{ "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": 267982 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "10003349", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "1", "companynumb": "US-PURDUE-USA-2014-0111828", "duplicate": "1", "reportduplicate": { "duplicatesource": "PURDUE", "duplicatenumb": "US-PURDUE-USA-2014-0111828" }, "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": "Cerebrovascular accident", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Blood pressure increased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Pain", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "MORPHINE SULFATE EXTENDED-RELEASE TABLETS (RHODES 74-862)", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "074862", "drugstructuredosagenumb": "180", "drugstructuredosageunit": "003", "drugdosagetext": "(60 MG X 3),180 MG, DAILY", "drugdosageform": "PROLONGED-RELEASE TABLET", "drugadministrationroute": "048", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": "MORPHINE SULFATE (SIMILAR TO NDA 19-516)", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": "180", "drugstructuredosageunit": "003", "drugdosagetext": "6 X 30 MG, 180 MG DAILY", "drugdosageform": "Other", "drugadministrationroute": "048", "drugindication": "BACK PAIN", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": "AMLODIPINE", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": "5", "drugstructuredosageunit": "003", "drugdosagetext": "5 MG, UNK", "drugindication": "HYPERTENSION", "actiondrug": "4", "openfda": { "application_number": [ "NDA219531", "NDA214439", "NDA211340" ], "brand_name": [ "SDAMLO", "NORLIQVA", "KATERZIA" ], "generic_name": [ "AMLODIPINE" ], "manufacturer_name": [ "Pangea Pharmaceuticals, LLC", "CMP Pharma, Inc.", "Azurity Pharmaceuticals, Inc." ], "product_ndc": [ "81279-133", "81279-134", "81279-135", "46287-035", "46287-037", "52652-5001" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AMLODIPINE BESYLATE", "AMLODIPINE", "AMLODIPINE BENZOATE" ], "rxcui": [ "2726058", "2726064", "2726065", "2726067", "2726068", "2726070", "2599173", "2599179", "2184120", "2184126" ], "spl_id": [ "4b0523be-cded-6306-e063-6394a90a8a12", "63a6bb49-fb68-4351-be5f-a6b6e8f6b540", "4fee8eba-2fa2-4a9c-884a-ccec171e1977", "461e8d10-1805-e107-e063-6294a90aa288" ], "spl_set_id": [ "886a7f97-60a4-4206-a6c7-5206069ed487", "c1730a51-4383-4c61-a9a1-7e1326bd0abe", "614d974f-51c7-4b18-8171-39eb6e8d4c03", "df673a4d-acb8-444c-a472-c87ab8cbd366" ], "package_ndc": [ "81279-133-10", "81279-134-10", "81279-135-10", "46287-035-15", "46287-037-01", "52652-5001-1" ], "unii": [ "864V2Q084H", "1J444QC288", "XD75TQ8A2P" ], "nui": [ "N0000000069", "N0000175421", "N0000175566", "M0006414", "N0000190114" ], "pharm_class_moa": [ "Calcium Channel Antagonists [MoA]", "Cytochrome P450 3A Inhibitors [MoA]" ], "pharm_class_epc": [ "Dihydropyridine Calcium Channel Blocker [EPC]", "Calcium Channel Blocker [EPC]" ], "pharm_class_cs": [ "Dihydropyridines [CS]" ] } }, { "drugcharacterization": "1", "medicinalproduct": "TRIAMTERENE AND HYDROCHLOROTHIAZID", "drugbatchnumb": "UNKNOWN", "drugdosagetext": "UNK", "drugindication": "HYPERTENSION", "actiondrug": "4" }, { "drugcharacterization": "2", "medicinalproduct": "ASPIRIN", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugrecurreadministration": "3", "openfda": { "application_number": [ "M013", "M013.50", "part343", "M" ], "brand_name": [ "BAYER GENUINE ASPIRIN", "ASPIRIN", "ENTERIC ASPIRIN", "ADULT LOW DOSE ASPIRIN", "CHEWABLE ASPIRIN", "DRUG MART EFFERVESCENT PAIN RELIEF", "ASPIRIN LOW DOSE", "ASPIRIN ENTERIC COATED", "ASPIRIN 81", "ADULT CHEWABLE ASPIRIN", "ASPIRIN 81MG", "ADULT LOW DOSE ENTERIC COATED ASPIRIN", "ASPIRIN LOW DOSE SAFETY COATED", "GERITREX ASPIRIN", "BUFFERED ASPIRIN", "ENTERIC COATED ASPIRIN", "BUFFERIN REGULAR STRENGTH PAIN RELIEF", "WISPIRIN", "EQUATE ASPIRIN", "LOW DOSE ASPIRIN", "HEB EFFERVESCENT PAIN RELIEF", "PAIN RELIEF ASPIRIN LOW DOSE", "ASPIRIN 81 MG LOW DOSE", "ASPIRIN EXTRA STRENGTH", "BAYER CHEWABLE - 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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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"drugseparatedosagenumb": "3", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "TDS", "drugadministrationroute": "050", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "102", "drugstartdate": "20131007", "actiondrug": "4", "activesubstance": { "activesubstancename": "ADALIMUMAB" }, "openfda": { "application_number": [ "BLA125057" ], "brand_name": [ "HUMIRA" ], "generic_name": [ "ADALIMUMAB" ], "manufacturer_name": [ "Cordavis Limited", "AbbVie Inc." ], "product_ndc": [ "83457-124", "83457-554", "83457-243", "83457-616", "83457-817", "0074-0124", "0074-3799", "0074-4339", "0074-9374", "0074-0243", "0074-0554", "0074-0067", "0074-2540", "0074-1539", "0074-0616", "0074-0817" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "797544", "1726844", "1726846", "1872979", "1872980", "1921009", "1921010", "1921016", "1921017", "1921238", "1921240", "727703", "727705", "763564", "763565", "825169", "825170", 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"0074-2540-01", "0074-2540-03", "0074-0124-74", "0074-0124-73", "0074-0124-01", "0074-0124-03", "0074-0124-02", "0074-0124-04", "0074-1539-03", "0074-0616-71", "0074-0616-02", "0074-0817-02" ] } }, { "drugcharacterization": "2", "medicinalproduct": "AMLODIPINE", "drugdosagetext": "5", "drugadministrationroute": "048", "drugindication": "HYPERTENSION", "drugstartdateformat": "102", "drugstartdate": "20130219", "drugenddateformat": "102", "drugenddate": "20131127", "activesubstance": { "activesubstancename": "AMLODIPINE BESYLATE" }, "openfda": { "application_number": [ "NDA219531", "NDA214439", "NDA211340" ], "brand_name": [ "SDAMLO", "NORLIQVA", "KATERZIA" ], "generic_name": [ "AMLODIPINE" ], "manufacturer_name": [ "Pangea Pharmaceuticals, LLC", "CMP Pharma, Inc.", "Azurity Pharmaceuticals, Inc." ], "product_ndc": [ "81279-133", "81279-134", "81279-135", "46287-035", "46287-037", "52652-5001" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AMLODIPINE BESYLATE", "AMLODIPINE", "AMLODIPINE BENZOATE" ], "rxcui": [ "2726058", "2726064", "2726065", "2726067", "2726068", "2726070", "2599173", "2599179", "2184120", "2184126" ], "spl_id": [ "4b0523be-cded-6306-e063-6394a90a8a12", "63a6bb49-fb68-4351-be5f-a6b6e8f6b540", "4fee8eba-2fa2-4a9c-884a-ccec171e1977", "461e8d10-1805-e107-e063-6294a90aa288" ], "spl_set_id": [ "886a7f97-60a4-4206-a6c7-5206069ed487", "c1730a51-4383-4c61-a9a1-7e1326bd0abe", "614d974f-51c7-4b18-8171-39eb6e8d4c03", "df673a4d-acb8-444c-a472-c87ab8cbd366" ], "package_ndc": [ "81279-133-10", "81279-134-10", "81279-135-10", "46287-035-15", "46287-037-01", "52652-5001-1" ], "unii": [ "864V2Q084H", "1J444QC288", "XD75TQ8A2P" ], "nui": [ "N0000000069", "N0000175421", "N0000175566", "M0006414", "N0000190114" ], "pharm_class_moa": [ "Calcium Channel Antagonists [MoA]", "Cytochrome P450 3A Inhibitors [MoA]" ], "pharm_class_epc": [ "Dihydropyridine Calcium Channel Blocker [EPC]", "Calcium Channel Blocker [EPC]" ], "pharm_class_cs": [ "Dihydropyridines [CS]" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20131127" } } }, { "safetyreportversion": "4", "safetyreportid": "10003636", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150821", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20150403", "fulfillexpeditecriteria": "1", "companynumb": "US-PFIZER INC-2014070391", "duplicate": "1", "reportduplicate": { "duplicatesource": "PFIZER", "duplicatenumb": "US-PFIZER INC-2014070391" }, "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "77", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Dehydration", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "GRANULOCYTE MACROPHAGE COLONY STIM FACTOR", "drugdosagetext": "UNK", "drugindication": "METASTATIC RENAL CELL CARCINOMA", "drugstartdateformat": "102", "drugstartdate": "20120925", "actiondrug": "4", "activesubstance": { "activesubstancename": "GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR" } }, { "drugcharacterization": "2", "medicinalproduct": "CARVEDILOL.", "drugdosagetext": "UNK", "drugindication": "HYPERTENSION", "drugstartdateformat": "102", "drugstartdate": "20120724", "activesubstance": { "activesubstancename": "CARVEDILOL" }, "openfda": { "application_number": [ "ANDA078786", "ANDA076373", "ANDA078384", "ANDA077614", "ANDA078332", "ANDA078227", "ANDA076649", "NDA020297", "ANDA078165", "ANDA078251" ], "brand_name": [ "CARVEDILOL", "COREG" ], "generic_name": [ "CARVEDILOL" ], "manufacturer_name": [ "Advagen Pharma 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HYDROCORTISONE ALOE VERA", "THERA PLUS MAXIMUM STRENGTH HYDROCORTISONE", "BASIC CARE HYDROCORTISONE", "THERA PLUS", "GOOD NEIGHBOR PHARMACY HYDROCORTISONE WITH ALOE FOR SENSITIVE SKIN", "FAMILY WELLNESS", "HYDROCORTISONE 1", "SIGNATURE CARE HYDROCORTISONE", "MAXIMUM STRENGTH HYDROCORTISONE", "MEMBERS MARK HYDROCORTISONE", "MEDPRIDE", "INSTANT COOLING ITCH RELIEF", "HYDROXYM", "ANTI-ITCH PARABEN FREE", "AVEDANA HYDROCORTISONE CREAM WITH ALOE", "HYDROCORTISONE CREAM", "HYDROCORTISONE ANTI ITCH", "ASSURED", "BARMICIL PLUS", "EQUATE HYDROCORTISONE", "MONISTAT COMPLETE CARE INSTANT ITCH RELIEF", "SKIN RELIEF CREAM", "RAPIDOL", "ALKINDI SPRINKLE", "PUBLIX HYDRO", "PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOE", "QUALITY