Drug adverse event reports (FAERS)

Cholecystitis acute, Autoimmune thyroiditis, Immune-mediated lung disease +17

Drugs: OPDIVO, YERVOY

SeriousHospitalizationOther seriousReport 27325214
Safetyreportversion
1
Safetyreportid
27325214
Primarysourcecountry
EU
Occurcountry
EU
Transmissiondateformat
102
Transmissiondate
20261010
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
1
Companynumb
EU-BRISTOL-MYERS SQUIBB COMPANY-2026-109702
Primarysource
Reportercountry
EU
Qualification
1
Sender
Sendertype
6
Senderorganization
BRISTOL-MYERS SQUIBB COMPANY
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
62
Patientonsetageunit
801
Patientagegroup
5
Patientsex
1
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Cholecystitis acute
    Reactionoutcome
    6
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Autoimmune thyroiditis
    Reactionoutcome
    2
  3. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Immune-mediated lung disease
    Reactionoutcome
    2
  4. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Type 2 diabetes mellitus
    Reactionoutcome
    2
  5. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Diplopia
    Reactionoutcome
    6
  6. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Neuropathy peripheral
    Reactionoutcome
    6
  7. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Peripheral motor neuropathy
    Reactionoutcome
    6
  8. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Hydrocholecystis
    Reactionoutcome
    6
  9. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Cholecystitis
    Reactionoutcome
    6
  10. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Facial paresis
    Reactionoutcome
    6
  11. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Hepatic steatosis
    Reactionoutcome
    6
  12. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Splenomegaly
    Reactionoutcome
    6
  13. +8 more not shown
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    OPDIVO
    Drugauthorizationnumb
    125554
    Drugseparatedosagenumb
    1
    Drugadministrationroute
    042
    Drugindication
    Clear cell renal cell carcinoma
    Actiondrug
    4
    Drugrecurreadministration
    3
    Activesubstance
    Activesubstancename
    NIVOLUMAB
    Harmonized identifiers (openFDA)
    Application number
    BLA125554
    Brand name
    OPDIVO
    Generic name
    NIVOLUMAB
    Manufacturer name
    E.R. Squibb & Sons, L.L.C.
    Product NDC
    0003-3734, 0003-3772, 0003-3774, 0003-3756
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    INTRAVENOUS
    Substance name
    NIVOLUMAB
    RxCUI
    1657190, 1657192, 1657195, 1657196, 1991412, 1991413, 2569080, 2569081
    SPL ID
    1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
    SPL set ID
    f570b9c4-6846-4de2-abfa-4d0a4ae4e394
    Package NDC
    0003-3772-11, 0003-3774-12, 0003-3734-13, 0003-3756-14
    Nui
    N0000191260, N0000191259
    Pharm class epc
    Programmed Death Receptor-1 Blocking Antibody [EPC]
    Pharm class moa
    Programmed Death Receptor-1-directed Antibody Interactions [MoA]
    UNII
    31YO63LBSN
  2. Drugcharacterization
    1
    Medicinalproduct
    OPDIVO
    Drugauthorizationnumb
    125554
    Drugstructuredosagenumb
    240
    Drugstructuredosageunit
    003
    Drugseparatedosagenumb
    1
    Drugintervaldosageunitnumb
    4
    Drugintervaldosagedefinition
    803
    Drugstartdateformat
    102
    Drugstartdate
    20240214
    Actiondrug
    4
    Drugrecurreadministration
    3
    Activesubstance
    Activesubstancename
    NIVOLUMAB
    Harmonized identifiers (openFDA)
    Application number
    BLA125554
    Brand name
    OPDIVO
    Generic name
    NIVOLUMAB
    Manufacturer name
    E.R. Squibb & Sons, L.L.C.
    Product NDC
    0003-3734, 0003-3772, 0003-3774, 0003-3756
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    INTRAVENOUS
    Substance name
    NIVOLUMAB
    RxCUI
    1657190, 1657192, 1657195, 1657196, 1991412, 1991413, 2569080, 2569081
    SPL ID
    1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
    SPL set ID
    f570b9c4-6846-4de2-abfa-4d0a4ae4e394
    Package NDC
    0003-3772-11, 0003-3774-12, 0003-3734-13, 0003-3756-14
    Nui
    N0000191260, N0000191259
    Pharm class epc
    Programmed Death Receptor-1 Blocking Antibody [EPC]
    Pharm class moa
    Programmed Death Receptor-1-directed Antibody Interactions [MoA]
    UNII
    31YO63LBSN
  3. Drugcharacterization
    1
    Medicinalproduct
    OPDIVO
    Drugauthorizationnumb
    125554
    Drugstructuredosagenumb
    480
    Drugstructuredosageunit
    003
    Drugseparatedosagenumb
    1
    Drugadministrationroute
    042
    Actiondrug
    4
    Drugrecurreadministration
    3
    Activesubstance
    Activesubstancename
    NIVOLUMAB
    Harmonized identifiers (openFDA)
    Application number
    BLA125554
    Brand name
    OPDIVO
    Generic name
    NIVOLUMAB
    Manufacturer name
    E.R. Squibb & Sons, L.L.C.
    Product NDC
    0003-3734, 0003-3772, 0003-3774, 0003-3756
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    INTRAVENOUS
    Substance name
    NIVOLUMAB
    RxCUI
    1657190, 1657192, 1657195, 1657196, 1991412, 1991413, 2569080, 2569081
    SPL ID
    1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
    SPL set ID
    f570b9c4-6846-4de2-abfa-4d0a4ae4e394
    Package NDC
    0003-3772-11, 0003-3774-12, 0003-3734-13, 0003-3756-14
    Nui
    N0000191260, N0000191259
    Pharm class epc
    Programmed Death Receptor-1 Blocking Antibody [EPC]
    Pharm class moa
    Programmed Death Receptor-1-directed Antibody Interactions [MoA]
    UNII
    31YO63LBSN
  4. Drugcharacterization
    1
    Medicinalproduct
    YERVOY
    Drugauthorizationnumb
    125377
    Drugseparatedosagenumb
    1
    Drugindication
    Clear cell renal cell carcinoma
    Actiondrug
    5
    Drugrecurreadministration
    3
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    IPILIMUMAB
    Harmonized identifiers (openFDA)
    Application number
    BLA125377
    Brand name
    YERVOY
    Generic name
    IPILIMUMAB
    Manufacturer name
    E.R. Squibb & Sons, L.L.C.
    Product NDC
    0003-2327, 0003-2328
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    INTRAVENOUS
    Substance name
    IPILIMUMAB
    RxCUI
    1657005, 1657007, 1657012, 1657013
    SPL ID
    72755838-4a55-4245-949e-16cea13f2584
    SPL set ID
    2265ef30-253e-11df-8a39-0800200c9a66
    Package NDC
    0003-2327-11, 0003-2328-22
    Nui
    N0000182635, N0000182634, N0000182157
    Pharm class epc
    CTLA-4-directed Blocking Antibody [EPC]
    Pharm class moa
    CTLA-4-directed Antibody Interactions [MoA]
    Pharm class pe
    Increased T Lymphocyte Activation [PE]
    UNII
    6T8C155666
Summary
Narrativeincludeclinical
CASE EVENT DATE: 20240201
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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.