{ "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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Antagonist [EPC]" ], "unii": [ "5QZO15J2Z8" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20120224" } } }, { "safetyreportversion": "2", "safetyreportid": "10010361", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "1", "serious": "1", "seriousnessdeath": "1", "receivedateformat": "102", "receivedate": "20140314", "receiptdateformat": "102", "receiptdate": "20140401", "fulfillexpeditecriteria": "1", "companynumb": "US-BIOGENIDEC-2014BI020314", "duplicate": "1", "reportduplicate": { "duplicatesource": "BIOGEN", "duplicatenumb": "US-BIOGENIDEC-2014BI020314" }, "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "57", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Death", "reactionoutcome": "5" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Cervical vertebral fracture", "reactionoutcome": "5" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Fall", "reactionoutcome": "5" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "TYSABRI", "drugauthorizationnumb": "125104", "drugstructuredosagenumb": "300", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "802", "drugdosageform": "INTRAVENOUS INFUSION", "drugadministrationroute": "042", "drugindication": "MULTIPLE SCLEROSIS", "drugstartdateformat": "102", "drugstartdate": "20061010", "openfda": { "application_number": [ "BLA125104" ], "brand_name": [ "TYSABRI" ], "generic_name": [ "NATALIZUMAB" ], "manufacturer_name": [ "Biogen Inc." ], "product_ndc": [ "64406-008" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "NATALIZUMAB" ], "rxcui": [ "477484", "603541" ], "spl_id": [ "119c87a9-d153-4796-9525-694afdcdc1d6" ], "spl_set_id": [ "c5fdde91-1989-4dd2-9129-4f3323ea2962" ], "package_ndc": [ "64406-008-01" ], "nui": [ "N0000175775", "N0000175774" ], "pharm_class_epc": [ "Integrin Receptor Antagonist [EPC]" ], "pharm_class_moa": [ "Integrin Receptor Antagonists [MoA]" ], "unii": [ "3JB47N2Q2P" ] } }, { "drugcharacterization": "2", "medicinalproduct": "AVONEX", "drugstructuredosagenumb": "30", "drugstructuredosageunit": "004", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugadministrationroute": "030", "drugindication": "MULTIPLE SCLEROSIS", "actiondrug": "1", "openfda": { "application_number": [ "BLA103628" ], "brand_name": [ "AVONEX" ], "generic_name": [ "INTERFERON BETA-1A" ], "manufacturer_name": [ "Biogen Inc." ], "product_ndc": [ "59627-002", "59627-333", "59627-222", "59627-003" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR" ], "substance_name": [ "INTERFERON BETA-1A" ], "rxcui": [ "727813", "727816", "797544", "1650899", "1650901" ], "spl_id": [ "8c84155d-4436-404a-bb05-aee683889f0b" ], "spl_set_id": [ "d70a39cc-de15-4c12-a1ec-8063b69ea0e1" ], "package_ndc": [ "59627-333-04", "59627-222-05", "59627-003-01", "59627-002-07", "59627-002-06" ], "nui": [ "M0025715", "N0000191625" ], "pharm_class_cs": [ "Interferon-beta [CS]" ], "pharm_class_epc": [ "Interferon beta [EPC]" ], "unii": [ "XRO4566Q4R" ] } }, { "drugcharacterization": "2", "medicinalproduct": "OMEPRAZOLE", "drugstructuredosagenumb": "40", "drugstructuredosageunit": "003", "drugdosageform": "CAPSULE", "openfda": { "application_number": [ "NDA022032", "ANDA079182", "ANDA210593", "ANDA207891", "ANDA075410", "ANDA206877", "ANDA075757", "NDA209400", "ANDA206582", "ANDA075576", "ANDA216096", "ANDA091352", "ANDA203481", "ANDA207740", "ANDA076515", "ANDA076048", "ANDA211732", "ANDA204012", "ANDA218829", "ANDA091672", "ANDA213201", "ANDA078490", "ANDA212977", "ANDA203270" ], "brand_name": [ "GOOD NEIGHBOR PHARMACY OMEPRAZOLE", "OMEPRAZOLE/SODIUM BICARBONATE", "KIRKLAND SIGNATURE OMEPRAZOLE", "OMEPRAZOLE", "FOSTER AND THRIVE OMEPRAZOLE", "ACID REDUCER", "BERKLEY AND JENSEN OMEPRAZOLE", "GOOD NOW OMEPRAZOLE", "GOOD SENSE OMEPRAZOLE", "BASIC CARE OMEPRAZOLE", "UP AND UP OMEPRAZOLE", "EQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER", "DG HEALTH OMEPRAZOLE", "TOPCARE OMEPRAZOLE", "CAREONE OMEPRAZOLE", "EQUALINE OMEPRAZOLE", "LEADER OMEPRAZOLE", "EQUATE OMEPRAZOLE", "DG HEALTH OMPERAZOLE", "OMEPRAZOLE DELAYED-RELEASE", "SIGNATURE CARE OMEPRAZOLE", "MEMBERS MARK OMEPRAZOLE", "AMAZON BASIC CARE OMEPRAZOLE", "RUGBY OMEPRAZOLE", "TOPCARE OMEPRAZOLE DELAYED RELEASE", "24 HR OMEPRAZOLE", "CARE ONE OMEPRAZOLE", "EXCHANGE SELECT OMEPRAZOLE", "GOOD SENSE OMEPRAZOLE DELAYED RELEASE" ], "generic_name": [ "OMEPRAZOLE", "OMEPRAZOLE MAGNESIUM" ], "manufacturer_name": [ "Amerisource Bergen", "Strides Pharma Science Limited", "Costco Wholesale Company", "INNOVUS PHARMACEUTICALS, INC.", "OHM LABORATORIES INC.", "Strategic Sourcing Services LLC", "STRATEGIC SOURCING SERVICES LLC", "GERI-CARE PHARMACEUTICALS, CORP", "Lannett Company, Inc.", "WALGREEN CO.", "Sandoz Inc", "Cardinal Health", "Chartwell RX, LLC", "BJWC", "CVS Pharmacy, Inc.", "HARRIS TEETER", "PLD Acquisitions LLC DBA Avma Pharma Solutions", "RELIABLE 1 LABORATORIES LLC", "DISCOUNT DRUG MART", "Gobrands, Inc", "L. Perrigo Company", "WinCo Foods, LLC", "Aurohealth LLC", "Amazon.com Services LLC", "Meijer Distribution Inc.", "Meijer Distribution Inc", "CVS Pharmacy", "H E B", "Quallent Pharmaceuticals Health LLC", "Target Corporation", "Fred's, Inc.", "Wal-Mart Stores Inc", "THE KROGER COMPANY", "HyVee Inc", "Meijer, Inc.", "Dolgencorp, LLC", "Topco Associates LLC", "Dolgencorp Inc", "Zydus Lifesciences Limited", "NORTHEAST PHARMA", "Rite Aid Corporation", "P & L Development, LLC", "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "Retail Business Services, LLC", "Walgreen Company", "United Natural Foods, Inc. dba UNFI", "Little Pharma, Inc.", "American Sales Company", "Golden State Medical Supply, Inc.", "Padagis Israel Pharmaceuticals Ltd", "AMERISOURCE BERGEN", "BluePoint Laboratories", "Cardinal Health 110, LLC. dba Leader", "Twin Med LLC", "Sun Pharmaceutical Industries, Inc.", "Zydus Pharmaceuticals USA Inc.", "Walmart Inc.", "Apotex Corp", "Strategic Sourcing Services", "Rite Aid", "CHAIN DRUG MARKETING ASSOCIATION, INC.", "Rugby Laboratories", "VALU MERCHANDISERS COMPANY", "WALMART INC. (see also Equate)", "Camber Pharmaceuticals, Inc.", "H-E-B", "KROGER COMPANY", "Living Better Brands LLC", "Safeway", "Publix Super Markets Inc", "Sam's West Inc", "Camber Consumer Care Inc", "Glenmark Pharmaceuticals Inc., USA", "Family Dollar (FAMILY WELLNESS)", "Allegiant Health", "Dr. Reddy's Laboratories Limited", "Kroger Company", "NorthStar Rx LLC", "BI-MART", "Family Dollar Stores, LLC", "Chain