CHOICE", "PROCURE HYDROCORTISONE 1%", "SKIN A COOL HYDROCORTISONE ANTI-ITCH", "CAREONE ANTI ITCH", "CVS ANTI ITCH", "CORTISONE", "EQUALINE ANTI ITCH MAXIMUM STRENGTH", "CVS COOLS ITCH FAST", "QUADRYDERN", "KERA HC", "WINCO MAXIMUM STRENGTH HYDROCORTISONE", "ABSOLUT SKIN CORTICOSOOTHE ANTI-ITCH", "THOMPSON HYDROCORTISONE 1%", "LIVE BETTER HYDROCORTISONE WITH ALOE", "WALGREENS SCALP ITCH RELIEF", "FIXMYSKIN HEALING BALM VANILLA FLAVOR", "LYEON ANTI-ITCH CREAM", "GOOD SENSE ANTI ITCH", "CORTIZONE 10 EASY RELIEF", "AUDIOLOGIST ANTI-ITCH", "CORTENEMA", "FREDS HYDROCORTISONE WITH ALOE", "HYDROCORTISONE WITH ALOE", "HYDROCORTISONE CREAM WITH ALOE", "ITCH AND RASH CREAM", "TOTAL RELIEF", "CORTISOL PHENOLIC", "DR. SHEFFIELD HYDROCORTISONE ANTI ITCH", "PEDIADERMICS ECZEMA 2", "HYDROCORTISONE 1% ANTI-ITCH CREAM", "DG HEALTH HYDROCORTISONE MAXIMUM STRENGTH", "CORTISOL", "DIPROSPAN", "HEXASHIELD ANTI ITCH CREAM WITH HEALING ALOE", "FIXMYSKIN HEALING BALM FRAGRANCE-FREE", "THERACARE HYDROCORTISONE CREAM", "KHINDIVI", "MAXIMUM STRENGTH SCALP ITCH RELIEF ANTI-ITCH", "EQUATE HYDROCORTISONE INTENSIVE HEALING FORMULA", "CVS CORTISONE", "ANTI-ITCH REGULAR STRENGTH", "ITCH RELIEF", "CORTIZONE 10 INTENSIVE HEALING", "CORTIZONE 10 COOLING RELIEF", "CORTIZONE 10", "CORTIZONE 10 INTENSIVE HEALING ITCH RELIEF CREAM", "NIZORAL SCALP ITCH RELIEF", "HYDROCORTISONE ANTI-ITCH", "AVEENO HYDROCORTISONE ANTI-ITCH", "GOOD NEIGHBOR PHARMACY HYDROCORTISONE PLUS 12 MOISTURIZERS", "AEROSOOTHE", "INTENSIVE HEALING ECZEMA", "CORTIZONE 10 ULTRA SOOTHING ITCH RELIEF", "CRANE SAFETY HYDROCORTISONE", "FIXMYSKIN HEALING BALM UNFLAVORED", "PREPARATION H HYDROCORTISONE", "FAMILY WELLNESS MAX STRENGTH 1 HYDROCORTISONE CREAM", "THERAPLEX AIM ANTI-ITCH MOISTURIZING", "AOSI HEALTHCARE", "HEALING TREE CALMING ANTI-ITCH", "PROCURE HYDROCORTISONE CREAM PLUS", "GERIGENTLE", "AVEENO 1% HYDROCORTISONE ANTI-ITCH CREAM", "TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA", "FAMILY CARE ANTI-ITCH", "CORTIZONE 10 ITCH RELIEF MASSAGING ROLLERBALL", "FIFTHPULSE HYDROCORTISONE 4OZ", "UNISHIELD 1%", "ALA-SCALP", "QUATRIDERM ANTI-ITCH", "ELIXIRCORTIRELIEF", "WINCO FOODS HYDROCORTISONE CREAM INTENSIVE HEALING", "HEALTH BEYOND", "CORTIZONE-10 SOOTHING ALOE CREME", "ALOE CORT", "CORTEF", "CORTIZONE 10 FEMININE ITCH RELIEF", "FIFTHPULSE HYDROCORTISONE", "TEXACORT", "CORTIZONE 10 INTENSIVE HEALING FOR ECZEMA", "CVS HEALTH HYDROCORTISONE ANTI ITCH", "FREDS HYDROCORTISONE PLUS 12 MOISTURIZERS", "DISCOUNT DRUG MART ANTI-ITCH", "WESTLAKE ANTI-ITCH", "HYDROCORTISONE 1% WITH HEALING ALOE", "SHOPKO HYDROCORTISONE", "TRUELIPIDS 1% HYDROCORTISONE BARRIER CREAM", "EQUATE HYDROCORTISONE TOPICAL", "DERMACORT ANTI-ITCH", "NATUREPLEX HYDROCORTISONE HYDRO", "GEMBOOXT ECZEMA RELIEF CREAM", "QUADRIDERM NF", "ANA COOL RAPID SOOTHING COOLING FORMULA", "SCALPICIN ANTI-ITCH MAXIMUM STRENGTH", "AQUAPHOR ITCH RELIEF", "TOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS", "DERMAREST ECZEMA MEDICATED", "POST-TREATMENT REPAIR CREAM", "CLINICALM", "SUNMARK HYDROCORTISONE", "POST TREATMENT REPAIR CREAM", "HYDROCORTISONE INTENSIVE HEALING FORMULA", "THERA PLUS ANTI-ITCH WITH ALOE HYDROCORTISONE", "ALACORT", "PROCTO-MED HC", "HYDROCORTISONE RECTAL SUSPENSION (RETENTION)", "KIRKLAND SIGNATURE HYDROCORTISONE PLUS MAXIMUM STRENGTH", "CORTIZONE 10 ULTRA SOOTHING CREME", "SURVIVEX HYDROCORTISONE CREAM", "XPECT HYDROCORTISONE", "ANUSOL HC", "THERA PLUS ECZEMA HYDROCORTISONE ANTI ITCH", "PREPARATION H SOOTHING RELIEF ANTI-ITCH", "ALUMIER MD INTENSIVE RECOVERY", "VANICREAM HC ANTI-ITCH", "CVS NO MESS CORTISONE", "PETROCORT ANTIPRURITIC LIP 21", "CERAVE DEVELOPED WITH DERMATOLOGISTS ANTI ITCH", "CVS HEALTH MAXIMUM STRENGTH SCALP RELIEF ANTI-ITCH", "NO MESS HYDROCORTISONE APPLICATOR", "GOOD NEIGHBOR PHARMACY HYDROCORTISONE WITH ALOE", "CORTIZONE 10 COOLING", "HYDROCORTISONE ANTI-ITCH PLUS", "ANTI-ITCH" ], "generic_name": [ "HYDROCORTISONE", "ANTIPRURITIC (ANTI-ITCH)", "ANTI-ITCH CREAM", "HYDROCORTISONE CREAM", "HYDROCORTISONE 1%", "HYDROCORTISONE CREAM 1%", "ANTI-PRURITIC", "HYDROCORTISONE CONTINUOUS SPRAY", "HYDROCORTISONE LOTION", "HYDROCORTISONE ACETATE", "ANTI-ITCH", "COOL RELIEF GEL WITH ALOE", "HYDROCORTISONE SPRAY", "DRS. 