{ "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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Ovum Fertilization [PE]" ], "pharm_class_cs": [ "Allergens [CS]", "Glycerol [CS]", "Dietary Proteins [CS]", "Plant Proteins [CS]", "Catecholamines [CS]", "Bee Venoms [CS]", "Seed Storage Proteins [CS]", "Vegetable Proteins [CS]", "Food Additives [CS]", "Milk Proteins [CS]", "Copper [CS]", "Insect Proteins [CS]" ], "pharm_class_moa": [ "Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Agonists [MoA]" ], "unii": [ "BQN1B9B9HA", "7OV03QG267", "E4GA8884NN", "F9S9FFU82N", "95IT3W8JZE", "PDC6A3C0OX", "2788Z9758H", "J2B2A4N98G", "C151H8M554", "H6241UJ22B", "SK47B8698T", "FQ3DRG0N5K", "820LSF646I", "J41CSQ7QDS", "3B8D35Y7S4", "FST467XS7D", "0B4FDL9I6P", "YKH834O4BH", "7JM57I419K", "U0NQ8555JD", "7S82P3R43Z", "O80TY208ZW", "S7V92P67HO", "WQZ3G9PF0H", "2HU33I03UY", "T7J046YI2B", "18E7415PXQ", "G0R4UBI2ZZ", "0KD7R09EAS", "7SCP4N87CI", "23H32AOH17", "G72JA9DHK5", "VB06AV5US8", "QI7G114Y98", "1W0775VX6E", "91GQH8I5F7", "T7S323PKJS", "3POA0Q644U", "XK4IUX8MNB", "AJU5O1A5ZV", "2FXJ6SW4PK", "6IO182RP7A", "51BRR32WPP", "CZD6M4PY4B", "70FD1KFU70", "M9VVZ08EKQ", "QNS6W5US1Z", "877L01IZ0P", "79M2M2UDA9", "W2469WNO6U", "C9TD27U172", "GID333S43J", "4VBP01X99F", "XKC1657P78", "2P3VWU3H10", "1TH8Q20J0U", "J3TO6BUQ37", "279O8I0433", "ET3651ZLOU", "C88X29Y479", "HF539G9L3Q", "269XH13919", "S72O3284MS", "8724FJW4M5", "9W945B5H7R", "MA9CQJ3F7F", "7E889U5RNN", "EM5RP35463", "DJO934BRBD", "F79059A38U", "CI71S98N1Z", "V1V998DC17", "2E32821G6I", "O3B55K4YKI", "91D9GV0Z28", "451W47IQ8X", "70WT22SF4B", "E934B3V59H", "F5452U54PN", "IHN2NQ5OF9", "8I2PXY292P", "01G73H6H83", "MN0RX54EQA", "ML644HED2V", "3SW678MX72", "311PNK9CDZ", "YF70189L0N", "1NM3M2487K", "07YL55QKZ9", "050QZ2EDK7", "JWF5YAW3QW", "J86L1GUL6K", "CLF5YFS11O", "5AZZ2GHR69", "H6L0IFR3FE", "9315HN272X", "433OSF3U8A", "YHZ719F7M3", "RQ2CFA7WWJ", "5Q01F7TPJJ", "398DBS1PXN", "QDL83WN8C2", "79Y1949PYO", "I2XCB174VB", "81MCR2UQ6Q", "WWX61E1ZAK", "M6936L953C", "TP69J995TW", "917J3173FT", "9PP1T3TC5U", "U364V64HUN", "86H4S6K51N", "CT03BSA18U", "LZB7TFX1LT", "3D10KUA6BM", "62I3C8233L", "RU45X2JN0Z", "2CA71K0DLE", "789U1901C5", "QR44N9XPJQ", "ZW3Z11D0JV", "535787266D", "C9642I91WL", "T4423S18FM", "BOP122S791", "RI2K1BMA8B", "8P5F881OCY", "91MBZ8H3QO", "ZI0T668SF1", "90ZQ7G407W", "Y882YXF34X", "S546YLW6E6", "C4MO6809HU", "RWG7BD1032", "J2D46N657D", "1TI1O9028K", "1NT28V9397", "1K573LC5TV", "660YQ98I10", "I76KB35JEV", "27YLU75U4W", "6A001Y4M5A", "8EKI9QEE2H", "1MBW07J51Q", "492225Q21H", "5EF0HWI5WU", "639KR60Q1Q", "VSW71SS07I", "498M34P1VZ", "R9HH0NDE2E", "R06VWT372T", "N94C2U587S", "L6L8KA2AA0", "42QO5P0NLM", "S003A158SB", "Q40Q9N063P", "8W75VCV53Q" ] } }, { "drugcharacterization": "2", "medicinalproduct": "B12", "drugindication": "PERNICIOUS ANAEMIA", "openfda": { "brand_name": [ "B05 GLUCO BALANCE", "B01 ACUTE RESCUE", "B19 ACUTE RESCUE", "B04 DIGESTION", "B21 