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Note: This document contains side effect information about ibrutinib. Some of the dosage forms listed on this page may not apply to the brand name Imbruvica.
Common side effects of Imbruvica 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.
Applies to ibrutinib: oral capsule, oral tablet
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:
Incidence not known
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:
Applies to ibrutinib: oral capsule, oral tablet
Very common (10% or more): Hypertension (17%)
Common (1% to 10%): Atrial fibrillation, atrial flutter
-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%).
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%)
Postmarketing reports: Anaphylactic shock (fatal), urticaria, angioedema
Frequency not reported: Progressive multifocal leukoencephalopathy (PML)
Grade 3 or higher infections including urinary tract infection, pneumonia, skin infections, and sinusitis were reported.
Very common (10% or more): Musculoskeletal pain (37%), arthralgia (23%), muscle spasms (19%)
Very common (10% or more): Blurred vision (10%)
Very common (10% or more): Elevated uric acid levels (40%), decreased appetite (21%), hyperuricemia (15%), dehydration (12%)
Frequency not reported: Tumor lysis syndrome
Very common (10% or more): Anxiety (10%), insomnia (10%)
Very common (10% or more): Urinary tract infection (14%)
Very common (10% or more): Second primary malignancies (10%)
Common (1% to 10%): Non-melanoma skin cancer, carcinomas
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%)
Very common (10% or more): Fatigue (41%), peripheral edema (35%), pyrexia (25%), asthenia (14%), chills (13%)
Frequency not reported: Gait instability
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.
Very common (10% or more): Dizziness (21%), headache (19%), peripheral neuropathy (10%)
Common (1% to 10%): Subdural hematoma
Frequency not reported: Intracranial hemorrhage, lethargy
Very common (14%): Urinary tract infection
Common (1% to 10%): Increased creatinine
Frequency not reported: Renal failure (fatal and serious cases)
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%).
petechiae (17%), contusion (11%), laceration (10%)
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