{ "summary": { "safetyreportid": "10478410", "receivedate": "20140926", "serious": "1", "seriousnessdeath": null, "age": null, "sex": null, "drugs": [ "IBUPROFEN.", "SODIUM CHLORITE", "IBUPROFEN." ], "reactions": [ "Sepsis", "Burn of internal organs", "Suicide attempt", "Renal failure acute", "Bronchopneumonia", "Disseminated intravascular coagulation", "Hypotension", "Intentional overdose" ], "source_url": "/docs/faers/10478410.html" }, "raw": { "safetyreportversion": "1", "safetyreportid": "10478410", "primarysourcecountry": "SK", "occurcountry": "SK", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "1", "serious": "1", "seriousnesslifethreatening": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140926", "receiptdateformat": "102", "receiptdate": "20140926", "fulfillexpeditecriteria": "1", "companynumb": "SK-MYLANLABS-2014M1005303", "duplicate": "1", "reportduplicate": { "duplicatesource": "MYLAN", "duplicatenumb": "SK-MYLANLABS-2014M1005303" }, "primarysource": { "reportercountry": "SK", "qualification": "3", "literaturereference": "GEBHARDTOVA A, VAVRINEC P, VAVRINCOVA-YAGHI D, SEELEN M, DOBISOVA A, FLASSIKOVA Z, ET AL. A CASE OF SEVERE CHLORITE POISONING SUCCESSFULLY TREATED WITH EARLY ADMINISTRATION OF METHYLENE BLUE, RENAL REPLACEMENT THERAPY, AND RED BLOOD CELL TRANSFUSION: CASE REPORT. MEDICINE 2014; 93(9) E60" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Sepsis", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Burn of internal organs", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Suicide attempt", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Renal failure acute", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Bronchopneumonia", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Disseminated intravascular coagulation", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Hypotension", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Intentional overdose", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Haemolytic anaemia", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Methaemoglobinaemia", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "IBUPROFEN.", "drugauthorizationnumb": "070045", "drugindication": "OFF LABEL USE", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "IBUPROFEN" }, "openfda": { "application_number": [ "ANDA078682", "ANDA077349", "505G(a)(3)", "ANDA079174", "ANDA074937", "ANDA210602", "ANDA202312", "ANDA075217", "ANDA091355", "ANDA075010", "ANDA076359", "ANDA209179", "ANDA210755", "NDA020944", "ANDA091239", "ANDA075682", "NDA020589", "ANDA202413", "ANDA091237", "NDA020516", "ANDA210149", "ANDA072096", "ANDA207095", "ANDA220239", "ANDA206568", "ANDA217261", "ANDA204469", "ANDA207753", "ANDA079233", "ANDA079205", "ANDA206999", "ANDA075139", "NDA020402", 