{ "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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"DEHYDRATION", "activesubstance": { "activesubstancename": "AMINO ACIDS\\DEXTROSE\\ELECTROLYTES NOS\\VITAMINS" } }, { "drugcharacterization": "2", "medicinalproduct": "LASIX", "drugstructuredosagenumb": "70", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugcumulativedosagenumb": "710", "drugcumulativedosageunit": "003", "drugdosagetext": "70 MG MILLIGRAM(S), DAILY DOSE", "drugdosageform": "INJECTION", "drugadministrationroute": "042", "drugstartdateformat": "102", "drugstartdate": "20140218", "drugenddateformat": "102", "drugenddate": "20140218", "activesubstance": { "activesubstancename": "FUROSEMIDE" }, "openfda": { "application_number": [ "NDA016273" ], "brand_name": [ "LASIX" ], "generic_name": [ "FUROSEMIDE" ], "manufacturer_name": [ "Validus Pharmaceuticals LLC" ], "product_ndc": [ "30698-060", "30698-067", "30698-066" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "FUROSEMIDE" ], "rxcui": [ "197732", "200801", "200809", "205732", "310429", "313988" ], "spl_id": [ "4002943d-0b4b-4ff0-e063-6394a90ae63b" ], "spl_set_id": [ "2c9b4d8f-0770-482d-a9e6-9c616a440b1a" ], "package_ndc": [ "30698-067-01", "30698-067-10", "30698-060-01", "30698-060-10", "30698-060-50", "30698-066-05", "30698-066-50" ], "nui": [ "N0000175366", "N0000175590" ], "pharm_class_pe": [ "Increased Diuresis at Loop of Henle [PE]" ], "pharm_class_epc": [ "Loop Diuretic [EPC]" ], "unii": [ "7LXU5N7ZO5" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140226" } } }, { "safetyreportversion": "1", "safetyreportid": "10007139", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20140313", "fulfillexpeditecriteria": "2", "companynumb": "US-PFIZER 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"f4853677-1622-4037-688b-fdf533a11d96" ], "package_ndc": [ "0186-5020-31", "0186-5020-54", "0186-5020-82", "0186-4010-01", "0186-4010-02", "0186-4020-01", "0186-4040-01", "0186-4040-02", "0186-5040-31", "0186-5040-35", "0186-5040-55", "0186-5040-85", "0186-5040-54", "0186-5040-82", "0186-5040-05", "0186-4025-01", "0186-4025-02", "0186-4050-01" ], "unii": [ "R6DXU4WAY9" ] } }, { "drugcharacterization": "2", "medicinalproduct": "RANITIDINE", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "RANITIDINE\\RANITIDINE HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA078192", "ANDA075294", "ANDA209859", "ANDA077824", "ANDA210243", "ANDA211289", "ANDA077405" ], "brand_name": [ "RANITIDINE", "RANITIDINE COOL MINT" ], "generic_name": [ "RANITIDINE" ], "manufacturer_name": [ "Dr. Reddy's Laboratories Limited", "Ajanta Pharma USA Inc.", "Amneal Pharmaceuticals of New York LLC", "Granules India Ltd", "Rising Pharma Holdings, Inc.", "Pharmaceutical Associates, Inc." ], "product_ndc": [ "55111-404", "55111-131", "27241-109", "27241-110", "53746-253", "53746-254", "62207-773", "62207-774", "64980-636", "64980-637", "0121-0727", "0121-4727" ], "product_type": [ "HUMAN OTC DRUG", "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "RANITIDINE HYDROCHLORIDE", "RANITIDINE" ], "rxcui": [ "198191", "312773", "198190", "198192", "198193", "705610" ], "spl_id": [ "c47f1d10-c4d9-5df4-84e8-55956b47568b", "210e3c0b-be93-aa50-550d-e383e7d5f19e", "d7fd99da-f17a-4124-9014-70bbe43d78f6", "906b462d-e4a3-4f23-8d1b-2605476c40e8", "44f2b222-ae43-eef4-e063-6394a90ab2b6", "b4d3aa30-82b1-45e5-89bb-829c5ccf7ffe", "d56a22ea-5dab-e98a-e053-2a95a90a34c4" ], "spl_set_id": [ "00df8a42-296f-80dd-98af-ee8b30eb38cc", "12a38e29-130c-6d41-1753-acccb0b41efe", "fb67e8c7-b817-4253-a1a1-5ecdcee694cf", "b38a3332-5c54-453f-aeb7-070f830955c2", "aab81d9f-397d-49fb-8083-77a1872cc71f", "0fba6615-37c2-4ba6-b6e5-09599369a5bc", "d0da9dd6-c691-4614-99c7-531b0bf34837" ], "package_ndc": [ "55111-404-34", "55111-404-32", "55111-404-36", "55111-404-50", "55111-404-61", "55111-404-55", "55111-404-62", "55111-404-90", "55111-404-02", "55111-404-65", "55111-404-17", "55111-404-24", "55111-404-38", "55111-404-40", "55111-131-30", "55111-131-60", "55111-131-80", "55111-131-90", "55111-131-04", "55111-131-37", "55111-131-79", "55111-131-14", "55111-131-81", "55111-131-45", "27241-109-06", "27241-109-50", "27241-110-03", "27241-110-10", "53746-253-60", "53746-253-01", "53746-253-18", "53746-253-05", "53746-253-10", "53746-254-30", "53746-254-01", "53746-254-02", "62207-774-58", "62207-774-41", "62207-774-47", "62207-774-36", "62207-773-58", "62207-773-41", "62207-773-47", "62207-773-32", "62207-773-36", "64980-636-03", "64980-637-03", "0121-0727-16", "0121-4727-10" ], "unii": [ "BK76465IHM", "884KT10YB7" ], "nui": [ "N0000000151", "N0000175784" ], "pharm_class_moa": [ "Histamine H2 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Histamine-2 Receptor Antagonist [EPC]" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 201210" } } }, { "safetyreportversion": "2", "safetyreportid": "10009594", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "2", "companynumb": "US-INCYTE CORPORATION-2012IN001803", "duplicate": "1", "reportduplicate": { "duplicatesource": "INCYTE", "duplicatenumb": "US-INCYTE CORPORATION-2012IN001803" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "58", "patientonsetageunit": "801", "patientweight": "47.2", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Platelet count decreased", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Blood glucose decreased", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Asthenia", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "JAKAFI", "drugstructuredosagenumb": "15", "drugstructuredosageunit": "003", "drugdosagetext": "15 MG, BID", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "MYELOFIBROSIS", "drugstartdateformat": "610", "drugstartdate": "201208", "drugenddateformat": "102", "drugenddate": "20120910", "actiondrug": "2", "openfda": { "application_number": [ "NDA202192" ], "brand_name": [ "JAKAFI" ], "generic_name": [ "RUXOLITINIB" ], "manufacturer_name": [ "Incyte Corporation" ], "product_ndc": [ "50881-005", "50881-010", "50881-015", "50881-020", "50881-025", "50881-011", "50881-022", "50881-033", "50881-044", "50881-055" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "RUXOLITINIB" ], "rxcui": [ "1193331", "1193337", "1193339", "1193341", "1193343", "1193345", "1193347", "1193349", "1193351", "1193353", "2743012", "2743016", "2743019", "2743022", "2743025", "2743028", "2743032", "2743035", "2743041", "2743044" ], "spl_id": [ "1c261eb0-f426-47a1-8281-62282d207644" ], "spl_set_id": [ "f1c82580-87ae-11e0-bc84-0002a5d5c51b" ], "package_ndc": [ "50881-005-60", "50881-010-01", "50881-010-60", "50881-015-60", "50881-020-60", "50881-025-60", "50881-011-08", "50881-022-08", "50881-033-08", "50881-044-08", "50881-055-08" ], "nui": [ "N0000175605", "N0000190858", "N0000190857" ], "pharm_class_epc": [ "Kinase Inhibitor [EPC]", "Janus Kinase Inhibitor [EPC]" ], "pharm_class_moa": [ "Janus Kinase Inhibitors [MoA]" ], "unii": [ "82S8X8XX8H" ] } }, { "drugcharacterization": "1", "medicinalproduct": "JAKAFI", "drugbatchnumb": "A81294M", "drugstructuredosagenumb": "5", "drugstructuredosageunit": "003", "drugdosagetext": "5 MG, BID", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20120911", "actiondrug": "2", "openfda": { "application_number": [ "NDA202192" ], "brand_name": [ "JAKAFI" ], "generic_name": [ "RUXOLITINIB" ], "manufacturer_name": [ "Incyte Corporation" ], "product_ndc": [ "50881-005", "50881-010", "50881-015", "50881-020", "50881-025", "50881-011", "50881-022", "50881-033", "50881-044", "50881-055" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "RUXOLITINIB" ], "rxcui": [ "1193331", "1193337", "1193339", "1193341", "1193343", "1193345", "1193347", "1193349", "1193351", "1193353", "2743012", "2743016", "2743019", "2743022", "2743025", "2743028", "2743032", "2743035", "2743041", "2743044" ], "spl_id": [ "1c261eb0-f426-47a1-8281-62282d207644" ], "spl_set_id": [ "f1c82580-87ae-11e0-bc84-0002a5d5c51b" ], 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"de82c22d-ea25-44ef-8bcd-c3cda9e84e59" ], "spl_set_id": [ "3a1e73a2-3009-40d0-876c-b4cb2be56fc5" ], "package_ndc": [ "0169-7501-11", "0169-7501-90", "0169-3303-12", "0169-3303-91", "0169-3303-90", "0169-6339-10", "0169-6339-90", "0169-6339-97", "0169-6339-98", "0169-6338-10", "0169-6338-90", "0169-6338-97", "0169-2001-90", "0169-2100-11", "0169-2101-12", "0169-2101-25" ], "nui": [ "M0011417", "N0000175453" ], "pharm_class_cs": [ "Insulin [CS]" ], "pharm_class_epc": [ "Insulin Analog [EPC]" ], "unii": [ "D933668QVX", "059QF0KO0R" ] } }, { "drugcharacterization": "2", "medicinalproduct": "NIFEDIPINE", "openfda": { "application_number": [ "ANDA075269", "ANDA210184", "ANDA212016", "ANDA216896", "ANDA075289", "ANDA202644", "ANDA077127", "ANDA203126", "ANDA213361", "ANDA210012", "ANDA216067", "NDA019684", "ANDA076070", "ANDA202987", "ANDA210614" ], "brand_name": [ "NIFEDIPINE", "PROCARDIA XL" ], "generic_name": [ "NIFEDIPINE" ], "manufacturer_name": [ "Oceanside Pharmaceuticals", "Zydus Lifesciences Limited", "Elite Pharmaceutical Solution, Inc.", "Alembic Pharmaceuticals Inc.", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Chartwell RX, LLC", "Upsher-Smith Laboratories, LLC", "Aurobindo Pharma Limited", "Lannett Company, Inc.", "Ascend Laboratories, LLC", "Alembic Pharmaceuticals Limited", "Zydus Pharmaceuticals (USA) Inc.", "Pfizer Laboratories Div Pfizer Inc", "Ingenus Pharmaceuticals, LLC" ], "product_ndc": [ "68682-105", "70771-1365", "70771-1366", "70771-1367", "68682-106", "70807-503", "62332-732", "62332-733", "62332-734", "68682-108", "68682-109", "23155-194", "23155-195", "62135-521", "62135-522", "62135-523", "24979-009", "24979-011", "24979-010", "59651-295", "59651-296", "59651-297", "70771-1190", "70771-1191", "70771-1192", "62175-260", "62175-261", "62175-262", "67877-756", "67877-757", "67877-758", "46708-732", "46708-733", "46708-734", "68382-685", "68382-686", "68382-687", "0069-2650", "0069-2660", "0069-2670", "62135-739", 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"medicinalproduct": "MAGNESIUM LACTATE", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": "84", "drugstructuredosageunit": "003", "drugdosagetext": "84 MG (7 MEQ), BID", "drugadministrationroute": "048", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "activesubstance": { "activesubstancename": "MAGNESIUM LACTATE" } }, { "drugcharacterization": "2", "medicinalproduct": "POTASSIUM", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": "100", "drugstructuredosageunit": "003", "drugdosagetext": "100 