
Manufactured by Taiho Pharmaceutical Co., Ltd.
High Serious Adverse Event Rate for Trifluridine and Tipiracil
21,382 FDA adverse event reports analyzed
Last updated: 2026-05-12
TRIFLURIDINE AND TIPIRACIL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Taiho Pharmaceutical Co., Ltd.. Based on analysis of 21,382 FDA adverse event reports, TRIFLURIDINE AND TIPIRACIL has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for TRIFLURIDINE AND TIPIRACIL include DEATH, DISEASE PROGRESSION, FATIGUE, NAUSEA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TRIFLURIDINE AND TIPIRACIL.
Trifluridine And Tipiracil has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 21,382 adverse event reports for this medication, which is primarily manufactured by Taiho Pharmaceutical Co., Ltd..
The most commonly reported adverse events include Death, Disease Progression, Fatigue. Of classified reports, 78.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The drug has a high rate of serious adverse events, including death and disease progression.
Fatigue, nausea, and diarrhea are common side effects reported by patients. There is a significant risk of hematological adverse events, such as decreased white blood cell count and anemia. The drug is associated with a high incidence of gastrointestinal issues, including constipation and abdominal pain.
Patients taking Trifluridine And Tipiracil should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Trifluridine and Tipiracil can cause significant hematological and gastrointestinal side effects, and patients should be monitored closely for these issues. Drug interactions and inappropriate administration schedules are also important to avoid. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Trifluridine And Tipiracil received a safety concern score of 85/100 (high concern). This is based on a 78.5% serious event ratio across 10,345 classified reports. The score accounts for 21,382 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 5,883, Female: 4,255, Unknown: 1. The most frequently reported age groups are age 68 (275 reports), age 66 (262 reports), age 69 (261 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 10,345 classified reports for TRIFLURIDINE AND TIPIRACIL:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Trifluridine and Tipiracil can cause significant hematological and gastrointestinal side effects, and patients should be monitored closely for these issues. Drug interactions and inappropriate administration schedules are also important to avoid.
If you are taking Trifluridine And Tipiracil, here are important things to know. The most commonly reported side effects include death, disease progression, fatigue, nausea, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients closely for signs of hematological and gastrointestinal side effects, and adjust dosing as necessary. Educate patients on the importance of following the prescribed schedule and dosing instructions. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight is ongoing, with the FDA requiring post-marketing surveillance to monitor the drug's safety profile. Patients should report any adverse reactions to their healthcare provider immediately.
The FDA has received approximately 21,382 adverse event reports associated with Trifluridine And Tipiracil. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Trifluridine And Tipiracil include Death, Disease Progression, Fatigue, Nausea, Diarrhoea. By volume, the top reported reactions are: Death (3,062 reports), Disease Progression (1,779 reports), Fatigue (1,347 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Trifluridine And Tipiracil.
Out of 10,345 classified reports, 8,125 (78.5%) were classified as serious and 2,220 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Trifluridine And Tipiracil break down by patient sex as follows: Male: 5,883, Female: 4,255, Unknown: 1. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Trifluridine And Tipiracil adverse events are: age 68: 275 reports, age 66: 262 reports, age 69: 261 reports, age 62: 258 reports, age 70: 254 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Trifluridine And Tipiracil adverse event reports is Taiho Pharmaceutical Co., Ltd.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Trifluridine And Tipiracil include: Decreased Appetite, Vomiting, White Blood Cell Count Decreased, Asthenia, Drug Ineffective. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Trifluridine And Tipiracil to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Trifluridine And Tipiracil has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. The drug has a high rate of serious adverse events, including death and disease progression.
Key safety signals identified in Trifluridine And Tipiracil's adverse event data include: Death and disease progression are among the most serious reactions reported.. Hematological adverse events, particularly decreased white blood cell count and anemia, are frequent.. Gastrointestinal issues, such as constipation and abdominal pain, are commonly reported.. There is a notable risk of infections and sepsis.. The drug is associated with a high rate of hospitalization and therapy interruption.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Trifluridine and Tipiracil can cause significant hematological and gastrointestinal side effects, and patients should be monitored closely for these issues. Drug interactions and inappropriate administration schedules are also important to avoid. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Trifluridine And Tipiracil.
Monitor patients closely for signs of hematological and gastrointestinal side effects, and adjust dosing as necessary. Educate patients on the importance of following the prescribed schedule and dosing instructions.
Trifluridine And Tipiracil has 21,382 adverse event reports on file with the FDA. Fatigue, nausea, and diarrhea are common side effects reported by patients. The volume of reports for Trifluridine And Tipiracil reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with the FDA requiring post-marketing surveillance to monitor the drug's safety profile. Patients should report any adverse reactions to their healthcare provider immediately. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with TRIFLURIDINE AND TIPIRACIL:
Drugs related to TRIFLURIDINE AND TIPIRACIL based on therapeutic use, drug class, or shared indications: