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"receiptdateformat": "102", "receiptdate": "20150312", "fulfillexpeditecriteria": "2", "companynumb": "US-ABBVIE-13P-163-1090373-00", "duplicate": "1", "reportduplicate": { "duplicatesource": "ABBVIE", "duplicatenumb": "US-ABBVIE-13P-163-1090373-00" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "41", "patientonsetageunit": "801", "patientweight": "118.04", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Medication residue present", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "DEPAKOTE", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "018723", "drugseparatedosagenumb": "3", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "ONE IN AM AND TWO IN PM", "drugadministrationroute": "048", "drugindication": "BIPOLAR DISORDER", "actiondrug": "4", "activesubstance": { "activesubstancename": "DIVALPROEX SODIUM" }, "openfda": { "application_number": [ "NDA021168", "NDA018723", "NDA019680" ], "brand_name": [ "DEPAKOTE ER", "DEPAKOTE", "DEPAKOTE SPRINKLES" ], "generic_name": [ "DIVALPROEX SODIUM" ], "manufacturer_name": [ "AbbVie Inc." ], "product_ndc": [ "0074-7401", "0074-3826", "0074-7126", "0074-7402", "0074-7325", "0074-6212", "0074-6214", "0074-6215", "0074-7327", "0074-7326", "0074-6114" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DIVALPROEX SODIUM" ], "rxcui": [ "1099563", "1099565", "1099569", "1099571", "1099625", "1099626", "1099678", "1099679", "1099870", "1099871", "1099596", "1099598" ], "spl_id": [ "0ee65b66-ead3-44ef-911f-14965b067903", "7cc3a0b3-93f8-4825-88e1-bf6ddb0db23d", "d038b7e9-b014-4771-93be-90aeeaece03d" ], "spl_set_id": [ "0dc024ce-efc8-4690-7cb5-639c728fccac", "08a65cf4-7749-4ceb-6895-8f4805e2b01f", "4619aff4-0f80-444f-858d-42e4137aa809" ], "package_ndc": [ "0074-3826-13", "0074-3826-11", "0074-7401-13", "0074-7126-13", "0074-7126-53", "0074-7126-11", "0074-7126-72", "0074-7402-13", "0074-6212-13", "0074-6214-13", "0074-6214-53", "0074-6215-13", "0074-6215-53", "0074-7325-13", "0074-7327-13", "0074-7326-13", "0074-6114-13", "0074-6114-11" ], "unii": [ "644VL95AO6" ] } }, { "drugcharacterization": "2", "medicinalproduct": "INVEGA", "drugindication": "BIPOLAR DISORDER", "activesubstance": { "activesubstancename": "PALIPERIDONE" }, "openfda": { "application_number": [ "NDA021999" ], "brand_name": [ "INVEGA" ], "generic_name": [ "PALIPERIDONE" ], "manufacturer_name": [ "Janssen Pharmaceuticals, Inc." ], "product_ndc": [ "50458-550", "50458-551", "50458-552", "50458-554" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PALIPERIDONE" ], "rxcui": [ "672567", "672569", "672571", "686441", "686443", "686445", "866103", "866105" ], "spl_id": [ "3c5e5b30-a841-4dfe-88ce-361806c9275f" ], "spl_set_id": [ "7b8e5b26-b9e4-4704-921b-3c3c0d159916" ], "package_ndc": [ "50458-550-01", "50458-550-10", "50458-550-98", "50458-551-01", "50458-551-10", "50458-551-98", "50458-552-01", "50458-552-10", "50458-552-98", "50458-554-01", "50458-554-10", "50458-554-98" ], "nui": [ "N0000175430" ], "pharm_class_epc": [ "Atypical Antipsychotic [EPC]" ], "unii": [ "838F01T721" ] } }, { "drugcharacterization": "2", "medicinalproduct": "METFORMIN", "drugindication": "DIABETES MELLITUS", "activesubstance": { "activesubstancename": "METFORMIN HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA200690", "ANDA209674", "ANDA209313" ], "brand_name": [ "METFORMIN HYDROCHLORIDE", "METFORMIN" ], "generic_name": [ "METFORMIN", "METFORMIN ER 500 MG", "METFORMIN ER 750 MG" ], "manufacturer_name": [ "Mylan Pharmaceuticals Inc.", "Ingenus Pharmaceuticals, LLC", "Granules Pharmaceuticals Inc." ], "product_ndc": [ "0378-6001", "0378-6002", "50742-633", "50742-634", "70010-491", "70010-492" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "METFORMIN HYDROCHLORIDE" ], "rxcui": [ "1807894", "1807917", "860975", "860981" ], "spl_id": [ "2a0bac1b-3575-4b62-a74b-07f54ba064af", "3a97a225-ff03-4d81-a2fe-7f66611cc4c1", "537f5fd2-89a1-d029-e063-6394a90a9d0e" ], "spl_set_id": [ "7e41818c-60e9-4bcf-9586-7bb8d33d5e89", "49a0b5c2-ebaf-4c4c-905f-dfd1962ac647", "6d6ee6f8-9650-ff4f-e053-2991aa0acf19" ], "package_ndc": [ "0378-6002-91", "0378-6001-91", "50742-633-60", "50742-633-90", "50742-633-10", "50742-634-30", "50742-634-60", "50742-634-10", "70010-491-01", "70010-491-05", "70010-491-10", "70010-491-18", "70010-491-19", "70010-491-09", "70010-492-01", "70010-492-05", "70010-492-20", "70010-492-21" ], "unii": [ "786Z46389E" ] } }, { "drugcharacterization": "2", "medicinalproduct": "COGENTIN", "drugindication": "ADVERSE EVENT", "activesubstance": { "activesubstancename": "BENZTROPINE MESYLATE" } }, { "drugcharacterization": "2", "medicinalproduct": "BISOPROLOL", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "BISOPROLOL" }, "openfda": { "application_number": [ "ANDA218303", "ANDA075474" ], "brand_name": [ "BISOPROLOL" ], "generic_name": [ "BISOPROLOL FUMARATE" ], "manufacturer_name": [ "Micro Labs Limited", "TruPharma, LLC" ], "product_ndc": [ "42571-470", "42571-471", "52817-270", "52817-271" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "BISOPROLOL FUMARATE" ], "rxcui": [ "854901", "854905" ], "spl_id": [ "4cbe74e3-3af3-2b98-e063-6294a90a1c2b", "2a9e4180-cb1c-f924-e063-6394a90a60c6" ], "spl_set_id": [ "c3ee566c-74c4-45f4-a947-526a7313e326", "bba0bc2b-602f-4df1-a761-85bd3c80c7de" ], "package_ndc": [ "42571-470-30", "42571-470-01", "42571-470-05", "42571-471-30", "42571-471-01", "42571-471-05", "52817-270-10", "52817-270-30", "52817-271-10", "52817-271-30" ], "unii": [ "UR59KN573L" ] } }, { "drugcharacterization": "2", "medicinalproduct": "COGENTIN", "drugindication": "PROPHYLAXIS", "activesubstance": { "activesubstancename": "BENZTROPINE MESYLATE" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 201304" } } }, { "safetyreportversion": "1", "safetyreportid": "10003993", "primarysourcecountry": "DE", "occurcountry": "DE", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "1", "companynumb": "DE-AMGEN-DEUCT2014016330", "duplicate": "1", "reportduplicate": { "duplicatesource": "AMGEN", "duplicatenumb": "DE-AMGEN-DEUCT2014016330" }, "primarysource": { "reportercountry": "DE", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientweight": "74", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Metastases to bone", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Osteonecrosis of jaw", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "XGEVA", "drugauthorizationnumb": "125320", "drugstructuredosagenumb": "120", "drugstructuredosageunit": "003", "drugdosagetext": "120 MG, Q4WK", "drugdosageform": "SOLUTION FOR INJECTION", "drugadministrationroute": "058", "drugindication": "METASTASES TO BONE", "drugstartdateformat": "610", "drugstartdate": "201208", "actiondrug": "1", "openfda": { "application_number": [ "BLA125320" ], "brand_name": [ "XGEVA" ], "generic_name": [ "DENOSUMAB" ], "manufacturer_name": [ "Amgen, Inc" ], "product_ndc": [ "55513-730" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "DENOSUMAB" ], "rxcui": [ "1046398", "1046402" ], "spl_id": [ "3ce47aaf-105d-4615-9320-1f378a9d8d84" ], "spl_set_id": [ "628f0998-1206-4001-aeee-18133aa9f3bf" ], "package_ndc": [ "55513-730-01", "55513-730-21" ], "nui": [ "N0000187055", "N0000187054" ], "pharm_class_epc": [ "RANK Ligand Inhibitor [EPC]" ], "pharm_class_moa": [ "RANK Ligand Blocking Activity [MoA]" ], "unii": [ "4EQZ6YO2HI" ] } }, { "drugcharacterization": "1", "medicinalproduct": "AFINITOR", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "10 MG, QD", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "BREAST CANCER METASTATIC", "drugstartdateformat": "102", "drugstartdate": "20131002", "openfda": { "application_number": [ "NDA022334", "NDA203985" ], "brand_name": [ "AFINITOR", "AFINITOR DISPERZ" ], "generic_name": [ "EVEROLIMUS" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0566", "0078-0567", "0078-0594", "0078-0620", "0078-0626", "0078-0627", "0078-0628" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EVEROLIMUS" ], "rxcui": [ "845507", "845512", "845515", "845518", "998189", "998191", "1119400", "1119402", "1308428", "1308430", "1308432", "1310138", "1310144", "1310147" ], "spl_id": [ "b808a4e0-23a8-40c8-834d-b31cd642febe" ], "spl_set_id": [ "2150f73a-179b-4afc-b8ce-67c85cc72f04" ], "package_ndc": [ "0078-0566-61", "0078-0566-51", "0078-0567-61", "0078-0567-51", "0078-0594-61", "0078-0594-51", "0078-0620-61", "0078-0620-51", "0078-0626-61", "0078-0626-51", "0078-0627-61", "0078-0627-51", "0078-0628-61", "0078-0628-51" ], "nui": [ "N0000175605", "N0000175076", "N0000182141", "N0000182137", "N0000175625", "N0000175624", "N0000175550" ], "pharm_class_epc": [ "Kinase Inhibitor [EPC]", "mTOR 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"0363-0563-27", "0363-0563-14", "0363-0563-32", "0363-0563-63", "0363-0563-62", "0363-0563-22", "0363-0563-90", "16103-366-05", "16103-366-11", "79481-6450-5", "84324-017-01", "63868-373-05", "53943-146-01", "53943-146-02", "73408-620-33", "73408-099-33", "73408-618-33", "73408-616-33", "46122-596-02", "37835-577-01", "37835-577-25", "83586-104-05", "83586-104-10", "11673-188-53", "51824-057-36", "81522-018-11", "61504-105-03", "69790-620-33", "69790-616-33", "0363-6450-14", "0363-6450-07", "0363-6450-12", "0363-6450-60", "0363-6450-32", "53943-152-01", "84269-2501-2", "84269-2501-1" ], "nui": [ "N0000000160", "N0000008836", "M0001335", "N0000175722", "N0000175578", "N0000008832" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_pe": [ "Decreased Prostaglandin Production [PE]", "Decreased Platelet Aggregation [PE]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]", "Platelet Aggregation Inhibitor [EPC]" ], "unii": [ "R16CO5Y76E" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140205" } } }, { "safetyreportversion": "1", "safetyreportid": "10004360", "primarysourcecountry": "GB", "occurcountry": "GB", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "1", "companynumb": "GB-BRISTOL-MYERS SQUIBB COMPANY-20346771", "duplicate": "1", "reportduplicate": { "duplicatesource": "BRISTOL MYERS SQUIBB", "duplicatenumb": "GB-BRISTOL-MYERS SQUIBB COMPANY-20346771" }, "primarysource": { "reportercountry": "GB", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "58", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Grand mal convulsion", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Postictal state", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "ABATACEPT", "drugauthorizationnumb": "125118", "drugadministrationroute": "058", "drugindication": "RHEUMATOID ARTHRITIS", "drugstartdateformat": "102", "drugstartdate": "20140103", "drugenddateformat": "102", "drugenddate": "20140214", "openfda": { "application_number": [ "BLA125118" ], "brand_name": [ "ORENCIA" ], "generic_name": [ "ABATACEPT" ], "manufacturer_name": [ "E.R. Squibb & Sons, L.L.C." ], "product_ndc": [ "0003-2188", "0003-2187", "0003-2814", "0003-2818" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "INTRAVENOUS" ], "substance_name": [ "ABATACEPT" ], "rxcui": [ "616015", "616018", "1145929", "1145932", "1799228", "1799230", "1925254", "1925255", "1925256", "1925257" ], "spl_id": [ "962695b7-21f5-44bb-80e0-cb3b48c80be6" ], "spl_set_id": [ "0836c6ac-ee37-5640-2fed-a3185a0b16eb" ], "package_ndc": [ "0003-2187-10", "0003-2187-13", "0003-2188-11", "0003-2188-21", "0003-2188-91", "0003-2188-51", "0003-2188-50", "0003-2188-90", "0003-2814-11", "0003-2818-11" ], "nui": [ "N0000008571", "N0000182159", "M0018640" ], "pharm_class_pe": [ "Decreased Cytokine Activity [PE]" ], "pharm_class_epc": [ "Selective T Cell Costimulation Modulator [EPC]" ], "pharm_class_cs": [ "Recombinant Fusion Proteins [CS]" ], "unii": [ "7D0YB67S97" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ATORVASTATIN" }, { "drugcharacterization": "2", "medicinalproduct": "BISOPROLOL", "openfda": { "application_number": [ "ANDA218303", "ANDA075474" ], "brand_name": [ "BISOPROLOL" ], "generic_name": [ "BISOPROLOL FUMARATE" ], "manufacturer_name": [ "Micro Labs Limited", "TruPharma, LLC" ], "product_ndc": [ "42571-470", "42571-471", "52817-270", "52817-271" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "BISOPROLOL FUMARATE" ], "rxcui": [ "854901", "854905" ], "spl_id": [ "4cbe74e3-3af3-2b98-e063-6294a90a1c2b", "2a9e4180-cb1c-f924-e063-6394a90a60c6" ], "spl_set_id": [ "c3ee566c-74c4-45f4-a947-526a7313e326", "bba0bc2b-602f-4df1-a761-85bd3c80c7de" ], "package_ndc": [ "42571-470-30", "42571-470-01", "42571-470-05", "42571-471-30", "42571-471-01", "42571-471-05", "52817-270-10", "52817-270-30", "52817-271-10", "52817-271-30" ], "unii": [ "UR59KN573L" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CALCICHEW D3" }, { "drugcharacterization": "2", "medicinalproduct": "HYDROXYCHLOROQUINE", "openfda": { "application_number": [ "ANDA210543" ], "brand_name": [ "HYDROXYCHLOROQUINE" ], "generic_name": [ "HYDROXYCHLOROQUINE" ], "manufacturer_name": [ "Chartwell RX, LLC" ], "product_ndc": [ "62135-752" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "HYDROXYCHLOROQUINE SULFATE" ], "rxcui": [ "979092" ], "spl_id": [ "459cd828-6e8f-c7cf-e063-6394a90a5ab8" ], "spl_set_id": [ "7e09aeca-0cec-4a88-9dde-a2098a08b877" ], "package_ndc": [ "62135-752-90" ], "unii": [ "8Q2869CNVH" ] } }, { "drugcharacterization": "2", "medicinalproduct": "POLYETHYLENE GLYCOL 3350", "openfda": { "application_number": [ "ANDA209017", "ANDA078915", "ANDA090685", "ANDA203928", "ANDA202071", "ANDA090812", "M018", "ANDA214990", "ANDA206105", "ANDA202850", "NDA022015", "ANDA091077" ], "brand_name": [ "365 WHOLE FOODS MARKET POLYETHYLENE GLYCOL 3350", "POLYETHYLENE GLYCOL (3350)", "PURELAX", "UP AND UP POWDERLAX", "LEADER 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PHARMACEUTICAL, INC", "SKY Packaging", "DISCOUNT DRUG MART", "Kenvue Brands LLC", "L. Perrigo Company", "Kroger Company", "WALGREEN COMPANY", "Aurobindo Pharma Limited", "Retail Business Services, LLC", "Padagis Israel Pharmaceuticals Ltd", "Publix Super Markets Inc", "HyVee Inc", "Aldi, Inc", "Sun Pharmaceutical Industries, Inc.", "American Sales Company", "Gericare Pharmaceuticals", "Chattem, Inc.", "Costco Wholesale Company", "CHAIN DRUG MARKETING ASSOCIATION, INC.", "WALMART INC.", "Army & Air Force Exchange Service", "United Natural Foods, Inc. dba UNFI", "Dolgencorp Inc", "VALU MERCHANDISERS COMPANY", "Aurohealth LLC", "Bayer HealthCare LLC.", "Amazon.com Services LLC", "ANI Pharmaceuticals, Inc.", "Valley Medical Products, LLC", "KROGER COMPANY", "Lupin Pharmaceuticals,Inc.", "CARDINAL HEALTH 110, LLC. DBA LEADER", "Family Dollar Stores, LLC", "NorthStar Rx LLC", "YYBA Corp" ], "product_ndc": [ "42681-0059", "51079-306", "69842-458", "11673-306", "70000-0415", "79481-0090", "21130-847", "37808-306", "87362-119", "67091-447", "68196-306", "0904-6931", "0536-1052", "46122-805", "0363-0306", "49035-306", "57896-489", "41250-306", "60687-431", "70677-1157", "36800-306", "11822-1199", "72090-036", "72657-196", "68391-306", "55910-306", "59556-762", "0363-1323", "29943-002", "68001-607", "76162-119", "70677-1068", "69230-324", "11534-180", "63739-760", "53943-652", "69968-0365", "0113-6900", "30142-504", "0363-5260", "84386-125", "72476-723", "70677-1109", "45802-868", "56062-306", "42507-306", "29943-010", "64024-306", "51672-2104", "41520-306", "57896-490", "69968-0364", "41167-0223", "63981-306", "29943-004", "83324-002", "0113-1023", "79903-114", "59640-797", "59779-306", "30142-306", "55301-306", "29943-006", "11822-0306", "41163-306", "55910-846", "63941-489", "70000-0704", 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