{ "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": "2026-07-30", "results": { "skip": 0, "limit": 1, "total": 9 } }, "results": [ { "safetyreportversion": "5", "safetyreportid": "10244204", "primarysourcecountry": "FR", "occurcountry": "RU", "transmissiondateformat": "102", "transmissiondate": "20150720", "reporttype": "2", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140618", "receiptdateformat": "102", "receiptdate": "20150312", "fulfillexpeditecriteria": "1", "companynumb": "RU-FRI-1000068196", "duplicate": "1", "reportduplicate": { "duplicatesource": "FOREST", "duplicatenumb": "RU-FRI-1000068196" }, "primarysource": { "reportercountry": "RU", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "63", "patientonsetageunit": "801", "patientweight": "83", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Mental disorder due to a general medical condition", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Confusional state", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Psychomotor hyperactivity", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Asthenia", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Apathy", "reactionoutcome": "2" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "OMEPRAZOL", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "20 MG", "drugstartdateformat": "102", "drugstartdate": "20140603", "activesubstance": { "activesubstancename": "OMEPRAZOLE" } }, { "drugcharacterization": "2", "medicinalproduct": "CERETON", "drugstructuredosagenumb": "1000", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "1000 MG", "drugadministrationroute": "042", "drugstartdateformat": "102", "drugstartdate": "20140527" }, { "drugcharacterization": "2", "medicinalproduct": "CLOPIDOGREL", "drugstructuredosagenumb": "75", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "75 MG", "drugstartdateformat": "102", "drugstartdate": "20140514", "activesubstance": { "activesubstancename": "CLOPIDOGREL BISULFATE" }, "openfda": { "application_number": [ "ANDA202928", "ANDA076999", "ANDA203751", "ANDA090844", "NDA020839", "ANDA204165", "ANDA090540", "ANDA203632", "ANDA205345", "ANDA215388" ], "brand_name": [ "CLOPIDOGREL", "PLAVIX" ], "generic_name": [ "CLOPIDOGREL", "CLOPIDOGREL BISULFATE" ], "manufacturer_name": [ "NorthStar RxLLC", "Teva Pharmaceuticals USA, Inc.", "Amneal Pharmaceuticals LLC", "Torrent Pharmaceuticals Limited", "Macleods Pharmaceuticals Limited", "Sanofi-Aventis U.S. LLC", "Westminster Pharmaceuticals, LLC", "Aurobindo Pharma Limited", "Vensun Pharmaceuticals, Inc.", "Ascend Laboratories, LLC", "Camber Pharmaceuticals, Inc.", "Novadoz Pharmaceuticals LLC" ], "product_ndc": [ "16714-052", "0093-7314", "65162-414", "13668-141", "33342-060", "0024-1171", "0024-1332", "69367-194", "69367-200", "65862-357", "42543-713", "42543-714", "67877-276", "31722-758", "31722-759", "72205-199" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CLOPIDOGREL BISULFATE", "CLOPIDOGREL" ], "rxcui": [ "309362", "213169", "749196", "749198" ], "spl_id": [ "dbf6d86e-5d4f-40da-a933-b928843053b7", "a9df5ba4-ab12-4f72-9264-a1f7f377e35b", "360ed8dd-4f92-46fc-b31b-abe0d75e9bb3", "3cbfb162-4652-4a90-9afa-489e743fc16a", "05355b6d-3802-4542-bda2-cd6a17e57266", "ed60a9e7-49f4-469c-bb7a-08e1bb6057e2", "e988b70b-0906-4e72-b032-97033e37aa0e", "ff58c1f3-4875-4d10-aca7-c622af163cef", "4b480542-0dd3-4694-9d43-d5fdcdd64a0f", "21dbc638-2bc8-4ad0-bacd-e79907affc2b", "04d99965-cea0-8e7d-e063-6394a90ab281", "0b4edca9-12af-4534-baad-4fa5c1cc9ac8" ], "spl_set_id": [ "d176de1d-b1b3-4aa9-b783-d53f65a79e50", "bc747f6d-f52c-4dcb-bda5-2d0a9f954147", "0d010775-1160-4b2e-a928-563a02edd191", "ae07b785-b522-41c6-b27c-24c4d5cd814d", "063cd1eb-98fd-422e-8145-bba04c497efe", "de8b0b67-eb25-4684-83b5-7ad785314227", "bb3b5e96-e629-4db5-8ad5-40c17c6dae18", "0078fb3d-3595-4ae1-a059-1d5e81c879cf", "86ee71f2-850e-4c8e-87f3-c7a618d59d95", "db1161c9-6efd-4361-a766-6a37c241ccee", "b573aefa-e337-478f-97e4-eb8472a7e497", "1447a095-c663-4f05-91d4-f09bfc0c3d42" ], "package_ndc": [ "16714-052-01", "16714-052-03", "16714-052-11", "16714-052-02", "16714-052-04", "16714-052-10", "0093-7314-56", "0093-7314-98", "0093-7314-05", "65162-414-03", "65162-414-09", "65162-414-50", "65162-414-11", "13668-141-44", "13668-141-05", "13668-141-10", "13668-141-01", "13668-141-90", "13668-141-30", "33342-060-07", "33342-060-15", "33342-060-12", "33342-060-10", "33342-060-44", "0024-1171-90", "0024-1332-30", "69367-194-30", "69367-194-05", "69367-200-05", "65862-357-30", "65862-357-90", "65862-357-01", "65862-357-05", "65862-357-99", "65862-357-10", "42543-713-30", "42543-713-90", "42543-713-01", "42543-713-05", "42543-713-10", "42543-714-30", "42543-714-90", "42543-714-01", "42543-714-05", "67877-276-30", "67877-276-90", "67877-276-05", "31722-758-30", "31722-758-90", "31722-758-05", "31722-759-30", "31722-759-05", "72205-199-30", "72205-199-90", "72205-199-05", "72205-199-11", "72205-199-06", "72205-199-01" ], "unii": [ "08I79HTP27", "A74586SNO7" ], "nui": [ "N0000008832", "N0000182142", "N0000182143", "N0000187062" ], "pharm_class_pe": [ "Decreased Platelet Aggregation [PE]" ], "pharm_class_epc": [ "P2Y12 Platelet Inhibitor [EPC]" ], "pharm_class_moa": [ "P2Y12 Receptor Antagonists [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ATORVASTATIN", "drugstructuredosagenumb": "40", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "40 MG", "drugstartdateformat": "102", "drugstartdate": "20140516", "activesubstance": { "activesubstancename": "ATORVASTATIN" } }, { "drugcharacterization": "2", "medicinalproduct": "LORISTA", "drugstructuredosagenumb": "50", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "100 MG", "drugstartdateformat": "102", "drugstartdate": "20140519", "activesubstance": { "activesubstancename": "LOSARTAN POTASSIUM" } }, { "drugcharacterization": "2", "medicinalproduct": "AMLODIPIN", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "10 MG", "drugstartdateformat": "102", "drugstartdate": "20140522", "activesubstance": { "activesubstancename": "AMLODIPINE BESYLATE" } }, { "drugcharacterization": "1", "medicinalproduct": "LEVOMILNACIPRAN EXTENDED-RELEASE CAP", "drugauthorizationnumb": "204168", "drugstructuredosagenumb": "2", "drugstructuredosageunit": "032", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "2 DOSAGE FORMS", "drugdosageform": "CAPSULE", "drugadministrationroute": "048", "drugindication": "CEREBROVASCULAR ACCIDENT", "drugstartdateformat": "102", "drugstartdate": "20140522", "drugenddateformat": "102", "drugenddate": "20140605", "actiondrug": "1", "activesubstance": { "activesubstancename": "LEVOMILNACIPRAN" } }, { "drugcharacterization": "2", "medicinalproduct": "NORBACTIN", "drugstructuredosagenumb": "400", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "800 MG", "drugstartdateformat": "102", "drugstartdate": "20140522", "drugenddateformat": "102", "drugenddate": "20140603" }, { "drugcharacterization": "2", "medicinalproduct": "CORTEXIN", "drugdosagetext": "10 MG", "drugadministrationroute": "030", "drugstartdateformat": "102", "drugstartdate": "20140522", "drugenddateformat": "102", "drugenddate": "20140602" }, { "drugcharacterization": "2", "medicinalproduct": "HEPARIN", "drugstructuredosagenumb": "5000", "drugstructuredosageunit": "025", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "5000 IU", "drugadministrationroute": "058", "activesubstance": { "activesubstancename": "HEPARIN SODIUM" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140526" } } } ] }