ACUTE RESCUE", "B13 CELL SALT COMPLEX", "B06 STRESS RESISTANCE", "B07 DPRSN ANTITOX", "B14 BRONCHOTOX", "B08 MUCOUS MEMBRANES", "B03 SINUS RELIEF", "B09 ACUTE VIROTOX", "B11 INJUROTOX", "B20 ACUTE RESCUE", "B02 ADRENAL PEP" ], "generic_name": [ "ADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUM", "ACONITUM NAPELLUS, APIS MELLIFICA, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA ALBA, CALENDULA OFFICINALIS, CHAMOMILLA, CHERRY PLUM, CLEMATIS, COLOCYNTHIS, DULCAMARA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, HAMAMELIS VIRGINIANA, HISTAMINUM, HYPERICUM PERFORATUM, IMPATIENS, MILLEFOLIUM, RHUS TOXICODENDRON, ROCK ROSE, STAR OF BETHLEHEM, SULPHUR, SYMPHYTUM OFFICINALE, VERATRUM ALBUM", "ACONITUM NAPELLUS,APIS MELLIFICA,ARNICA MONTANA,ARSENICUM ALBUM,BELLADONNA,BELLIS PERENNIS,BRYONIA,CALENDULA OFFICINALIS,CHAMOMILLA,CHERRY PLUM,CLEMATIS VITALBA,COLOCYNTHIS,COMFREY,DULCAMARA LIGNOSA,ECHINACEA ANGUSTIFOLIA,ECHINACEA PURPUREA,EUPATORIUM PERFOLIATUM,FERRUM PHOSPHORICUM,HAMAMELIS VIRGINIANA,HISTAMINUM,HYPERICUM PERFORATUM,IMPATIENS GLANDULIFERA,LEDUM PALUSTRE,MENTHA PIPERITA,MILLEFOLIUM,ORNITHOGALUM UMBELLATUM,PLANTAGO MAJOR,RHUS TOXICODENDRON,ROCKROSE,SULPHUR,VERATRUM ALBUM,VERBASCUM THAPSUS", "ALFALFA, ANTIMONIUM CRUDUM, AVENA SATIVA, BERBERIS VULGARIS, CAJUPUTUM, CARBO ANIMALIS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, FEL TAURI, GENTIANA LUTEA, GLYCYRRHIZA GLABRA, ILLICIUM ANISATUM, INDOLUM, KALI CARBONICUM, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PANCREATINUM, PEPSINUM, RAPHANUS SATIVUS, RHAMNUS PURSHIANA, SKATOLUM", "ALLIUM SATIVUM, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CARBO VEGETABILIS, FERRUM IODATUM, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, PHOSPHORICUM ACIDUM, URTICA URENS", "AVENA SATIVA, CHAMOMILLA, CHERRY PLUM, CLEMATIS VITALBA, COFFEA CRUDA, ENGLISH OAK, ESCHSCHOLTZIA CALIFORNICA, EUROPEAN HORNBEAM, FICUS CARICA, HUMULUS LUPULUS, IGNATIA AMARA, IMPATIENS GLANDULIFERA, KALI PHOSPHORICUM, KALI SILICATUM, MELISSA OFFICINALIS, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PYRENEES STAR OF BETHLEHEM, ROCKROSE, SUS SCROFA PARASYMPATHETIC NERVE, PINEAL GLAND, SYMPATHETIC NERVE, VALERIANA OFFICINALIS, VERBENA OFFICINALIS, ZINCUM VALERIANICUM", "ADRENALINUM, AETHUSA CYNAPIUM, AGNUS CASTUS, ALFALFA, ARGENTUM NITRICUM, AURUM METALLICUM, AVENA SATIVA, CERATOSTIGMA WILLMOTTIANUM FLOWER, CHERRY PLUM FLOWER, DAMIANA, EUROPEAN ASPEN FLOWER, EUROPEAN HORNBEAM FLOWER, GORSE FLOWER, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, MANDRAGORA OFFICINARUM, NATRUM MURIATICUM, PASSIFLORA INCARNATA, ROSA CANINA FLOWER, SEPIA, SWEET CHESTNUT FLOWER, THYROIDINUM, WILD MUSTARD FLOWER", "BELLADONNA, BLATTA ORIENTALIS, COCCUS CACTI, CORALLIUM RUBRUM, CUPRUM METALLICUM, DROSERA ROTUNDIFOLIA, ECHINACEA ANGUSTIFOLIA, HEDERA HELIX, HYDRASTIS CANADENSIS, IPECACUANHA, KALI NITRICUM, LAC VACCINUM, LOBELIA INFLATA, PASSIFLORA