Drug adverse event reports (FAERS)

Chronic lymphocytic leukaemia recurrent, Drug interaction

Drugs: ACALABRUTINIB

SeriousOther seriousReport 27325182
Safetyreportversion
1
Safetyreportid
27325182
Primarysourcecountry
US
Occurcountry
US
Transmissiondateformat
102
Transmissiondate
20261010
Reporttype
2
Serious
1
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
2
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
1
Receivedateformat
102
Receivedate
20260930
Receiptdateformat
102
Receiptdate
20260930
Fulfillexpeditecriteria
1
Companynumb
US-AstraZeneca-CH-01209520A
Primarysource
Reportercountry
US
Qualification
3
Sender
Sendertype
6
Senderorganization
ALEXION PHARMACEUTICALS
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientagegroup
6
Patientsex
1
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Chronic lymphocytic leukaemia recurrent
    Reactionoutcome
    6
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Drug interaction
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    3
    Medicinalproduct
    ACALABRUTINIB
    Drugbatchnumb
    AA0172
    Drugauthorizationnumb
    210259
    Drugstructuredosagenumb
    100
    Drugstructuredosageunit
    003
    Drugseparatedosagenumb
    1
    Drugintervaldosageunitnumb
    12
    Drugintervaldosagedefinition
    805
    Drugdosagetext
    100 MILLIGRAM, Q12H
    Drugadministrationroute
    061
    Drugindication
    Chronic lymphocytic leukaemia refractory
    Actiondrug
    1
    Drugrecurreadministration
    3
    Activesubstance
    Activesubstancename
    ACALABRUTINIB
    Harmonized identifiers (openFDA)
    Application number
    NDA210259
    Brand name
    CALQUENCE
    Generic name
    ACALABRUTINIB
    Manufacturer name
    AstraZeneca Pharmaceuticals LP
    Product NDC
    0310-0512
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    ORAL
    Substance name
    ACALABRUTINIB
    RxCUI
    1986813, 1986819
    SPL ID
    aa4e8627-21c7-413a-9d0d-1957ded93283
    SPL set ID
    dd4835ef-e1bc-4997-a399-1ffa2556fbfe
    Package NDC
    0310-0512-60, 0310-0512-28, 0310-0512-95
    Nui
    N0000175605, N0000020001
    Pharm class epc
    Kinase Inhibitor [EPC]
    Pharm class moa
    Tyrosine Kinase Inhibitors [MoA]
    UNII
    I42748ELQW
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How to read this: Each report says someone told FDA an event happened while a product was used. A report does not show the product caused it, and counts rise and fall with how many people report. Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.