Pexidartinib
Pexidartinib (sold as Turalio) is a once-restricted-access kinase inhibitor capsule used to treat adults with symptomatic tenosynovial giant cell tumor (TGCT) that causes severe problems and can't be helped by surgery.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Pexidartinib (Turalio), a specialist kinase inhibitor on the market since about 2019, treats adults with symptomatic tenosynovial giant cell tumor (TGCT, a tumor of a joint lining) that surgery cannot help, mainly by blocking CSF1R, the receptor driving the tumor's growth. Everyday side effects are usually manageable, mostly hair color changes, tiredness, altered taste and puffy eyes. Its boxed warning is serious, potentially fatal liver injury, including vanishing bile duct syndrome (loss of the liver's bile ducts), so it comes only through a restricted program (Turalio REMS) with regular liver blood tests. Monitoring cannot catch everything, so report yellow skin or eyes, dark urine or severe itching right away.
Clinical pearls
- Take each dose with a low-fat meal, because a high-fat meal raises drug levels and, with them, the liver risk.
- Avoid proton pump inhibitors such as esomeprazole, which weaken it; a plain antacid is fine if taken two hours apart.
- Turalio can make hormonal birth control fail, so use a non-hormonal method during treatment and for one month after.
- Skip grapefruit, which raises drug levels, and St John's wort, which lowers them, plus any extra liver-straining medicines or supplements.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Turalio can cause serious and sometimes fatal liver injury. This includes vanishing bile duct syndrome, in which the liver's bile ducts are lost.
Your liver tests must be checked before you start and at set times during treatment. Your doctor may pause, lower or permanently stop the drug depending on results. Even with close monitoring and quick stopping, the risk may not go away completely.
Because of this risk, Turalio is available only through a restricted program called the Turalio REMS Program. Prescribers and pharmacies must be certified, and patients must enroll in a registry.
Patient information guide A plain-language walkthrough of Pexidartinib, written from its FDA label.
What Pexidartinib is used for
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Pexidartinib is used for one condition:
- Turalio (pexidartinib capsules) treats adults with symptomatic tenosynovial giant cell tumor (TGCT) that causes severe morbidity or functional limitations and cannot be improved with surgery.
How Pexidartinib works
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Pexidartinib is a tyrosine kinase inhibitor. It blocks CSF1R, KIT, and a mutated form of FLT3 known as FLT3-ITD.
In TGCT, too much of the signal that activates CSF1R drives cells to multiply and collect in the joint lining. Blocking CSF1R slows the growth of cells that depend on it.
Pexidartinib dosage
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Turalio is a capsule taken by mouth twice daily with a low-fat meal. It is continued until the disease progresses or side effects become unacceptable.
- Swallow capsules whole. Do not open, break or chew.
- Avoid high-fat meals, which raise drug levels and liver risk.
- If you vomit or miss a dose, take the next dose at the regular time.
- Your doctor may lower your dose for side effects, kidney or liver problems, or certain interacting drugs.
Dosing details from the FDA-approved label
From the Pexidartinib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosage (adults)
- 250 mg orally twice daily with a low-fat meal (approximately 11 to 14 grams of total fat) until disease progression or unacceptable toxicity
- Swallow capsules whole; avoid a high-fat meal (approximately 55 to 65 grams of total fat); if a dose is vomited or missed, take the next dose at its scheduled time
- Dose reductions for adverse reactions
- First reduction: 375 mg total daily dose (125 mg in the morning and 250 mg in the evening)
- Second reduction: 250 mg total daily dose (125 mg twice daily), with a low-fat meal
- Permanently discontinue in patients unable to tolerate 125 mg orally twice daily
- Concomitant use of moderate or strong CYP3A inhibitors or UGT inhibitors (if it cannot be avoided)
- From 500 mg total daily dose: 250 mg total daily dose (125 mg twice daily)
- From 375 mg: 250 mg (125 mg twice daily)
- From 250 mg: 125 mg (125 mg once daily), with a low-fat meal
- After the inhibitor is discontinued, increase to the prior dose after 3 plasma half-lives of the inhibitor
- Mild to severe renal impairment (CLcr 15 to 89 mL/min by Cockcroft-Gault using actual body weight)
- 125 mg in the morning and 250 mg in the evening with a low-fat meal
