{ "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-07-30", "results": { "skip": 0, "limit": 10, "total": 66081 } }, "results": [ { "safetyreportversion": "2", "safetyreportid": "10003713", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140611", "fulfillexpeditecriteria": "2", "companynumb": "US-INCYTE CORPORATION-2014IN000100", "duplicate": "1", "reportduplicate": { "duplicatesource": "INCYTE", "duplicatenumb": "US-INCYTE CORPORATION-2014IN000100" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Rash", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "JAKAFI", "drugbatchnumb": "AA5270J", "drugstructuredosagenumb": "5", "drugstructuredosageunit": "003", "drugdosagetext": "5 MG, BID", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20130320", "actiondrug": "1", "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": "AA5271R", "drugstructuredosagenumb": "5", "drugstructuredosageunit": "003", "drugdosagetext": "5 MG, QD", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugenddateformat": "602", "drugenddate": "2014", "actiondrug": "1", "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": "2", "medicinalproduct": "ATORVASTATIN" }, { "drugcharacterization": "2", "medicinalproduct": "APEXICON" }, { "drugcharacterization": "2", "medicinalproduct": "MENEST /00073001/" }, { "drugcharacterization": "2", "medicinalproduct": "VOLTAREN GEL /00372301/" }, { "drugcharacterization": "2", "medicinalproduct": "CIPRODEX /00697202/" }, { "drugcharacterization": "2", "medicinalproduct": "ALEVE", "openfda": { "application_number": [ "NDA020204", "NDA021920" ], "brand_name": [ "ALEVE CAPLETS", "ALEVE CAPLETS SOFT GRIP ARTHRITIS", "ALEVE CAPLETS EASY OPEN ARTHRITIS", "ALEVE GELCAPS", "ALEVE BACK AND MUSCLE PAIN", "ALEVE CAPLETS - 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"drugcharacterization": "2", "medicinalproduct": "ASPIRIN", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "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", "MEDLINE", "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 DIRECT CHEWABLE ASPIRIN", "FOSTER AND THRIVE ASPIRIN", "ENTERIC COATED ASPIRIN REGULAR STRENGTH", "LIL DRUG STORE ASPIRIN 325", "DOLLAR GENERAL EFFERVESCENT PAIN RELIEVER", "ASPIRIN CHEWABLE, LOW DOSE", "ASPIRIN LOW DOSE CHEWABLE ORANGE", "ADULT LOW DOSE PAIN RELIEVER", "ASPIRIN PAIN RELIVER", "DG HEALTH ASPIRIN", "LOW DOSE CHEWABLE ASPIRIN", "ASPIRIN REGIMEN", "GREEN GUARD CHEWABLE ASPIRIN 81 MG", "ECOTRIN REGULAR STRENGTH", "GENCARE-ASPIRIN LOW DOSE PAIN RELIEVER (NSAID)", "ASPIRIN LOW DOSE ENTERIC COATED", "PHYSICIANS CARE ASPIRIN", "ASPIRIN 325", "BAYER LOW DOSE", "MARKET BASKET EFFERVESCENT PAIN RELIEF", "BAYER ASPIRIN REGIMEN CHEWABLE LOW DOSE ASPIRIN ORANGE", "WINCO FOODS EFFERVESCENT PAIN RELIEF", "MEIJER LOW DOSE ASPIRIN", "ASPIRIN LOW STRENGTH", "LOW STRENGTH CHEWABLE ASPIRIN", "MEDIQUE PRODUCTS CHEWABLE LOW DOSE ASPIRIN", "PAIN RELIEF ASPIRIN CHEWABLE, LOW DOSE", "ASPIRIN 81MG ADULT LOW DOSE", "ECOTRIN", "EXTRA STRENGTH ASPIRIN", "LOW DOSE ASPIRIN 81MG", "NOBLEAID PAIN RELIEVER", "COATED ASPIRIN", "TOPCARE EFFERVESCENT PAIN RELIEF", "ASPIRIN 325 MG EC", "XPECT CHEWABLE ASPIRIN", "MCKESSON ASPIRIN", "GOOD SENSE EFFERVESCENT PAIN RELIEF", "MEIJER EFFERVESCENT PAIN RELIEF", "ASPIRIN CHEWABLE", "PAIN RELIEF ASPIRIN", "UP AND UP CHEWABLE ASPIRIN", "REGULAR STRENGTH ASPIRIN 325 MG", "ST. 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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"drugcharacterization": "2", "medicinalproduct": "NORTRIPTYLINE HCL", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": {} }, { "drugcharacterization": "2", "medicinalproduct": "OMEPRAZOLE", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "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", 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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", "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.", "Rite Aid Corporation", "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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"activesubstance": { "activesubstancename": "CEFACLOR" }, "openfda": { "application_number": [ "ANDA065146", "ANDA065058", "ANDA065412" ], "brand_name": [ "CEFACLOR" ], "generic_name": [ "CEFACLOR" ], "manufacturer_name": [ "Carlsbad Technology, Inc.", "Teva Pharmaceuticals USA, Inc.", "Azorian Pharma, LLC" ], "product_ndc": [ "61442-171", "61442-172", "0093-1087", "81948-6250" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CEFACLOR" ], "rxcui": [ "197449", "309045", "309043", "313888" ], "spl_id": [ "3417e20b-604b-3cdd-e063-6394a90ac707", "61ec00e0-d37d-4aa4-8f50-031ee7a37ecc", "a6a7fcf7-b9dc-4dac-b127-418588586a8a" ], "spl_set_id": [ "2f61354e-bcb0-41aa-955f-51eabc11387b", "0878bdc2-0410-4938-9890-96523aa81c2f", "224af904-38f3-4210-a750-e21006db4c66" ], "package_ndc": [ "61442-171-30", "61442-171-01", "61442-171-05", "61442-172-30", "61442-172-01", "61442-172-05", "0093-1087-01", "81948-6250-1" ], "unii": [ "69K7K19H4L" ] } }, { "drugcharacterization": "2", "medicinalproduct": "HYDROCODONE/ACETAMINOPHEN", "drugdosagetext": "UNK", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20091024", "activesubstance": { "activesubstancename": "ACETAMINOPHEN\\HYDROCODONE" } }, { "drugcharacterization": "2", "medicinalproduct": "NAPROXEN