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Imbruvica Side Effects

Generic name: ibrutinib

Medically reviewed by Philip Thornton, DipPharm. Last updated on Feb 15, 2024.

Note: This document contains side effect information about ibrutinib. Some dosage forms listed on this page may not apply to the brand name Imbruvica.

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

Serious side effects of Imbruvica

Along with its needed effects, ibrutinib (the active ingredient contained in Imbruvica) 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

Less common

Incidence not known

Other side effects of Imbruvica

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

For Healthcare Professionals

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

General

The most common adverse reactions in patients with B-cell malignancies were thrombocytopenia, diarrhea, fatigue, musculoskeletal pain, neutropenia, rash, anemia, bruising, nausea, hemorrhage, arthralgia, and upper respiratory tract infection.

The most common adverse reactions in patients with chronic graft-versus-host disease were fatigue, anemia, bruising, diarrhea, thrombocytopenia, musculoskeletal pain, pyrexia, muscle spasms, stomatitis, hemorrhage, nausea, abdominal pain, pneumonia, and headache.[Ref]

Cardiovascular

Very common (10% or more): Hypertension (up to 42%), atrial fibrillation (up to 15%), sinus tachycardia (up to 11%)

Common (1% to 10%): Atrial flutter, cardiac failure, ventricular tachyarrhythmias (includes ventricular extrasystoles, ventricular arrhythmias, ventricular fibrillation, ventricular flutter, ventricular tachycardia), deaths due to cardiac causes/sudden deaths

Uncommon (0.1% to 1%): Cardiac arrest

Frequency not reported: Cardiac arrhythmias

Postmarketing reports: Cardiac failure, ventricular tachyarrhythmia

Hypertension occurred in 19% of 1476 patients with B-cell malignancies who received this drug in clinical trials; grade 3 or greater hypertension occurred in 8% of patients. Based on data from a subset of these patients (N=1124), the median time to onset was 5.9 months (range: 0 to 24 months). In a long-term safety analysis over 5 years of 1284 patients with B-cell malignancies treated for a median of 36 months (range: 0 to 98 months), the cumulative rate of hypertension increased over time. The prevalence for grade 3 or greater hypertension was 4% (year 0 to 1), 7% (year 1 to 2), 9% (year 2 to 3), 9% (year 3 to 4), and 9% (year 4 to 5); the overall incidence for the 5-year period was 11%.

Fatal and serious cardiac arrhythmias and cardiac failure have occurred with this drug. Deaths due to cardiac causes or sudden deaths occurred in 1% of 4896 patients who received this drug in clinical trials, including in those who received this drug in unapproved monotherapy or combination regimens. These adverse reactions occurred in patients with and without preexisting hypertension or cardiac comorbidities.

Grade 3 or greater ventricular tachyarrhythmias were reported in 0.2%, grade 3 or greater atrial fibrillation and atrial flutter were reported in 3.7%, and grade 3 or greater cardiac failure was reported in 1.3% of 4896 patients who received this drug in clinical trials, including in those who received this drug in unapproved monotherapy or combination regimens, and especially in patients with acute infections or cardiac risk factors (including hypertension, diabetes mellitus, history of cardiac arrhythmias).

Dermatologic

Very common (10% or more): Bruising/contusion (up to 51%), rash (up to 49%), petechiae (up to 16%), skin infection (up to 18%), pruritus (up to 13%)

Common (1% to 10%): Erythema, urticaria

Uncommon (0.1% to 1%): Angioedema

Postmarketing reports: Angioedema, urticaria, Stevens-Johnson syndrome, onychoclasis, panniculitis, neutrophilic dermatoses, erythema

Gastrointestinal

Very common (10% or more): Diarrhea (up to 59%), nausea (up to 40%), stomatitis (up to 29%), abdominal pain (up to 23%), constipation (up to 22%), vomiting (up to 19%), dyspepsia (up to 16%), gastroesophageal reflux disease (up to 12%)

Genitourinary

Very common (10% or more): Urinary tract infection (up to 13%)

Hematologic

Very common (10% or more): Decreased platelets (up to 69%), neutropenia (up to 66%), decreased neutrophils (up to 55%), decreased hemoglobin (up to 49%), bleeding events (including bruising, petechiae; up to 39%), thrombocytopenia (up to 36%), hemorrhage (up to 32%), anemia (up to 17%), lymphocytosis (up to 15%)

Common (1% to 10%): Major hemorrhage (e.g., intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, postprocedural hemorrhage), febrile neutropenia, leukocytosis, subdural hematoma

Uncommon (0.1% to 1%): Fatal bleeding events, leukostasis syndrome

Fatal bleeding events have occurred in patients who received this drug. Major hemorrhage (grade 3 or greater, serious, or any central nervous system events, e.g., intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and postprocedural hemorrhage) occurred in 4.2% of patients, with fatalities occurring in 0.4% of 2838 patients who received this drug in 27 clinical trials. Bleeding events (any grade) including bruising and petechiae occurred in 39% and excluding bruising and petechiae occurred in 23% of patients who received this drug, respectively.

