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Idelalisib Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jan 22, 2025.

Applies to idelalisib: oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Serious hepatotoxicity, including fatalities, has been reported in 16% of patients administered idelalisib.

Fatal and/or serious diarrhea and colitis has also been reported in 20% of idelalisib patients.

Monitor hepatic function before and during treatment and monitor for the development of diarrhea or colitis.

Fatal and/or serious pneumonitis occurred in 4% of idelalisib patients.

Monitor for pulmonary symptoms and bilateral interstitial infiltrates.

Serious infections, including fatalities, have been reported in 48% of idelalisib patients.

Monitor for signs and symptoms of infection.

Fatal and serious intestinal perforation may occur.

Interrupt, reduce dose, or discontinue treatment with idelalisib as recommended.

Discontinue use if intestinal perforation occurs.

Precautions

It is very important that your doctor check your progress at regular visits while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Female patients should use effective birth control during treatment with this medicine and for at least 1 month after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Idelalisib may 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.

Idelalisib may cause diarrhea, 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 continues or gets worse, check with your doctor.

This medicine may cause serious infections (eg, pneumonia, sepsis). Check with your doctor right away if you have chest pain or tightness, cough, fever or chills, confusion, dizziness, lightheadedness, or fainting, fast heartbeat, sneezing, or trouble breathing.

Tell your doctor right away if you have a cough, trouble breathing, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem called pneumonitis.

Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness while you are using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may cause serious bowel problems, including perforation (hole). Check with your doctor right away if you have black, tarry stools, diarrhea, fever, severe vomiting, sometimes with blood, or stomach cramps or pain.

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 idelalisib

Along with its needed effects, idelalisib 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 idelalisib:

More common side effects

  • black, tarry stools
  • body aches or pain
  • chest tightness
  • chills
  • clay colored stools
  • confusion
  • cough
  • cough producing mucus
  • dark urine
  • decreased appetite
  • difficulty with breathing
  • dizziness
  • ear congestion
  • fainting
  • fast heartbeat
  • fever
  • headache
  • itching or skin rash
  • lightheadedness
  • loss of appetite
  • loss of voice
  • lower back or side pain
  • nausea and vomiting
  • pain
  • pain or tenderness around the eyes and cheekbones
  • painful or difficult urination
  • pale skin
  • rapid, shallow breathing
  • sneezing
  • sore throat
  • stomach cramps, pain, or tenderness
  • stuffy or runny nose
  • swelling of the feet or lower legs
  • trouble breathing
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • watery or bloody diarrhea
  • yellow eyes or skin

Less common side effects

  • bladder pain
  • bloody or cloudy urine
  • difficult, burning, or painful urination
  • frequent urge to urinate
  • lower back or side pain

Incidence not known

  • blistering, peeling, or loosening of the skin
  • chest pain
  • cracks in the skin
  • difficulty with swallowing
  • general feeling of discomfort or illness
  • heartburn
  • hives
  • indigestion
  • joint or muscle pain
  • loss of heat from the body
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • red, swollen skin
  • scaly skin
  • severe abdominal or stomach pain, cramping, or burning
  • thickening of bronchial secretions
  • vomiting of material that looks like coffee grounds, severe and continuing

Other side effects of idelalisib

Some side effects of idelalisib 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

  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • decreased appetite
  • difficulty with moving
  • muscle pain or stiffness
  • night sweats
  • pain in the joints
  • rapid weight gain
  • tingling of the hands or feet
  • trouble sleeping
  • unusual weight gain or loss

For healthcare professionals

Applies to idelalisib: oral tablet.

General adverse events

The most commonly occurring adverse reactions were pneumonia, pyrexia, sepsis, febrile neutropenia, cough, abdominal pain, chills, rash, fatigue, and diarrhea.[Ref]

Hepatic

Gastrointestinal

Respiratory

Hematologic

Metabolic

Other

Immunologic

Dermatologic

Musculoskeletal

Nervous system

Psychiatric

See also:

References

1. (2014) "Product Information. Zydelig (idelalisib)." Gilead Sciences

Frequently asked questions

Further information

Idelalisib 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.