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Ibrutinib Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Feb 25, 2022.

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 capsules and tablets

Side effects include:

Mantle cell lymphoma, marginal-zone lymphoma, CLL/SLL, or Waldenstrom macroglobulinemia (≥30%): Thrombocytopenia, diarrhea, anemia, neutropenia, musculoskeletal pain, rash, bruising, nausea, fatigue.

Chronic GVHD (≥20%): Fatigue, bruising, diarrhea, thrombocytopenia, muscle spasms, stomatitis, nausea, hemorrhage, anemia, pneumonia.

For Healthcare Professionals

Applies to ibrutinib: oral capsule, oral suspension, oral tablet

Cardiovascular

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

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

Hematologic

-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 (77%), decreased platelets (71%), decreased neutrophils (54%), bleeding events (all grades; approximately 50%), decreased hemoglobin (44%), neutropenia (29%), thrombocytopenia (17%)

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

Uncommon (less than 1%): Leukostasis

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

Hypersensitivity

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

Immunologic

Frequency not reported: Progressive multifocal leukoencephalopathy (PML)[Ref]

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

Musculoskeletal

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

Ocular

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

Metabolic

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

Frequency not reported: Tumor lysis syndrome[Ref]

Psychiatric

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

Genitourinary

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

Oncologic

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

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

Respiratory

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]

Other

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

Frequency not reported: Gait instability[Ref]

General

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

Nervous system

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

Common (1% to 10%): Subdural hematoma

Frequency not reported: Intracranial hemorrhage, lethargy[Ref]

Renal

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]

Dermatologic

petechiae (17%), contusion (11%), laceration (10%)[Ref]

Gastrointestinal

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

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

Frequently asked questions

References

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

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

3. "Product Information. Imbruvica (ibrutinib)." Pharmacyclics Inc (2013):

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.