Drug adverse event reports (FAERS)

Placental disorder, Preterm premature rupture of membranes, Oligohydramnios +2

Drugs: DUPIXENT, SYMBICORT

SeriousHospitalizationOther seriousReport 26940089
Safetyreportversion
1
Safetyreportid
26940089
Primarysourcecountry
EU
Occurcountry
EU
Transmissiondateformat
102
Transmissiondate
20260709
Reporttype
1
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
EU-EMB-M202502125-1
Duplicate
1
Reportduplicate
  1. Duplicatesource
    BFARM
    Duplicatenumb
    EU-BFARM-26002881
  2. Duplicatesource
    EMB
    Duplicatenumb
    EU-EMB-M202502125-1
Primarysource
Reportercountry
EU
Qualification
1
Sender
Sendertype
6
Senderorganization
SANOFI AVENTIS
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
44
Patientonsetageunit
801
Patientsex
2
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Placental disorder
    Reactionoutcome
    1
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Preterm premature rupture of membranes
    Reactionoutcome
    1
  3. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Oligohydramnios
    Reactionoutcome
    1
  4. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Abortion spontaneous
    Reactionoutcome
    4
  5. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Exposure during pregnancy
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    DUPIXENT
    Drugauthorizationnumb
    761055
    Drugseparatedosagenumb
    1
    Drugintervaldosageunitnumb
    2
    Drugintervaldosagedefinition
    803
    Drugdosagetext
    DOSAGE UNKNOWN, ADMINISTERED EVERY 2 WEEKS
    Drugstartdateformat
    610
    Drugstartdate
    202501
    Drugenddateformat
    610
    Drugenddate
    202505
    Drugtreatmentduration
    8
    Drugtreatmentdurationunit
    804
    Actiondrug
    1
    Drugrecurreadministration
    3
    Drugadditional
    1
    Activesubstance
    Activesubstancename
    DUPILUMAB
    Harmonized identifiers (openFDA)
    Application number
    BLA761055
    Brand name
    DUPIXENT
    Generic name
    DUPILUMAB
    Manufacturer name
    Sanofi-Aventis U.S. LLC
    Product NDC
    0024-5914, 0024-5918, 0024-5915, 0024-5919
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    SUBCUTANEOUS
    Substance name
    DUPILUMAB
    RxCUI
    1876401, 1876406, 2099300, 2099302, 2375327, 2375329, 2559706, 2559707
    SPL ID
    06b9c64b-52b1-490b-b118-bd079e69264e
    SPL set ID
    595f437d-2729-40bb-9c62-c8ece1f82780
    Package NDC
    0024-5914-00, 0024-5914-01, 0024-5914-20, 0024-5914-02, 0024-5918-00, 0024-5918-01, 0024-5918-20, 0024-5918-02, 0024-5915-00, 0024-5915-02, 0024-5915-01, 0024-5915-20, 0024-5919-00, 0024-5919-02, 0024-5919-01, 0024-5919-20
    Nui
    N0000193342, N0000193341, M0001357
    Pharm class epc
    Interleukin-4 Receptor alpha Antagonist [EPC]
    Pharm class moa
    Interleukin 4 Receptor alpha Antagonists [MoA]
    Pharm class cs
    Antibodies, Monoclonal [CS]
    UNII
    420K487FSG
  2. Drugcharacterization
    1
    Medicinalproduct
    SYMBICORT
    Drugseparatedosagenumb
    1
    Drugintervaldosageunitnumb
    1
    Drugintervaldosagedefinition
    804
    Drugdosagetext
    DOSAGE UNKNOWN, DAILY ADMINISTERED
    Drugstartdateformat
    610
    Drugstartdate
    202501
    Drugenddateformat
    610
    Drugenddate
    202505
    Drugtreatmentduration
    124
    Drugtreatmentdurationunit
    804
    Actiondrug
    1
    Drugadditional
    1
    Activesubstance
    Activesubstancename
    BUDESONIDE\FORMOTEROL FUMARATE DIHYDRATE
    Harmonized identifiers (openFDA)
    Application number
    NDA021929
    Brand name
    SYMBICORT
    Generic name
    BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE
    Manufacturer name
    AstraZeneca Pharmaceuticals LP
    Product NDC
    0186-0370, 0186-0372
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    RESPIRATORY (INHALATION)
    Substance name
    BUDESONIDE, FORMOTEROL FUMARATE
    RxCUI
    1246288, 1246290, 1246304, 1246306, 1246314, 1246315, 1246316, 1246317
    SPL ID
    1f05ded1-7d31-4cfc-8537-0e75f99ad452
    SPL set ID
    fafa4cf1-99c2-43d5-73ad-51f256de3be0
    Package NDC
    0186-0370-20, 0186-0370-28, 0186-0370-60, 0186-0372-20, 0186-0372-28, 0186-0372-60
    Nui
    N0000175576, N0000175450
    Pharm class epc
    Corticosteroid [EPC]
    Pharm class moa
    Corticosteroid Hormone Receptor Agonists [MoA]
    UNII
    Q3OKS62Q6X, W34SHF8J2K
Summary
Narrativeincludeclinical
CASE EVENT DATE: 20250501
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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.