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Acalabrutinib Side Effects

The most commonly reported side effects of acalabrutinib include death, fatigue, and headache, based on 10,912 FDA adverse event reports from 2004 to 2025.

Acalabrutinib side effects

Percentages show how often each reaction appears relative to total reports for acalabrutinib.

1
Death17.8%1,942
2
Fatigue5.7%619
3
Headache5.4%584
4
Product Dose Omission Issue3.5%383
5
Diarrhoea3.4%375
6
Fall2.9%315
7
Malignant Neoplasm Progression2.7%300
8
Dyspnoea2.7%299
9
Contusion2.7%299
10
Pneumonia2.6%285
11
Asthenia2.6%283
12
Pain2.4%261
13
Off Label Use2.4%259
14
Atrial Fibrillation2.3%254
15
Arthralgia2.2%244

These are voluntary reports and do not establish that acalabrutinib caused these reactions.

Report severity

82.4%Serious8,992 reports
25.9%Hospitalizations2,829 reports
22.0%Fatal2,402 reports

Seriousness is determined by the reporter, not by OpenClaim.

Acalabrutinib drug interactions

Other drugs that appear in adverse event reports alongside acalabrutinib. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Rituximab4.0%436
2
Venetoclax3.2%351
3
Ibrutinib2.5%277
4
Obinutuzumab2.3%251
5
Bendamustine-hydrochloride1.9%208
6
Cyclophosphamide1.1%124
7
Metoprolol1.1%122
8
Prednisone0.9%99
9
Doxorubicin-hydrochloride0.9%95
10
Vincristine-sulfate0.9%93
11
Cytarabine0.8%83
12
Lenalidomide0.7%74
13
Omeprazole0.5%57
14
Dexamethasone0.5%56
15
Apixaban0.4%41

Taken alongside

1
Allopurinol5.2%562
2
Acetaminophen5.0%548
3
Ergocalciferol4.7%509
4
Atorvastatin-calcium4.4%475
5
Aspirin4.3%466
6
Acyclovir3.5%378
7
Metoprolol3.3%357
8
Levothyroxine-sodium3.1%334
9
Ondansetron2.7%298
10
Furosemide2.6%287
11
Apixaban2.6%283
12
Amlodipine2.6%279
13
Tamsulosin-hydrochloride2.5%268
14
Cyanocobalamin2.4%257
15
Metformin2.2%244

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports acalabrutinib side effects

30.9% of acalabrutinib adverse event reports involve female patients and 52.1% involve male patients. The largest age group is elderly at 80%. These figures reflect who reports side effects, not underlying risk.

Sex

Female30.9%
Male52.1%
Unknown17.0%

Age group

< 2<0.1%
2–11<0.1%
12–17<0.1%
18–6419.8%
65+80.1%

What is acalabrutinib used for

Conditions and purposes for which patients were taking acalabrutinib when the adverse event was reported.

Abdominal PainAcquired Gene MutationAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia RecurrentAnaemiaAnaplastic Large Cell Lymphoma T- And Null-cell TypesAsthmaAcanthamoeba InfectionAcute LeukaemiaAcute Lymphocytic LeukaemiaAcute Myeloid LeukaemiaAdverse Drug ReactionAllergy ProphylaxisAnaemiaAntibiotic Therapy

Showing 15 of 242 indications

Acalabrutinib brand names and reporting trend

Acalabrutinib is sold under brand names including Acalabrutinib, Calquence.

Brand names

Acalabrutinib4,842
Calquence90

Quarterly reports (20042025)

20042010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking acalabrutinib with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.