SODIUM.", "drugstructuredosagenumb": "550", "drugstructuredosageunit": "003", "drugdosagetext": "550 MG, UNK", "drugindication": "PAIN", "drugstartdateformat": "102", "drugstartdate": "20091022", "activesubstance": { "activesubstancename": "NAPROXEN SODIUM" }, "openfda": { "application_number": [ "ANDA091353", "ANDA075168", "ANDA079096", "ANDA208363", "ANDA075416", "NDA021920", "NDA020204", "ANDA074661", "ANDA205497", "ANDA204872", "ANDA200629", "ANDA074140", "ANDA090545", "NDA020353", "ANDA212199", "ANDA202807", "ANDA214463", "ANDA078314", "ANDA209726", "ANDA078486", "ANDA211065" ], "brand_name": [ "NAPROXEN SODIUM", "LIL DRUG STORE PAIN RELIEF ALL DAY", "ALEVE CAPLETS", "ALEVE CAPLETS SOFT GRIP ARTHRITIS", "ALEVE CAPLETS EASY OPEN ARTHRITIS", "DG HEALTH NAPROXEN SODIUM", "NAPROXEN SODIUM HEADACHE PAIN", "NAPROXEN", "ALL DAY PAIN RELIEF", "TOPCARE ALL DAY PAIN RELIEF", "ALEVE GELCAPS", "ALEVE BACK AND MUSCLE PAIN", "ALL DAY RELIEF", "CAREALL NAPROXEN", "ANADENT", "NAPROXEN BACK AND MUSCLE PAIN", "EQUALINE NAPROXEN SODIUM", "ALEVE CAPLETS - EASY OPEN ARTHRITIS CAP", "UP AND UP NAPROXEN SODIUM", "GOOD SENSE NAPROXEN SODIUM", "BASIC CARE NAPROXEN SODIUM", "FLANAX", "CARE ONE NAPROXEN SODIUM", "BELMORA FLANAX", "NAPRELAN", "ALL DAY BACK AND MUSCLE PAIN RELIEF", "ALEVE HEADACHE PAIN", "ALEVE", "ALEVE EASY OPEN ARTHRITIS", "MEDIQUE MEDIPROXEN", "ALEVE, TRAVEL BASIX", "ANA-DENT PAIN RELIEF", "FLANAX MENSTRUAL PAIN RELIEVER", "CAREALL NAPROXEN SODIUM", "NAPROXEN SODIUM BACK AND MUSCLE PAIN", "KIRKLAND SIGNATURE NAPROXEN SODIUM", "BETR HEADACHE PAIN RELIEF", "CAREONE NAPROXEN SODIUM", "NAPROXEN SODIUM CAPLETS", "FLANAX PAIN RELIEVER/FEVER REDUCER", "DR SIMI ALL DAY PAIN RELIEF", "RUGBY ALL DAY RELIEF", "LEADER ALL DAY PAIN RELIEF", "ALEVE LIQUID GELS", "ALEVE EASY OPEN ARTHRITIS CAP", "PAIN RELIEF", "NAPROXEN SODIUM PM", "EXCHANGE SELECT NAPROXEN SODIUM", "BACK AND MUSCLE PAIN", "FOSTER AND THRIVE ALL DAY PAIN RELIEF", "FIRST AID DIRECT ALL DAY PAIN RELIEF", "NAPROXEN HEADACHE PAIN", "RAPIDOL NAPROXEN", "NAPROXEN SODIUM (NSAID) FEVER REDUCER/ PAIN RELIEVER", "PROXEN NP 660", "NAPROXEN SODIUM HEADACHE PAIN CAPLETS", "NAPROXEN SODIUM BACK AND MUSCLE PAIN CAPLETS", "CALMADOL PAIN RELIEVER", "BERKLEY AND JENSEN NAPROXEN SODIUM", "AMAZON BASIC CARE NAPROXEN SODIUM", "BAYER ALEVE", "TOPCARE BACK AND MUSCLE PAIN", "SIGNATURE CARE NAPROXEN SODIUM", "MEDIQUE AT HOME MEDIPROXEN" ], "generic_name": [ "NAPROXEN SODIUM", "NAPROXEN SODIUM 220MG", "NAPROXEN SODIUM, COATED TABLETS", "NAPROXEN SODIUM TABLET, COATED" ], "manufacturer_name": [ "CVS", "Kroger Company", "Lil' Drug Store Products, Inc.", "TARGET Corporation", "HYVEE INC", 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(DOLLAR GENERAL & REXALL)", "Belmora LLC", "L.N.K. International, Inc.", "United Natural Foods, Inc. dba UNFI", "MEIJER DISTRIBUTION INC", "Target Corporation", "Aurobindo Pharma Limited", "L. Perrigo Company", "Amazon.com Services LLC", "Lidl US LLC", "Care One (Retail Business Services, LLC.)", "American Sales Company", "Athlete's Needs Inc", "CVS Pharmacy", "TARGET CORPORATION", "Upsher-Smith Laboratories, LLC", "Wal-Mart Stores, Inc.", "Publix Super Markets Inc", "Better Living Brands, LLC", "H E B", "ScieGen Pharmaceuticals, Inc.", "Zapotol Products Corp", "Walmart Inc.", "CVS Pharmacy, Inc.", "FSA STORE INC.", "TIME CAP LABORATORIES, INC", "AAA Pharmaceutical, Inc.", "SPIRIT PHARMACEUTICALS,LLC", "Dr.Reddy's Laboratories Limited", "Unifirst First Aid Corporation", "WALMART INC.", "WALGREENS", "Lil' Drug Store Products, Inc", "WALGREEN COMPANY", "Costco Wholesale Company", "Family Dollar Services Inc", "KROGER COMPANY", "CHAIN DRUG MARKETING ASSOCIATION, INC.", "Meijer Distribution Inc", "Live Betr LLC", "MARKSANS PHARMA LIMITED", "DISCOUNT DRUG MART", "Albertsons Companies", "Dr Reddy's Laboratories Inc", "Harris Teeter", "PuraCap Pharmaceutical LLC", "Farmacias De Similares TX LLC", "Productos Zapotol Corp.", "Rugby Laboratories", "Cardinal Health 110, LLC. dba Leader", "SA3, LLC", "Bayer Healthcare LLC", "DISCOUNT DRUG MART, INC.", "Glenmark Pharmaceuticals Inc., USA", "Bi-Mart", "AMERIFOODS TRADING COMPANY", "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)", "BETTER LIVING BRANDS, LLC", "Safeway", "Army & Air Force Exchange Service", "SUPERVALU INC", "Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd", "Alvogen Inc.", "Almatica Pharma LLC", "Walgreens", "Cintas Corporation", "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "Pharmadel LLC", "Amneal Pharmaceuticals of New York LLC", "AMERISOURCE BERGEN", "OPMX LLC", "Dr.Reddy's Laboratories Inc", "Geri-Care Pharmaceutical Corp", "Safeway, Inc", "BETTER LIVING BRANDS LLC.", "GRANDALL DISTRIBUTING, LLC", "BJWC", "Dr. Reddy's Laboratories Inc.", "Gobrands, Inc", "CHAIN DRUG MARKETING ASSOCIATION INC.", "Bayer HealthCare LLC", "Chain Drug Marketing Association", "Care One (American Sales Company)", "AAFES/Your Military Exchanges", "Padagis Israel Pharmaceuticals Ltd", "Camber Consumer Care Inc", "Premier Value Alliance LLC" ], "product_ndc": [ "51316-761", "30142-954", "66715-9740", "11673-748", "42507-844", "0480-0951", "0480-0952", "0480-0953", "21130-748", 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"43598-494-01", "43598-494-05", "43598-494-10", "43598-495-30", "43598-495-01", "43598-495-05", "43598-495-10", "82501-1576-1", "63868-830-20", "0280-0041-01", "0280-0041-02", "0280-0041-04", "0280-0041-03", "0280-0041-05", "63868-465-50", "63868-465-01", "41520-748-80", "41520-748-20", "43598-071-01", "43598-072-01", "43598-073-01", "43598-074-01", "47682-488-50", "62011-0396-1", "55301-748-20", "45802-490-71", "45802-490-78", "45802-490-75", "69230-329-24", "69230-329-50", "69230-329-01", "69230-329-02", "69230-329-05", "69230-329-10", "36800-696-78", "36800-696-75", "72288-368-82", "72288-368-87", "72288-368-78", "72288-368-75", "63868-466-25", "63868-466-50", "63868-466-01", "68016-056-40", "0113-4368-62", "0113-4368-71", "0113-4368-78", "0113-4368-76", "0113-4368-79", "0113-4368-75", "0113-4368-00", "0113-4368-82", "42507-245-01", "42507-245-14", "55910-490-62", "55910-490-71", "55910-490-78", "21130-180-62", "21130-180-71", "21130-180-78", "21130-180-79", "21130-180-75", "47682-737-46", "47682-737-50" ], "unii": [ "9TN87S3A3C", "57Y76R9ATQ", "TC2D6JAD40" ], "nui": [ "N0000000160", "M0001335", "N0000175722" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]" ] } }, { "drugcharacterization": "1", "medicinalproduct": "YAZ", "drugauthorizationnumb": "021676", "drugdosagetext": "UNK", "drugdosageform": "FILM-COATED TABLET", "drugstartdateformat": "602", "drugstartdate": "2008", "drugenddateformat": "602", "drugenddate": "2009", "activesubstance": { "activesubstancename": "DROSPIRENONE\\ETHINYL ESTRADIOL" }, "openfda": { "application_number": [ "NDA021676" ], "brand_name": [ "YAZ" ], "generic_name": [ "DROSPIRENONE AND ETHINYL ESTRADIOL" ], "manufacturer_name": [ "Bayer HealthCare Pharmaceuticals Inc." ], "product_ndc": [ "50419-405" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "630734", "748797", "748798", "748856" ], "spl_id": [ "4f14f9c9-411b-48b0-a3d3-cac639cdfb8b" ], "spl_set_id": [ "065f33e4-b587-4e66-b896-ca9ab7b7c876" ], "package_ndc": [ "50419-405-03" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PROZAC", "drugdosagetext": "UNK", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20091024", "activesubstance": { "activesubstancename": "FLUOXETINE HYDROCHLORIDE" }, "openfda": { "application_number": [ "NDA018936" ], "brand_name": [ "PROZAC" ], "generic_name": [ "FLUOXETINE HYDROCHLORIDE" ], "manufacturer_name": [ "Dista Products Company" ], "product_ndc": [ "0777-3104", "0777-3105", "0777-3107" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "FLUOXETINE HYDROCHLORIDE" ], "rxcui": [ "104849", "205535", "261287", "310384", "310385", "313989" ], "spl_id": [ "e49a90e3-e7da-4377-8736-ebe9f53c3097" ], "spl_set_id": [ "c88f33ed-6dfb-4c5e-bc01-d8e36dd97299" ], "package_ndc": [ "0777-3104-02", "0777-3105-02", "0777-3105-30", "0777-3107-30" ], "unii": [ "I9W7N6B1KJ" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 200910" } } }, { "safetyreportversion": "4", "safetyreportid": "10006361", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150720", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20150130", "fulfillexpeditecriteria": "1", "companynumb": "US-PFIZER INC-2014068387", "duplicate": "1", "reportduplicate": { "duplicatesource": "PFIZER", "duplicatenumb": "US-PFIZER INC-2014068387" }, "primarysource": { "reportercountry": "US", "qualification": "4" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "73", "patientonsetageunit": "801", "patientweight": "54", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Arthritis", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Type 2 diabetes mellitus", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "LIPITOR", "drugauthorizationnumb": "020702", "drugdosageform": "FILM-COATED TABLET", "drugindication": "BLOOD TRIGLYCERIDES INCREASED", "actiondrug": "5", "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "openfda": { "application_number": [ "NDA020702" ], "brand_name": [ "LIPITOR" ], "generic_name": [ "ATORVASTATIN CALCIUM" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-155", "58151-156", "58151-157", "58151-158" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATORVASTATIN CALCIUM TRIHYDRATE" ], "rxcui": [ "259255", "262095", "617310", "617311", "617312", "617314", "617318", "617320" ], "spl_id": [ "dd011a82-7356-4b83-86c4-b21cd9138fc6" ], "spl_set_id": [ "a60cc18b-0631-4cf0-b021-9f52224ece65" ], "package_ndc": [ "58151-155-77", "58151-156-77", "58151-157-77", "58151-158-77" ], "unii": [ "48A5M73Z4Q" ] } }, { "drugcharacterization": "1", "medicinalproduct": "LIPITOR", "drugauthorizationnumb": "020702", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "20 MG, 1X/DAY", "drugdosageform": "FILM-COATED TABLET", "drugadministrationroute": "048", "drugindication": "LOW DENSITY LIPOPROTEIN INCREASED", "drugstartdateformat": "610", "drugstartdate": "200801", "drugenddateformat": "602", "drugenddate": "2013", "actiondrug": "5", "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "openfda": { "application_number": [ "NDA020702" ], "brand_name": [ "LIPITOR" ], "generic_name": [ "ATORVASTATIN