- Renal impairment adjustment
- Moderate hepatic impairment (total bilirubin >1.5 to 3 × ULN, not due to Gilbert's syndrome, with any AST)
- 125 mg twice daily with a low-fat meal
- Not studied in severe hepatic impairment (total bilirubin >3 to 10 × ULN and any AST)
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Recommended Dosage : 250 mg orally twice daily with a low-fat meal (approximately 11 to 14 grams of total fat). ( 2.1 ) See full prescribing information for dosage modifications due to adverse reactions, renal impairment and hepatic impairment. ( 2.2 , 2.5 , 2.6 ) 2.1 Recommended Dosage The recommended dosage of TURALIO is 250 mg taken orally twice daily with a low-fat meal (approximately 11 to 14 grams of total fat) until disease progression or unacceptable toxicity [see Clinical Pharmacology (12.3) ] . Taking TURALIO with a high-fat meal (approximately 55 to 65 grams of total fat) increases pexidartinib concentrations and may increase the risk of adverse reactions, including hepatotoxicity [see Warnings and Precautions (5.1 , 5.4) , Drug Interactions (7.2) , Clinical Pharmacology (12.2 , 12.3) ] . Swallow TURALIO capsules whole. Do not open, break, or chew the capsules. If a patient vomits or misses a dose of TURALIO, instruct the patient to take the next dose at its scheduled time. 2.2 Dosage Modifications for Adverse Reactions The recommended dose reductions for adverse reactions are provided in Table 1. Table 1: Recommended Dose Reductions for TURALIO for Adverse Reactions Dose Reduction Total Daily Dose Administration of Total Daily Dose with Low-Fat Meal First 375 mg 125 mg in the morning and 250 mg in the evening Second 250 mg 125 mg twice daily Permanently discontinue TURALIO in patients who are unable to tolerate 125 mg orally twice daily. The recommended dosage modifications for adverse reactions are summarized in Table 2. Table 2: Recommended Dosage Modifications for TURALIO for Adverse Reactions Adverse Reaction Severity TURALIO Dosage Modifications ALT = alanine aminotransferase; ALP = alkaline phosphatase; AST = aspartate aminotransferase; DB = direct bilirubin; GGT = gamma-glutamyl transferase; TB = total bilirubin; ULN = upper limit of normal Hepatotoxicity [see Warnings and Precautions (5.1) ] Increased ALT and/or AST Greater than 3 to 5 times ULN Withhold and monitor liver tests weekly . If AST and ALT are less than or equal to 3 times ULN within 4 weeks, resume at reduced dose. If AST or ALT is not less than or equal to 3 times ULN in 4 weeks, permanently discontinue TURALIO. Greater than 5 to 10 times ULN Withhold and monitor liver tests twice weekly .
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Pexidartinib side effects
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The most common side effects seen with Turalio include:
Common side effects
- Hair color changes
- Tiredness (fatigue)
- Rash
- Swelling around the eyes
- Changed or lost sense of taste
- Nausea and vomiting
- Swelling in the hands, feet or face
- High blood pressure
- Swelling around the eyes, and swelling in other parts of the body
- Abnormal blood tests, such as raised liver enzymes, cholesterol and lower blood counts
When to get medical help
- Call your doctor right away if you notice signs of liver trouble, such as severe itching, yellowing of the skin or eyes, dark urine, belly pain, or unusual tiredness.
- Get help if nausea, vomiting or dizziness become severe or won't go away.
- Tell your doctor if you may be pregnant or become pregnant while taking it.
- Report any severe or intolerable side effect so your dose can be paused or lowered.
Serious liver injury is the main concern. Contact your doctor promptly about any signs of liver problems or severe side effects.
Pexidartinib warnings and precautions
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- Liver injury: can be serious or fatal, and may occur despite monitoring. Regular liver tests are required.
- REMS program: Turalio is available only through a restricted program with certified prescribers and pharmacies.
- High-fat meals: raise drug levels and may worsen side effects, including liver toxicity.
- Pregnancy: may cause fetal harm and may impair fertility.
Pexidartinib interactions
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Several drugs and foods change pexidartinib levels or are affected by it:
- Other liver-toxic products: avoid, since Turalio can harm the liver.
- Moderate or strong CYP3A inhibitors, including grapefruit: raise levels, so a dose reduction may be needed.
- UGT inhibitors: raise levels, so a lower dose may be needed.
- Strong CYP3A inducers, such as St John's wort: lower levels and may reduce effectiveness.
- Proton pump inhibitors: lower levels, so avoid them.
