Drug adverse event reports (FAERS)

Pulmonary sepsis, Visual impairment, Prostatomegaly +2

Drugs: BUDESONIDE\FORMOTEROL\GLYCOPYRRONIUM

SeriousOther seriousReport 27325202
Safetyreportversion
1
Safetyreportid
27325202
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-01208868A
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
    Pulmonary sepsis
    Reactionoutcome
    6
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Visual impairment
    Reactionoutcome
    6
  3. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Prostatomegaly
    Reactionoutcome
    6
  4. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Confusional state
    Reactionoutcome
    6
  5. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Feeling abnormal
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    BUDESONIDE\FORMOTEROL\GLYCOPYRRONIUM
    Drugbatchnumb
    Unknown
    Drugauthorizationnumb
    212122
    Drugseparatedosagenumb
    1
    Drugadministrationroute
    065
    Actiondrug
    4
    Drugrecurreadministration
    3
    Activesubstance
    Activesubstancename
    BUDESONIDE\FORMOTEROL\GLYCOPYRRONIUM
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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.