Drug adverse event reports (FAERS)

Blood potassium increased, Glaucoma, Blood creatinine abnormal +1

Drugs: RAVULIZUMAB

SeriousHospitalizationOther seriousReport 26940054
Safetyreportversion
1
Safetyreportid
26940054
Primarysourcecountry
US
Occurcountry
US
Transmissiondateformat
102
Transmissiondate
20260709
Reporttype
2
Serious
1
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
1
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
1
Receivedateformat
102
Receivedate
20260630
Receiptdateformat
102
Receiptdate
20260630
Fulfillexpeditecriteria
1
Companynumb
US-AstraZeneca-CH-01149525A
Primarysource
Reportercountry
US
Qualification
5
Sender
Sendertype
6
Senderorganization
ALEXION PHARMACEUTICALS
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientagegroup
5
Patientsex
1
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Blood potassium increased
    Reactionoutcome
    1
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Glaucoma
    Reactionoutcome
    6
  3. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Blood creatinine abnormal
    Reactionoutcome
    6
  4. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Glomerular filtration rate increased
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    RAVULIZUMAB
    Drugauthorizationnumb
    761108
    Drugseparatedosagenumb
    1
    Drugdosagetext
    UNK
    Drugadministrationroute
    065
    Drugindication
    Atypical haemolytic uraemic syndrome
    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.