{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-28", "results": { "skip": 0, "limit": 1, "total": 88 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "22957015", "primarysourcecountry": "US", "transmissiondateformat": "102", "transmissiondate": "20231029", "reporttype": "1", "serious": "1", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "1", "seriousnessdisabling": "1", "seriousnesscongenitalanomali": "2", "seriousnessother": "2", "receivedate": "20230916", "receiptdate": "20230916", "fulfillexpeditecriteria": "3", "authoritynumb": "FDA-CDER-CTU-2023-68453", "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "37", "patientonsetageunit": "802", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "26.0", "reactionmeddrapt": "Heart rate irregular" }, { "reactionmeddraversionpt": "26.0", "reactionmeddrapt": "Myocardial infarction" }, { "reactionmeddraversionpt": "26.0", "reactionmeddrapt": "Product quality issue" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "TIRZEPATIDE", "drugstartdateformat": "102", "drugstartdate": "20230807", "drugenddateformat": "102", "drugenddate": "20230911", "drugrecurreadministration": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "openfda": { "application_number": [ "NDA215866", "NDA217806" ], "brand_name": [ "MOUNJARO", "MOUNJARO KWIKPEN", "ZEPBOUND", "ZEPBOUND 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", 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"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", "0002-3422-11", "0002-3411-01", "0002-3411-11", "0002-2506-01", "0002-2506-80", "0002-2506-61", "0002-2495-01", "0002-2495-80", "0002-2484-01", "0002-2484-80", "0002-2471-01", "0002-2471-80", "0002-2460-01", "0002-2460-80", "0002-2457-01", "0002-2457-80", "0002-0152-01", "0002-0152-04", "0002-0152-61", "0002-0243-01", "0002-0243-04", "0002-1214-01", "0002-1214-04", "0002-1340-01", "0002-1340-04", "0002-1423-01", "0002-1423-04", "0002-2002-01", "0002-2002-04", "0002-6052-01", "0002-6052-11", "0002-6103-01", "0002-6103-11", "0002-6210-01", "0002-6210-11", "0002-6304-01", "0002-6304-11", "0002-6523-01", "0002-6523-11", "0002-6612-01", "0002-6612-11", "0002-3566-01", "0002-3566-11", "0002-3566-99", "0002-3555-01", "0002-3555-11", "0002-3544-01", "0002-3544-11", "0002-3533-01", "0002-3533-11", "0002-3522-01", "0002-3522-11", "0002-3511-01", "0002-3511-11" ], "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" ] } }, { "drugcharacterization": "1", "medicinalproduct": "SEMAGLUTIDE", "activesubstance": { "activesubstancename": "SEMAGLUTIDE" }, "openfda": { "application_number": [ "NDA209637", "NDA218316", "NDA215256" ], "brand_name": [ "OZEMPIC", "WEGOVY" ], "generic_name": [ "SEMAGLUTIDE" ], "manufacturer_name": [ "Novo Nordisk Pharmaceutical Industries, LP" ], "product_ndc": [ "0169-4772", "0169-4136", "0169-4132", "0169-4130", "0169-4181", "0169-1302", "0169-1305", "0169-1310", "0169-4409", "0169-4525", "0169-4505", "0169-4501", "0169-4517", "0169-4524", "0169-4572", "0169-1602", "0169-1605", "0169-1610", "0169-1617", "0169-1624", "0169-4404", "0169-4415", "0169-4425" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "ORAL" ], "substance_name": [ "SEMAGLUTIDE" ], "rxcui": [ "1991306", "1991311", "1991316", "1991317", "2398841", "2398842", "2599362", "2599365", "2619152", "2619154", "2553501", "2553506", "2553601", "2553603", "2553802", "2553803", "2553901", "2553903", "2554102", "2554104", "2707547", "2707551", "2707555", "2730161", "2730163", "2730165", "2730167", "2730169", "2739768", "2739771" ], "spl_id": [ "852fff2d-704e-4b01-9244-439a28094202", "2cf550fd-3019-4202-b112-2009de398600" ], "spl_set_id": [ "adec4fd2-6858-4c99-91d4-531f5f2a2d79", "ee06186f-2aa3-4990-a760-757579d8f77b" ], "package_ndc": [ "0169-4136-11", "0169-4136-02", "0169-4132-90", "0169-4132-97", "0169-4132-11", "0169-4132-12", "0169-4130-01", "0169-4130-13", "0169-4772-11", "0169-4772-12", "0169-4772-90", "0169-4772-97", "0169-4181-03", "0169-4181-13", "0169-4181-90", "0169-4181-97", "0169-1302-01", "0169-1302-14", "0169-1302-90", "0169-1302-94", "0169-1305-01", "0169-1305-14", "0169-1310-01", "0169-1310-14", "0169-4525-01", "0169-4525-14", "0169-4525-90", "0169-4525-94", "0169-4505-01", "0169-4505-14", "0169-4501-01", "0169-4501-14", "0169-4517-01", "0169-4517-14", "0169-4524-01", "0169-4524-14", "0169-4572-01", "0169-4572-14", "0169-1602-01", "0169-1602-14", "0169-1602-90", "0169-1602-94", "0169-1605-01", "0169-1605-14", "0169-1610-01", "0169-1610-14", "0169-1617-01", "0169-1617-14", "0169-1624-01", "0169-1624-14", "0169-4404-31", "0169-4415-31", "0169-4415-92", "0169-4409-31", "0169-4425-31" ], "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" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20230911" } } } ] }