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. Continue reading for a comprehensive list of adverse effects.

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]