- Antacids and H2-blockers: separate timing from Turalio.
- Hormonal contraceptives and other CYP3A substrates: Turalio can lower their levels.
Interactions listed in the FDA-approved label
From the Pexidartinib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Other products known to cause hepatotoxicity: TURALIO can cause hepatotoxicity; this applies particularly in patients with increased serum transaminases, total bilirubin, or direct bilirubin (>ULN) or active liver or biliary tract disease. Avoid coadministration of TURALIO with other products known to cause hepatotoxicity.
- Moderate or strong CYP3A inhibitors (including grapefruit or grapefruit juice): May increase pexidartinib concentrations, which may increase the incidence and severity of adverse reactions. Avoid; if concomitant use cannot be avoided, reduce the TURALIO dose.
- Strong CYP3A inducers (including St John's wort): Decrease pexidartinib concentrations, which may decrease the efficacy of TURALIO. Avoid concomitant use.
- UGT inhibitors: Increase pexidartinib concentrations, which may increase the incidence and severity of adverse reactions. Reduce TURALIO dosage if concomitant use cannot be avoided.
- Proton pump inhibitors (PPIs): Decrease pexidartinib concentrations, which may decrease the efficacy of TURALIO. Avoid concomitant use. As an alternative, use locally-acting antacids or H2-receptor antagonists.
- Locally-acting antacids: Alternative to PPIs when acid reduction is needed. Administer TURALIO 2 hours before or 2 hours after the antacid.
- Histamine-2 (H2) receptor antagonists: Alternative to PPIs when acid reduction is needed. Administer TURALIO at least 2 hours before or 10 hours after the H2-receptor antagonist.
- High-fat meal: Increases pexidartinib concentrations, which may increase the incidence and severity of adverse reactions, including hepatotoxicity. Take TURALIO with a low-fat meal (approximately 11 to 14 grams of total fat); avoid a high-fat meal (approximately 55 to 65 grams of total fat).
- CYP3A substrates: TURALIO is a moderate CYP3A inducer and decreases the concentration of CYP3A substrates, which may reduce their efficacy. Avoid use where minimal concentration changes may lead to serious therapeutic failure; if unavoidable, increase the CYP3A substrate dosage in accordance with its approved labeling.
- Hormonal contraceptives: TURALIO is a moderate CYP3A inducer and may decrease concentrations of CYP3A substrates, which may reduce their efficacy. Avoid coadministration of TURALIO with hormonal contraceptives.
Read the label’s full interactions text
7 DRUG INTERACTIONS Use with Hepatotoxic Products : Avoid coadministration of TURALIO with other products known to cause hepatotoxicity. ( 7.1 ) Moderate or Strong CYP3A Inhibitors : Reduce the dose of TURALIO if concomitant use of moderate or strong CYP3A inhibitors cannot be avoided. ( 2.3 , 7.2 ) Strong CYP3A Inducers : Avoid concomitant use of strong CYP3A inducers. ( 7.2 ) UGT Inhibitors : Reduce the dose of TURALIO if concomitant use of UGT inhibitors cannot be avoided. ( 2.3 , 7.2 ) Acid-Reducing Agents : Avoid concomitant use of proton pump inhibitors. Use histamine-2 receptor antagonists or antacids if needed. ( 2.4 , 7.2 ) High-Fat Meal : Avoid taking TURALIO with a high-fat meal. ( 2.1 , 5.4 , 7.2 ). CYP3A Substrates : Avoid concomitant use with CYP3A substrates where minimal concentration changes may lead to serious therapeutic failure. ( 7.3 ) 7.1 Use with Hepatotoxic Products TURALIO can cause hepatotoxicity. In patients with increased serum transaminases, total bilirubin, or direct bilirubin (>ULN) or active liver or biliary tract disease, avoid coadministration of TURALIO with other products known to cause hepatotoxicity [see Warnings and Precautions (5.1) ] . 7.2 Effect of Other Drugs or Food on TURALIO Table 7: Effect of Other Drugs or Food on TURALIO Moderate or Strong CYP3A Inhibitors Clinical Impact Concomitant use of a moderate or strong CYP3A inhibitor may increase pexidartinib concentrations [see Clinical Pharmacology (12.3) ], which may increase the incidence and severity of adverse reactions of TURALIO. Management Reduce TURALIO dosage if concomitant use of moderate or strong CYP3A inhibitors, including grapefruit or grapefruit juice, cannot be avoided [see Dosage and Administration (2.3) ]. Strong CYP3A Inducers Clinical Impact Concomitant use of a strong CYP3A inducer decreases pexidartinib concentrations [see Clinical Pharmacology (12.3) ] , which may decrease the efficacy of TURALIO.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Pexidartinib
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- There are no listed contraindications.
