Drug adverse event reports (FAERS)

Heart rate irregular, Jaw cyst, Hypersensitivity

Drugs: RAVULIZUMAB

SeriousHospitalizationReport 27325181
Safetyreportversion
1
Safetyreportid
27325181
Primarysourcecountry
US
Occurcountry
US
Transmissiondateformat
102
Transmissiondate
20261008
Reporttype
2
Serious
1
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
1
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
2
Receivedateformat
102
Receivedate
20260930
Receiptdateformat
102
Receiptdate
20260930
Fulfillexpeditecriteria
1
Companynumb
US-AstraZeneca-CH-01210620A
Primarysource
Reportercountry
US
Qualification
5
Sender
Sendertype
6
Senderorganization
ALEXION PHARMACEUTICALS
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientagegroup
6
Patientsex
1
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Heart rate irregular
    Reactionoutcome
    6
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Jaw cyst
    Reactionoutcome
    6
  3. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Hypersensitivity
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    RAVULIZUMAB
    Drugauthorizationnumb
    761108
    Drugseparatedosagenumb
    1
    Drugdosagetext
    UNK
    Drugadministrationroute
    065
    Drugindication
    Myasthenia gravis
    Actiondrug
    5
    Drugrecurreadministration
    3
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    RAVULIZUMAB
    Harmonized identifiers (openFDA)
    Application number
    BLA761108
    Brand name
    ULTOMIRIS
    Generic name
    RAVULIZUMAB
    Manufacturer name
    Alexion Pharmaceuticals Inc.
    Product NDC
    25682-022, 25682-025, 25682-028
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    INTRAVENOUS
    Substance name
    RAVULIZUMAB
    RxCUI
    2107320, 2107325, 2461134, 2461136, 2461139, 2461140
    SPL ID
    41262953-a849-4095-b9c2-5a1d8b0238cc
    SPL set ID
    a9a590d9-0217-43c7-908d-e62a71279791
    Package NDC
    25682-022-01, 25682-025-01, 25682-028-01
    Nui
    N0000175575, N0000175974
    Pharm class epc
    Complement Inhibitor [EPC]
    Pharm class moa
    Complement Inhibitors [MoA]
    UNII
    C3VX249T6L
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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.