Imbruvica Side Effects
Generic name: ibrutinib
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.
For the Consumer
Applies to ibrutinib: oral capsule, oral tablet
Side effects requiring immediate medical attention
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:
- Back pain
- 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
- decreased frequency or amount of urine
- difficult, burning, or painful urination
- dizziness or lightheadedness
- dry mouth
- fast or irregular heartbeat
- frequent urge to urinate
- increased thirst
- irregular heartbeat
- loss of appetite
- lower back or side pain
- rapid weight gain
- severe headache
- severe stomach pain
- sore throat
- tightness of the chest
- tingling of the hands or feet
- troubled breathing
- 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
- wrinkled skin
- 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
Incidence not known
- Blistering, peeling, or loosening of the skin
- dark urine
- difficulty swallowing
- general feeling of tiredness or weakness
- hives, skin rash
- joint pain, stiffness, or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- light-colored stools
- muscle pain
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red skin lesions, often with a purple center
- red, irritated eyes
- yellow eyes or skin
Side effects not requiring immediate medical attention
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:
- decreased appetite
- difficulty having a bowel movement
- heartburn or indigestion
- lack or loss of strength
- muscle stiffness or spasms
- 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, oral tablet
Very common (10% or more): Hypertension (17%)
-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
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
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]
Very common (10% or more): Musculoskeletal pain (37%), arthralgia (23%), muscle spasms (19%)[Ref]
Very common (10% or more): Blurred vision (10%)[Ref]
Very common (10% or more): Elevated uric acid levels (40%), decreased appetite (21%), hyperuricemia (15%), dehydration (12%)
Very common (10% or more): Urinary tract infection (14%)[Ref]
Very common (10% or more): Second primary malignancies (10%)
Common (1% to 10%): Non-melanoma skin cancer, carcinomas[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): Fatigue (41%), peripheral edema (35%), pyrexia (25%), asthenia (14%), chills (13%)
Frequency not reported: Gait instability[Ref]
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]
Very common (10% or more): Dizziness (21%), headache (19%), peripheral neuropathy (10%)
Common (1% to 10%): Subdural hematoma
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]
petechiae (17%), contusion (11%), laceration (10%)[Ref]
Common (1% to 10%): Dry mouth[Ref]
Frequently asked questions
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More about Imbruvica (ibrutinib)
- Drug interactions
- Dosage information
- During pregnancy or Breastfeeding
- Reviews (45)
- Patient tips
- Drug images
- Compare alternatives
- Pricing & coupons
- En español
- Drug class: BTK inhibitors
- FDA approval history
- Drug Information
- Imbruvica (Advanced Reading)
- Imbruvica (Ibrutinib Capsules)
- Imbruvica (Ibrutinib Tablets)
Related treatment guides
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):
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.