Acalabrutinib Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 31, 2023.

Applies to acalabrutinib: oral tablet.

Serious side effects of acalabrutinib

Along with its needed effects, acalabrutinib 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 acalabrutinib:

More common side effects

• black, tarry stools
• bleeding gums
• blood in the urine or stools
• body aches or pain
• chills
• collection of blood under the skin
• coughing up blood
• difficulty in breathing or swallowing
• dizziness
• ear congestion
• fever
• headache
• increased menstrual flow or vaginal bleeding
• itching, pain, redness, or swelling
• large, flat, blue or purplish patches in the skin
• loss of voice
• lower back or side pain
• muscle or bone pain
• nosebleeds
• painful or difficult urination
• paralysis
• pinpoint red spots on the skin
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• sneezing
• sore throat
• stuffy or runny nose
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness

Other side effects of acalabrutinib

Some side effects of acalabrutinib 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 side effects

• constipation
• diarrhea
• difficulty in moving
• joint pain or swelling
• muscle cramps or stiffness
• nausea
• rash
• stomach pain
• vomiting

For healthcare professionals

Applies to acalabrutinib: oral capsule, oral tablet.

General adverse events

The most common adverse reactions (reported incidence of 20% or greater) were anemia, thrombocytopenia, headache, neutropenia, diarrhea, fatigue, myalgia, and bruising.^[Ref]

Cardiovascular

• Very common (10% or more): Bleeding events (50%)
• Common (1% to 10%): Hemorrhage/hematoma
• Uncommon (0.1% to 1%): Atrial fibrillation, atrial flutter^[Ref]

Hematologic

• Very common (10% or more): Decreased hemoglobin (46%), decreased platelets (44%), decreased neutrophils (36%), neutropenia (23%), anemia (11%)
• Common (1% to 10%): Thrombocytopenia^[Ref]

Nervous system

• Very common (10% or more): Headache (39%)^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (31%), nausea (19%), abdominal pain (15%), constipation (15%), vomiting (13%)^[Ref]

Dermatologic

• Very common (10% or more): Bruising/petechiae/ecchymosis/contusion (21%), rash (18%)^[Ref]

Musculoskeletal

• Very common (10% or more): Myalgia (21%)^[Ref]

Oncologic

• Very common (10% or more): Second primary malignancies (11%)
• Common (1% to 10%): Skin cancer^[Ref]

Hepatic

• Common (1% to 10%): Increased creatinine^[Ref]

Respiratory

• Common (1% to 10%): Epistaxis
• Frequency not reported: Pneumonia^[Ref]

Other

• Very common (10% or more): Fatigue (28%)
• Frequency not reported: Infections^[Ref]

Frequently asked questions

• Acalabrutinib vs. ibrutinib: How do they compare?

Further information

Acalabrutinib side effects can vary depending on the individual. 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.

Medical Disclaimer