Drug Marketing Association INC", "AMERISOURCEBERGEN DRUG CORPORATION", "CVS Pharamacy, Inc", "Bi-Mart", "Dr. Reddys Laboratories Inc", "Aurobindo Pharma Limited", "UP & UP", "Winco Foods, LLC.", "Xiromed, LLC", "WALMART INC.", "7-Eleven", "Army & Air Force Exchange Service", "Best Choice", "Rising Pharma Holdings, Inc.", "Walgreens", "Wal-Mart Stores, Inc." ], "product_ndc": [ "46122-281", "64380-182", "64380-183", "63981-915", "57483-740", "51660-029", "70677-1275", "70677-1098", "57896-659", "62175-114", "62175-118", "62175-136", "0363-1008", "0781-2785", "0781-2790", "70000-0521", 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"8Q2869CNVH" ] } }, { "drugcharacterization": "2", "medicinalproduct": "GUAIFENESIN", "drugstructuredosagenumb": "200", "drugstructuredosageunit": "003", "drugdosageform": "TABLET", "openfda": { "application_number": [ "ANDA213420", "M012", "ANDA217780", "ANDA207342", "ANDA078912", "ANDA209215", "ANDA215932", "ANDA210453", "NDA021282", "ANDA209254", "part341" ], "brand_name": [ "MUCUS RELIEF", "GUAIFENESIN", "SIMPEX GUAIFENESIN", "MUCUS RELIEF EXTENDED RELEASE", "DRX CHOICE FRUIT PUNCH", "RUGBY CHEST CONGESTION RELIEF G450", "RUGBY MUCUS RELIEF ER", "MUCUS RELIEF MAXIMUM STRENGTH", "FOSTER AND THRIVE MUCUS RELIEF", "SDA LABORATORIES TUSSIN", "QUALITY CHOICE MUCUS RELIEF", "MARCS MUCUS RELIEF", "EQUATE MUCUS RELIEF", "GUAIFENESIN EXTENDED RELEASE 600 MG", "GUAIFENESIN EXTENDED RELEASE 1200 MG", "GUAIFENESIN 400MG", "QUALITY CHOICE ADULT TUSSIN EXPECTORANT", "CURIST MUCUS RELIEF", "GUAIFENESIN 600 MG", "GUAIFENESIN 1200 MG", "CUREWELL TUSSIN", "12 HOUR MUCUS RELIEF", "BERKLEY AND JENSEN 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Perrigo Company", "Spirit Pharmaceutical LLC", "Meijer, Inc.", "TWIN MED LLC", "Better Living Brands, LLC", "Wal-Mart Stores, Inc.", "Haleon US Holdings LLC", "SAM'S WEST INC", "Dr. Reddy's Laboratories Limited", "Unifirst First Aid Corporation", "Chartwell RX, LLC", "CVS Pharmacy", "TIME CAP LABORATORIES,INC", "Kenvue Brands LLC", "Aurohealth LLC", "AptaPharma Inc.", "Chain Drug Marketing Association Inc.", "Uline", "Breeden Brothers, LLC", "FSA STORE INC.", "Amerisource Bergen", "Target Corporation", "Shield Pharmaceuticals Corp", "CVS", "Amazon.com Services LLC", "Advagen Pharma Ltd.", "WALGREEN COMPANY", "Cintas Corporation", "Sun Pharmaceutical Industries, Inc.", "EQUATE (Wal-Mart Stores, Inc.) 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"reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Sinusitis", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Adenotonsillectomy", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Sinus operation", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Product quality issue", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Inappropriate schedule of drug administration", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Drug administration error", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "NASONEX", "drugbatchnumb": "3MAA534A", "drugauthorizationnumb": "020762", "drugstructuredosagenumb": "100", "drugstructuredosageunit": "004", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "50 MCG/ONE SPRAY 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