Fedratinib Side Effects

Medically reviewed by Drugs.com. Last updated on May 19, 2024.

Applies to fedratinib: oral capsule.

Precautions

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

Tell your doctor if you are using ruxolitinib (Jakafi®) before starting this medicine. Using these medicines together may cause serious side effects.

This medicine may cause encephalopathy (brain disease), including Wernicke’s encephalopathy, which may be serious and life-threatening. Wernicke’s encephalopathy is caused by acute thiamine (Vitamin B1) deficiency. Check with your doctor right away if you have confusion, drowsiness, double vision, diarrhea, nausea, vomiting, problems with muscle control or coordination, shakiness and unsteady walk, trembling, trouble remembering, and weight loss (leading to malnutrition and lower thiamine levels).

Fedratinib will lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Fedratinib may cause diarrhea, nausea, or vomiting, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea, nausea, or vomiting continues, or gets worse, check with your doctor.

This medicine may increase your risk of serious heart or blood vessel problems, including heart attack or stroke. Call your doctor right away if you have chest pain or discomfort, confusion, difficulty in speaking, double vision, headache, inability to move arms, legs, or facial muscles, nausea, pain or discomfort in the arms, jaw, back, or neck, sweating, trouble breathing, or vomiting.

Check with your doctor right away if you have anxiety, chest pain, cough, dizziness, lightheadedness, or fainting, fast heartbeat, pain, redness, or swelling in the arm or leg, pains in the chest, groin, or legs, especially calves of the legs, severe headaches, sudden loss of coordination, sudden onset of slurred speech, sudden vision changes, or trouble breathing. These may be symptoms of serious blood clots (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis).

This medicine may increase your risk of cancer (eg, lymphoma, non-melanoma skin cancer). Tell your doctor right away if you have black, tarry stools, general feeling of illness, swollen glands, weight loss, yellow skin and eyes, persistent non-healing sore, reddish patch or irritated area, shiny bump, pink growth, or white, yellow or waxy scar-like area on the skin.

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.

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:

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:

For healthcare professionals

Applies to fedratinib: oral capsule.

General adverse events

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]

See also:

Further information

Fedratinib 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