INCARNATA, PERTUSSINUM, SAMBUCUS NIGRA, THYMUS SERPYLLUM, VALERIANA OFFICINALIS", "BALSAMUM PERUVIANUM, BORAX, BRYONIA, CALCAREA ACETICA, COCCUS CACTI, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUCALYPTUS GLOBULUS, EUPHORBIUM OFFICINARUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, KALI BICHROMICUM, LUFFA OPERCULATA, MERCURIUS CYANATUS, MERCURIUS DULCIS, MERCURIUS SULPHURATUS RUBER, NATRUM ARSENICICUM, PANCREATINUM, SAMBUCUS NIGRA, SANGUINARINUM NITRICUM, SAPONARIA OFFICINALIS", "ALLIUM CEPA, CALCAREA IODATA, CALCAREA SULPHURICA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUPHORBIUM OFFICINARUM, HEPAR SULPHURIS CALCAREUM, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, KALI MURIATICUM, KALI SULPHURICUM, LAC DEFLORATUM, LUFFA OPERCULATA, MERCURIUS SULPHURATUS RUBER, PHOSPHORUS, PULSATILLA VULGARIS, SACCHARUM LACTIS, THUJA OCCIDENTALIS", "ACONITUM NAPELLUS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CHERRY PLUM, CLEMATIS VITALBA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, EUROPEAN OLIVE, FERRUM PHOSPHORICUM, GENTIANA LUTEA, IMPATIENS GLANDULIFERA, INFLUENZA A VIRUS, LACHESIS MUTUS, LUFFA OPERCULATA, ORNITHOGALUM UMBELLATUM, PHOSPHORUS, ROCKROSE, SARCOLACTICUM ACIDUM, VERATRUM ALBUM, YELLOW JASMINE", "ARISTOLOCHIA MILHOMENS, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA, CALENDULA OFFICINALIS, CARBO VEGETABILIS, CHAMOMILLA, CHERRY PLUM FLOWER, CLEMATIS VITALBA FLOWER, ECHINACEA ANGUSTIFOLIA, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, IMPATIENS GLANDULIFERA FLOWER, LACHESIS MUTUS, MILLEFOLIUM, PYRENEES STAR OF BETHLEHEM, RHUS TOXICODENDRON, ROCKROSE FLOWER, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SULPHUR IODATUM, SYMPHYTUM OFFICINALE, VERATRUM ALBUM", "ACONITUM NAPELLUS, APIS MELLIFICA, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA, CALENDULA, CHAMOMILLA, CHERRY PLUM, CLEMATIS VITALBA, COLOCYNTHIS, DULCAMARA LIGNOSA, ECHINACEA, EUPATORIUM, FERRUM PHOSPHORICUM, HAMAMELIS VIRGINIANA, HISTAMINUM, HYPERICUM PERFORATUM, IMPATIENS GLANDULIFERA, LEDUM PALUSTRE, MENTHA PIPERITA, MILLEFOLIUM, PLANTAGO MAJOR, PYRENEES STAR OF BETHLEHEM, RHUS TOXICODENDRON, ROCKROSE, SULFUR, COMFREY, VERATRUM ALBUM, VERBASCUM THAPSUS", "ACETICUM ACIDUM, ADRENALINUM, AMERICAN GINSENG, ARNICA MONTANA, BALSAMUM PERUVIANUM, BOS TAURUS PITUITARUM POSTERIUM, CHERRY PLUM FLOWER, CHININUM ARSENICOSUM, CINCHONA OFFICINALIS, CLEMATIS VITALBA FLOWER, DAMIANA, EUROPEAN HORNBEAM FLOWER, EUROPEAN OLIVE FLOWER, GLYCYRRHIZA GLABRA, IMPATIENS GLANDULIFERA FLOWER, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYRENEES STAR OF BETHLEHEM, ROCKROSE FLOWER, SELENIUM METALLICUM, THYROIDINUM" ], "manufacturer_name": [ "Apex Energetics Inc." ], "product_ndc": [ "63479-0205", "63479-0201", "63479-0219", "63479-0204", "63479-0221", "63479-0213", "63479-0206", "63479-0207", "63479-0214", "63479-0208", "63479-0203", "63479-0209", "63479-0211", "63479-0220", "63479-0202" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "SUBLINGUAL", "TOPICAL" ], "substance_name": [ "POTASSIUM CARBONATE", "NICKEL", "PHOSPHORIC ACID", "LACTIC ACID, L-", "SILVER NITRATE", "GLYCERIN", "GLYCYRRHIZA GLABRA", "LACTOSE, UNSPECIFIED FORM", "SUCROSE", "SELENIUM", "MAGNESIUM SULFATE HEPTAHYDRATE", "PANCRELIPASE", "SYZYGIUM CUMINI SEED", "ZINC", "LACTIC ACID, DL-", "SACCHARIN", "THYROID, UNSPECIFIED", "EPINEPHRINE", "BOS TAURUS PITUITARY GLAND, POSTERIOR", "ACONITUM NAPELLUS", "APIS MELLIFERA", "ARNICA MONTANA", "ARSENIC TRIOXIDE", "ATROPA BELLADONNA", "BELLIS PERENNIS", "BRYONIA ALBA ROOT", "CALENDULA OFFICINALIS FLOWERING TOP", "MATRICARIA CHAMOMILLA", "PRUNUS CERASIFERA FLOWER", "CLEMATIS VITALBA FLOWER", "CITRULLUS COLOCYNTHIS FRUIT PULP", "SOLANUM DULCAMARA WHOLE", "ECHINACEA ANGUSTIFOLIA", "ECHINACEA PURPUREA", "EUPATORIUM PERFOLIATUM FLOWERING TOP", "FERROSOFERRIC PHOSPHATE", "HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK", "HISTAMINE DIHYDROCHLORIDE", "HYPERICUM PERFORATUM", "IMPATIENS GLANDULIFERA FLOWER", "ACHILLEA MILLEFOLIUM", "TOXICODENDRON PUBESCENS LEAF", "HELIANTHEMUM NUMMULARIUM FLOWER", "ORNITHOGALUM UMBELLATUM FLOWERING TOP", "SULFUR", "COMFREY ROOT", "VERATRUM ALBUM ROOT", "LEDUM PALUSTRE TWIG", "MENTHA PIPERITA", "PLANTAGO MAJOR", "VERBASCUM THAPSUS", "MATRICARIA CHAMOMILLA WHOLE", "PEPSIN", "FRANGULA PURSHIANA BARK", "STAR ANISE", "ACTIVATED CHARCOAL", "BERBERIS VULGARIS ROOT BARK", "CAJUPUT OIL", "CARBO ANIMALIS", "BOS TAURUS BILE", "LYCOPODIUM CLAVATUM SPORE", "MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE", "STRYCHNOS NUX-VOMICA SEED", "GENTIANA LUTEA ROOT", "INDOLE", "SKATOLE", "AVENA SATIVA FLOWERING TOP", "CHELIDONIUM MAJUS", "RADISH", "ALFALFA", "ANTIMONY TRISULFIDE", "POTASSIUM PHOSPHATE, DIBASIC", "GARLIC", "OYSTER SHELL CALCIUM CARBONATE, CRUDE", "CALCIUM FLUORIDE", "TRIBASIC CALCIUM PHOSPHATE", "SODIUM CHLORIDE", "SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE", "CALCIUM SULFATE ANHYDROUS", "FERROUS IODIDE", "URTICA URENS", "FICUS CARICA FLOWER BUD", "HOPS", "ZINC VALERATE DIHYDRATE", "QUERCUS ROBUR FLOWER", "ARABICA COFFEE BEAN", "DIBASIC POTASSIUM PHOSPHATE", "VERBENA OFFICINALIS FLOWERING TOP", "MELISSA OFFICINALIS", "STRYCHNOS IGNATII SEED", "CARPINUS BETULUS FLOWER", "SUS SCROFA PINEAL GLAND", "VALERIAN", "POTASSIUM SILICATE", "PASSIFLORA INCARNATA FLOWERING TOP", "SUS SCROFA PARASYMPATHETIC NERVE", "SUS SCROFA SYMPATHETIC NERVE", "ESCHSCHOLZIA CALIFORNICA", "CHASTE TREE", "CASTANEA SATIVA FLOWER", "TURNERA DIFFUSA LEAFY TWIG", "POPULUS TREMULA FLOWERING TOP", "ULEX EUROPAEUS FLOWER", "SEPIA OFFICINALIS JUICE", "GOLD", "MANDRAGORA OFFICINARUM ROOT", "ROSA CANINA FLOWER", "SINAPIS ARVENSIS FLOWERING/FRUITING TOP", "AETHUSA CYNAPIUM", "CERATOSTIGMA WILLMOTTIANUM FLOWER", "COW MILK", "LOBELIA INFLATA", "HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED", "THYMUS SERPYLLUM", "SAMBUCUS NIGRA FLOWERING TOP", "PROTORTONIA CACTI", "HEDERA HELIX FLOWERING TWIG", "IPECAC", "POTASSIUM NITRATE", "CORALLIUM RUBRUM EXOSKELETON", "COPPER", "DROSERA ROTUNDIFOLIA", "GOLDENSEAL", "BLATTA ORIENTALIS", "EUPHRASIA STRICTA", "POTASSIUM DICHROMATE", "SANGUINARINE NITRATE", "SAPONARIA OFFICINALIS ROOT", "BALSAM PERU", "SODIUM BORATE", "MERCURIC SULFIDE", "SODIUM ARSENATE, DIBASIC, HEPTAHYDRATE", "CALCIUM ACETATE", "EUCALYPTUS GLOBULUS LEAF", "LUFFA OPERCULATA FRUIT", "MERCURIC CYANIDE", "CALOMEL", "EUPHORBIA RESINIFERA RESIN", "THUJA OCCIDENTALIS LEAFY TWIG", "POTASSIUM SULFATE", "POTASSIUM CHLORIDE", "PULSATILLA VULGARIS", "PHOSPHORUS", "SKIM MILK", "CALCIUM IODIDE", "CALCIUM SULFIDE", "ONION", "BAPTISIA TINCTORIA ROOT", "GELSEMIUM SEMPERVIRENS ROOT", "LACHESIS MUTA VENOM", "OLEA EUROPAEA 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"drugstartdateformat": "602", "drugstartdate": "2008" }, { "drugcharacterization": "2", "medicinalproduct": "HUMALOG", "drugindication": "DIABETES MELLITUS", "drugstartdateformat": "610", "drugstartdate": "201203", "openfda": { "application_number": [ "BLA021017", "BLA020563", "BLA205747", "BLA021018" ], "brand_name": [ "HUMALOG MIX75/25 KWIKPEN", "HUMALOG MIX75/25", "HUMALOG", "HUMALOG KWIKPEN", "HUMALOG JUNIOR KWIKPEN", "HUMALOG TEMPO PEN", "HUMALOG MIX50/50 KWIKPEN" ], "generic_name": [ "INSULIN LISPRO" ], "manufacturer_name": [ "Eli Lilly and Company" ], "product_ndc": [ "0002-8797", "0002-7511", "0002-7510", "0002-7533", "0002-8799", "0002-7516", "0002-7714", "0002-8213", "0002-0800", "0002-7712", "0002-8208", "0002-8798", "0002-7512" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "INTRAVENOUS" ], "substance_name": [ "INSULIN LISPRO" ], "rxcui": [ "259111", "752388", "847252", "847254", "242120", "865098", "1652239", "1652242", "1652639", "1652640", 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Metabolic Inhibitor [EPC]" ], "pharm_class_moa": [ "Folic Acid Metabolism Inhibitors [MoA]" ] } }, { "drugcharacterization": "1", "medicinalproduct": "PIVALONE", "drugstructuredosagenumb": "2", "drugstructuredosageunit": "032", "drugcumulativedosagenumb": "60", "drugcumulativedosageunit": "032", "drugdosagetext": "2 DF, 5QD", "drugadministrationroute": "045", "drugindication": "RHINITIS", "drugstartdateformat": "102", "drugstartdate": "20140203", "drugenddateformat": "102", "drugenddate": "20140208", "actiondrug": "1", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "TIXOCORTOL PIVALATE" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140210" } } }, { "safetyreportversion": "1", "safetyreportid": "10004383", "primarysourcecountry": "GB", "occurcountry": "GB", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "1", "companynumb": "GB-WATSON-2014-04185", "duplicate": "1", "reportduplicate": { "duplicatesource": "WATSON", "duplicatenumb": "GB-WATSON-2014-04185" }, "primarysource": { "reportercountry": "GB", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "48", "patientonsetageunit": "801", "patientweight": "56", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Neuropathy