CALCIUM" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-155", "58151-156", "58151-157", "58151-158" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATORVASTATIN CALCIUM TRIHYDRATE" ], "rxcui": [ "259255", "262095", "617310", "617311", "617312", "617314", "617318", "617320" ], "spl_id": [ "dd011a82-7356-4b83-86c4-b21cd9138fc6" ], "spl_set_id": [ "a60cc18b-0631-4cf0-b021-9f52224ece65" ], "package_ndc": [ "58151-155-77", "58151-156-77", "58151-157-77", "58151-158-77" ], "unii": [ "48A5M73Z4Q" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ALEVE", "drugdosagetext": "UNK, FOUR PILLS A WEEK AS NEEDED", "drugindication": "BACK PAIN", "drugstartdateformat": "602", "drugstartdate": "1999", "activesubstance": { "activesubstancename": "NAPROXEN SODIUM" }, "openfda": { "application_number": [ "NDA020204", "NDA021920" ], "brand_name": [ "ALEVE CAPLETS", "ALEVE CAPLETS SOFT GRIP ARTHRITIS", "ALEVE CAPLETS EASY OPEN ARTHRITIS", "ALEVE GELCAPS", 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[ "ATORVASTATIN CALCIUM" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-155", "58151-156", "58151-157", "58151-158" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATORVASTATIN CALCIUM TRIHYDRATE" ], "rxcui": [ "259255", "262095", "617310", "617311", "617312", "617314", "617318", "617320" ], "spl_id": [ "dd011a82-7356-4b83-86c4-b21cd9138fc6" ], "spl_set_id": [ "a60cc18b-0631-4cf0-b021-9f52224ece65" ], "package_ndc": [ "58151-155-77", "58151-156-77", "58151-157-77", "58151-158-77" ], "unii": [ "48A5M73Z4Q" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LEVOTHROID", "drugstructuredosagenumb": "100", "drugstructuredosageunit": "004", "drugdosagetext": "100 UG, UNK", "drugindication": "THYROID DISORDER", "drugstartdateformat": "602", "drugstartdate": "2009", "drugenddateformat": "602", "drugenddate": "2014", "activesubstance": { "activesubstancename": "LEVOTHYROXINE SODIUM" } }, { "drugcharacterization": "1", "medicinalproduct": "LIPITOR", "drugauthorizationnumb": "020702", "drugdosageform": "FILM-COATED TABLET", "drugindication": "BLOOD CHOLESTEROL INCREASED", "actiondrug": "5", "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "openfda": { "application_number": [ "NDA020702" ], "brand_name": [ "LIPITOR" ], "generic_name": [ "ATORVASTATIN CALCIUM" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-155", "58151-156", "58151-157", "58151-158" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATORVASTATIN CALCIUM TRIHYDRATE" ], "rxcui": [ "259255", "262095", "617310", "617311", "617312", "617314", "617318", "617320" ], "spl_id": [ "dd011a82-7356-4b83-86c4-b21cd9138fc6" ], "spl_set_id": [ "a60cc18b-0631-4cf0-b021-9f52224ece65" ], "package_ndc": [ "58151-155-77", "58151-156-77", "58151-157-77", "58151-158-77" ], "unii": [ "48A5M73Z4Q" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 2010" } } }, { "safetyreportversion": "5", "safetyreportid": "10006507", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20140722", "fulfillexpeditecriteria": "1", "companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-20351722", "duplicate": "1", "reportduplicate": { "duplicatesource": "BRISTOL MYERS SQUIBB", "duplicatenumb": "US-BRISTOL-MYERS SQUIBB COMPANY-20351722" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "60", "patientonsetageunit": "801", "patientweight": "119.2", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": 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"bb6533e5-e6a9-488c-b8ab-a6a06e87ede9", "015a6179-bacb-452d-b594-4de628ddc11d", "dd87e342-b0cb-4111-9f15-415dbcda4b77", "1b164780-ec84-4187-8afa-6f8a0da550fc" ], "package_ndc": [ "50580-566-25", "50580-495-01", "50580-458-11", "50580-458-50", "50580-458-10", "50580-496-60", "50580-496-98", "50580-475-11", "50580-475-50", "50580-475-10", "50580-451-03", "50580-451-10", "50580-451-50", "50580-451-70", "50580-590-01", "50580-590-02", "50580-590-03", "50580-590-04", "50580-590-05", "50580-590-06", "50580-692-01", "50580-692-02", "50580-692-03", "50580-488-10", "50580-488-24", "50580-488-25", "50580-488-28", "50580-488-01", "50580-488-52", "50580-488-02", "50580-488-50", "50580-488-22" ], "nui": [ "N0000193956", "N0000008867", "N0000009560" ], "pharm_class_epc": [ "Expectorant [EPC]" ], "pharm_class_pe": [ "Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]" ], "unii": [ "362O9ITL9D", "495W7451VQ", "04JA59TNSJ" ] } }, { "drugcharacterization": "1", "medicinalproduct": "IPILIMUMAB", "drugstructuredosagenumb": "3", "drugstructuredosageunit": "007", "drugdosagetext": "INTERRUPTED ON 04FEB2014", "drugdosageform": "INJECTION", "drugadministrationroute": "042", "drugindication": "METASTATIC MALIGNANT MELANOMA", "drugstartdateformat": "102", "drugstartdate": "20131203", "actiondrug": "1", "activesubstance": { "activesubstancename": "IPILIMUMAB" }, "openfda": { "application_number": [ "BLA125377" ], "brand_name": [ "YERVOY" ], "generic_name": [ "IPILIMUMAB" ], "manufacturer_name": [ "E.R. Squibb & Sons, L.L.C." ], "product_ndc": [ "0003-2327", "0003-2328" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "IPILIMUMAB" ], "spl_id": [ "2326eaab-757e-4696-bc53-a0653148f0c3" ], "spl_set_id": [ "2265ef30-253e-11df-8a39-0800200c9a66" ], "package_ndc": [ "0003-2327-11", "0003-2328-22" ], "nui": [ "N0000182635", "N0000182634", "N0000182157" ], "pharm_class_epc": [ "CTLA-4-directed Blocking Antibody [EPC]" ], "pharm_class_moa": [ "CTLA-4-directed Antibody Interactions [MoA]" ], "pharm_class_pe": [ "Increased T Lymphocyte Activation [PE]" ], "unii": [ "6T8C155666" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140224" } } }, { "safetyreportversion": "9", "safetyreportid": "10006547", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20190204", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20181228", "fulfillexpeditecriteria": "1", "companynumb": "US-BAYER-2014-035909", "duplicate": "1", "reportduplicate": { "duplicatesource": "BAYER", "duplicatenumb": "US-BAYER-2014-035909" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "36", "patientonsetageunit": "801", "patientagegroup": "5", "patientweight": "90.7", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Weight decreased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Dizziness", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Tachycardia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Dysmenorrhoea", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Vaginal haemorrhage", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Genital haemorrhage", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Pelvic pain", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Menorrhagia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Immunodeficiency", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Autoimmune disorder", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Abdominal pain", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Fatigue", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Depression", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Device monitoring procedure not performed", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Ectopic pregnancy with contraceptive device", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Cardio-respiratory arrest", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Haemorrhage in pregnancy", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Nausea", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Patient-device incompatibility", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Migraine", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Device dislocation", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Medical device monitoring error", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Weight increased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Palpitations", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Foreign body in reproductive tract", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Ruptured ectopic pregnancy", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Subcutaneous abscess", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Abdominal pain lower", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "FAMOTIDINE.", "drugadministrationroute": "048", "drugindication": "GASTRITIS", "activesubstance": { "activesubstancename": "FAMOTIDINE" }, "openfda": { 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[ "INTRAMUSCULAR", "SUBCUTANEOUS", "NASAL" ], "substance_name": [ "CYANOCOBALAMIN" ], "rxcui": [ "309594", "861113", "861115" ], "spl_id": [ "a10756d3-74a9-4adf-9d2a-0bbac8ad941b", "6ac6e28b-b969-4b66-bc1e-cca8a2cb66f3", "a0566c8d-7cb0-4ee7-8599-f2e8dc8992c7", "4dd615b9-bf7c-f227-e063-6294a90acc91", "fab6a2d8-d9a0-2f8f-e053-6394a90a22bc", "7c3b0e85-bd17-4998-aaf4-1a873a357ab4", "44f5a26b-5965-9a7b-e063-6294a90a682a", "8a611106-589f-4896-baa7-653137dc27ab", "4cf650d9-6d6c-4112-88f2-cd2e94f1f416", "58925d4c-edff-43c6-9c9b-07102e84e41f", "b2ee60e7-c10a-45e1-81e8-28d6838161eb", "4291e3b9-37cb-4aa8-ac03-992725a41c1d", "51b65719-bc88-6e2d-e063-6294a90af60a", "28421ba1-7e37-429c-9c66-62cc36f5847c", "510f352d-5de9-48cb-9c96-71b08f089995", "bdfaf6c3-67ca-4323-a93e-72eba47805d9", "bb7b94e1-b5cd-486f-9e34-38fc9595547a", "771cf601-8f92-4e4f-a29f-b18e71b1ba96", "45724f81-e7a3-88cf-e063-6294a90ade9c", "5a299d3b-fc7a-44a0-a9bc-fbcd7eb83e19", "088857ed-e065-4c6e-aa7e-b2bfc072c130", 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"064c6841-3ed2-417f-a77c-a730785b6036", "b1e35c97-2157-454e-967f-53a4300827de", "ccf5b124-083d-4465-a666-c1bc6e84d630", "8b1cdee5-3368-40e4-90bf-31a64df1f38a", "ef300a08-8212-40a9-847a-1b62348896dd", "acff4ff3-4435-4995-a117-dbfcdf72334a", "7e10c47d-1036-47c1-a0ed-6929636366c2" ], "package_ndc": [ "70069-005-01", "70069-005-10", "70069-172-01", "70069-172-10", "70069-172-25", "70710-1663-1", "70710-1663-7", "70710-1664-1", "70710-1664-6", "70710-1664-7", "70710-1665-1", "70710-1665-5", "55150-364-01", "55150-364-10", "55150-364-25", "87188-111-01", "87188-111-90", "87188-112-01", "87188-113-01", "68001-542-59", "68001-542-60", "69680-112-01", "69680-112-25", "69680-112-10", "69680-113-10", "69680-113-99", "69680-121-05", "69680-121-30", "69680-121-10", "68001-640-59", "68001-640-60", "71288-303-91", "71288-303-92", "45802-491-84", "0143-9621-01", "0143-9621-25", "0143-9620-01", "0143-9620-10", "0143-9619-01", "0143-9619-10", "71288-300-01", "71288-300-02", "71288-301-10", "71288-301-11", "71288-302-30", "49884-270-82", "49884-270-52", "85551-120-30", "0517-0031-01", "0517-0031-25", "0517-0032-01", "0517-0032-25", "0517-0130-01", "70069-171-05", "70069-171-10", "72603-650-01", "72603-650-25", "43386-237-70", "43386-237-60", "68083-449-25", "68083-561-25", "68083-562-01", "70512-840-01", "70512-840-25", "71288-300-91", "71288-300-92", "70756-635-10", "70756-635-25", "70756-636-25", "70756-636-10", "70756-637-05", "70756-637-88", "70756-637-10", "71288-303-01", "71288-303-02", "63323-044-41", "63323-044-44", "70771-1688-1", "70771-1688-7", "70771-1689-1", "70771-1689-6", "70771-1689-7", "70771-1690-1", "70771-1690-5", "63323-044-00", "63323-044-01", "25021-502-01" ], "nui": [ "M0022794", "N0000175951" ], "pharm_class_cs": [ "Vitamin B 12 [CS]" ], "pharm_class_epc": [ "Vitamin B12 [EPC]" ], "unii": [ "P6YC3EG204" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 201203" } } }, { "safetyreportversion": "1", "safetyreportid": "10006721", 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"generic_name": [ "VALACYCLOVIR HYDROCHLORIDE" ], "manufacturer_name": [ "GlaxoSmithKline LLC" ], "product_ndc": [ "0173-0565", "0173-0933" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "VALACYCLOVIR HYDROCHLORIDE" ], "rxcui": [ "108780", "212448", "313564", "313565" ], "spl_id": [ "861c5801-9c12-4a6b-9bf4-aacb183a58b0" ], "spl_set_id": [ "f8e0d8f8-cb73-4206-a484-88f5c4fbd719" ], "package_ndc": [ "0173-0933-08", "0173-0933-10", "0173-0565-04", "0173-0565-10" ], "unii": [ "G447S0T1VC" ] } }, { "drugcharacterization": "1", "medicinalproduct": "ALEVE", "drugdosagetext": "UNK", "actiondrug": "5", "openfda": { "application_number": [ "NDA020204", "NDA021920" ], "brand_name": [ "ALEVE CAPLETS", "ALEVE CAPLETS SOFT GRIP ARTHRITIS", "ALEVE CAPLETS EASY OPEN ARTHRITIS", "ALEVE GELCAPS", "ALEVE BACK AND MUSCLE PAIN", "ALEVE CAPLETS - EASY OPEN ARTHRITIS CAP", "ALEVE HEADACHE PAIN", "ALEVE", "ALEVE EASY OPEN ARTHRITIS", "ALEVE EASY OPEN ARTHRITIS CAP" ], "generic_name": [ "NAPROXEN SODIUM", "NAPROXEN SODIUM TABLET" ], "manufacturer_name": [ "Bayer HealthCare LLC.", "Lil' Drug Store Products, Inc" ], "product_ndc": [ "0280-0114", "0280-0115", "0280-0130", "0280-6020", "0280-0111", "0280-6050", "0280-6070", "0280-0112", "0280-6010", "0280-0113", "0280-0131", "66715-6402", "66715-9702", "66715-6502", "66715-6411", "0280-8252", "0280-6080", "66715-5103", "0280-6091", "0280-6060", "0280-6000" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "NAPROXEN SODIUM" ], "rxcui": [ "849574", "849728", "1112231", "1112233" ], "spl_id": [ "4cd9cec2-0e06-99a3-e063-6394a90a1943", "4526be49-a72d-1db7-e063-6394a90a1937", "31bae77b-42dc-94eb-e063-6294a90ad570", "3271583e-5034-ed79-e063-6294a90a0b0e", "4526b744-fa19-0f7b-e063-6394a90a916e", "31baf777-c806-21ea-e063-6394a90abbd8", "4526b265-424f-3e71-e063-6294a90a21a8", "31bad2d9-c0ba-7f20-e063-6294a90acb17", "2b10873f-6944-0eaf-e063-6294a90a7041", 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"0280-0114-03", "0280-0114-04", "0280-0114-05", "0280-0114-08", "0280-6020-20", "0280-6020-40", "0280-6020-80", "0280-6020-16", "0280-6020-02", "0280-0111-01", "0280-0111-02", "0280-0111-03", "0280-0111-04", "0280-0111-05", "0280-0111-06", "0280-0111-07", "0280-6050-50", "0280-6050-01", "0280-6050-27", "0280-6050-02", "0280-6050-03", "0280-6050-04", "0280-6050-06", "0280-6050-05", "0280-6070-40", "0280-0112-01", "0280-0112-02", "0280-0112-03", "0280-0112-04", "0280-6010-24", "0280-6010-50", "0280-6010-01", "0280-6010-02", "0280-6010-03", "0280-6010-04", "0280-6010-06", "0280-6010-05", "0280-6010-07", "0280-6010-09", "0280-6010-10", "0280-0113-01", "0280-0113-02", "0280-0113-03", "0280-0113-04", "0280-0113-05", "0280-0113-06", "0280-0131-01", "66715-6402-8", "66715-9702-1", "66715-9702-2", "66715-9702-3", "66715-9702-0", "66715-6502-2", "66715-6411-2", "0280-8252-24", "0280-8252-10", "0280-6080-20", "0280-6080-40", "0280-6080-80", "0280-6080-16", "0280-6080-01", "0280-6080-02", "0280-6080-03", "0280-6080-04", "66715-5103-0", "0280-6091-80", "0280-6060-20", "0280-6060-25", "0280-6060-32", "0280-6000-06", "0280-6000-24", "0280-6000-50", "0280-6000-10", "0280-6000-15", "0280-6000-02", "0280-6000-27", "0280-6000-32", "0280-6000-70", "0280-6000-75", "0280-6000-01", "0280-6000-03", "0280-6000-04", "0280-6000-05", "0280-6000-07", "0280-6000-08", "0280-6000-12", "0280-6000-09", "0280-6000-16" ], "unii": [ "9TN87S3A3C" ] } }, { "drugcharacterization": "1", "medicinalproduct": "DISALCID", "drugdosagetext": "UNK", "actiondrug": "5" }, { "drugcharacterization": "1", "medicinalproduct": "CYMBALTA", "drugdosagetext": "UNK", "actiondrug": "5", "openfda": { "application_number": [ "NDA021427" ], "brand_name": [ "CYMBALTA" ], "generic_name": [ "DULOXETINE HYDROCHLORIDE" ], "manufacturer_name": [ "Eli Lilly and Company" ], "product_ndc": [ "0002-3235", "0002-3240", "0002-3270" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DULOXETINE HYDROCHLORIDE" ], "rxcui": [ "596926", "596928", "596930", "596932", "596934", "615186" ], "spl_id": [ "aa5061b1-f237-425a-9d05-575c333dfd37" ], "spl_set_id": [ "2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba" ], "package_ndc": [ "0002-3235-60", "0002-3240-30", "0002-3240-90", "0002-3270-30" ], "unii": [ "9044SC542W" ] } }, { "drugcharacterization": "1", "medicinalproduct": "MOTRIN", "drugdosagetext": "UNK", "actiondrug": "5", "openfda": { "application_number": [ "NDA020603", "ANDA079113" ], "brand_name": [ "MOTRIN INFANTS", "MOTRIN PM" ], "generic_name": [ "IBUPROFEN", "IBUPROFEN AND DIPHENHYDRAMINE CITRATE" ], "manufacturer_name": [ "Kenvue Brands LLC" ], "product_ndc": [ "50580-198", "50580-563" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "IBUPROFEN", "DIPHENHYDRAMINE CITRATE" ], "rxcui": [ "204442", "854762", "895664", "895666" ], "spl_id": [ "519a1a5f-e816-0d56-e063-6294a90a337d", "39a34ab2-9fae-444e-e063-6294a90a9152" ], "spl_set_id": [ "c57f6ded-c0bd-45ae-823a-4c02ce334d98", "55403f19-58ae-450b-8a7b-0bc544088f20" ], "package_ndc": [ "50580-198-50", "50580-198-51", "50580-198-52", "50580-198-05", "50580-563-20", "50580-563-40", "50580-563-80" ], "nui": [ "N0000000160", "M0001335", "N0000175722" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]" ], "unii": [ "WK2XYI10QM", "4OD433S209" ] } } ] } }, { "safetyreportversion": "3", "safetyreportid": "10008436", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150528", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20141105", "fulfillexpeditecriteria": "1", "companynumb": "US-BAYER-2014-035990", "duplicate": "1", "reportduplicate": { "duplicatesource": "BAYER", "duplicatenumb": "US-BAYER-2014-035990" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "52", "patientonsetageunit": "801", "patientagegroup": "5", "patientweight": "90.7", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Incorrect drug administration duration", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Gastrointestinal haemorrhage", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Gastric ulcer", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Duodenal ulcer", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "TAMSULOSIN", "activesubstance": { "activesubstancename": "TAMSULOSIN" } }, { "drugcharacterization": "1", "medicinalproduct": "ALEVE", "drugauthorizationnumb": "020204", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "032", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "1 DF, BID", "drugdosageform": "FILM-COATED TABLET", "drugadministrationroute": "048", "drugindication": "MUSCULOSKELETAL PAIN", "drugstartdateformat": "602", "drugstartdate": "2013", "drugenddateformat": "610", "drugenddate": "201309", "actiondrug": "1", "activesubstance": { "activesubstancename": "NAPROXEN SODIUM" }, "openfda": { "application_number": [ "NDA020204", "NDA021920" ], "brand_name": [ "ALEVE CAPLETS", "ALEVE CAPLETS SOFT GRIP ARTHRITIS", "ALEVE CAPLETS EASY OPEN ARTHRITIS", "ALEVE GELCAPS", "ALEVE BACK AND MUSCLE PAIN", "ALEVE CAPLETS - EASY OPEN ARTHRITIS CAP", "ALEVE HEADACHE PAIN", "ALEVE", "ALEVE EASY OPEN ARTHRITIS", "ALEVE EASY OPEN ARTHRITIS CAP" ], "generic_name": [ "NAPROXEN SODIUM", "NAPROXEN SODIUM TABLET" ], "manufacturer_name": [ "Bayer HealthCare LLC.", "Lil' Drug Store Products, Inc" ], "product_ndc": [ "0280-0114", "0280-0115", "0280-0130", "0280-6020", "0280-0111", "0280-6050", "0280-6070", "0280-0112", "0280-6010", "0280-0113", "0280-0131", "66715-6402", "66715-9702", "66715-6502", "66715-6411", "0280-8252", "0280-6080", "66715-5103", "0280-6091", "0280-6060", "0280-6000" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "NAPROXEN SODIUM" ], "rxcui": [ "849574", "849728", "1112231", "1112233" ], "spl_id": [ "4cd9cec2-0e06-99a3-e063-6394a90a1943", "4526be49-a72d-1db7-e063-6394a90a1937", "31bae77b-42dc-94eb-e063-6294a90ad570", "3271583e-5034-ed79-e063-6294a90a0b0e", "4526b744-fa19-0f7b-e063-6394a90a916e", "31baf777-c806-21ea-e063-6394a90abbd8", "4526b265-424f-3e71-e063-6294a90a21a8", "31bad2d9-c0ba-7f20-e063-6294a90acb17", "2b10873f-6944-0eaf-e063-6294a90a7041", "3ba28e47-1293-bec7-e063-6294a90ac80a", "4526c253-b571-1d84-e063-6394a90ae3f9", "ef307cfd-6227-37cc-e053-2995a90aeba8", "4526c253-b572-1d84-e063-6394a90ae3f9", "4526be49-a72f-1db7-e063-6394a90a1937", "4526b744-fa15-0f7b-e063-6394a90a916e" ], "spl_set_id": [ "02941928-128a-2c88-e063-6294a90ac6ba", "0ad8bbb9-dd5f-4273-b085-ee3e5ed22613", "31bae77b-42dd-94eb-e063-6294a90ad570", "94f09ef7-0695-4499-83c1-95f1e42baf98", "acea54a2-5a92-428e-a778-bb4f9d676782", "31baf777-c805-21ea-e063-6394a90abbd8", "00ef5b30-71d0-4cb4-84a3-48c67d1cea2a", "31bad2d9-c0bb-7f20-e063-6294a90acb17", "abfcf13e-6eba-49e2-8ebf-459348714270", "3ba28e47-1294-bec7-e063-6294a90ac80a", "1266393e-b55e-4e34-9710-0b87209f4158", "d82586b5-c2ee-3f56-e053-2a95a90a42c4", "3b5442c6-c6e1-4df3-8cec-40bbb4ec469f", "3c0ddd25-5a9a-4628-a971-65fe2a9775b5", "a3745850-3e32-4884-b315-161bcb9996ed" ], "package_ndc": [ "0280-0115-02", "0280-0115-01", "0280-0115-03", "0280-0130-02", "0280-0130-01", "0280-0114-01", "0280-0114-02", "0280-0114-03", "0280-0114-04", "0280-0114-05", "0280-0114-08", "0280-6020-20", "0280-6020-40", "0280-6020-80", "0280-6020-16", "0280-6020-02", "0280-0111-01", "0280-0111-02", "0280-0111-03", "0280-0111-04", "0280-0111-05", "0280-0111-06", "0280-0111-07", "0280-6050-50", "0280-6050-01", "0280-6050-27", "0280-6050-02", "0280-6050-03", "0280-6050-04", "0280-6050-06", "0280-6050-05", "0280-6070-40", "0280-0112-01", "0280-0112-02", "0280-0112-03", "0280-0112-04", "0280-6010-24", "0280-6010-50", "0280-6010-01", "0280-6010-02", "0280-6010-03", "0280-6010-04", "0280-6010-06", "0280-6010-05", "0280-6010-07", "0280-6010-09", "0280-6010-10", "0280-0113-01", "0280-0113-02", "0280-0113-03", "0280-0113-04", "0280-0113-05", "0280-0113-06", "0280-0131-01", "66715-6402-8", "66715-9702-1", "66715-9702-2", "66715-9702-3", "66715-9702-0", "66715-6502-2", "66715-6411-2", "0280-8252-24", "0280-8252-10", "0280-6080-20", "0280-6080-40", "0280-6080-80", "0280-6080-16", "0280-6080-01", "0280-6080-02", "0280-6080-03", "0280-6080-04", "66715-5103-0", "0280-6091-80", "0280-6060-20", "0280-6060-25", "0280-6060-32", "0280-6000-06", "0280-6000-24", "0280-6000-50", "0280-6000-10", "0280-6000-15", "0280-6000-02", "0280-6000-27", "0280-6000-32", "0280-6000-70", "0280-6000-75", "0280-6000-01", "0280-6000-03", "0280-6000-04", "0280-6000-05", "0280-6000-07", "0280-6000-08", "0280-6000-12", "0280-6000-09", "0280-6000-16" ], "unii": [ "9TN87S3A3C" ] } }, { "drugcharacterization": "1", "medicinalproduct": "ALEVE", "drugauthorizationnumb": "020204", "drugdosageform": "FILM-COATED TABLET", "drugindication": "BACK PAIN", "actiondrug": "1", "activesubstance": { "activesubstancename": "NAPROXEN SODIUM" }, "openfda": { "application_number": [ "NDA020204", "NDA021920" ], "brand_name": [ "ALEVE CAPLETS", "ALEVE CAPLETS SOFT GRIP ARTHRITIS", "ALEVE CAPLETS EASY OPEN ARTHRITIS", "ALEVE GELCAPS", "ALEVE BACK AND MUSCLE PAIN", "ALEVE CAPLETS - EASY OPEN ARTHRITIS CAP", "ALEVE HEADACHE PAIN", "ALEVE", "ALEVE EASY OPEN ARTHRITIS", "ALEVE EASY OPEN ARTHRITIS CAP" ], "generic_name": [ "NAPROXEN SODIUM", "NAPROXEN SODIUM TABLET" ], "manufacturer_name": [ "Bayer HealthCare LLC.", "Lil' Drug Store Products, Inc" ], "product_ndc": [ "0280-0114", "0280-0115", "0280-0130", "0280-6020", "0280-0111", "0280-6050", "0280-6070", "0280-0112", "0280-6010", "0280-0113", "0280-0131", "66715-6402", "66715-9702", "66715-6502", "66715-6411", "0280-8252", "0280-6080", "66715-5103", "0280-6091", "0280-6060", "0280-6000" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "NAPROXEN SODIUM" ], "rxcui": [ "849574", "849728", "1112231", "1112233" ], "spl_id": [ "4cd9cec2-0e06-99a3-e063-6394a90a1943", "4526be49-a72d-1db7-e063-6394a90a1937", "31bae77b-42dc-94eb-e063-6294a90ad570", "3271583e-5034-ed79-e063-6294a90a0b0e", "4526b744-fa19-0f7b-e063-6394a90a916e", "31baf777-c806-21ea-e063-6394a90abbd8", "4526b265-424f-3e71-e063-6294a90a21a8", "31bad2d9-c0ba-7f20-e063-6294a90acb17", "2b10873f-6944-0eaf-e063-6294a90a7041", "3ba28e47-1293-bec7-e063-6294a90ac80a", "4526c253-b571-1d84-e063-6394a90ae3f9", "ef307cfd-6227-37cc-e053-2995a90aeba8", "4526c253-b572-1d84-e063-6394a90ae3f9", "4526be49-a72f-1db7-e063-6394a90a1937", "4526b744-fa15-0f7b-e063-6394a90a916e" ], "spl_set_id": [ "02941928-128a-2c88-e063-6294a90ac6ba", "0ad8bbb9-dd5f-4273-b085-ee3e5ed22613", "31bae77b-42dd-94eb-e063-6294a90ad570", "94f09ef7-0695-4499-83c1-95f1e42baf98", "acea54a2-5a92-428e-a778-bb4f9d676782", "31baf777-c805-21ea-e063-6394a90abbd8", "00ef5b30-71d0-4cb4-84a3-48c67d1cea2a", "31bad2d9-c0bb-7f20-e063-6294a90acb17", "abfcf13e-6eba-49e2-8ebf-459348714270", "3ba28e47-1294-bec7-e063-6294a90ac80a", "1266393e-b55e-4e34-9710-0b87209f4158", "d82586b5-c2ee-3f56-e053-2a95a90a42c4", "3b5442c6-c6e1-4df3-8cec-40bbb4ec469f", "3c0ddd25-5a9a-4628-a971-65fe2a9775b5", "a3745850-3e32-4884-b315-161bcb9996ed" ], "package_ndc": [ "0280-0115-02", "0280-0115-01", "0280-0115-03", "0280-0130-02", "0280-0130-01", "0280-0114-01", "0280-0114-02", "0280-0114-03", "0280-0114-04", "0280-0114-05", "0280-0114-08", "0280-6020-20", "0280-6020-40", "0280-6020-80", "0280-6020-16", "0280-6020-02", "0280-0111-01", "0280-0111-02", "0280-0111-03", "0280-0111-04", "0280-0111-05", "0280-0111-06", "0280-0111-07", "0280-6050-50", "0280-6050-01", "0280-6050-27", "0280-6050-02", "0280-6050-03", "0280-6050-04", "0280-6050-06", "0280-6050-05", "0280-6070-40", "0280-0112-01", "0280-0112-02", "0280-0112-03", "0280-0112-04", "0280-6010-24", "0280-6010-50", "0280-6010-01", "0280-6010-02", "0280-6010-03", "0280-6010-04", "0280-6010-06", "0280-6010-05", "0280-6010-07", "0280-6010-09", "0280-6010-10", "0280-0113-01", "0280-0113-02", "0280-0113-03", "0280-0113-04", "0280-0113-05", "0280-0113-06", "0280-0131-01", "66715-6402-8", "66715-9702-1", "66715-9702-2", "66715-9702-3", "66715-9702-0", "66715-6502-2", "66715-6411-2", "0280-8252-24", "0280-8252-10", "0280-6080-20", "0280-6080-40", "0280-6080-80", "0280-6080-16", "0280-6080-01", "0280-6080-02", "0280-6080-03", "0280-6080-04", "66715-5103-0", "0280-6091-80", "0280-6060-20", "0280-6060-25", "0280-6060-32", "0280-6000-06", "0280-6000-24", "0280-6000-50", "0280-6000-10", "0280-6000-15", "0280-6000-02", "0280-6000-27", "0280-6000-32", "0280-6000-70", "0280-6000-75", "0280-6000-01", "0280-6000-03", "0280-6000-04", "0280-6000-05", "0280-6000-07", "0280-6000-08", "0280-6000-12", "0280-6000-09", "0280-6000-16" ], "unii": [ "9TN87S3A3C" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LEVOTHYROXINE", "activesubstance": { "activesubstancename": "LEVOTHYROXINE" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 2013" } } } ] }