- Tell your doctor about liver or bile duct disease.
- Kidney impairment (mild to severe) and moderate liver impairment call for lower doses.
- It has not been studied in severe liver impairment.
- Avoid in pregnancy. Check pregnancy status before starting and use non-hormonal contraception.
- Do not breastfeed during treatment and for at least 1 week after.
- Not established in children. Limited data in people 65 and older.
Pexidartinib overdose
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Pexidartinib binds strongly to proteins in the blood, so dialysis is not expected to remove it. If you think you've taken too much, seek medical help right away.
What Pexidartinib does in the body
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Higher pexidartinib exposure is linked to a higher risk of raised liver enzymes (ALT and AST). At two times the highest exposure from the recommended dose, it did not prolong the QTc interval (a heart rhythm measure) in any clinically relevant way.
How your body processes Pexidartinib
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Turalio peaks in the blood at about 2.5 hours. Taking it with a high-fat meal roughly doubles drug levels, and a low-fat meal raises them by about 56 to 59%. The body clears it mostly through the liver enzymes CYP3A4 and UGT1A4.
Its half-life is about 26.6 hours, and steady levels are reached in about 7 days. Most of a dose leaves in the stool, with the rest in urine.
How to store Pexidartinib
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Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Pexidartinib
173 supplements and herbal products have documented interactions with Pexidartinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 6
- Moderate · 131
- Minor · 36
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Pexidartinib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Pexidartinib — the kind of thing our pharmacy team would talk through with you at the counter.
What is Turalio for?
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How should I take it?
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What's the biggest safety concern?
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What side effects are common?
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Can I take my heartburn medicine or supplements with it?
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What about pregnancy and birth control?
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Is Pexidartinib available over the counter?
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When was Pexidartinib first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Pexidartinib on HelloPharmacist
Pexidartinib forms and strengths (how it comes)
Pexidartinib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Pexidartinib inactive ingredients by manufacturer.
Capsule
How this form is used
- Turalio is used for adults with symptomatic tenosynovial giant cell tumor (TGCT) with severe morbidity or functional limitations that surgery can't improve.
- Turalio is taken by mouth twice daily with a low-fat meal.
- Swallow Turalio capsules whole. Do not open, break or chew them.
- If you vomit or miss a dose of Turalio, take the next dose at its scheduled time.
- Avoid taking Turalio with a high-fat meal.
Pexidartinib on the U.S. market: products, makers and brands
How Pexidartinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Pexidartinib product record with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2019. Brand names on the directory include Turalio; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Pexidartinib is used (Medicaid data)
A general measure of how commonly Pexidartinib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Pexidartinib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Pexidartinib prescribed? Of the 1,601 medications we measure, Pexidartinib ranks #1,461 by Medicaid prescriptions — more than 9% of them.
Utilization by Pexidartinib product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
pexidartinib 125 MG Oral Capsule
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2626397
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Pexidartinib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 3 listed Pexidartinib NDCs with Medicaid activity.
Compare Pexidartinib products
A representative set of FDA-listed product records for Pexidartinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 125 mg | Oral | Daiichi Sankyo Inc. | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Pexidartinib NDCs →
Pexidartinib side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Pexidartinib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Pexidartinib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Pexidartinib FDA approval history
How Pexidartinib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Pexidartinib recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Pexidartinib recalls since July 2021.
✅No Pexidartinib recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2183102 1 dose form · 1 strength
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Dose form (SCDF) Oral Capsule RxCUI 2183124In current FDA listingsClinical drug / strength (SCD) 125 MGRxCUI 2626397
Look up RxCUI 2183102 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Pexidartinib supply and shortage status
Whether Pexidartinib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Pexidartinib brand names
Pexidartinib is sold under one brand name in the FDA directory — Turalio. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Pexidartinib: manufacturers and labelers
One company lists Pexidartinib products with the FDA. By number of product records, the largest are Daiichi Sankyo Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Pexidartinib drug class (RxNorm)
Pexidartinib belongs to the Kinase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Pexidartinib page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Daiichi Sankyo, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →