Prescription medicine
Pexidartinib Brand names: Turalio
Pexidartinib (Turalio) is a prescription medicine with an FDA approval on record since 2019. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the pexidartinib FDA label on DailyMed (effective January 16, 2025, Daiichi Sankyo Inc.); the NDA 211810 record on Drugs@FDA; every pexidartinib label on DailyMed.
Highlights of the record
FDA label of January 16, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
HEPATOTOXICITY.
TURALIO can cause serious and potentially fatal liver injury, including vanishing bile duct syndrome [see Warnings and Precautions (5.1) ]. Monitor liver tests prior to initiation of TURALIO and at specified intervals during treatment. Withhold and dose reduce or permanently discontinue TURALIO based on severity of hepatotoxicity. Monitoring and prompt cessation of TURALIO may not eliminate the risk of serious and potentially fatal liver injury [see Dosage and Administration (2.2), Warnings and Precautions (5.1) ]. TURALIO is available only through a restricted program called the TURALIO Risk Evaluation and Mitigation Strategy (REMS) Program [see Warnings and Precautions (5.2) ]. WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. TURALIO can cause serious and potentially fatal liver injury, including vanishing bile duct syndrome. ( 5.1 ) Monitor liver tests prior to initiation of TURALIO and at specified intervals during treatment. Withhold and dose reduce or permanently discontinue TURALIO based on severity of hepatotoxicity. Monitoring and prompt cessation of TURALIO may not eliminate the risk of serious and potentially fatal liver injury. ( 2.2 , 5.1 ) TURALIO is available only through a restricted program called the TURALIO Risk Evaluation and Mitigation Strategy (REMS) Program.
Used for
From the label: indications and usageTURALIO is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.
Forms and strengths
- 125 mg
Capsule.
On the market
- Earliest approval on file
- August 2, 2019 Turalio, Daiichi Sankyo Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 24, 2038 Turalio capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 713 through July 30, 2026
What is pexidartinib used for?
From the label: indications and usageTURALIO is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. TURALIO is a kinase inhibitor indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Turalio), Daiichi Sankyo Inc., effective January 16, 2025 (SPL set 7b0ec4bf-b2ac-49ee-96af-7740ad3f2e16), via openFDA; the full label on DailyMed
What does the patient leaflet for pexidartinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TURALIO?TURALIO can cause serious side effects, including: Serious liver problems which may be severe and can lead to death, including liver failure and a liver injury called vanishing bile duct syndrome (VBDS) that can cause the loss of bile ducts in the liver. Severe or life-threatening liver problems can happen with TURALIO even if your healthcare provider monitors liver blood tests during treatment and stops treatment with TURALIO. Your healthcare provider will do blood tests to check for liver problems: before starting treatment with TURALIO, every week for the first 8 weeks during treatment, every 2 weeks for the next month, then, every 3 months after that. If you develop liver problems during treatment with TURALIO, your healthcare provider may do blood tests more often to monitor you or refer you to a liver specialist (hepatologist). It is important to stay under the care of your healthcare provider during treatment with TURALIO. Stop taking TURALIO and call your healthcare provider right away if you develop: yellowing of your skin and whites of your eyes dark urine Tell your healthcare provider right away if you have any of these symptoms of liver problems during treatment with TURALIO: lack or loss of appetite right upper stomach-area (abdomen) pain or tenderness feeling overly tired nausea vomiting fever rash itching TURALIO Risk Evaluation and Mitigation Strategy (REMS). Because of the risk of serious liver problems, TURALIO is available only through a restricted program called the TURALIO REMS Program. Your healthcare provider must be enrolled in the program in order for you to be prescribed TURALIO. There is a registry that collects information about the effects of taking TURALIO over time. […]
From the patient leaflet: What should I avoid while taking TURALIO?Avoid grapefruit or drinking grapefruit juice during treatment with TURALIO. Grapefruit or grapefruit juice can cause you to have too much TURALIO in your blood and may lead to increased side effects and more severe side effects. Avoid spending prolonged time in sunlight. TURALIO can make your skin sensitive to the sun (photosensitivity), and you may burn more easily. You should use sunscreen and wear protective clothing that covers your skin to help protect against sunburn if you have to be in the sunlight during treatment with TURALIO.
From the patient leaflet: How should I store TURALIO?Store TURALIO at room temperature between 68°F to 77°F (20°C to 25°C). Keep the TURALIO container closed tightly. TURALIO comes with a drying agent (desiccant) in the container. Keep the desiccant in the container. Keep TURALIO and all medicines out of the reach of children.
Source: FDA drug label (Turalio), Daiichi Sankyo Inc., effective January 16, 2025 (SPL set 7b0ec4bf-b2ac-49ee-96af-7740ad3f2e16), via openFDA; the full label on DailyMed
Is there a generic for pexidartinib (Turalio)?
No generic pexidartinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 12 patents for Turalio capsules: the compound patent runs to May 5, 2036, and the last listed entry to July 24, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for pexidartinib?
The FDA Adverse Event Reporting System holds 713 reports that list pexidartinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11 are coded as a death and 53 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Pexidartinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other