Skip to main content

Fedratinib Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 19, 2023.

Applies to fedratinib: oral capsule.

Warning

Oral route (Capsule)

Warning: Encephalopathy including Wernicke'sSerious and fatal encephalopathy, including Wernicke’s, has occurred in patients treated with fedratinib. Wernicke’s encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting fedratinib, periodically during treatment, and as clinically indicated. Do not start fedratinib in patients with thiamine deficiency; replete thiamine prior to treatment initiation. If encephalopathy is suspected, immediately discontinue fedratinib and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize.

Serious side effects of Fedratinib

Along with its needed effects, fedratinib 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 fedratinib:

More common

Less common

Incidence not known

Other side effects of Fedratinib

Some side effects of fedratinib 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

For Healthcare Professionals

Applies to fedratinib: oral capsule.

General

The most commonly reported side effects included anemia, diarrhea, nausea, and increased blood creatinine.[Ref]

Cardiovascular

Common (1% to 10%): Cardiac failure, cardiogenic shock, hypertension, myocardial ischemia

Frequency not reported: Major adverse cardiac events (MACE), thrombosis[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 67.5%), nausea (up to 62%), vomiting (up to 44.8%), increased lipase (up to 35%), increased amylase (up to 24%)

Common (1% to 10%): Constipation, dyspepsia

Frequency not reported: Gastrointestinal toxicity[Ref]

Genitourinary

Common (1% to 10%): Dysuria, urinary tract infection[Ref]

Hematologic

Very common (10% or more): Anemia (up to 99%), thrombocytopenia (up to 68.5%), neutropenia (up to 23%)

Common (1% to 10%): Bleeding[Ref]

Hepatic

Very common (10% or more): Elevated ALT (up to 43%), elevated AST (up to 40%)

Frequency not reported: Liver toxicity[Ref]

Metabolic

Very common (10% or more): Hyponatremia (up to 26%)

Common (1% to 10%): Weight gain[Ref]

Musculoskeletal

Very common (10% or more): Muscle spasms (up to 12%), extremity pain (up to 10%)

Common (1% to 10%): Bone pain[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache, Wernicke's encephalopathy

Frequency not reported: Encephalopathy[Ref]

Other

Very common (10% or more): Asthenia/fatigue (up to 19%)[Ref]

Renal

Very common (10% or more): Blood creatinine increased (up to 59%)

Frequency not reported: Cystitis[Ref]

Oncologic

Frequency not reported: Secondary malignancies[Ref]

References

1. Product Information. Inrebic (fedratinib). Bristol-Myers Squibb. 2022.

2. Product Information. Inrebic (fedratinib). Bristol-Myers Squibb Pharmaceuticals Ltd. 2021.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer