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Idelalisib Side Effects

In Summary

Commonly reported side effects of idelalisib include: hepatotoxicity, pneumonitis, severe colitis, severe diarrhea, exfoliative dermatitis, pneumonia, colitis, abdominal pain, cough, dyspnea, erythematous rash, fever, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, macular eruption, maculopapular rash, nausea, neutropenia, pruritic rash, skin rash, and vomiting. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to idelalisib: oral tablet

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
  • Abdominal or stomach pain or tenderness
  • black, tarry stools
  • body aches or pain
  • 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
  • stuffy or runny nose
  • swelling of the feet or lower legs
  • tightness in the chest
  • troubled 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
  • 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

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
  • 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

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

Hepatic

Very common (10% or more): Increased ALT (up to 50%), increased AST (up to 41%), increased GGT (up to 26%)[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 47%), nausea (up to 29%), abdominal pain (up to 26%), vomiting (up to 15%)
Common (1% to 10%): Gastroesophageal reflux disease, stomatitis[Ref]

Respiratory

Very common (10% or more): Cough (up to 29%), pneumonia (up to 25%), dyspnea (up to 17%), upper respiratory tract infection (up to 12%)
Common (1% to 10%): Nasal congestion[Ref]

Hematologic

Very common (10% or more): Decreased neutrophils (up to 60%), decreased hemoglobin (up to 28%), decreased platelets (up to 26%), increased lymphocytes (up to 25%), decreased lymphocytes (up to 20%)[Ref]

Metabolic

Very common (10% or more): Hypertriglyceridemia (up to 56%), hyperglycemia (up to 54%), hyponatremia (up to 20%), decreased appetite (up to 16%), hypoglycemia (up to 11%)[Ref]

Other

Very common (10% or more): Pyrexia (up to 35%), fatigue (up to 30%), chills (up to 21%), asthenia (up to 12%), peripheral edema (up to 10%)
Common (1% to 10%): Pain[Ref]

Immunologic

Common (1% to 10%): Sepsis, bronchitis, sinusitis, urinary tract infection[Ref]

Dermatologic

Very common (10% or more): Rash (up to 21%), night sweats (up to 12%)[Ref]

Musculoskeletal

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

Nervous system

Very common (10% or more): Headache (up to 11%)[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 12%)[Ref]

References

1. "Product Information. Zydelig (idelalisib)." Gilead Sciences, Foster City, CA.

Some side effects of idelalisib may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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