Olutasidenib Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 24, 2024.

Applies to olutasidenib: oral capsule.

Serious side effects of olutasidenib

Along with its needed effects, olutasidenib 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 olutasidenib:

Other side effects of olutasidenib

Some side effects of olutasidenib 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:

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine may increase your risk of having a condition called differentiation syndrome, which may be life-threatening. It may occur as early as 1 day and up to 18 months after starting this medicine. Check with your doctor right away if you start to have a chills, cough, dizziness or lightheadedness, eye pain, fever, general feeling of illness, headache, rapid weight gain, sore throat, swelling in the arms or legs, trouble breathing, unusual tiredness. Your doctor may give you a steroid medicine (eg, dexamethasone) to help treat these symptoms.

Check with your doctor right away if you have dark urine, fatigue, loss of appetite, nausea or vomiting, stomach pain, or yellow eyes or skin. These may be symptoms of a serious liver problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

For healthcare professionals

Applies to olutasidenib: oral capsule.

General adverse events

The most common (20% or greater frequency) adverse reactions, including laboratory abnormalities, were aspartate aminotransferase increased, alanine aminotransferase increased, potassium decreased, sodium decreased, alkaline phosphatase increased, nausea, creatinine increased, fatigue/malaise, arthralgia, constipation, lymphocytes increased, bilirubin increased, leukocytosis, uric acid increased, dyspnea, pyrexia, rash, lipase increased, mucositis, diarrhea and transaminitis.

Serious adverse reactions were reported in 25% of patients which included differentiation syndrome (9%) and transaminitis (6%).

Adverse reactions that led to permanent discontinuation of this drug were reported in 8% of patients which included transaminitis, differentiation syndrome, and gallbladder disorders.^[Ref]

Dermatologic

• Very common (10% or more): Rash (24%)^[Ref]

Gastrointestinal

• Very common (10% or more): Abdominal pain (18%), constipation (26%), diarrhea (20%), mucositis (23%), nausea (38%), vomiting (17%)^[Ref]

Cardiovascular

• Frequency not reported: Electrocardiogram QT prolongation^[Ref]

Hematologic

• Very common (10% or more): Differentiation syndrome (16%), hypertension (10%), leukocytosis (25%)^[Ref]

Hepatic

• Very common (10% or more): Transaminitis (20%)
• Frequency not reported: Biliary tract disorder, biliary colic, cholangitis, and cholestasis^[Ref]

Metabolic

• Very common (10% or more): Decreased appetite (16%)^[Ref]

Musculoskeletal

• Very common (10% or more): Arthralgia (28%)^[Ref]

Nervous system

• Very common (10% or more): Headache (13%)^[Ref]

Other

• Very common (10% or more): Edema (18%), fatigue/malaise (36%), pyrexia (24%)^[Ref]

Respiratory

• Very common (10% or more): Cough (17%), dyspnea (24%)^[Ref]

See also:

Further information

Olutasidenib 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