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Acalabrutinib Side Effects

For the Consumer

Applies to acalabrutinib: oral capsule

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
  • Bleeding gums
  • collection of blood under the skin
  • coughing up blood
  • difficulty in breathing or swallowing
  • dizziness
  • headache
  • increased menstrual flow or vaginal bleeding
  • itching, pain, redness, or swelling
  • large, flat, blue or purplish patches in the skin
  • nosebleeds
  • paralysis
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine

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

For Healthcare Professionals

Applies to acalabrutinib: oral capsule

General

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]

References

1. "Product Information. Calquence (acalabrutinib)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

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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