Quick answers
- What is Trifluridine and tipiracil used for?
- The FDA-approved label (Lonsurf, Taiho Pharmaceutical Co., Ltd., November 5, 2025) says: “LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Trifluridine and tipiracil?
- The “Adverse Reactions” section of the FDA label (Lonsurf, Taiho Pharmaceutical Co., Ltd., November 5, 2025) begins: “The following clinically significant adverse reactions are described elsewhere in the labeling: Severe Myelosuppression [see Warnings and Precautions (5.1)] The most common adverse reactions or laboratory abnormalities for single agent LONSURF (≥10%) are neutropenia, anemia, thrombocytopenia, fatigue, nausea, decreased appetite, diarrhea, vomiting, abdominal pain, and pyrexia.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Trifluridine and tipiracil have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Trifluridine and tipiracil?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Trifluridine and tipiracil been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Trifluridine and tipiracil?
- 1 company lists prescription products of Trifluridine and tipiracil in the FDA NDC Directory, including Taiho Pharmaceutical Co., Ltd.
What Trifluridine and tipiracil is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS …
— FDA label: Lonsurf, Taiho Pharmaceutical Co., Ltd., effective November 5, 2025. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, film coated, oral), Lonsurf, Taiho Pharmaceutical Co., Ltd.; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Trifluridine and tipiracil side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
The following clinically significant adverse reactions are described elsewhere in the labeling: Severe Myelosuppression [see Warnings and Precautions (5.1)] The most common adverse reactions or laboratory abnormalities for single agent LONSURF (≥10%) are neutropenia, anemia, thrombocytopenia, fatigue, nausea, decreased appetite, diarrhea, vomiting, abdominal pain, and pyrexia.
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(6.1) The most common adverse reactions or laboratory abnormalities for LONSURF in combination with bevacizumab (≥20%) are neutropenia, anemia, thrombocytopenia, fatigue, nausea, increased AST, increased ALT, increased alkaline phosphatase, decreased sodium, diarrhea, abdominal pain, and decreased appetite. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Taiho Oncology, Inc. at 1-844-878-2446 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described in the WARNINGS AND PRECAUTIONS section and below reflect exposure to LONSURF at the recommended dose in 533 patients with metastatic colorectal cancer in RECOURSE, 246 patients with metastatic colorectal cancer treated with LONSURF as monotherapy in SUNLIGHT and 335 patients with metastatic gastric cancer in TAGS. Among the 1114 patients who received LONSURF as a single agent, 12% were exposed for 6 months or longer and 1% were exposed for 12 months or longer. The most common adverse reactions or laboratory abnormalities (≥10%) were neutropenia, anemia, thrombocytopenia, fatigue, nausea, decreased appetite, diarrhea, vomiting, abdominal pain, and pyrexia. Among the 246 patients with metastatic colorectal cancer treated with LONSURF in combination with bevacizumab in SUNLIGHT, 39% were exposed for 6 months or longer, and 14% were exposed for 12 months or longer. The most common adverse reactions or laboratory abnormalities (≥20%) were neutropenia, anemia, thrombocytopenia, fatigue, nausea, increased AST, increased ALT, increased alkaline phosphatase, decreased sodium, diarrhea, abdominal pain, and decreased appetite. Metastatic Colorectal Cancer LONSURF as a single agent The safety of LONSURF was evaluated in RECOURSE, a randomized (2:1), double-blind, placebo-controlled trial in patients with previously treated metastatic colorectal cancer [see Clinical Studies (14.1)]. Patients received LONSURF 35 mg/m 2 /dose (n=533) or placebo (n=265) twice daily on Days 1 through 5 and Days 8 through 12 of each 28-day cycle. In RECOURSE, 12% of patients received LONSURF for more than 6 months and 1% of patients received LONSURF for more than 1 year. The study population characteristics were: median age 63 years; 61% male; 57% White, 35% Asian, and 1% Black.
— FDA label: Lonsurf, Taiho Pharmaceutical Co., Ltd., effective November 5, 2025. This is part of the section. Read the full label on DailyMed →
Trifluridine and tipiracil dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Recommended Dosage: 35 mg/m 2 /dose orally twice daily with food on Days 1 through 5 and Days 8 through 12 of each 28-day cycle. (2.1) 2.1 Recommended Dosage The recommended dosage of LONSURF as a single agent or in combination with bevacizumab is 35 mg/m 2 up to a maximum of 80 mg per dose (based on the trifluridine component) orally twice daily with food on Days 1 through 5 and Days 8 through 12 of each 28-day cycle until disease progression or unacceptable toxicity.