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Co., Ltd.", "Veridian Healthcare", "United Exchange Corp.", "New World Imports, Inc", "United Natural Foods, Inc. dba UNFI", "Three Nations Corp", "BJWC", "ASTONEA LABS PRIVATE LIMITED", "Geri-Care Pharmaceuticals, Corp", "OL PHARMA TECH,LLC", "Water-Jel Technologies", "Fourstar Group USA, Inc", "Amazon.com Services LLC", "Encube Ethicals, Inc.", "Trifecta Pharmaceuticals Usa Llc", "Zhejiang Jingwei Pharmaceutical Co., Ltd.", "HART Health", "Kroger Company", "Pharmacy Value Alliance LLC", "DLC Laboratories, Inc", "Sam's West Inc", "VIVE HEALTH LLC", "Shield Line LLC", "CVS Pharmacy", "Aurobindo Pharma Limited", "Eywa Pharma Inc", "AKRON PHARMA INC", "PureTek Corporation", "Weeks & Leo Co., Inc.", "H E B", "Unipack LLC", "Trifecta Pharmaceuticals USA", "Crown Laboratories", "Zhejiang Jingwei Pharmaceutic Al Co., Ltd.", "ANI Pharmaceuticals, Inc.", "ALLIED TRADE LINK LLC", "Aldermed Inc.", "Wal-Mart Stores Inc", "Insight Pharmaceuticals LLC", "Henry Schein", "Spa de Soleil", "Pharmadel LLC", "Eton Pharmaceuticals, Inc.", "Click Industries LLC", "Chartwell RX, LLC", "Amneal Pharmaceuticals of New York LLC", "Chain Drug Marketing Association Inc.", "Chain Drug Marketing Association, Inc.", "Twin Med LLC", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc", "Ana-Cool, LLC", "E. 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MARDER SKINCARE, LLC", "Energique, Inc.", "Sheffield Pharmaceuticals LLC", "Cardinal Health", "RENU LABORATORIES, LLC", "DLC Laboratories, Inc.", "Dolgencorp Inc", "Deseret Biologicals, Inc.", "Oncora Pharma, LLC", "Premier Brands of America, Inc.", "Rite Aid", "Wal-Mart Stores Inc.", "STRATEGIC SOURCING SERVICES LLC", "Kramer Laboratories", "J&A Digital Inc.", "Universal Distribution Center LLC", "Allegis Holdings LLC", "Trifluent Pharma LLC", "Kenvue Brands LLC", "New World Imports, Inc.", "Aero Healthcare US LLC", "Crane Safety LLC", "Haleon US Holdings LLC", "Family Dollar Stores, Inc", "THERAPLEX, LLC", "Renu Laboratories, LLC", "Rooftop Consumer Health, Inc.", "GERI-GENTLE CORPORATION", "Walgreens Company", "Rugby Laboratories", "JHK Inc dba American Safety & First Aid", "Unishield", "Derm Ventures LLC", "ViaDerma Distribution, Inc.", "ELIXIR HEALTHCARE USA, LLC.", "Actavis Pharma, Inc.", "CVS PHARMACY, INC", "Walgreens Co.", "Topiderm, Inc.", "A2A Integrated Pharmaceuticals, 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"048", "actiondrug": "3", "activesubstance": { "activesubstancename": "PROPRANOLOL HYDROCHLORIDE" } }, { "drugcharacterization": "1", "medicinalproduct": "SANDOSTATIN LAR DEPOT", "drugauthorizationnumb": "021008", "drugstructuredosagenumb": "30", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "802", "drugdosagetext": "30 MG, QMO, EVERY 28 DAYS", "drugadministrationroute": "030", "actiondrug": "2", "activesubstance": { "activesubstancename": "OCTREOTIDE ACETATE" }, "openfda": { "application_number": [ "NDA021008" ], "brand_name": [ "SANDOSTATIN LAR DEPOT" ], "generic_name": [ "OCTREOTIDE ACETATE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0811", "0078-0818", "0078-0825" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "898589", "898591", "898601", "898603", "898605", "898607" ], "spl_id": [ "2a2ad59f-21cd-4734-9c4b-0154e9db1642" ], "spl_set_id": [ "d0b7fe9e-7000-4b79-ba3b-291ce92c14f9" ], "package_ndc": [ "0078-0811-81", "0078-0790-61", "0078-0818-81", "0078-0797-61", "0078-0825-81", "0078-0804-61" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ENALAPRIL", "drugstructuredosagenumb": "2", "drugstructuredosageunit": "032", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "2 DF (TABLET OF 20 MG), QD", "drugdosageform": "TABLET", "drugadministrationroute": "048", "actiondrug": "4", "activesubstance": { "activesubstancename": "ENALAPRIL" }, "openfda": { "application_number": [ "ANDA212894" ], "brand_name": [ "ENALAPRIL MALEATE" ], "generic_name": [ "ENALAPRIL" ], "manufacturer_name": [ "Amneal Pharmaceuticals NY LLC" ], "product_ndc": [ "69238-1729" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ENALAPRIL MALEATE" ], "rxcui": [ "1435624" ], "spl_id": [ "4f8091c3-1233-48b9-a15e-e5da07c4272c" ], "spl_set_id": [ "e81a8aca-0e7c-4a02-b596-09e4ac22c70e" ], "package_ndc": [ "69238-1729-7" ], "unii": [ "9O25354EPJ" ] } }, { "drugcharacterization": "1", "medicinalproduct": "SANDOSTATIN LAR DEPOT", "drugauthorizationnumb": "021008", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "802", "drugdosagetext": "10 MG, QMO, EVERY 28 DAYS", "drugadministrationroute": "030", "drugindication": "ACROMEGALY", "drugstartdateformat": "610", "drugstartdate": "200210", "drugenddateformat": "610", "drugenddate": "201401", "actiondrug": "2", "activesubstance": { "activesubstancename": "OCTREOTIDE ACETATE" }, "openfda": { "application_number": [ "NDA021008" ], "brand_name": [ "SANDOSTATIN LAR DEPOT" ], "generic_name": [ "OCTREOTIDE ACETATE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0811", "0078-0818", "0078-0825" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "898589", "898591", "898601", "898603", "898605", "898607" ], "spl_id": [ "2a2ad59f-21cd-4734-9c4b-0154e9db1642" ], "spl_set_id": [ "d0b7fe9e-7000-4b79-ba3b-291ce92c14f9" ], "package_ndc": [ "0078-0811-81", "0078-0790-61", "0078-0818-81", "0078-0797-61", "0078-0825-81", "0078-0804-61" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PROPANOLOL", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "032", "drugdosagetext": "1 DF, QHS", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "HYPERTENSION", "drugstartdateformat": "602", "drugstartdate": "1999", "actiondrug": "3", "activesubstance": { "activesubstancename": "PROPRANOLOL HYDROCHLORIDE" } }, { "drugcharacterization": "1", "medicinalproduct": "SANDOSTATIN LAR DEPOT", "drugauthorizationnumb": "021008", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugdosagetext": "10 MG, EACH 28 DAYS", "drugadministrationroute": "030", "actiondrug": "2", "activesubstance": { "activesubstancename": "OCTREOTIDE ACETATE" }, "openfda": { "application_number": [ "NDA021008" ], "brand_name": [ "SANDOSTATIN LAR DEPOT" ], "generic_name": [ "OCTREOTIDE ACETATE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0811", "0078-0818", "0078-0825" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "898589", "898591", "898601", "898603", "898605", "898607" ], "spl_id": [ "2a2ad59f-21cd-4734-9c4b-0154e9db1642" ], "spl_set_id": [ "d0b7fe9e-7000-4b79-ba3b-291ce92c14f9" ], "package_ndc": [ "0078-0811-81", "0078-0790-61", "0078-0818-81", "0078-0797-61", "0078-0825-81", "0078-0804-61" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 2007" } } }, { "safetyreportversion": "1", "safetyreportid": "10003976", "primarysourcecountry": "GB", "occurcountry": "GB", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "seriousnessdisabling": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "1", "companynumb": "GB-MYLANLABS-2014S1004595", "duplicate": "1", "reportduplicate": { "duplicatesource": "MYLAN", "duplicatenumb": "GB-MYLANLABS-2014S1004595" }, "primarysource": { "reportercountry": "GB", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "63", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Hypomagnesaemia", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Drug interaction", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "OMEPRAZOLE", "drugauthorizationnumb": "075876", "drugstructuredosagenumb": "40", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugadministrationroute": "048", "drugindication": "GASTROOESOPHAGEAL REFLUX DISEASE", "drugstartdateformat": "102", "drugstartdate": "20101129", "drugenddateformat": "610", "drugenddate": "201312", "actiondrug": "1", "drugrecurreadministration": "1", "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.", 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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. 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[EPC]" ], "pharm_class_moa": [ "Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]" ], "unii": [ "KG60484QX9", "8MDF5V39QO", "426QFE7XLK" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ASPIRIN", "drugstructuredosagenumb": "81", "drugstructuredosageunit": "003", "drugdosagetext": "81 MG, UNK", "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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Perrigo Company", "Rugby Laboratories", "Gendose Pharmaceuticals, LLC", "Hy-Vee", "Reliable 1 Laboratories LLC", "TOP CARE (Topco Associates LLC)", "TIME CAP LABORATORIES, INC", "Strive Pharmaceuticals Inc.", "HyVee Inc", "Strategic Sourcing Services LLC", "BETTER LIVING BRANDS, LLC", "JHK Inc dba American Safety & First Aid", "Meijer", "Direct Safety", "Salado Sales, Inc.", "Cintas Corp", "Geri-Care Pharmaceuticals, Corp", "Family Dollar Services Inc", "Dolgencorp, Inc", "Pinnacle RX LLC", "GOODSENSE", "Health Pharma USA, LLC", "TWIN MED LLC", "Pioneer Life Sciences, LLC", "Meijer Distribution Inc", "Dolgencorp, LLC", "Marlex Pharmaceuticals Inc.", "Sam's West Inc", "WinCo Foods, LLC", "Unifirst First Aid Corporaiton", "Safeway", "Medtech Products Inc.", "Lodaat LLC", "Acme United Corporation", "McKesson Medical-Surgical, Inc.", "DEMOULAS SUPER MARKETS, INC.", "Winco Foods, LLC", "Meijer, Inc.", "Richmond Pharmaceuticals, Inc", "Famora Inc.", "PUBLIX SUPER MARKETS INC", "FSA STORE INC.", "Pharbest Pharmaceuticals, Inc.", "Discount Drug Mart", "Dr. Wayne's", "H-E-B", "TopCare", "HHH Pharmaceuticals", "Athlete's Needs Inc", "Noble Otc LLC", "TOPCO ASSOCIATES LLC", "Cintas Corporation", "McKesson Medical-Surgical", "AMERIFOODS TRADING COMPANY", "TIME CAP LABS INC", "Perrigo Direct, Inc.", "Walmart Inc.", "Target Corporation", "Kroger", "HEB", "AmerisourceBergen (Good Neighbor Pharmacy) 46122", "Foundation Consumer