MG, UNK", "drugadministrationroute": "048", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "activesubstance": { "activesubstancename": "POTASSIUM" } }, { "drugcharacterization": "2", "medicinalproduct": "TERAZOSIN HCL", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugdosagetext": "10 MG, QD EACH EVENING", "drugadministrationroute": "048", "drugindication": "NEPHROPROTECTIVE THERAPY", "actiondrug": "5", "activesubstance": { "activesubstancename": "TERAZOSIN HYDROCHLORIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "PANTOPRAZOLE SODIUM", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": "40", "drugstructuredosageunit": "003", "drugdosagetext": "40 MG, QD EACH MORNING", "drugadministrationroute": "048", "drugindication": "GASTRIC DISORDER", "actiondrug": "5", "activesubstance": { "activesubstancename": "PANTOPRAZOLE SODIUM" }, "openfda": { "application_number": [ "ANDA090970", "ANDA204400", "ANDA216171", "ANDA213725", "ANDA217923", "NDA209463", "NDA020988", "ANDA215860", "ANDA202882", "ANDA216021", "ANDA202038", "ANDA090074", "ANDA213778", "NDA217512", "ANDA219230", "ANDA205119", "ANDA217282", "ANDA214680", "ANDA217416", "ANDA205675", "ANDA216139", "ANDA219087", "ANDA216247", "ANDA078281", "ANDA209524", "ANDA077674", "NDA020987", "NDA022020", "ANDA215074" ], "brand_name": [ "PANTOPRAZOLE SODIUM", "PROTONIX I.V.", "PANTOPRAZOLE SODIUM I.V.", "PROTONIX DELAYED-RELEASE" ], "generic_name": [ "PANTOPRAZOLE SODIUM", "PANTOPRAZOLE", "PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE", "PANTOPRAZOLE SODIUM INJECTION" ], "manufacturer_name": [ "Mylan Pharmaceuticals Inc.", "Sun Pharmaceutical Industries Limited", "Novadoz Pharmaceuticals LLC", "Sun Pharmaceutical Industries, Inc.", "Aurobindo Pharma Limited", "Civica, Inc.", "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.", "Northstar Rx LLC", "NorthStar RxLLC", "XLCare Pharmaceuticals Inc.", "Fresenius Kabi USA, LLC", "NorthStar Rx LLC", "Quallent Pharmaceuticals Health LLC", "Torrent Pharmaceuticals Limited", "Camber Pharmaceuticals, Inc.", "Sagent Pharmaceuticals", "Baxter Healthcare Company", "Meitheal Pharmaceuticals Inc.", "Alembic Pharmaceuticals Limited", "Amneal Pharmaceuticals LLC", "Granules Pharmaceuticals Inc.", "Piramal Critical Care", "Burel Pharmaceuticals, LLC", "Ajanta Pharma USA Inc.", "Gland Pharma Limited", "Eugia US LLC", "BE Pharmaceuticals Inc.", "Rising Pharma Holdings, Inc.", "Edenbridge Pharmaceuticals LLC.", "Lannett Company, Inc.", "Alembic Pharmaceuticals Inc.", "Hikma Pharmaceuticals USA Inc.", "American Health Packaging", "Sandoz Inc", "Devatis Inc.", "Chartwell RX, LLC" ], "product_ndc": [ "0378-6688", "0378-6689", "70095-024", "72205-180", "62756-071", "59651-671", "72572-553", "0008-0923", "72603-128", "72603-317", "72865-229", "72865-230", "65219-385", "72603-746", "82009-010", "82009-011", "13668-096", "13668-429", "31722-204", "25021-751", "0338-9644", "0338-9646", "0338-9648", "71288-600", "46708-071", "65162-636", "65162-637", "70010-190", "70010-191", "31722-712", "31722-713", "65862-559", "65862-560", "0008-4001", "66794-258", "35573-428", "27241-256", "68083-493", "55150-202", "31722-032", "71839-122", "64980-676", "64980-677", "42799-952", "62175-617", "62175-180", "62175-618", "62332-071", "0143-9300", "60687-767", "0143-9284", "0781-3480", "62756-129", "0008-0841", "0008-0843", "0008-0844", "73043-020", 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