Last reviewed 2026-04-20 · How we verify

PEXIDARTINIB HYDROCHLORIDE

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• WARNING: 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. ( 5.2 )

Common side effects

• 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

Serious adverse events

• Abnormal liver tests
• Hepatotoxicity
• Cholangitis
• Liver disorder
• Cognitive disorders
• Photosensitivity reactions
• Stomatitis
• Mouth ulceration
• Pyrexia
• Alopecia

Key clinical trials

• Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS) (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• PEXIDARTINIB HYDROCHLORIDE CI brief — competitive landscape report
• PEXIDARTINIB HYDROCHLORIDE updates RSS · CI watch RSS