Healthcare", "Aarkish Pharmaceuticals NJ Inc.", "OPMX LLC", "Foundation Consumer Healthcare LLC", "INVAHEALTH INC", "UNITED NATURAL FOODS, INC. DBA UNFI", "NUVICARE LLC", "Thompson", "FSA Store Inc.", "ULINE", "Wildman Business Group" ], "product_ndc": [ "47682-456", "71679-302", "36800-545", "0363-0587", "63868-898", "80513-289", "37808-157", "83324-075", "53943-431", "70677-1121", "50844-600", "83324-058", "85828-372", "57237-302", "72036-252", "21130-428", "37835-571", "69396-173", "68998-146", "72476-263", "54162-940", "70000-0147", "53943-081", "50066-610", "87580-001", "49035-467", "17714-009", "59726-065", "37808-861", "70000-0253", "11822-0600", "54738-128", "63941-249", "54257-274", "83324-090", "49483-382", "0280-2090", "69168-318", "46122-691", "59961-616", "59961-620", "0574-7034", "17714-010", "41163-563", "58228-0071", "0363-0218", "42507-605", "36800-274", "57237-349", "63981-563", "57896-981", "55758-363", "21130-051", "51824-077", "0904-6783", "11822-6910", "56062-274", "17714-121", "70000-0014", "41520-157", "49035-563", "55910-765", "0280-2000", "49483-330", "49483-349", "63941-081", "24385-278", 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Aggregation Inhibitor [EPC]" ], "unii": [ "R16CO5Y76E" ] } } ] } }, { "safetyreportversion": "3", "safetyreportid": "10004057", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20200713", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20200421", "fulfillexpeditecriteria": "2", "companynumb": "US-INCYTE CORPORATION-2013IN002783", "duplicate": "1", "reportduplicate": { "duplicatesource": "INCYTE", "duplicatenumb": "US-INCYTE CORPORATION-2013IN002783" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "reaction": [ { "reactionmeddraversionpt": "23.0", "reactionmeddrapt": "Malaise", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "23.0", "reactionmeddrapt": "Nausea", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "23.0", "reactionmeddrapt": "Haemoglobin decreased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "23.0", "reactionmeddrapt": "Headache", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "JAKAFI", "drugbatchnumb": "AA5270H", "drugauthorizationnumb": "202192", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "10 MG, BID", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "MYELOFIBROSIS", "drugstartdateformat": "102", "drugstartdate": "20131114", "drugenddateformat": "602", "drugenddate": "2013", "actiondrug": "1", "drugadditional": "2", "activesubstance": { "activesubstancename": "RUXOLITINIB" }, "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": [ 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UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "ESCITALOPRAM OXALATE" }, "openfda": { "application_number": [ "NDA021323" ], "brand_name": [ "LEXAPRO" ], "generic_name": [ "ESCITALOPRAM" ], "manufacturer_name": [ "Allergan, Inc." ], "product_ndc": [ "0456-2005", "0456-2010", "0456-2020", "0456-2101" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ESCITALOPRAM OXALATE" ], "rxcui": [ "349332", "351249", "351250", "351285", "352272", "352273", "404408", "404420" ], "spl_id": [ "9ff46a66-0f97-4a78-9d18-ec576f63bae7" ], "spl_set_id": [ "13bb8267-1cab-43e5-acae-55a4d957630a" ], "package_ndc": [ "0456-2005-01", "0456-2010-01", "0456-2010-11", "0456-2010-63", "0456-2020-01", "0456-2020-11", "0456-2020-63", "0456-2101-08" ], "unii": [ "5U85DBW7LO" ] } }, { "drugcharacterization": "1", "medicinalproduct": "JAKAFI", "drugbatchnumb": "8434857", "drugauthorizationnumb": "202192", "drugstructuredosagenumb": "5", "drugstructuredosageunit": 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[ "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": "ASPIRIN.", "drugstructuredosagenumb": "81", "drugstructuredosageunit": "003", "drugdosagetext": "81 MG, UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "ASPIRIN" }, "openfda": { "application_number": [ "M013", "M013.50", "part343", "M" ], "brand_name": [ "BAYER GENUINE ASPIRIN", "ASPIRIN", "ENTERIC ASPIRIN", "ADULT LOW DOSE ASPIRIN", 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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", 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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. DBA Leader", "DISCOUNT DRUG MART", "Genomma Lab USA", "Wisdrug AG", "Wal-Mart Stores Inc", "Advance Pharmaceutical Inc.", "P & L Development, LLC", "H. E. BUTT GROCERY COMPANY", "Rite Aid Corporation", "Richmond Pharmaceuticals, Inc.", "Valu Merchandisers Company", "Magno-Humphries, Inc.", "CHAIN DRUG MARKETING ASSOCIATION, INC.", "Time-Cap Labs, Inc", "Bayer HealthCare LLC.", "Allegiant Health", "Amerisource Bergen", "Bellegrove Medical Supply, Inc.", "Padagis US LLC", "United Natural Foods, Inc. dba UNFI", "PROSTAT FIRST AID", "HYVEE INC", "Topco Associates LLC", "COSTCO WHOLESALE CORPORATION", "Geri-Care Pharmaceutical Corp", "Pharmadel LLC", "Better Living Brands LLC", "New World Imports, Inc", "MAJOR PHARMACEUTICALS", "Publix Super Markets Inc", "CARDINAL HEALTH, INC.", "FOODHOLD U.S.A., LLC", "Dolgencorp, Inc. 