peripheral", "reactionoutcome": "4" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Muscle spasms", "reactionoutcome": "4" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Myopathy", "reactionoutcome": "4" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Sleep disorder", "reactionoutcome": "4" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Blood glucose increased", "reactionoutcome": "4" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "ATORVASTATIN CALCIUM (UNKNOWN)", "drugbatchnumb": "UNCONFIRMED", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugdosagetext": "10 MG, UNKNOWN", "drugdosageform": "Unk", "drugadministrationroute": "048", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "610", "drugstartdate": "200709", "drugenddateformat": "610", "drugenddate": "200710", "actiondrug": "1" }, { "drugcharacterization": "1", "medicinalproduct": "SIMVASTATIN (UNKNOWN)", "drugbatchnumb": "UNCONFIRMED", "drugauthorizationnumb": "076685", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugdosagetext": "10 MG, UNKNOWN", "drugdosageform": "Unk", "drugadministrationroute": "048", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "602", "drugstartdate": "2005", "drugenddateformat": "610", "drugenddate": "200709", "actiondrug": "1" }, { "drugcharacterization": "1", "medicinalproduct": "PRAVASTATIN SODIUM (UNKNOWN)", "drugbatchnumb": "UNCONFIRMED", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugdosagetext": "20 MG, UNKNOWN", "drugdosageform": "Unk", "drugadministrationroute": "048", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "610", "drugstartdate": "201211", "drugenddateformat": "610", "drugenddate": "201303", "actiondrug": "1" }, { "drugcharacterization": "2", "medicinalproduct": "ASPIRIN", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugrecurreadministration": "3", "openfda": { "application_number": [ "M013", "M013.50", "part343", "M" ], "brand_name": [ "BAYER GENUINE ASPIRIN", "ASPIRIN", "ENTERIC ASPIRIN", "ADULT LOW DOSE ASPIRIN", "CHEWABLE ASPIRIN", "DRUG MART EFFERVESCENT PAIN RELIEF", "ASPIRIN LOW DOSE", "ASPIRIN ENTERIC COATED", "ASPIRIN 81", "ADULT CHEWABLE ASPIRIN", "ASPIRIN 81MG", "ADULT LOW DOSE ENTERIC COATED ASPIRIN", "ASPIRIN LOW DOSE SAFETY COATED", "GERITREX ASPIRIN", "BUFFERED ASPIRIN", "ENTERIC COATED ASPIRIN", "BUFFERIN REGULAR STRENGTH PAIN RELIEF", "WISPIRIN", "EQUATE ASPIRIN", "LOW DOSE ASPIRIN", "HEB EFFERVESCENT PAIN RELIEF", "PAIN RELIEF ASPIRIN LOW DOSE", "ASPIRIN 81 MG LOW DOSE", "ASPIRIN EXTRA STRENGTH", "BAYER CHEWABLE - ASPIRIN REGIMEN LOW DOSE ASPIRIN CHERRY FLAVORED", "TRAVEL SAVVY ASPIRIN", "CHEWABLE ASPIRIN 81 MG", "TOPCARE ASPIRIN", "RAPIDOL ASPIRIN", "CAREALL ASPIRIN", "ASPIRIN REGULAR STRENGTH", "REGULAR STRENGTH ASPIRIN", "LOW DOSE MINIPRIN ENTERIC SAFETY COATED", "ASPIRIN DELAYED RELEASE", "GOOD