{ "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. 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"medicinalproduct": "DOCUSATE SODIUM", "openfda": { "application_number": [ "M007", "M" ], "brand_name": [ "DOCUSATE SODIUM 100MG TWO-TONE", "STOOL SOFTENER LAXATIVE", "DOCUSATE SODIUM", "WINCO STOOL SOFTENER", "GENTLE STOOL SOFTENER", "TOPCARE STOOL SOFTENER", "STOOL SOFTENER", "GERICARE DOCUSATE SODIUM LIQUID", "COLACE", "HEB STOOL SOFTENER", "DOCUSATE SODIUM LIQUID", "DOCUSATE SODIUM, EXTRA STRENGTH 250 MG", "DULCOLAX STOOL SOFTENER", "ENEMEEZ KIDS", "H E B STOOL SOFTENER LAXATIVE", "EXCHANGE SELECT STOOL SOFTENER", "STOOL SOFTENER EXTRA STRENGTH", "DOCUSATE MINI ENEMA", "GOOD SENSE STOOL SOFTENER", "DOCUSATE SODIUM - STOOL SOFTENER LAXATIVE", "DOCUSATE SODIUM 100MG", "PREFERRED STOOL SOFTENER", "COLACE EXTRA STRENGTH STOOL SOFTNER", "STOOL SOFTENER LAXATIVE EXTRA STRENGTH", "ENEMEEZ", "WALGREENS STOOL SOFTENER FRUIT PUNCH", "FLEET", "GOOD NEIGHBOR STOOL SOFTENER LAXATIVE", "PHILLIPS STOOL SOFTENER BULK DOCUSATE", "BASIC CARE STOOL SOFTENER", "STOOL SOFTENER REGULAR STRENGTH", 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"drugdosagetext": "40 MG, QD, STRENGTH: 25MG/2.5ML", "drugdosageform": "SOLUTION FOR INJECTION", "drugadministrationroute": "042", "drugindication": "NEUROMUSCULAR BLOCKING THERAPY", "drugstartdateformat": "102", "drugstartdate": "20140221", "drugenddateformat": "102", "drugenddate": "20140221", "activesubstance": { "activesubstancename": "ROCURONIUM BROMIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "MUSCULAX", "drugdosagetext": "DAILY DOSAGE UNKNOWN", "drugdosageform": "POWDER FOR INJECTION", "drugadministrationroute": "042", "drugindication": "NEUROMUSCULAR BLOCKING THERAPY", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "VECURONIUM BROMIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "FENTANYL.", "drugdosagetext": "DAILY DOSAGE UNKNOWN", "drugdosageform": "INJECTION", "drugadministrationroute": "042", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "FENTANYL" }, "openfda": { 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Healthcare Company", "Shandong New Time Pharmaceutical Co., Ltd.", "Sandoz Inc.", "Lannett Company, Inc.", "Mullan Pharmaceutical Inc.", "Halocarbon Life Sciences, LLC" ], "product_ndc": [ "66794-022", "0074-4456", "10019-653", "10019-657", "10019-651", "10019-655", "66794-012", "42677-308", "0781-6160", "0527-6123", "83301-0070", "12164-005", "66794-015" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "RESPIRATORY (INHALATION)" ], "substance_name": [ "SEVOFLURANE" ], "rxcui": [ "200243", "541963", "997625" ], "spl_id": [ "44f127bd-86a2-1a85-e063-6394a90a1c58", "20a177a4-8440-46f9-98f4-c51d395e4a46", "e04090f9-97a3-4fe5-9bc1-c4a86ac9a6a1", "51e533f0-ea5a-4210-8fa9-11c1897093a6", "44ded994-d330-0d67-e063-6394a90a92db", "535139ad-7d0e-fbf6-e063-6394a90ab048", "ecf89ead-16b2-91cf-e053-2995a90adc93", "f3d34dea-e901-46b9-80f8-b314ca57020c", "4db52cc7-3ca6-0aaf-e063-6294a90a0dc1", "2409685f-f867-4b3d-bc58-6bd2749bbb2a", "4b7ba14d-8de1-4f87-910e-87fdd984b24d", "404235ad-60f3-7e4a-e063-6394a90a47d9" ], "spl_set_id": [ "b23e14d7-9e5b-13f4-e053-2a95a90a0cde", "4c6e76bc-c964-4955-e0a3-511d3386a9cc", "22700993-851a-48aa-941e-1d2b6b04081f", "ea8bf997-2c71-4014-b18d-4f7ab45dfa19", "fedfd1db-7e32-44b2-89e9-7bb00ee6810d", "c808afe1-ebf1-44cf-9187-09656331bff5", "8604f245-fa99-4092-9042-058aa42e0b74", "5bfc1cef-824d-4ebf-bb4d-fbc46c0abb79", "0ca6da3a-6a18-400d-8c49-08a5534b025f", "bdde7502-6218-401c-9a4f-dd3bc3a80f72", "c9aa6489-5a36-44ed-9512-b996833d82f7", "3dbab949-6ab7-4040-9c81-314e5bb61d41" ], "package_ndc": [ "66794-022-25", "0074-4456-04", "10019-653-64", "10019-657-06", "10019-651-64", "10019-655-06", "66794-012-25", "42677-308-01", "0781-6160-43", "0781-6160-86", "0527-6123-74", "83301-0070-1", "12164-005-25", "0074-4456-51", "66794-015-25" ], "nui": [ "N0000175975", "N0000175681" ], "pharm_class_pe": [ "General Anesthesia [PE]" ], "pharm_class_epc": [ "General Anesthetic [EPC]" ], "unii": [ "38LVP0K73A" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140221" } } }, { "safetyreportversion": "1", "safetyreportid": "10016759", "primarysourcecountry": "CZ", "occurcountry": "CZ", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140318", "receiptdateformat": "102", "receiptdate": "20140318", "fulfillexpeditecriteria": "1", "companynumb": "PHHY2014CZ028150", "duplicate": "1", "reportduplicate": { "duplicatesource": "SANDOZ", "duplicatenumb": "PHHY2014CZ028150" }, "primarysource": { "reportercountry": "CZ", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "25", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Proteinuria", "reactionoutcome": "6" }, { 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"medicinalproduct": "RED BLOOD CELLS", "drugadministrationroute": "065", "drugindication": "ANAEMIA", "drugstartdateformat": "102", "drugstartdate": "20130504", "drugenddateformat": "102", "drugenddate": "20130504", "activesubstance": { "activesubstancename": "HUMAN RED BLOOD CELL" } }, { "drugcharacterization": "1", "medicinalproduct": "DOXORUBICIN", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "3", "drugintervaldosagedefinition": "803", "drugdosagetext": "LAST DOSE TAKEN: 100MG, MOST RECENT DOSE ON 21/NOV/2012", "drugadministrationroute": "042", "drugindication": "NON-HODGKIN^S LYMPHOMA UNSPECIFIED HISTOLOGY INDOLENT", "drugstartdateformat": "102", "drugstartdate": "20120808", "activesubstance": { "activesubstancename": "DOXORUBICIN" }, "openfda": { "application_number": [ "ANDA208888" ], "brand_name": [ "DOXORUBICIN HYDROCHLORIDE" ], "generic_name": [ "DOXORUBICIN" ], "manufacturer_name": [ "Amneal Pharmaceuticals LLC" ], "product_ndc": [ "70121-1218", "70121-1219" 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"64380-784-08", "64380-784-06", "64380-785-06", "64380-785-07", "64380-785-08", "64380-785-01", "64380-949-06", "64380-949-01", "63561-0120-1", "63561-0120-2", "63561-0120-5", "63561-0121-1", "63561-0121-2", "63561-0121-5", "63561-0122-1", "63561-0122-2", "63561-0122-5", "60219-1707-1", "60219-1707-5", "60219-1707-2", "60219-1707-3", "60219-1708-1", "60219-1708-5", "70954-057-10", "70954-058-10", "70954-058-20", "70954-058-30", "70954-058-40", "70954-059-10", "70954-059-20", "70954-059-30", "70954-059-40", "70954-060-10", "70954-060-20", "70954-060-30", "70954-061-10", "0591-5052-01", "0591-5052-10", "0591-5052-21", "0591-5052-43", "0591-5442-01", "0591-5442-05", "0591-5442-10", "0591-5442-21", "0591-5442-43", "0591-5443-01", "0591-5443-05", "0591-5443-10" ], "nui": [ "N0000175576", "N0000175450" ], "pharm_class_epc": [ "Corticosteroid [EPC]" ], "pharm_class_moa": [ "Corticosteroid Hormone Receptor Agonists [MoA]" ], "unii": [ "VB0R961HZT" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PARACETAMOL", "drugadministrationroute": "065", "drugindication": "PYREXIA", "drugstartdateformat": "102", "drugstartdate": "20120808", "activesubstance": { "activesubstancename": "ACETAMINOPHEN" } }, { "drugcharacterization": "2", "medicinalproduct": "HYDROCORTISONUM", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20121212", "activesubstance": { "activesubstancename": "HYDROCORTISONE" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20130401" } } }, { "safetyreportversion": "1", "safetyreportid": "10022347", "primarysourcecountry": "JP", "occurcountry": "JP", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140319", "receiptdateformat": "102", "receiptdate": "20140319", "fulfillexpeditecriteria": "1", "companynumb": "JP-AMGEN-JPNCT2014018725", "duplicate": "1", "reportduplicate": { "duplicatesource": "AMGEN", "duplicatenumb": "JP-AMGEN-JPNCT2014018725" }, "primarysource": { "reportercountry": "JP", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "67", "patientonsetageunit": "801", "patientweight": "57", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Shunt stenosis", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Abdominal discomfort", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Nasopharyngitis", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Insomnia", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Nasopharyngitis", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Abdominal pain upper", 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"actiondrug": "5", "activesubstance": { "activesubstancename": "METHYLPREDNISOLONE" }, "openfda": { "application_number": [ "NDA011153" ], "brand_name": [ "MEDROL" ], "generic_name": [ "METHYLPREDNISOLONE" ], "manufacturer_name": [ "Pharmacia & Upjohn Company LLC" ], "product_ndc": [ "0009-0020", "0009-0049", "0009-0056", "0009-0022", "0009-0073", "0009-0176" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "METHYLPREDNISOLONE" ], "rxcui": [ "197969", "197971", "197973", "207136", "207137", "207138", "207141", "259966", "260330", "328161", "762675", "834023" ], "spl_id": [ "e4a8e5b4-af77-4eca-92de-cd0982969b82" ], "spl_set_id": [ "39d5270b-d957-4821-93d6-501b7b9f02d4" ], "package_ndc": [ "0009-0049-02", "0009-0056-02", "0009-0056-04", "0009-0022-01", "0009-0073-01", "0009-0176-01", "0009-0020-01" ], "nui": [ "N0000175576", "N0000175450" ], "pharm_class_epc": [ "Corticosteroid [EPC]" ], "pharm_class_moa": [ "Corticosteroid Hormone Receptor Agonists [MoA]" ], "unii": [ "X4W7ZR7023" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20130614" } } }, { "safetyreportversion": "1", "safetyreportid": "10028120", "primarysourcecountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140319", "receiptdateformat": "102", "receiptdate": "20140319", "fulfillexpeditecriteria": "1", "companynumb": "ADE14-008", "duplicate": "1", "reportduplicate": { "duplicatesource": "SAGENT", "duplicatenumb": "ADE14-008" }, "primarysource": { "reportercountry": "US", "qualification": "2" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "51", "patientonsetageunit": "801", "patientweight": "65", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Drug ineffective" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Product quality issue" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "HEPARIN SODIUM", "drugbatchnumb": "WG328N", "drugauthorizationnumb": "90808", "drugdosagetext": "33,000 U TOTAL DOSE IV.", "drugadministrationroute": "042", "drugindication": "MITRAL VALVE REPAIR", "openfda": { "application_number": [ "ANDA212441", "NDA017029", "ANDA089522", "ANDA088100", "ANDA206552", "ANDA090809", "ANDA211004", "ANDA211005", "ANDA203198", "ANDA202957", "ANDA202733", "ANDA202732", "ANDA214839", "NDA017651", "ANDA214804", "ANDA091682", "ANDA205323", "ANDA090808", "ANDA212061", "NDA019339", "NDA017037", "ANDA211007", "ANDA212060", "NDA018916", "ANDA090571", "NDA018609", "NDA201370", "ANDA203851", "ANDA090810" ], "brand_name": [ "HEPARIN SODIUM", "HEPARIN SODIUM AND DEXTROSE", "HEPARIN SODIUM IN SODIUM CHLORIDE" ], "generic_name": [ "HEPARIN SODIUM" ], "manufacturer_name": [ 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