Pexidartinib Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 12, 2024.

Applies to pexidartinib: oral capsule.

Important warnings This medicine can cause some serious health issues

Oral route (capsule)

Pexidartinib can cause serious and potentially fatal liver injury.

Monitor liver tests prior to initiation of pexidartinib and at specified intervals during treatment.

Withhold and dose reduce or permanently discontinue pexidartinib based on severity of hepatotoxicity.

Pexidartinib is available only through a restricted program called the Turalio Risk Evaluation and Mitigation Strategy (REMS) Program.

Serious side effects of pexidartinib

Along with its needed effects, pexidartinib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pexidartinib:

More common side effects

• blurred vision
• decreased appetite
• dizziness
• fever
• headache
• itching or skin rash
• loss of appetite
• nausea and vomiting
• nervousness
• pounding in the ears
• slow or fast heartbeat
• swelling of the feet or lower legs

Less common side effects

• clay colored stools
• confusion
• dark urine
• defects in intelligence, short-term memory, learning ability, and attention
• stomach pain or tenderness
• unusual tiredness or weakness
• yellow eyes or skin

Other side effects of pexidartinib

Some side effects of pexidartinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

• burning, tingling, numbness or pain in the hands, arms, feet, or legs
• change or loss of taste
• difficulty having a bowel movement (stool)
• hair color changes
• sensation of pins and needles
• stabbing pain
• swelling of the eyes

Less common side effects

• change in color vision
• changes in skin coloring
• darkening or lightening of skin color
• decrease in vision
• difficulty seeing at night
• double vision, seeing double
• dry mouth
• hair loss, thinning of hair
• increased sensitivity of the eyes to sunlight
• irritation, soreness, or swelling of the mouth

For healthcare professionals

Applies to pexidartinib: oral capsule.

General adverse events

The most common adverse reactions with a frequency of more than 20%, including laboratory abnormalities were increased lactate dehydrogenase (LDH), increased AST, hair color changes, fatigue, increased ALT, decreased neutrophils, increased cholesterol, increased ALP, decreased lymphocytes, eye edema, decreased hemoglobin, rash, dysgeusia, and decreased phosphate. Dose reductions or interruptions due to adverse events occurred in 38% of the patients who received this drug.^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (15%)^[Ref]

Dermatologic

• Very common (10% or more): Hair color changes (67%), rash (e.g., maculopapular rash, rash pruritic, urticaria, erythema, dermatitis acneiform, dermatitis allergic) (28%), pruritus (18%)
• Common (1% to 10%): Alopecia, skin pigment changes (hypopigmentation, depigmentation, discoloration, hyperpigmentation)^[Ref]

Gastrointestinal

• Very common (10% or more): Vomiting (20%), constipation (12%)
• Common (1% to 10%): Dry mouth, stomatitis, mouth ulceration^[Ref]

Hematologic

• Very common (10% or more): Decreased neutrophils (44%), decreased lymphocytes (38%), decreased hemoglobin (30%), decreased platelets (15%)^[Ref]

Hepatic

• Very common (10% or more): Increased AST (61%), increased ALT (31%), increased ALP (31%)
• Common (1% to 10%): Increased bilirubin, cholangitis, hepatotoxicity, liver disorder

Postmarketing: Vanishing bile duct syndrome^[Ref]

Metabolic

• Very common (10% or more): Increased lactate dehydrogenase (92%), increased cholesterol (44%), decreased phosphate (25%), anorexia (16%)^[Ref]

Nervous system

• Very common (10% or more): Dysgeusia/ageusia (26%), neuropathy (e.g., neuropathy peripheral, paresthesia, hypoesthesia, burning sensation) (10%)
• Common (1% to 10%): Cognitive disorders (memory impairment, amnesia, confusional state, disturbance in attention, attention deficit/hyperactivity disorder)^[Ref]

Ocular

• Very common (10% or more): Eye edema (30%)
• Common (1% to 10%): Blurred vision, photophobia, diplopia, reduced visual acuity^[Ref]

Other

• Very common (10% or more): Fatigue (64%), peripheral edema (20%)
• Common (1% to 10%): Pyrexia^[Ref]

Further information

Pexidartinib side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer