Acalabrutinib Side Effects

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

Applies to acalabrutinib: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 1 week after your last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, headache, dizziness, or weakness, pain, swelling, or discomfort in a joint, pinpoint red spots on your skin, unusual nosebleeds, or unusual vaginal bleeding that is heavier than normal. These may be signs of bleeding problems.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before and after having surgery.

Call your doctor right away if you start to have a cough that would not go away, weight loss, night sweats, fever, chills, flu-like symptoms (eg, runny or stuffy nose, headache, blurred vision, or feeling generally ill), painful or difficult urination, or sores, ulcers, or white spots in the mouth or on the lips. These may be signs that you have an infection.

Acalabrutinib may lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Using this medicine may increase your risk of getting new cancers, including skin cancer. Avoid sun exposure. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

This medicine may cause heart rhythm problems (eg, atrial flutter, atrial fibrillation). Check with your doctor right away if you have a fast or irregular heartbeat, trouble breathing, lightheadedness, dizziness, or fainting.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

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]

See also:

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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer