Drug adverse event reports (FAERS)

Impaired gastric emptying, Emotional distress

Drugs: OZEMPIC

SeriousHospitalizationOther seriousReport 27325228
Safetyreportversion
1
Safetyreportid
27325228
Primarysourcecountry
US
Occurcountry
US
Transmissiondateformat
102
Transmissiondate
20261008
Reporttype
1
Serious
1
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
1
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
1
Receivedateformat
102
Receivedate
20260930
Receiptdateformat
102
Receiptdate
20260930
Fulfillexpeditecriteria
2
Companynumb
US-NOVOPROD-3710583
Primarysource
Reportercountry
US
Qualification
5
Sender
Sendertype
6
Senderorganization
NOVO NORDISK A/S
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
32
Patientonsetageunit
801
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Impaired gastric emptying
    Reactionoutcome
    3
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Emotional distress
    Reactionoutcome
    3
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    OZEMPIC
    Drugauthorizationnumb
    209637
    Drugseparatedosagenumb
    1
    Drugdosagetext
    UNKNOWN
    Drugdosageform
    Solution for injection
    Drugindication
    Type 2 diabetes mellitus
    Actiondrug
    5
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    SEMAGLUTIDE
    Harmonized identifiers (openFDA)
    Application number
    NDA213051
    Brand name
    OZEMPIC
    Generic name
    ORAL SEMAGLUTIDE
    Manufacturer name
    Novo Nordisk Pharmaceutical Industries, LP
    Product NDC
    0169-1704, 0169-1715, 0169-1709, 0169-4303, 0169-4307, 0169-4314, 0169-4815, 0169-4804, 0169-4809
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    ORAL
    Substance name
    SEMAGLUTIDE
    RxCUI
    2200644, 2200650, 2200652, 2200654, 2200656, 2200658, 2707547, 2707549, 2707551, 2707553, 2707555, 2707557, 2736944, 2736946, 2736948
    SPL ID
    6834044a-22f1-4f35-b846-b3448ee84c16
    SPL set ID
    27f15fac-7d98-4114-a2ec-92494a91da98
    Package NDC
    0169-1715-30, 0169-1715-90, 0169-1704-30, 0169-1709-30, 0169-4303-01, 0169-4303-13, 0169-4303-90, 0169-4303-93, 0169-4303-30, 0169-4303-99, 0169-4307-01, 0169-4307-13, 0169-4307-30, 0169-4314-01, 0169-4314-13, 0169-4314-30, 0169-4815-30, 0169-4815-90, 0169-4804-30, 0169-4809-30
    Nui
    N0000178480, M0160181, N0000020058
    Pharm class epc
    GLP-1 Receptor Agonist [EPC]
    Pharm class cs
    Glucagon-Like Peptide 1 [CS]
    Pharm class moa
    Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
    UNII
    53AXN4NNHX
  2. Drugcharacterization
    1
    Medicinalproduct
    OZEMPIC
    Drugauthorizationnumb
    209637
    Drugindication
    Cardiovascular event prophylaxis
    Actiondrug
    5
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    SEMAGLUTIDE
    Harmonized identifiers (openFDA)
    Application number
    NDA213051
    Brand name
    OZEMPIC
    Generic name
    ORAL SEMAGLUTIDE
    Manufacturer name
    Novo Nordisk Pharmaceutical Industries, LP
    Product NDC
    0169-1704, 0169-1715, 0169-1709, 0169-4303, 0169-4307, 0169-4314, 0169-4815, 0169-4804, 0169-4809
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    ORAL
    Substance name
    SEMAGLUTIDE
    RxCUI
    2200644, 2200650, 2200652, 2200654, 2200656, 2200658, 2707547, 2707549, 2707551, 2707553, 2707555, 2707557, 2736944, 2736946, 2736948
    SPL ID
    6834044a-22f1-4f35-b846-b3448ee84c16
    SPL set ID
    27f15fac-7d98-4114-a2ec-92494a91da98
    Package NDC
    0169-1715-30, 0169-1715-90, 0169-1704-30, 0169-1709-30, 0169-4303-01, 0169-4303-13, 0169-4303-90, 0169-4303-93, 0169-4303-30, 0169-4303-99, 0169-4307-01, 0169-4307-13, 0169-4307-30, 0169-4314-01, 0169-4314-13, 0169-4314-30, 0169-4815-30, 0169-4815-90, 0169-4804-30, 0169-4809-30
    Nui
    N0000178480, M0160181, N0000020058
    Pharm class epc
    GLP-1 Receptor Agonist [EPC]
    Pharm class cs
    Glucagon-Like Peptide 1 [CS]
    Pharm class moa
    Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
    UNII
    53AXN4NNHX
  3. Drugcharacterization
    1
    Medicinalproduct
    OZEMPIC
    Drugauthorizationnumb
    209637
    Drugindication
    Weight control
    Actiondrug
    5
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    SEMAGLUTIDE
    Harmonized identifiers (openFDA)
    Application number
    NDA213051
    Brand name
    OZEMPIC
    Generic name
    ORAL SEMAGLUTIDE
    Manufacturer name
    Novo Nordisk Pharmaceutical Industries, LP
    Product NDC
    0169-1704, 0169-1715, 0169-1709, 0169-4303, 0169-4307, 0169-4314, 0169-4815, 0169-4804, 0169-4809
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    ORAL
    Substance name
    SEMAGLUTIDE
    RxCUI
    2200644, 2200650, 2200652, 2200654, 2200656, 2200658, 2707547, 2707549, 2707551, 2707553, 2707555, 2707557, 2736944, 2736946, 2736948
    SPL ID
    6834044a-22f1-4f35-b846-b3448ee84c16
    SPL set ID
    27f15fac-7d98-4114-a2ec-92494a91da98
    Package NDC
    0169-1715-30, 0169-1715-90, 0169-1704-30, 0169-1709-30, 0169-4303-01, 0169-4303-13, 0169-4303-90, 0169-4303-93, 0169-4303-30, 0169-4303-99, 0169-4307-01, 0169-4307-13, 0169-4307-30, 0169-4314-01, 0169-4314-13, 0169-4314-30, 0169-4815-30, 0169-4815-90, 0169-4804-30, 0169-4809-30
    Nui
    N0000178480, M0160181, N0000020058
    Pharm class epc
    GLP-1 Receptor Agonist [EPC]
    Pharm class cs
    Glucagon-Like Peptide 1 [CS]
    Pharm class moa
    Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
    UNII
    53AXN4NNHX
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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.