ACALABRUTINIB

N/A

Manufactured by AstraZeneca Pharmaceuticals LP

15,655 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ACALABRUTINIB

ACALABRUTINIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AstraZeneca Pharmaceuticals LP. The most commonly reported adverse reactions for ACALABRUTINIB include DEATH, FATIGUE, HEADACHE, PRODUCT DOSE OMISSION ISSUE, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACALABRUTINIB.

Top Adverse Reactions

DEATH1,938 reports
FATIGUE611 reports
HEADACHE579 reports
PRODUCT DOSE OMISSION ISSUE383 reports
DIARRHOEA372 reports
FALL312 reports
MALIGNANT NEOPLASM PROGRESSION300 reports
CONTUSION297 reports
DYSPNOEA293 reports
PNEUMONIA282 reports
ASTHENIA277 reports
OFF LABEL USE254 reports
ATRIAL FIBRILLATION253 reports
PAIN250 reports
ARTHRALGIA237 reports
NAUSEA235 reports
COVID 19233 reports
DIZZINESS227 reports
RASH214 reports
PYREXIA212 reports
ANAEMIA202 reports
DRUG INEFFECTIVE179 reports
MYALGIA172 reports
WHITE BLOOD CELL COUNT INCREASED166 reports
HAEMORRHAGE161 reports
PLATELET COUNT DECREASED157 reports
PERIPHERAL SWELLING155 reports
LYMPHADENOPATHY154 reports
DISEASE PROGRESSION151 reports
HAEMOGLOBIN DECREASED147 reports
NEUTROPENIA146 reports
COUGH139 reports
INFECTION137 reports
MYOCARDIAL INFARCTION137 reports
VOMITING133 reports
HYPERTENSION132 reports
THROMBOCYTOPENIA132 reports
MALAISE130 reports
HYPOTENSION129 reports
CEREBROVASCULAR ACCIDENT128 reports
DEHYDRATION128 reports
NEUROPATHY PERIPHERAL127 reports
WEIGHT DECREASED126 reports
BACK PAIN125 reports
PAIN IN EXTREMITY122 reports
WHITE BLOOD CELL COUNT DECREASED120 reports
CARDIAC DISORDER118 reports
DRUG INTERACTION117 reports
FEELING ABNORMAL111 reports
TOXICITY TO VARIOUS AGENTS109 reports
ILLNESS108 reports
MUSCLE SPASMS105 reports
PLEURAL EFFUSION104 reports
PRURITUS104 reports
TUMOUR LYSIS SYNDROME104 reports
DECREASED APPETITE103 reports
CHEST PAIN102 reports
URINARY TRACT INFECTION98 reports
WEIGHT INCREASED97 reports
ABDOMINAL DISCOMFORT96 reports
INSOMNIA89 reports
NEPHROLITHIASIS89 reports
CONSTIPATION87 reports
PRODUCT USE ISSUE84 reports
CARDIAC FAILURE81 reports
DRUG INTOLERANCE81 reports
WHITE BLOOD CELL COUNT ABNORMAL80 reports
RENAL IMPAIRMENT78 reports
THROMBOSIS78 reports
PULMONARY OEDEMA76 reports
GAIT DISTURBANCE73 reports
LOSS OF CONSCIOUSNESS73 reports
ABDOMINAL PAIN UPPER71 reports
GASTROOESOPHAGEAL REFLUX DISEASE71 reports
PANCYTOPENIA71 reports
ANXIETY69 reports
FEBRILE NEUTROPENIA68 reports
PALPITATIONS68 reports
SEPSIS68 reports
CHRONIC LYMPHOCYTIC LEUKAEMIA67 reports
DYSPEPSIA67 reports
TREMOR67 reports
CATARACT66 reports
ALOPECIA63 reports
CONFUSIONAL STATE63 reports
DEPRESSION60 reports
MEMORY IMPAIRMENT58 reports
ACUTE KIDNEY INJURY57 reports
ERYTHEMA57 reports
HEART RATE INCREASED57 reports
OEDEMA PERIPHERAL57 reports
SKIN DISCOLOURATION57 reports
HYPERSENSITIVITY56 reports
BALANCE DISORDER55 reports
CARDIAC FAILURE CONGESTIVE55 reports
CHILLS55 reports
SOMNOLENCE54 reports
DIABETES MELLITUS53 reports
HAEMATOMA53 reports
RED BLOOD CELL COUNT DECREASED53 reports

Report Outcomes

Out of 10,806 classified reports for ACALABRUTINIB:

Serious 82.5%Non-Serious 17.5%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male5,637 (62.9%)
Female3,325 (37.1%)

Reports by Age

Age 70120 reports
Age 80106 reports
Age 77101 reports
Age 7499 reports
Age 7298 reports
Age 6897 reports
Age 7897 reports
Age 7196 reports
Age 6793 reports
Age 7591 reports
Age 7690 reports
Age 6687 reports
Age 8186 reports
Age 6478 reports
Age 6977 reports
Age 8576 reports
Age 7375 reports
Age 7975 reports
Age 8270 reports
Age 6565 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ACALABRUTINIB?

This profile reflects 15,655 FDA FAERS reports that mention ACALABRUTINIB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ACALABRUTINIB?

Frequently reported terms in FAERS include DEATH, FATIGUE, HEADACHE, PRODUCT DOSE OMISSION ISSUE, DIARRHOEA, FALL. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ACALABRUTINIB?

Labeling and FAERS entries often list AstraZeneca Pharmaceuticals LP in connection with ACALABRUTINIB. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.