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"0187-0063-01", "0187-0063-50", "0187-0063-10", "0187-0064-01", "0187-0064-50", "0187-0064-10", "0187-0065-01", "0187-0065-50", "0187-0065-10", "0093-3425-01", "0093-3425-05", "0093-3425-10", "0093-3426-01", "0093-3426-05", "0093-3426-10", "0093-3427-01", "0093-3427-05", "0093-3427-10", "62135-549-43", "62135-861-01", "62135-862-01", "62135-863-01", "62559-195-01", "62559-195-05", "62559-195-10", "62559-196-01", "62559-196-05", "62559-196-10", "62559-197-01", "62559-197-05", "62559-197-10", "0641-6044-01", "0641-6044-25", "0641-6046-01", "0641-6046-10", "0641-6045-01", "0641-6045-25", "0641-6047-01", "0641-6047-10", "72572-380-01", "72572-380-25", "69315-904-01", "69315-904-05", "69315-904-10", "69315-905-01", "69315-905-05", "69315-905-10", "69315-906-01", "69315-906-05", "69315-906-10", "0409-1539-03", "0409-1539-31", "0409-1985-03", "0409-1985-30", "63304-772-90", "63304-772-01", "63304-772-05", "63304-772-10", "63304-773-90", "63304-773-01", "63304-773-05", "63304-773-10", "63304-774-90", "63304-774-01", "63304-774-05", "63304-774-10", "0641-6003-01", "0641-6003-25", "0641-6002-01", "0641-6002-10", "0641-6001-01", "0641-6001-25", "0641-6000-01", "0641-6000-10" ], "nui": [ "N0000175694", "M0002356" ], "pharm_class_epc": [ "Benzodiazepine [EPC]" ], "pharm_class_cs": [ "Benzodiazepines [CS]" ], "unii": [ "O26FZP769L" ] } }, { "drugcharacterization": "2", "medicinalproduct": "TYLENOL PM", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "ACETAMINOPHEN\\DIPHENHYDRAMINE" }, "openfda": { "application_number": [ "M013" ], "brand_name": [ "TYLENOL PM EXTRA STRENGTH" ], "generic_name": [ "ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE", "ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE" ], "manufacturer_name": [ "Jones Healthcare Group - Packaging Services, Inc", "Kenvue Brands LLC" ], "product_ndc": [ "67414-608", "50580-608" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DIPHENHYDRAMINE HYDROCHLORIDE" ], "rxcui": [ "1092189", "1092378" ], "spl_id": [ "20aec2bd-9934-370f-e063-6294a90a2bae", "57301337-05f3-6afe-e063-6394a90aa4dd" ], "spl_set_id": [ "639f4e01-9723-a619-e053-2991aa0a549a", "ce58105b-f010-47af-8f31-6dd4ce4e9cba" ], "package_ndc": [ "67414-608-06", "67414-608-00", "50580-608-01", "50580-608-02", "50580-608-03", "50580-608-04", "50580-608-05", "50580-608-06", "50580-608-07", "50580-608-08" ], "unii": [ "362O9ITL9D", "TC2D6JAD40" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PRILOSEC", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "OMEPRAZOLE MAGNESIUM" }, "openfda": { "application_number": [ "NDA022056" ], "brand_name": [ "PRILOSEC" ], "generic_name": [ "OMEPRAZOLE MAGNESIUM" ], "manufacturer_name": [ "Covis Pharma US, Inc" ], "product_ndc": [ "70515-610", "70515-625" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "OMEPRAZOLE MAGNESIUM" ], "rxcui": [ "797058", "797061", "797063", "797065" ], "spl_id": [ "296db0e8-af6e-4053-874d-2a7c8f7aba50" ], "spl_set_id": [ "b6761f84-53ac-4745-a8c8-1e5427d7e179" ], "package_ndc": [ "70515-625-01", "70515-610-01" ], "unii": [ "426QFE7XLK" ] } }, { "drugcharacterization": "2", "medicinalproduct": "AMLODIPINE", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "AMLODIPINE BESYLATE" }, "openfda": { "application_number": [ "NDA219531", "NDA214439", "NDA211340" ], "brand_name": [ "SDAMLO", "NORLIQVA", "KATERZIA" ], "generic_name": [ "AMLODIPINE" ], "manufacturer_name": [ "Pangea Pharmaceuticals, LLC", "CMP Pharma, Inc.", "Azurity Pharmaceuticals, Inc." ], "product_ndc": [ "81279-133", "81279-134", "81279-135", "46287-035", "46287-037", "52652-5001" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AMLODIPINE BESYLATE", "AMLODIPINE", "AMLODIPINE BENZOATE" ], "rxcui": [ "2726058", "2726064", "2726065", "2726067", "2726068", "2726070", "2599173", "2599179", "2184120", "2184126" ], "spl_id": [ "4b0523be-cded-6306-e063-6394a90a8a12", "63a6bb49-fb68-4351-be5f-a6b6e8f6b540", "4fee8eba-2fa2-4a9c-884a-ccec171e1977", "461e8d10-1805-e107-e063-6294a90aa288" ], "spl_set_id": [ "886a7f97-60a4-4206-a6c7-5206069ed487", "c1730a51-4383-4c61-a9a1-7e1326bd0abe", "614d974f-51c7-4b18-8171-39eb6e8d4c03", "df673a4d-acb8-444c-a472-c87ab8cbd366" ], "package_ndc": [ "81279-133-10", "81279-134-10", "81279-135-10", "46287-035-15", "46287-037-01", "52652-5001-1" ], "unii": [ "864V2Q084H", "1J444QC288", "XD75TQ8A2P" ], "nui": [ "N0000000069", "N0000175421", "N0000175566", "M0006414", "N0000190114" ], "pharm_class_moa": [ "Calcium Channel Antagonists [MoA]", "Cytochrome P450 3A Inhibitors [MoA]" ], "pharm_class_epc": [ "Dihydropyridine Calcium Channel Blocker [EPC]", "Calcium Channel Blocker [EPC]" ], "pharm_class_cs": [ "Dihydropyridines [CS]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "SYMBICORT", "drugdosageform": "INHALER", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "BUDESONIDE\\FORMOTEROL FUMARATE DIHYDRATE" }, "openfda": { "application_number": [ "NDA021929" ], "brand_name": [ "SYMBICORT" ], "generic_name": [ "BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE" ], "manufacturer_name": [ "AstraZeneca Pharmaceuticals LP" ], "product_ndc": [ "0186-0370", "0186-0372" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "RESPIRATORY (INHALATION)" ], "substance_name": [ "BUDESONIDE", "FORMOTEROL FUMARATE" ], "rxcui": [ "1246288", "1246290", "1246304", "1246306", "1246314", "1246315", "1246316", "1246317" ], "spl_id": [ "1f05ded1-7d31-4cfc-8537-0e75f99ad452" ], "spl_set_id": [ "fafa4cf1-99c2-43d5-73ad-51f256de3be0" ], "package_ndc": [ "0186-0370-20", "0186-0370-28", "0186-0370-60", "0186-0372-20", "0186-0372-28", "0186-0372-60" ], "nui": [ "N0000175576", "N0000175450" ], "pharm_class_epc": [ "Corticosteroid [EPC]" ], "pharm_class_moa": [ "Corticosteroid Hormone Receptor Agonists [MoA]" ], "unii": [ "W34SHF8J2K", "Q3OKS62Q6X" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 2013" } } }, { "safetyreportversion": "2", "safetyreportid": "10004505", "primarysourcecountry": "CL", "occurcountry": "CL", "transmissiondateformat": "102", "transmissiondate": "20160304", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20151112", "fulfillexpeditecriteria": "1", "companynumb": "CL-PFIZER INC-2014067796", "duplicate": "1", "reportduplicate": { "duplicatesource": "PFIZER", "duplicatenumb": "CL-PFIZER INC-2014067796" }, "primarysource": { "reportercountry": "CL", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "78", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "Angiopathy", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "Hearing impaired", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "XALATAN", "drugauthorizationnumb": "020597", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "031", "drugdosagetext": "1 GTT IN EACH EYE, DAILY", "drugdosageform": "EYE DROPS, SOLUTION", "drugadministrationroute": "047", "drugindication": "GLAUCOMA", "actiondrug": "4", "activesubstance": { "activesubstancename": "LATANOPROST" }, "openfda": { "application_number": [ "NDA020597" ], "brand_name": [ "XALATAN" ], "generic_name": [ "LATANOPROST" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-419" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "OPHTHALMIC" ], "substance_name": [ "LATANOPROST" ], "rxcui": [ "314072", "542527" ], "spl_id": [ "45489b8b-2aab-4336-8552-1524493289f9" ], "spl_set_id": [ "a98595b3-9f47-48e0-b18d-550a2095f264" ], "package_ndc": [ "58151-419-35" ], "nui": [ "N0000175454", "M0017805" ], "pharm_class_epc": [ "Prostaglandin Analog [EPC]" ], "pharm_class_cs": [ "Prostaglandins [CS]" ], "unii": [ "6Z5B6HVF6O" ] } }, { "drugcharacterization": "2", "medicinalproduct": "HYDROCHLOROTHIAZIDE.", "drugdosagetext": "UNK", "activesubstance": { "activesubstancename": "HYDROCHLOROTHIAZIDE" }, "openfda": { "application_number": [ "ANDA040780", "ANDA203018", "ANDA040412", "ANDA085182", "ANDA203561", "ANDA078164", "ANDA087059", "ANDA087068", "ANDA090510", "ANDA040702", "ANDA040907", "NDA219141", "ANDA202556", "ANDA040707", "ANDA083177", "ANDA200645", "NDA020504" ], "brand_name": [ "HYDROCHLOROTHIAZIDE", "INZIRQO" ], "generic_name": [ 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"81279-133-10", "81279-134-10", "81279-135-10", "46287-035-15", "46287-037-01", "52652-5001-1" ], "unii": [ "864V2Q084H", "1J444QC288", "XD75TQ8A2P" ], "nui": [ "N0000000069", "N0000175421", "N0000175566", "M0006414", "N0000190114" ], "pharm_class_moa": [ "Calcium Channel Antagonists [MoA]", "Cytochrome P450 3A Inhibitors [MoA]" ], "pharm_class_epc": [ "Dihydropyridine Calcium Channel Blocker [EPC]", "Calcium Channel Blocker [EPC]" ], "pharm_class_cs": [ "Dihydropyridines [CS]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "KOPODEX", "drugdosagetext": "UNK", "activesubstance": { "activesubstancename": "LEVETIRACETAM" } }, { "drugcharacterization": "2", "medicinalproduct": "ATORVASTATIN", "drugdosagetext": "UNK", "activesubstance": { "activesubstancename": "ATORVASTATIN" } } ] } } ] }