What the label lists and what reports show
Pexidartinib side effects
Pexidartinib's FDA label: “Most common adverse reactions (>20%) were increased lactate dehydrogenase, increased aspartate aminotransferase, hair color changes, fatigue, increased alanine aminotransferase, decreased neutrophils, increased cholesterol, increased alkaline phosphatase …” FAERS holds 713 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (252 reports).
- No generic listed
- Boxed warning
Check it at the source: the pexidartinib FDA label on DailyMed (effective January 16, 2025, Daiichi Sankyo Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of TURALIO?TURALIO can cause serious side effects. See " What is the most important information I should know about TURALIO? " There are possible risks if TURALIO is taken with a high-fat meal. Avoid taking TURALIO with a high-fat meal (about 55 to 65 grams of total fat). Taking TURALIO with a high-fat meal increases the amount of medicine in your blood. This may make it more likely for you to develop side effects and may cause more severe side effects, including serious liver problems. Take TURALIO with a low-fat meal (about 11 to 14 grams of total fat). […]
Source: FDA drug label, Daiichi Sankyo Inc., effective January 16, 2025 (SPL set 7b0ec4bf-b2ac-49ee-96af-7740ad3f2e16), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (>20%) were increased lactate dehydrogenase, increased aspartate aminotransferase, hair color changes, fatigue, increased alanine aminotransferase, decreased neutrophils, increased cholesterol, increased alkaline phosphatase, decreased lymphocytes, eye edema, decreased hemoglobin, rash, dysgeusia, and decreased phosphate.
Table 4: Adverse Reactions (≥10% All Grades or >2% Grade ≥ 3) in Patients Receiving TURALIO with a Difference Between Arms of >5% Compared to Placebo Through Week 25 in ENLIVEN
| Adverse Reaction | All Grades (%) | Grade ≥ 3 (%) | All Grades (%) | Grade ≥ 3 (%) |
|---|---|---|---|---|
| Hair color changes | 67 | 0 | 3.4 | 0 |
| Rash Rash includes rash, maculo-papular rash, rash pruritic, urticaria, erythema,… | 28 | 1.6 | 7 | 0 |
| Pruritus Pruritis includes pruritus, pruritus generalized. | 18 | 0 | 3.4 | 0 |
| Fatigue Fatigue includes fatigue, asthenia, malaise. | 64 | 0 | 41 | 0 |
| Peripheral edema Peripheral edema includes face edema, localized edema, edema peripheral,… | 20 | 0 | 7 | 0 |
| Eye edema Eye edema includes periorbital edema, eye edema, eyelid edema, papilledema. | 30 | 1.6 | 5 | 0 |
| Dysgeusia Dysgeusia includes dysgeusia, ageusia. | 26 | 0 | 1.7 | 0 |
| Neuropathy Neuropathy includes neuropathy peripheral, paresthesia, hypoesthesia, burning… | 10 | 0 | 5 | 0 |
| Vomiting | 20 | 1.6 | 5 | 0 |
| Constipation | 12 | 0 | 5 | 0 |
| Decreased appetite | 16 | 0 | 10 | 0 |
| Hypertension | 15 | 4.9 | 10 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Hepatotoxicity [see Warnings and Precautions (5.1) ]. Most common adverse reactions (>20%) were increased lactate dehydrogenase, increased aspartate aminotransferase, hair color changes, fatigue, increased alanine aminotransferase, decreased neutrophils, increased cholesterol, increased alkaline phosphatase, decreased lymphocytes, eye edema, decreased hemoglobin, rash, dysgeusia, and decreased phosphate. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 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 safety of TURALIO 250 mg orally twice daily administered with a low-fat meal has been established based on adequate and well-controlled studies of TURALIO 400 mg orally twice daily administered on an empty stomach and additional pharmacokinetic data that indicate there is no clinically significant difference in the relative exposure between the two dosages [see Clinical Pharmacology (12.3) ]. …
Source: FDA drug label, Daiichi Sankyo Inc., effective January 16, 2025 (SPL set 7b0ec4bf-b2ac-49ee-96af-7740ad3f2e16), via openFDA; the full label on DailyMed
What do FAERS reports show?
713 reports list pexidartinib among the medicines taken, 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. Of the 20 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Pexidartinib: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions