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Ibrutinib Side Effects

In Summary

Commonly reported side effects of ibrutinib include: infection, anemia, neutropenia, thrombocytopenia, bruise, and cytopenia. Other side effects include: malignant neoplasm, malignant neoplasm of skin, subdural hematoma, gastrointestinal hemorrhage, and hematuria. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ibrutinib: oral capsule, oral tablet

Along with its needed effects, ibrutinib 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 ibrutinib:

More Common

  • Back pain
  • bladder pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or black, tarry stools
  • bloody or cloudy urine
  • blurred vision
  • body aches or pain
  • chest pain
  • chills
  • confusion
  • cough or hoarseness
  • decreased frequency or amount of urine
  • difficult, burning, or painful urination
  • dizziness or lightheadedness
  • drowsiness
  • dry mouth
  • fainting
  • fast or irregular heartbeat
  • fever
  • frequent urge to urinate
  • headache
  • increased thirst
  • irregular heartbeat
  • itching
  • loss of appetite
  • lower back or side pain
  • nausea and vomiting
  • rapid weight gain
  • seizures
  • severe headache
  • severe stomach pain
  • sore throat
  • tightness of the chest
  • tingling of the hands or feet
  • troubled breathing
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vomiting of blood or material that looks like coffee grounds
  • wrinkled skin

Less Common

  • Persistent non-healing sore
  • pink skin growth
  • reddish skin patch or irritated area
  • shiny skin bump
  • white, yellow or waxy scar-like area on the skin

Some side effects of ibrutinib 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

  • Belching
  • decreased appetite
  • difficulty having a bowel movement
  • heartburn or indigestion
  • indigestion
  • joint or muscle pain
  • lack or loss of strength
  • muscle stiffness or spasms
  • rash
  • small red or purple spots on the skin
  • stomach discomfort, upset, or pain
  • swelling or inflammation of the mouth

For Healthcare Professionals

Applies to ibrutinib: oral capsule, oral tablet


-Lymphocytosis occurred in up to 77% of treated patients. Typical onset of isolated lymphocytosis was within the first month of starting the drug and resolved approximately at 8 weeks.

-Bleeding events occurred in up to 50% of treated patients. Bleeding events ranged from minor hemorrhagic events such as petechiae and contusions to Grade 3 or higher bleeding events. Approximately 6% of patients experienced a Grade 3 or higher bleeding event including cases of subdural hematoma, gastrointestinal bleeding, hematuria and post procedural hemorrhage

-Treatment-emergent Grade 3 or 4 cytopenias included neutropenia (19% to 29%), thrombocytopenia (5% to 17%), and anemia (0 to 9%).[Ref]

Very common (10% or more): Lymphocytosis (up to 77%), decreased platelets (up to 71%), decreased neutrophils (up to 54%), bleeding events (all grades; approximately 50%), decreased hemoglobin (up to 44%), neutropenia (up to 29%), thrombocytopenia (up to 17%)

Common (1% to 10%): Bleeding events, anemia, febrile neutropenia

Uncommon (less than 1%): Leukostasis

Very common (10% or more): Upper respiratory tract infection (up to 34%), urinary tract infection (up to 14%), pneumonia (up to 14%), skin infections (up to 14%), sinusitis (up to 13%)[Ref]


Very common (10% or more): Hypertension (up to 17%)

Common (1% to 10%): Atrial fibrillation, atrial flutter[Ref]


Other malignancies (5% to 14%) including non-skin carcinomas (1% to 3%) have been reported. Non-melanoma skin cancer was the most frequent second primary malignancy reported (4% to 11%).[Ref]

Very common (10% or more): Second primary malignancies (up to 10%)

Common (1% to 10%): Non-melanoma skin cancer, carcinomas[Ref]


Very common (10% or more): Fatigue (up to 41%), peripheral edema (up to 35%), pyrexia (up to 25%), asthenia (up to 14%), chills (up to 13%)

Frequency not reported: Gait instability[Ref]


Very common (10% or more): Upper respiratory tract infection (up to 48%), dyspnea (up to 27%), sinusitis (up to 21%), cough (up to 19%), oropharyngeal pain (up to 15%), pneumonia (up to 15%), epistaxis (up to 11%)[Ref]


Very common (10% or more): Elevated uric acid levels (up to 40%), decreased appetite (up to 21%), hyperuricemia (up to 15%), dehydration (up to 12%)

Frequency not reported: Tumor lysis syndrome[Ref]


Very common (10% or more): Musculoskeletal pain (up to 37%), arthralgia (up to 23%), muscle spasms (up to 19%)[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 21%), headache (up to 19%), peripheral neuropathy (up to 10%)

Common (1% to 10%): Subdural hematoma

Frequency not reported: Intracranial hemorrhage, lethargy[Ref]


Very common (10% or more): Bruising (up to 54%), rash (up to 27%), skin infections (up to 17%), petechiae (up to 17%), contusion (up to 11%), laceration (up to 10%)[Ref]


Very common (10% or more): Diarrhea (up to 63%), nausea (up to 31%), constipation (up to 25%), abdominal pain (up to 24%), vomiting (up to 23%), stomatitis (up to 21%), dyspepsia (up to 13%)

Common (1% to 10%): Dry mouth[Ref]


Very common (10% or more): Urinary tract infection (up to 14%)[Ref]


Grade 3 or higher infections including urinary tract infection, pneumonia, skin infections, and sinusitis were reported.[Ref]

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

Frequency not reported: Progressive multifocal leukoencephalopathy[Ref]


Very common (10% or more): Blurred vision (up to 10%)[Ref]


Very common (10% or more): Anxiety (up to 10%), insomnia (up to 10%)[Ref]


Very common (14%): Urinary tract infection

Common (1% to 10%): Increased creatinine

Frequency not reported: Renal failure (fatal and serious cases)[Ref]

Fatal and serious cases of renal failure have been reported. Increases in creatinine 1.5 to 3 times the upper limit of normal have been observed (9%).[Ref]


The most commonly occurring adverse reactions (greater than or equal to 25%) included thrombocytopenia, neutropenia, diarrhea, anemia, fatigue, musculoskeletal pain, bruising, nausea, upper respiratory tract infection, and rash.[Ref]


Postmarketing reports: Anaphylactic shock (fatal), urticaria, and angioedema[Ref]


1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Imbruvica (ibrutinib)." Pharmacyclics Inc, Sunnyvale, CA.

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.