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"50844-353-16", "0363-0438-32", "0363-0438-98", "0363-0438-99", "0363-0438-12", "0363-0438-15", "55910-399-23", "55910-399-80", "55910-399-12", "55910-399-20" ], "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" ] } }, { "drugcharacterization": "1", "medicinalproduct": "SODIUM CHLORITE", "drugdosagetext": "ABOUT 100ML OF 28%", "drugadministrationroute": "048", "drugindication": "OVERDOSE", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "SODIUM CHLORITE" }, "openfda": { "brand_name": [ "PURE O2STICK", "V DOCTOR PURE CHLORINE DIOXIDE", "EASYSTICK", "DEFENDER SIGNATURE", "DOCTOR GUARDSTICK", "ISTICK", "DEFENDERSTICK", "D.PRO PACK SOLID", "PURE O2 PACK-SOLID", "NARYN CARE STICK", "QVE - S" ], "generic_name": [ "SODIUM CHLORITE" ], "manufacturer_name": [ "Pure O2" ], "product_ndc": [ "75124-0003", "75124-0006", "75124-0004", "75124-0012", "75124-0005", "75124-0008", "75124-0013", "75124-0011", "75124-0002", "75124-0009", "75124-0010" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "TOPICAL" ], "substance_name": [ "SODIUM CHLORITE" ], "spl_id": [ "0a4eb0be-cd45-6702-e063-6294a90ab9a3", "a492a053-5919-58fa-e053-2a95a90aba0b", "0a4eb0be-cd46-6702-e063-6294a90ab9a3", "c0293cb2-be63-25bb-e053-2995a90a9d6a", "0a4e3811-94d7-57dd-e063-6394a90af493", "0a4eb2ef-b05b-8d1a-e063-6394a90aa3b8", "c02915ef-e7fd-4811-e053-2a95a90a9770", "c0289ea3-c593-0760-e053-2a95a90a0cfd", "adfee65d-2c7c-0781-e053-2995a90a43db", "0a4ec641-f746-afa2-e063-6294a90a35f0", "acde31eb-b011-5f00-e053-2a95a90a36eb" ], "spl_set_id": [ "a39a1e99-d714-645d-e053-2995a90a024c", "a492a03c-c28e-fcd6-e053-2a95a90a65d4", "a39b9ce6-a074-4165-e053-2995a90a277a", "c029345a-d44b-74db-e053-2995a90a1dbe", "a39b49fd-9eac-73b4-e053-2995a90a180d", "a6f7ea11-3cbe-6739-e053-2a95a90a41cf", "c02915ef-e7fc-4811-e053-2a95a90a9770", "c0289ea3-c592-0760-e053-2a95a90a0cfd", "a397afb9-53a7-e6d8-e053-2a95a90a54d4", "a6fb2adf-5312-84c4-e053-2a95a90a5ded", "acdeca69-4e20-9502-e053-2a95a90a5327" ], "package_ndc": [ "75124-0003-1", "75124-0006-1", "75124-0004-1", "75124-0012-1", "75124-0005-1", "75124-0008-1", "75124-0013-1", "75124-0011-1", "75124-0002-1", "75124-0009-1", "75124-0010-1" ], "unii": [ "G538EBV4VF" ] } }, { "drugcharacterization": "1", "medicinalproduct": "IBUPROFEN.", "drugauthorizationnumb": "070045", "drugdosagetext": "12 TABLETS OF 400 MG", "drugadministrationroute": "048", "drugindication": "OVERDOSE", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "IBUPROFEN" }, "openfda": { "application_number": [ "ANDA078682", "ANDA077349", "505G(a)(3)", "ANDA079174", "ANDA074937", "ANDA210602", "ANDA202312", "ANDA075217", "ANDA091355", "ANDA075010", "ANDA076359", "ANDA209179", "ANDA210755", "NDA020944", "ANDA091239", "ANDA075682", "NDA020589", "ANDA202413", "ANDA091237", "NDA020516", "ANDA210149", "ANDA072096", "ANDA207095", "ANDA220239", "ANDA206568", "ANDA217261", "ANDA204469", "ANDA207753", "ANDA079233", "ANDA079205", "ANDA206999", "ANDA075139", "NDA020402", "ANDA213794", "NDA022348", "ANDA079129", "ANDA215318", "ANDA208865", "M", "ANDA078329", "ANDA078558", "ANDA209204", "ANDA214789", "NDA018989", "ANDA071268", "ANDA074916", "ANDA071333", "NDA020603", "ANDA202300", "ANDA209207", "ANDA203599", "ANDA215311", "ANDA071334", "ANDA209178", "ANDA071935", "ANDA091625", "M013", "ANDA079058", "ANDA072199", "NDA020812", "ANDA071265", "ANDA090796", "ANDA071335", "ANDA211666", "ANDA215777", "ANDA074978", "ANDA076925", "NDA020267", "M012", "ANDA213506" ], "brand_name": [ "IBUPROFEN", "CAREONE IBUPROFEN", "GOOD REMEDIES IBUPROFEN 200 MG", "IBUPROFEN CHILDRENS", "CHILDRENS IBUPROFEN ORAL SUSPENSION, DYE FREE", "INFANTS DYE FREE IBUPROFEN", "LEADER CHILDRENS IBUPROFEN", "GOOD SENSE CHILDRENS IBUPROFEN", "CABINET PAIN RELIEVER AND FEVER REDUCER", "CHILDRENS IBUPROFEN", "CONCENTRATED IBUPROFEN INFANTS", "JUNIOR STRENGTH ADVIL", "IBU", "MEDIQUE IPRIN", "MEDI-FIRST IBUPROFEN", "MEDI-FIRST PLUS IBUPROFEN", "DOVER ADDAPRIN", "GREEN GUARD IBUPRO RELIEF", "CHILDRENS ADVIL", "CARE ONE IBUPROFEN CHILDRENS", "CHILDRENS MOTRIN", "CHILDRENS IBUPROFEN ORAL SUSPENSION DYE FREE", "ULINE IBUPROFEN", "GOOD NEIGHBOR PHARMACY IBUPROFEN", "UP AND UP CHILDRENS IBUPROFEN", "DYE FREE CHILDRENS IBUPROFEN", "BASIC CARE IBUPROFEN", "XPECT IBUPROFEN", "IBUPROFEN INFANTS", "IBUPROFEN MINIS", "KOSHER MEDS", "EQUATE IBUPROFEN", "FOSTER AND THRIVE CHILDRENS IBUPROFEN IB", "DYE-FREE PAIN RELIEF", "IBUPROFEN MINI DYE FREE", "DOLEX FLEX", "IBUPAK", "DYE FREE IBUPROFEN", "ADVIL LIQUI-GELS", "BETR PAIN RELIEF", "EQUALINE CHILDRENS IBUPROFEN", "CHILDRENS IBUPROFEN BUBBLEGUM", "CHILDRENS IBUPROFEN FRUIT", "CHILDRENS IBUPROFEN BLUE RASPBERRY", "CHILDRENS IBUPROFEN GRAPE", "IBUPROFEN IB", "KOSHER MEDS DYE-FREE IBUPROFEN", "TOPCARE CHILDRENS IBUPROFEN", "REXALL IBUPROFEN", "ADVIL MIGRAINE", "IBUPROFEN 200MG", "DG HEALTH IBUPROFEN", "CALDOLOR", "EQUATE IBUPROFEN CHILDRENS", "GOOD NEIGHBOR PHARMACY CHILDRENS IBUPROFEN", "BERKLEY AND JENSEN IBUPROFEN", "EQUALINE IBUPROFEN", "HENRY SCHEIN IBUPROFEN", "PROFEN IB INFANTS", "IBUPROFEN MIGRAINE", "ASSURED IBUPROFEN", "UP AND UP IBUPROFEN", "CAREONE CHILDRENS IBUPROFEN", "CHILDRENS IBUPROFEN ORAL SUSPENSION", "BASIC CARE CHILDRENS IBUPROFEN", "PROFEN IB CHILDRENS", "BASIC CARE INFANTS IBUPROFEN", "ADVIL", "EQUALINE IBUPROFEN CHILDRENS", "FOSTER AND THRIVE IBUPROFEN", "IBUPROFEN PAIN RELEIVER/ FEVER REDUCER", "IBUPROFEN 24/7 LIFE BY 7-ELEVEN", "LEADER IBUPROFEN", "GOOD SENSE IBUPROFEN CHILDRENS", "INFANTS MOTRIN", "IBUPROFEN THOMPSON", "DYE-FREE IBUPROFEN", "IBUPROFEN DYE FREE", "MOTRIN INFANTS", "IBUPROFEN