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Round dose to the nearest 5 mg increment. Refer to the Prescribing Information for bevacizumab dosing information. Instruct patients to swallow LONSURF tablets whole. Instruct patients not to retake doses of LONSURF that are vomited or missed and to continue with the next scheduled dose. LONSURF is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 Table 1 shows the calculated initial daily dose based on body surface area (BSA). Table 1: Recommended Dosage According to Body Surface Area (BSA) BSA (m2) Total daily dose (mg) Dose (mg) administered twice daily Tablets per dose 15 mg 20 mg < 1.07 70 35 1 1 1.07 – 1.22 80 40 0 2 1.23 – 1.37 90 45 3 0 1.38 – 1.52 100 50 2 1 1.53 – 1.68 110 55 1 2 1.69 – 1.83 120 60 0 3 1.84 – 1.98 130 65 3 1 1.99 – 2.14 140 70 2 2 2.15 – 2.29 150 75 1 3 ≥2.30 160 80 0 4 2.2 Dosage Modifications for Adverse Reactions Obtain complete blood cell counts prior to and on Day 15 of each cycle [see Warnings and Precautions (5.1)]. Do not initiate the cycle of LONSURF until: Absolute neutrophil count (ANC) greater than or equal to 1,500/mm 3 or febrile neutropenia is resolved Platelets greater than or equal to 75,000/mm 3 Grade 3 or 4 non-hematological adverse reactions are resolved to Grade 0 or 1 Within a treatment cycle, withhold LONSURF for any of the following: Absolute neutrophil count (ANC) less than 500/mm 3 or febrile neutropenia Platelets less than 50,000/mm 3 Grade 3 or 4 non-hematologic adverse reaction After recovery, resume LONSURF after reducing the dose by 5 mg/m 2 /dose from the previous dose, if the following occur: Febrile neutropenia Uncomplicated Grade 4 neutropenia (which has recovered to greater than or equal to 1,500/mm 3) or thrombocytopenia (which has recovered to greater than or equal to 75,000/mm 3) that results in more than 1 week delay in start of next cycle Non-hematologic Grade 3 or Grade 4 adverse reaction except for Grade 3 nausea and/or vomiting controlled by antiemetic therapy or Grade 3 diarrhea responsive to antidiarrheal medication A maximum of 3 dose reductions are permitted. Permanently discontinue LONSURF in patients who are unable to tolerate a dose of 20 mg/m 2 orally twice daily. Do not escalate LONSURF dosage after it has been reduced.
Table from the label
| BSA (m2) | Total daily dose (mg) | Dose (mg) administered twice daily | Tablets per dose | |
|---|---|---|---|---|
| 15 mg | 20 mg | |||
| < 1.07 | 70 | 35 | 1 | 1 |
| 1.07 – 1.22 | 80 | 40 | 0 | 2 |
| 1.23 – 1.37 | 90 | 45 | 3 | 0 |
| 1.38 – 1.52 | 100 | 50 | 2 | 1 |
| 1.53 – 1.68 | 110 | 55 | 1 | 2 |
| 1.69 – 1.83 | 120 | 60 | 0 | 3 |
| 1.84 – 1.98 | 130 | 65 | 3 | 1 |
| 1.99 – 2.14 | 140 | 70 | 2 | 2 |
| 2.15 – 2.29 | 150 | 75 | 1 | 3 |
| ≥2.30 | 160 | 80 | 0 | 4 |
— FDA label: Lonsurf, Taiho Pharmaceutical Co., Ltd., effective November 5, 2025. This is part of the section. Read the full label on DailyMed →
Trifluridine and tipiracil in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Risk Summary Based on animal data and its mechanism of action [see Clinical Pharmacology (12.2)], LONSURF can cause fetal harm. LONSURF caused embryo-fetal lethality and embryo-fetal toxicity in pregnant rats when given during gestation at doses resulting in exposures lower than or similar to human exposures at the recommended clinical dose (see Data). There are no available data on LONSURF use in pregnant women. Advise pregnant women of the potential risk to a fetus.
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In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Trifluridine/tipiracil was administered orally once daily to female rats during organogenesis at dose levels of 15, 50, and 150 mg/kg [trifluridine (FTD) equivalent]. Decreased fetal weight was observed at FTD doses ≥50 mg/kg (approximately 0.33 times the FTD exposure at the clinical dose of 35 mg/m 2 twice daily). At the FTD dose of 150 mg/kg (approximately 0.92 times the FTD exposure at the clinical dose of 35 mg/m 2 twice daily) embryolethality and structural anomalies (kinked tail, cleft palate, ectrodactyly, anasarca, alterations in great vessels, and skeletal anomalies) were observed.
— FDA label: Lonsurf, Taiho Pharmaceutical Co., Ltd., effective November 5, 2025. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Lonsurf |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Taiho Pharmaceutical Co., Ltd.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA207981 LONSURF | Taiho Oncology | September 22, 2015 | 8, latest August 2, 2023 2023: Efficacy · 2020: Labeling · 2019: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1670311, 1670316, 1670322, 1670324 |
|---|---|
| SPL set ID of the quoted label | f5beed22-d71d-4c0d-8dca-2c7317d65d85 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA207981 |
| Active ingredients (FDA) | TIPIRACIL / TRIFLURIDINE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- Colorectal cancerCondition named on the label: hospitals that treat it
- Taiho Pharmaceutical Co., Ltd.Maker or distributor
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Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lonsurf, Taiho Pharmaceutical Co., Ltd., effective November 5, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →