{ "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": 198655 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "10003301", "primarysourcecountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140228", "receiptdateformat": "102", "receiptdate": "20140228", "fulfillexpeditecriteria": "2", "companynumb": "US-JNJFOC-20130719067", "duplicate": "1", "reportduplicate": { "duplicatesource": "JANSSEN", "duplicatenumb": "US-JNJFOC-20130719067" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Dyspepsia" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Renal impairment" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "IBUPROFEN", "drugauthorizationnumb": "17463", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugrecurreadministration": "3", "drugadditional": "3", "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", "ANDA091625", "ANDA213794", "NDA022348", "ANDA079129", "ANDA215318", "ANDA074916", 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Inc.", "Chain Drug Consortium, LLC", "JHK Inc dba American Safety & First Aid", "Harris Teeter, LLC", "Demoulas Super Markets, Inc", "ADVANCED FIRST AID, INC.", "Sam's West Inc", "Family Dollar Services Inc", "DISCOUNT DRUG MART", "Unifirst First Aid", "RANDOB LABS,LTD. 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"companynumb": "US-BAYER-2014-035819", "duplicate": "1", "reportduplicate": { "duplicatesource": "BAYER", "duplicatenumb": "US-BAYER-2014-035819" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "18", "patientonsetageunit": "801", "patientweight": "73", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Cerebral venous thrombosis", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Jugular vein thrombosis", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "YAZ", "drugauthorizationnumb": "021676", "drugdosageform": "FILM-COATED TABLET", "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": "1", "medicinalproduct": "GIANVI", "drugauthorizationnumb": "021676", "drugdosageform": "FILM-COATED TABLET" }, { "drugcharacterization": "2", "medicinalproduct": "TUSSIONEX" }, { "drugcharacterization": "2", "medicinalproduct": "IBUPROFEN", "drugstructuredosagenumb": "600", "drugstructuredosageunit": "003", "drugdosagetext": "600 MG, UNK", "openfda": { "application_number": [ "ANDA078682", "ANDA077349", "505G(a)(3)", "ANDA079174", "ANDA074937", "ANDA210602", "ANDA202312", "ANDA075217", "ANDA091355", "ANDA075010", "ANDA076359", "ANDA209179", "ANDA210755", "NDA020944", "ANDA091239", "ANDA075682", "NDA020589", 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International, Inc.", "Retail Business Services, LLC", "Geri-Care Pharmaceutical Corp", "Dolgencorp Inc", "Cumberland Pharmaceuticals Inc.", "Family Dollar (FAMILY WELLNESS)", "Westminster Pharmaceuticals, LLC", "Chain Drug Marketing Association, Inc.", "VALU MERCHANDISERS COMPANY", "TIME CAP LABORATORIES, INC.", "FSA Store Inc. 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Perrigo Company", "Spirit Pharmaceutical LLC", "Meijer, Inc.", "TWIN MED LLC", "Better Living Brands, LLC", "Wal-Mart Stores, Inc.", "Haleon US Holdings LLC", "SAM'S WEST INC", "Dr. Reddy's Laboratories Limited", "Unifirst First Aid Corporation", "Chartwell RX, LLC", "CVS Pharmacy", "TIME CAP LABORATORIES,INC", "Kenvue Brands LLC", "Aurohealth LLC", "AptaPharma Inc.", "Chain Drug Marketing Association Inc.", "Uline", "Breeden Brothers, LLC", "FSA STORE INC.", "Amerisource Bergen", "Target Corporation", "Shield Pharmaceuticals Corp", "CVS", "Amazon.com Services LLC", "Advagen Pharma Ltd.", "WALGREEN COMPANY", "Cintas Corporation", "Sun Pharmaceutical Industries, Inc.", "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)", "Mollec Inc", "INGLES MARKETS, INC.", "BJWC", "Strides Pharma Inc.", "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)", "Granules India Limited", "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.", "Family Dollar (FAMILY WELLNESS)", "Westminster Pharmaceuticals, LLC", "Chain Drug Marketing Association, Inc.", "VALU MERCHANDISERS COMPANY", "TIME CAP LABORATORIES, INC.", "FSA Store Inc. (Caring Mills)", "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)", "PLD Acquisitions LLC DBA Avma Pharma Solutions", "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.", "Puro Pharma Inc.", "Aurobindo Pharma Limited", "Melaleuca, Inc", "Costco Wholesale", "P & L Development, LLC", "Albertsons Companies", "Discount Drug Mart, Inc", "PROSTAT FIRST AID", "Wildman Business Group", "Unishield", "MEIJER DISTRIBUTION INC.", "Granules Pharmaceuticals Inc.", "TARGET CORPORATION", "Ascend Laboratories, LLC", "Safeway, Inc.", "CVS Pharmacy. Inc.", "Chain Drug Consortium, LLC", "JHK Inc dba American Safety & First Aid", "Harris Teeter, LLC", "Demoulas Super Markets, Inc", "ADVANCED FIRST AID, INC.", "Sam's West Inc", "Family Dollar Services Inc", "DISCOUNT DRUG MART", "Unifirst First Aid", "RANDOB LABS,LTD. 