PAIN RELIEVER/FEVER REDUCER", "PAIN RELIEF IBUPROFEN", "IBUPROFEN IMMEDIATE RELEASE", "PROFEN IB", "MOTRIN IB", "BETR REMEDIES IBUPROFEN", "CHILDRENS IBUPROFEN 572", "KIRKLAND SIGNATURE IBUPROFEN", "IBUPROFEN 200 MG", "CHILDRENS IBUPROFEN 100", "CHILDRENS FLANAX ORAL", "AMAZON BASIC CARE IBUPROFEN", "TOPCARE IBUPROFEN", "CHILDRENS IBUPROFEN ORAL SUSPENSION ORIGINAL BERRY FLAVOR", "COUNTERACT IB", "SIGNATURE CARE CHILDRENS IBUPROFEN", "PAIN RELIEF", "CHILDRENS IBUPROFEN BUBBLEGUM DYE FREE", "RIGHT REMEDIES IBUPROFEN 200 MG", "UNISHIELD IBUPROFEN", "IBUPROFEN CA", "DYE-FREE IBUPROFEN 200", "IBUPROFEN 100", "IBUPROFEN 250", "GOOD SENSE IBUPROFEN", "INFANTS IBUPROFEN", "IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER", "CARE ONE IBUPROFEN", "CHILDRENS IBUPROFEN ORAL SUSPENSION, BUBBLE GUM", "GREEN GUARD IBUPROFEN RELIEF", "KIRKLAND SIGNATURE IBUPROFEN IB", "PEDIACARE CHILDRENS IBUPROFEN BERRY", "GOOD SENSE IBUPROFEN INFANTS", "INFANTS ADVIL", "CIRCLE K IBUPROFEN", "CVS IBUPROFEN", "SIGNATURE CARE IBUPROFEN", "PARENTS CHOICE INFANTS IBUPROFEN", "LEADER INFANTS IBUPROFEN", "GOOD NEIGHBOR PHARMACY IBUPROFEN CHILDRENS", "TOPCARE INFANTS IBUPROFEN", "GOODNOW PAIN RELIEF", "FLEX-PRIN", "PAIN RELIEF - IBUPROFEN 200 MG", "DIRECT SAFETY IBUPROFEN", "IBUPROFEN, LIL DRUG STORE", "MEDIQUE AT HOME IPRIN", "IBUPROFEN FAST RELIEF MEDICINE FOR PAIN", "IBUPROFEN INFANTS DROPS", "MIGRAINE RELIEF", "LIL DRUG STORE IBUPROFEN", "MCKESSON IBUPROFEN 200 MG", "IBUPROFEN 200", "DG HEALTH CHILDRENS IBUPROFEN", "IBUPROFEN, CIRCLE K, 50CT", "IBUPROFEN, CASEYS, 50CT", "IBUPROFEN, LIL DRUG STORE, 50CT", "IBUPROFEN, LIL DRUG STORE, 24CT", "MOTRIN IB, TRAVEL BASIX", "MOTRIN IB, CVP HEALTH", "CAREALL IBUPROFEN", "GOOD SENSE INFANTS IBUPROFEN", "VALUMEDS IBUPROFEN", "DOLEX CHILDREN", "IBUPROFEN DYE-FREE", "MOTRIN IB MIGRAINE", "FAST PAIN RELIEF", "FOSTER AND THRIVE INFANTS IBUPROFEN" ], "generic_name": [ "IBUPROFEN", "IBUPROFEN CAPSULES 200 MG", "IBUPROFEN TABLETS USP, 200MG", "IBUPROFEN TABLET, FILM COATED", "IBUPROFEN ORAL", "IBUPROFEN 200MG", "IBUPFROFEN", "IBUPROFEN TABLET, FILM-COATED", "IBUPROFEN 200 MG", "IBUPROFEN CAPSULE" ], "manufacturer_name": [ "DOLGENCORP INC", "American Sales Company", "Strive Pharmaceuticals Inc.", "Rite Aid Corporation", "Dolgencorp, Inc.", "HyVee Inc", "Best Choice", "Harris Teeter", "Kroger Company", "Cardinal Health 110, LLC. dba Leader", "PuraCap Pharmaceutical LLC", "NUVICARE LLC", "Geritrex LLC", "L. 