Applies to fedratinib: oral capsule.

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

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• chills
• cough
• fever
• lower back or side pain
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• sore throat
• trouble breathing with exertion
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Bladder pain
• cloudy urine
• confusion
• difficult, burning, or painful urination
• drowsiness
• frequent urge to urinate
• lower back or side pain
• shakiness and unsteady walk
• trouble remembering
• uncontrolled eye movements
• unsteadiness, trembling, or other problems with muscle control or coordination

Incidence not known

• Anxiety
• chest pain
• dizziness or lightheadedness
• fainting
• fast heartbeat
• general feeling of illness
• pain, redness, or swelling in arm or leg
• pains in the chest, groin, or legs, especially calves of legs
• persistent non-healing sore
• pink growth
• reddish patch or irritated area
• shiny bump
• sudden loss of coordination
• sudden onset of slurred speech
• sudden vision changes
• swollen glands
• weight loss
• white, yellow or waxy scar-like area
• yellow skin and eyes

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

• Bone pain
• diarrhea
• headache
• lack or loss of strength
• muscle spasms
• nausea
• pain in the arms or legs
• vomiting
• weight gain

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]