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"11673-991-20", "11673-991-50", "11673-991-88", "21130-818-62", "21130-818-71", "21130-818-78", "21130-818-90", "68998-012-03", "50844-353-02", "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", "63981-750-36" ], "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" ] } } ] } }, { "safetyreportversion": "1", "safetyreportid": "10004208", "primarysourcecountry": "GB", "occurcountry": "GB", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnesslifethreatening": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "1", "companynumb": "GB-PFIZER INC-2014069998", "duplicate": "1", "reportduplicate": { "duplicatesource": "PFIZER", "duplicatenumb": "GB-PFIZER INC-2014069998" }, "primarysource": { "reportercountry": "GB", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "13", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Off label use", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Stevens-Johnson syndrome", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Consciousness fluctuating", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Lip swelling", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Lip discolouration", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Blister", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Pain", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Skin exfoliation", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Chapped lips", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Eye disorder", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Scab", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Scar", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Weight decreased", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Skin disorder", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Rash generalised", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Hypersensitivity", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Malaise", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "IBUPROFEN", "drugauthorizationnumb": "020589", "drugdosagetext": "UNK, GIVEN STANDARD DOSE OF LIQUID IBUPROFEN.", "drugdosageform": "ORAL SUSPENSION", "drugindication": "NASOPHARYNGITIS", "actiondrug": "5", "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", "ANDA091625", "ANDA213794", "NDA022348", "ANDA079129", "ANDA215318", "ANDA074916", "ANDA208865", "M", "ANDA078329", "ANDA078558", "ANDA209204", "ANDA214789", "NDA018989", "ANDA071268", "ANDA071333", "NDA020603", "ANDA076460", "ANDA202300", "ANDA209207", "ANDA203599", "ANDA215311", "ANDA071334", "ANDA209178", "ANDA071935", "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", 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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", "PROFEN IB", "MOTRIN IB", "BETR REMEDIES IBUPROFEN", "CHILDRENS IBUPROFEN 572", "KIRKLAND SIGNATURE IBUPROFEN", "GOOD SENSE IBUPROFEN", "IBUPROFEN 200 MG", "CHILDRENS IBUPROFEN 100", "CHILDRENS FLANAX ORAL", "AMAZON BASIC CARE IBUPROFEN", "TOPCARE IBUPROFEN", "CHILDRENS IBUPROFEN ORAL SUSPENSION ORIGINAL BERRY FLAVOR", "UP AND UP DYE FREE INFANTS CONCENTRATED IBUPROFEN", "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", "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", "IBUPROFEN INFANTS DROPS", "CVS IBUPROFEN", "SIGNATURE CARE IBUPROFEN", "PARENTS CHOICE INFANTS IBUPROFEN", "LEADER INFANTS IBUPROFEN", "GOOD NEIGHBOR PHARMACY IBUPROFEN CHILDRENS", "TOPCARE INFANTS IBUPROFEN", "GOODNOW PAIN RELIEF", "CHILDRENS IBUPROFEN 100 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"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.", "Amerisource Bergen", "Target Corporation", "Shield Pharmaceuticals Corp", "CVS", "Amazon.com Services LLC", "Advagen Pharma Ltd.", "WALGREEN COMPANY", "Cintas Corporation", "Sun Pharmaceutical Industries, Inc.", "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)", "Mollec Inc", "INGLES MARKETS, INC.", "BJWC", "Strides Pharma Inc.", "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)", "Granules India Limited", "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.", "Family Dollar (FAMILY WELLNESS)", "Westminster Pharmaceuticals, LLC", "Chain Drug Marketing Association, Inc.", "VALU MERCHANDISERS COMPANY", "TIME CAP LABORATORIES, INC.", "FSA Store Inc. 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"US-PFIZER INC-2014070871", "duplicate": "1", "reportduplicate": { "duplicatesource": "PFIZER", "duplicatenumb": "US-PFIZER INC-2014070871" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Hallucination, auditory", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Nervousness", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Feeling abnormal", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "VARENICLINE TARTRATE", "drugauthorizationnumb": "021928", "drugdosagetext": "UNK", "drugindication": "SMOKING CESSATION THERAPY", "drugstartdateformat": "602", "drugstartdate": "2011", "actiondrug": "1", "openfda": { 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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", 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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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"0363-0563-27", "0363-0563-14", "0363-0563-32", "0363-0563-63", "0363-0563-62", "0363-0563-22", "0363-0563-90", "16103-366-05", "16103-366-11", "79481-6450-5", "84324-017-01", "63868-373-05", "53943-146-01", "53943-146-02", "73408-620-33", "73408-099-33", "73408-618-33", "73408-616-33", "46122-596-02", "37835-577-01", "37835-577-25", "83586-104-05", "83586-104-10", "11673-188-53", "51824-057-36", "81522-018-11", "61504-105-03", "69790-620-33", "69790-616-33", "0363-6450-14", "0363-6450-07", "0363-6450-12", "0363-6450-60", "0363-6450-32", "53943-152-01", "84269-2501-2", "84269-2501-1" ], "nui": [ "N0000000160", "N0000008836", "M0001335", "N0000175722", "N0000175578", "N0000008832" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_pe": [ "Decreased Prostaglandin Production [PE]", "Decreased Platelet Aggregation [PE]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]", "Platelet Aggregation Inhibitor [EPC]" ], "unii": [ "R16CO5Y76E" ] } } ] } }, { "safetyreportversion": "1", "safetyreportid": "10004874", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "2", "companynumb": "US-PFIZER INC-2014067506", "duplicate": "1", "reportduplicate": { "duplicatesource": "PFIZER", "duplicatenumb": "US-PFIZER INC-2014067506" }, "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "69", "patientonsetageunit": "801", "patientweight": "79.3", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Drug hypersensitivity", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "LIPITOR", "drugauthorizationnumb": "020702", "drugdosagetext": "UNK", "drugdosageform": "FILM-COATED TABLET", "actiondrug": "5", "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": "IBUPROFEN", "drugauthorizationnumb": "018989", "drugdosagetext": "UNK", "actiondrug": "5", "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", "ANDA091625", "ANDA213794", "NDA022348", "ANDA079129", "ANDA215318", "ANDA074916", "ANDA208865", "M", "ANDA078329", "ANDA078558", "ANDA209204", "ANDA214789", "NDA018989", "ANDA071268", "ANDA071333", "NDA020603", "ANDA076460", "ANDA202300", "ANDA209207", "ANDA203599", "ANDA215311", "ANDA071334", "ANDA209178", "ANDA071935", "M013", "ANDA079058", "ANDA072199", "NDA020812", "ANDA071265", "ANDA090796", "ANDA071335", "ANDA211666", "ANDA215777", 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Inc.", "Chain Drug Consortium, LLC", "JHK Inc dba American Safety & First Aid", "Harris Teeter, LLC", "Demoulas Super Markets, Inc", "ADVANCED FIRST AID, INC.", "Sam's West Inc", "Family Dollar Services Inc", "DISCOUNT DRUG MART", "Unifirst First Aid", "RANDOB LABS,LTD. 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