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.", "Shield Pharmaceuticals Corp", "Amerisource Bergen", "Target Corporation", "CVS", "Amazon.com Services LLC", "Advagen Pharma Ltd.", "WALGREEN COMPANY", "Cintas Corporation", "Sun Pharmaceutical Industries, Inc.", "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)", "Mollec Inc", "INGLES MARKETS, INC.", "BJWC", "Pioneer Life Sciences, LLC", "Wal-Mart Stores Inc", "Strategic Sourcing Services LLC", "Bionpharma Inc.", "Grocery Outlet, Inc.", "Randob Labs., Ltd.", "CHAIN DRUG MARKETING ASSOCIATION INC.", "Amneal Pharmaceuticals of New York LLC", "Winco Foods, LLC", "Walgreens", "Pharmadel LLC", "RETAIL BUSINESS SERVICES , LLC.", "PureTek Corporation", "CHAIN DRUG MARKETING ASSOCIATION INC", "Lil Drug Store Products, Inc", "H E B", "Live Betr LLC", "Softgel Healthcare Private Limited", "United Natural Foods, Inc. dba UNFI", "Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd", "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)", "Guardian Drug Company", "WINCO FOODS, LLC", "NorthStar Rx LLC", "Major Pharmaceuticals", "Topco Associates LLC", "Dolgencorp, LLC", "Allegiant Health", "Walgreen Company", "Care One (American Sales Company)", "L.N.K. International, Inc.", "Retail Business Services, LLC", "Geri-Care Pharmaceutical Corp", "Dolgencorp Inc", "Cumberland Pharmaceuticals Inc.", "GOODSENSE", "Family Dollar (FAMILY WELLNESS)", "Westminster Pharmaceuticals, LLC", "Chain Drug Marketing Association, Inc.", "VALU MERCHANDISERS COMPANY", "TIME CAP LABORATORIES, INC.", "Spirit Pharmaceuticals LLC", "WR Group, Inc.", "BETTER LIVING BRANDS, LLC", "Rugby Laboratories, Inc.", "HART Health", "Henry Schein Inc.", "MARKSANS PHARMA LIMITED", "Topco Associates, LLC", "WALGREENS", "Publix Super Markets Inc", "SOLA Pharmaceuticals, LLC", "Meijer Distribution Inc", "Best Choice (Valu Merchandisers Company)", "TOPCO ASSOCIATES LLC", "Trifecta Pharmaceuticals USA LLC", "AMERISOURCE BERGEN", "RITE AID", "PAI Holdings, LLC dba PAI Pharma", "TOP CARE (Topco Associates LLC)", "Marc Glassman, Inc.", "Chain Drug Consortium", "RITE AID CORPORATION", "HEB", "Amneal Pharmaceuticals LLC", "Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd", "Pharmaceutical Associates, Inc.", "Amneal Pharmaceuticals NY LLC", "KROGER COMPANY", "Lil' Drug Store Products, Inc.", "PURACAP PHARMACEUTICAL LLC", "Thompson Safety", "FSA Store Inc. (Caring Mill)", "Cardinal Health 110, LLC. DBA Leader", "Lidl US LLC", "BluePoint Laboratories", "WALMART INC.", "BETTER LIVING BRANDS LLC.", "Sam's West, Inc", "MARC GLASSMAN, INC.", "Strides Pharma Inc", "Chalkboard Health", "TIME CAP LABORATORIES, INC", "Family Dollar Services, Inc.", "BJWC (Berkley & Jensen / BJ's)", "Costco Wholesale Company", "Safeway", "RETAIL BUSINESS SERVICES,LLC.", "Discount Drug Mart", "Basic Drugs, Inc.", "Padagis Israel Pharmaceuticals Ltd", "Strides Pharma Science Limited", "AiPing Pharmaceutical, Inc.", "DEMOULAS SUPERMARKETS INC.", "ARMY AND AIR FORCE EXCHANGE SERVICE", "Belmora LLC", "The Kroger Co.", "WALGREEN CO.", "Gobrands, Inc. 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