Across clinical trials, 3.1% of 2838 patients who received this drug without antiplatelet or anticoagulant therapy experienced major hemorrhage. The addition of antiplatelet therapy (with or without anticoagulant therapy) increased the incidence to 4.4%, and the addition of anticoagulant therapy (with or without antiplatelet therapy) increased the incidence to 6.1%.

In 645 patients with B-cell malignancies who received this drug as a single agent, grade 3 or 4 neutropenia occurred in 23% of patients, grade 3 or 4 thrombocytopenia in 8% of patients, and grade 3 or 4 anemia in 2.8% of patients, based on laboratory measurements.

Hepatic

Very common (10% or more): Increased bilirubin (up to 30%), increased AST (up to 25%), increased ALT (up to 11%)

Postmarketing reports: Hepatic failure (including acute events, fatal events), hepatic cirrhosis, hepatitis B reactivation, hepatotoxicity

Hypersensitivity

Postmarketing reports: Anaphylactic shock

Immunologic

Very common (10% or more): Hypogammaglobulinemia (up to 11%)

Metabolic

Very common (10% or more): Hyperuricemia (up to 19%), decreased appetite (up to 16%), hypokalemia (up to 15%)

Common (1% to 10%): Tumor lysis syndrome, hyponatremia

Postmarketing reports: Tumor lysis syndrome

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (up to 61%), arthralgia (up to 41%), muscle spasms (up to 29%), osteonecrosis (up to 11%)

Nervous system

Very common (10% or more): Headache (up to 40%), dizziness (up to 21%), peripheral neuropathy (up to 19%)

Common (1% to 10%): Ischemic cerebrovascular events (includes cerebrovascular accidents, ischemic stroke, cerebral ischemia, transient ischemic attack)

Frequency not reported: Progressive multifocal leukoencephalopathy

Postmarketing reports: Peripheral neuropathy, cerebrovascular accident, transient ischemic attack, ischemic stroke

Ocular

Very common (10% or more): Dry eye (up to 17%), blurred vision (up to 13%), increased lacrimation (up to 13%), reduced visual acuity (up to 11%), conjunctivitis (up to 11%)

Postmarketing reports: Eye hemorrhage

Oncologic

Other malignancies (10%), including nonskin carcinomas (3.9%), occurred among the 1476 patients with B-cell malignancies who received this drug in clinical trials. The most frequent second primary malignancy was nonmelanoma skin cancer (6%).

Very common (10% or more): Second malignancies (10%), other malignancies (including nonskin carcinomas; 10%)

Common (1% to 10%): Nonmelanoma skin cancer, nonskin carcinomas, basal cell carcinoma, squamous cell carcinoma

Frequency not reported: Histiocytic sarcoma

Other

Very common (10% or more): Fatigue (up to 80%), pyrexia (up to 30%), peripheral edema (up to 28%), infusion related reaction (up to 25%), pain (up to 23%), infections (at least 21%), fall (up to 17%), asthenia (up to 14%), chills (up to 12%), sepsis (up to 11%), decreased weight (10%)

Uncommon (0.1% to 1%): Cryptococcal infections, Pneumocystis infections, Aspergillus infections

Frequency not reported: Fatal/nonfatal infections (including bacterial, viral, fungal)

Fatal and nonfatal infections (including bacterial, viral, or fungal) have occurred with this drug. Grade 3 or greater infections occurred in 21% of 1476 patients with B cell malignancies who received this drug in clinical trials.

Psychiatric

Very common (10% or more): Insomnia (up to 16%)

Renal

Very common (10% or more): Increased blood creatinine (up to 38%)

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 47%), cough (up to 32%), pneumonia (up to 23%), dyspnea (up to 22%), sinusitis (up to 22%), oropharyngeal pain (up to 14%), bronchitis (up to 13%), nasopharyngitis (up to 12%), influenza (up to 12%), viral upper respiratory tract infection (up to 11%)

Common (1% to 10%): Epistaxis

Frequency not reported: Pneumocystis jirovecii pneumonia, acute respiratory distress syndrome

Postmarketing reports: Interstitial lung disease

Frequently asked questions

References

1. Product Information. Imbruvica (ibrutinib). Pharmacyclics Inc. 2023;SUPPL-40.

2. Product Information. Imbruvica (ibrutinib). Janssen-Cilag Pty Ltd. 2023.

3. Product Information. Imbruvica (ibrutinib). Janssen-Cilag Ltd. 2023.

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.

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