Drug adverse event reports (FAERS)

Resorption bone increased, Nerve injury, Eye injury

Drugs: KISUNLA

Not seriousReport 26940073
Safetyreportversion
1
Safetyreportid
26940073
Primarysourcecountry
US
Occurcountry
US
Transmissiondateformat
102
Transmissiondate
20260709
Reporttype
1
Serious
2
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
2
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
2
Receivedateformat
102
Receivedate
20260630
Receiptdateformat
102
Receiptdate
20260630
Fulfillexpeditecriteria
2
Companynumb
US-ELI_LILLY_AND_COMPANY-US202606030712
Primarysource
Reportercountry
US
Qualification
5
Sender
Sendertype
6
Senderorganization
ELI LILLY AND CO
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientsex
2
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Resorption bone increased
    Reactionoutcome
    6
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Nerve injury
    Reactionoutcome
    6
  3. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Eye injury
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    KISUNLA
    Drugauthorizationnumb
    761248
    Drugseparatedosagenumb
    1
    Drugdosagetext
    UNK, UNKNOWN
    Drugindication
    Product used for unknown indication
    Actiondrug
    5
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    DONANEMAB-AZBT
    Harmonized identifiers (openFDA)
    Application number
    BLA761248
    Brand name
    KISUNLA
    Generic name
    DONANEMAB-AZBT
    Manufacturer name
    Eli Lilly and Company
    Product NDC
    0002-9401
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    INTRAVENOUS
    Substance name
    DONANEMAB
    RxCUI
    2687972, 2687979
    SPL ID
    85d3d68b-57f9-45e6-a1a7-fa19bc843f33
    SPL set ID
    190352d4-ef62-4679-b4fa-e846e2766afa
    Package NDC
    0002-9401-01
    UNII
    1ADB65P1KK
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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.