Drug adverse event reports (FAERS)

Off label use, Tendonitis

Drugs: MOUNJARO

Not seriousReport 26940075
Safetyreportversion
1
Safetyreportid
26940075
Primarysourcecountry
US
Occurcountry
US
Transmissiondateformat
102
Transmissiondate
20260709
Reporttype
1
Serious
2
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
2
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
2
Receivedateformat
102
Receivedate
20260630
Receiptdateformat
102
Receiptdate
20260630
Fulfillexpeditecriteria
2
Companynumb
US-ELI_LILLY_AND_COMPANY-US202606019179
Primarysource
Reportercountry
US
Qualification
3
Sender
Sendertype
6
Senderorganization
ELI LILLY AND CO
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
65
Patientonsetageunit
801
Patientagegroup
6
Patientsex
1
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Off label use
    Reactionoutcome
    6
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Tendonitis
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    MOUNJARO
    Drugauthorizationnumb
    215866
    Drugstructuredosagenumb
    15
    Drugstructuredosageunit
    003
    Drugseparatedosagenumb
    1
    Drugdosagetext
    15 MG, UNKNOWN
    Drugindication
    Weight control
    Actiondrug
    1
    Activesubstance
    Activesubstancename
    TIRZEPATIDE
    Harmonized identifiers (openFDA)
    Application number
    NDA215866
    Brand name
    MOUNJARO, MOUNJARO KWIKPEN
    Generic name
    TIRZEPATIDE
    Manufacturer name
    Eli Lilly and Company
    Product NDC
    0002-3002, 0002-1506, 0002-1495, 0002-1484, 0002-1471, 0002-1460, 0002-1457, 0002-1152, 0002-1243, 0002-2214, 0002-2340, 0002-2423, 0002-4052, 0002-4103, 0002-4210, 0002-4304, 0002-4523, 0002-4612, 0002-3466, 0002-3455, 0002-3444, 0002-3433, 0002-3422, 0002-3411
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    SUBCUTANEOUS
    Substance name
    TIRZEPATIDE
    RxCUI
    2601743, 2601746, 2601755, 2601758, 2601761, 2601764, 2601767, 2601770, 2601773, 2601776, 2601784, 2601785, 2644396, 2644399, 2644401, 2644403, 2644405, 2644407, 2644409, 2644411, 2644413, 2644415, 2644417, 2644419, 2732437, 2732442, 2732446, 2732449, 2732452, 2732456, 2733666, 2733668, 2733670, 2733671, 2733673, 2733675, 2734623, 2734628, 2734632, 2734636 +8 more
    SPL ID
    8f6367b6-bf0d-46e1-ba7d-0417523474e5
    SPL set ID
    d2d7da5d-ad07-4228-955f-cf7e355c8cc0
    Package NDC
    0002-1506-01, 0002-1506-80, 0002-1506-61, 0002-1495-01, 0002-1495-80, 0002-1484-01, 0002-1484-80, 0002-1471-01, 0002-1471-80, 0002-1460-01, 0002-1460-80, 0002-1457-01, 0002-1457-80, 0002-1152-01, 0002-1243-01, 0002-2214-01, 0002-2340-01, 0002-2423-01, 0002-3002-01, 0002-4052-01, 0002-4052-11, 0002-4103-01, 0002-4103-11, 0002-4210-01, 0002-4210-11, 0002-4304-01, 0002-4304-11, 0002-4523-01, 0002-4523-11, 0002-4612-01, 0002-4612-11, 0002-3466-01, 0002-3466-11, 0002-3455-01, 0002-3455-11, 0002-3444-01, 0002-3444-11, 0002-3433-01, 0002-3433-11, 0002-3422-01 +3 more
    Nui
    N0000194015, N0000000152, N0000178480, N0000020058
    Pharm class epc
    Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC], GLP-1 Receptor Agonist [EPC]
    Pharm class moa
    G-Protein-linked Receptor Interactions [MoA], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
    UNII
    OYN3CCI6QE
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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.