Tipiracil / trifluridine Side Effects

In Summary

Commonly reported side effects of tipiracil/trifluridine include: infection, anemia, asthenia, diarrhea, fatigue, fever, nausea, neutropenia, thrombocytopenia, vomiting, and decreased appetite. Other side effects include: alopecia, and dysgeusia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to tipiracil / trifluridine: oral tablet

Along with its needed effects, tipiracil/trifluridine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tipiracil / trifluridine:

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• cough or hoarseness
• fever or chills
• lower back or side pain
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• sore throat
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness

• Bladder pain
• bloody or cloudy urine
• frequent urge to urinate
• headache
• muscle aches
• stuffy or runny nose

Some side effects of tipiracil / trifluridine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach pain
• change in taste
• decreased appetite
• diarrhea
• hair loss or thinning of the hair
• lack or loss of strength
• loss of taste
• nausea
• swelling or inflammation of the mouth
• vomiting

For Healthcare Professionals

Applies to tipiracil / trifluridine: oral tablet

Hematologic

Very common (10% or more): Anemia (77%), neutropenia (67%), thrombocytopenia (42%)
Common (1% to 10%): Febrile neutropenia^[Ref]

Other

Very common (10% or more): Asthenia/fatigue (52%), infections (27%), pyrexia (19%)^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (48%), diarrhea (32%), vomiting (28%), abdominal pain (21%)
Common (1% to 10%): Stomatitis (8%)^[Ref]

General

3.6% of patients discontinued treatment for an adverse event; 13.7% required a dose reduction, most commonly for neutropenia, anemia, febrile neutropenia, fatigue, and diarrhea.^[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, pulmonary emboli
Uncommon (0.1% to 1%): Interstitial lung disease^[Ref]

Metabolic

Very common (10% or more): Decreased appetite (39%)^[Ref]

Cardiovascular

Common (1% to 10%): QTc interval prolongation^[Ref]

Nervous system

Common (1% to 10%): Dysgeusia^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infections^[Ref]

Dermatologic

Common (1% to 10%): Alopecia^[Ref]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer