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Imbruvica Side Effects

Generic Name: ibrutinib

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

Not all side effects for Imbruvica may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to ibrutinib: oral capsule

In addition to its needed effects, some unwanted effects may be caused by ibrutinib (the active ingredient contained in Imbruvica). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking ibrutinib:

More common
  • 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
  • dry mouth
  • fainting
  • fast or irregular heartbeat
  • fever
  • frequent urge to urinate
  • increased thirst
  • irregular heartbeat
  • itching
  • loss of appetite
  • lower back or side pain
  • nausea and vomiting
  • rapid weight gain
  • severe headache
  • severe stomach pain
  • shortness of breath or troubled breathing
  • sore throat
  • tightness of the chest
  • tingling of the hands or feet
  • 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
  • warmth on the skin
  • weight gain
  • 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 of the side effects that can occur with ibrutinib may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Belching
  • decreased appetite
  • difficulty having a bowel movement (stool)
  • 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


-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. "UK Summary of Product Characteristics." O 0

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.