NEIGHBOR PHARMACY ASPIRIN", "LEADER ASPIRIN", "CHEWABLE LOW DOSE ASPIRIN", "CIRCLE K ASPIRIN 325", "LOW DOSE ASPIRIN ENTERIC SAFETY COATED", "ASPIRIN 81MG ENTERIC COATED", "CHILDRENS ASPIRIN", "CVS EFFERVESCENT PAIN RELIEVER", "BASIC CARE ASPIRIN", "SIGNATURE SELECT EFFERVESCENT PAIN RELIEF", "TRI-BUFFERED ASPIRIN", "ASPIRIN ENTERIC COATED, REGULAR STRENGTH", "ASPIRIN LOW DOSE CHEWABLE", "ASPIRIN ENTERIC SAFETY COATED", "ASPIRIN 325 MG", "MEDIQUE AT HOME ASPIRIN", "REGULAR STRENGTH ENTERIC COATED ASPIRIN", "DYE-FREE ASPIRIN 81", "PUBLIX FAST RELIEF EFFERVESCENT - ORIGINAL FLAVOR", "BEST CHOICE EFFERVESCENT PAIN RELIEVER 36", "ASPIRIN 81 MG", "BAYER ASPIRIN ORIGINAL, TRAVEL BASIX", "BAYER ASPIRIN ORIGINAL, CVP HEALTH", "BAYER", "QUALITY CHOICE EFFERVESCENT PAIN RELIEF", "ASPI-COR", "UNISHIELD ASPIRIN", "FAMILY WELLNESS PAIN RELIEVER", "ASPIRINA CAPLETS", "ASPIRIN 81MG ENTERIC COATED LOW STRENGTH ASPIRIN REGIMEN", "EQUATE ASPIRIN CHEWABLE", "GOOD SENSE ASPIRIN", "BAYER ASPIRIN REGIMEN ENTERIC COATED", "RUGBY ASPIRIN", "ASPIRIN NSAID", "RIGHT REMEDIES LOW DOSE ASPIRIN 81MG", "ASPIRIN 50 CT", "SUNMARK ASPIRIN", "ASPIRIN PAIN RELIEF", "DIRECT SAFETY ASPIRIN", "ASPIRIN 81MG ENTERIC COATED DELAYED RELEASE", "FIRST AID 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JOSEPH LOW DOSE ASPIRIN", "CARDIASPIRIN PROTECT", "ST. JOSEPH CHEWABLE LOW DOSE ASPIRIN", "MEDIQUE PRODUCTS ASPIRIN", "MEDI-FIRST ASPIRIN", "MEDI-FIRST PLUS ASPIRIN", "EQUALINE EFFERVESCENT PAIN RELIEVER", "ASPIRIN ENTERIC COATED LOW DOSE", "ADULT LOW STRENGTH ASPIRIN", "THOMPSON ASPIRIN", "LOW DOSE ASPIRIUN", "ULINE ASPIRIN" ], "generic_name": [ "ASPIRIN", "ASPIRIN 81 MG", "ASPIRIN 325 MG" ], "manufacturer_name": [ "Unifirst First Aid Corporation", "Health Pharma USA LLC", "Topco Associates, LLC", "Walgreen Company", "CHAIN DRUG MARKETING ASSOCIATION INC", "Advanced Rx LLC", "H E B", "Chain Drug Marketing Association, Inc.", "Discount Drug Mart Inc", "STRATEGIC SOURCING SERVICES LLC", "L.N.K. International, Inc.", "Grocery Outlet", "Rising Pharma Holdings, Inc.", "HARRIS TEETER", "BETTER LIVING BRANDS LLC.", "Bi-Mart", "Trifecta Pharmaceuticals USA LLC", "Marc Glassman, Inc.", "Care One (Retail Business Services, LLC.)", "Geritrex LLC", "Cardinal Health 110, LLC. 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"reportercountry": "BR", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientweight": "85", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Visual acuity reduced", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Intervertebral disc protrusion", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Fall", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Gastrooesophageal reflux disease", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Hypertension", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Local swelling", "reactionoutcome": "6" }, { 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