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"71288-203-03", "71288-203-04", "71288-203-05", "71288-203-10", "71288-203-11", "16729-500-30", "16729-500-08", "16729-501-64", "16729-501-43", "16729-502-03", "16729-502-43", "10135-832-90", "10135-832-10", "10135-832-01", "10135-833-90", "10135-833-10", "10135-833-01", "10135-834-90", "10135-834-05", "10135-834-01", "81565-201-01", "81565-201-02", "62135-753-90", "62135-754-90", "69315-116-01", "69315-116-10", "69315-117-01", "69315-117-10", "69315-118-01", "69315-118-05", "73542-101-25", "73542-102-25", "73542-103-25", "83634-302-42", "83634-302-02", "83634-302-43", "83634-302-04", "83634-302-41", "83634-302-10", "63323-280-41", "63323-280-16", "63323-280-43", "63323-280-26", "63323-280-45", "63323-280-36", "0409-6102-35", "0409-6102-25", "0409-6102-36", "0409-6102-26", "0409-6102-37", "0409-6102-27", "42571-436-75", "42571-436-87", "42571-437-86", "42571-437-66", "42571-438-56", "42571-438-85", "64980-562-01", "64980-562-10", "64980-563-01", "64980-563-10", "64980-564-01", "64980-564-50", "71288-203-91", "71288-203-92", "71288-203-93", "71288-203-94", "63561-0164-9", "63561-0164-2", "63561-0164-1", "63561-0165-9", "63561-0165-2", "63561-0165-1", "63561-0166-9", "63561-0166-5", "63561-0166-1", "59651-796-01", "59651-796-99", "59651-797-01", "59651-797-99", "59651-798-01", "59651-798-05", "63323-280-01", "63323-280-02", "63323-280-03", "63323-280-04", "63323-280-05", "63323-280-10", "73043-022-01", "73043-023-01", "73043-024-01", "73043-025-01", "73043-026-01", "72603-133-01", "72603-133-25", "72603-251-01", "72603-251-25", "72603-474-01", "72603-474-25", "0409-6102-19", "0409-6102-02", "0409-6102-18", "0409-6102-04", "0409-6102-20", "0409-6102-10", "36000-063-05", "36000-064-05", "36000-065-05", "36000-282-25", "36000-283-25", "36000-284-25", "0143-9155-01", "0143-9155-25", "0143-9156-01", "0143-9156-10", "0143-9157-01", "0143-9157-10", "0143-9158-01", "0143-9159-01", "43547-401-10", "43547-401-11", "43547-401-51", "43547-401-94", "43547-402-10", "43547-402-11", "43547-402-51", "43547-402-94", "43547-403-10", "43547-403-50", "43547-403-11", "43547-403-94", "31722-310-31", "31722-310-32", "31722-309-31", "31722-309-32", "31722-311-10", "31722-311-31", "81137-001-15", "81137-001-35", "72572-275-01", "72572-275-10", "70756-618-82", "70756-618-05", "70756-618-25", "70756-619-85", "70756-619-05", "70756-619-10", "70756-619-25", "70756-620-86", "70756-620-25", "70756-620-10" ], "nui": [ "N0000175366", "N0000175590" ], "pharm_class_pe": [ "Increased Diuresis at Loop of Henle [PE]" ], "pharm_class_epc": [ "Loop Diuretic [EPC]" ], "unii": [ "7LXU5N7ZO5" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 2008" } } }, { "safetyreportversion": "4", "safetyreportid": "10968630", "primarysourcecountry": "DE", "occurcountry": "DE", "transmissiondateformat": "102", "transmissiondate": "20160304", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20150330", "receiptdateformat": "102", "receiptdate": "20151001", "fulfillexpeditecriteria": "1", "companynumb": "PHHO2015DE004664", "duplicate": "1", "reportduplicate": { "duplicatesource": "NOVARTIS", "duplicatenumb": "PHHO2015DE004664" }, "primarysource": { "reportercountry": "DE", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "71", "patientonsetageunit": "801", "patientweight": "86", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "Urinary incontinence", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "Incontinence", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "Dysuria", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "BLINDED LCZ696", "drugdosagetext": "CODE NOT BROKEN", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "CARDIAC FAILURE CHRONIC", "drugstartdateformat": "102", "drugstartdate": "20150331", "actiondrug": "4", "activesubstance": { "activesubstancename": "SACUBITRIL" } }, { "drugcharacterization": "1", "medicinalproduct": "ENTRESTO", "drugstructuredosagenumb": "100", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "100 MG, BID", "drugadministrationroute": "048", "drugindication": "CARDIAC FAILURE CHRONIC", "drugstartdateformat": "102", "drugstartdate": "20150310", "actiondrug": "4", "activesubstance": { "activesubstancename": "SACUBITRIL\\VALSARTAN" }, "openfda": { "application_number": [ "NDA207620", "NDA218591" ], "brand_name": [ "ENTRESTO" ], "generic_name": [ "SACUBITRIL AND VALSARTAN" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0659", "0078-0777", "0078-9659", "0078-9777", "0078-0696", "0078-1231", "0078-1238" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SACUBITRIL", "VALSARTAN" ], "rxcui": [ "1656340", "1656346", "1656349", "1656351", "1656354", "1656356", "2679793", "2679797", "2679800", "2679802" ], "spl_id": [ "27616611-6b9c-4e50-b93b-ed29c24f9857" ], "spl_set_id": [ "000dc81d-ab91-450c-8eae-8eb74e72296f" ], "package_ndc": [ "0078-0659-20", "0078-0659-67", "0078-0659-61", "0078-0659-35", "0078-0777-20", "0078-0777-67", "0078-0777-61", "0078-0777-35", "0078-9659-50", "0078-9777-50", "0078-0696-20", "0078-0696-67", "0078-0696-61", "0078-0696-35", "0078-1231-20", "0078-1238-20" ], "nui": [ "N0000000070", "N0000175561" ], "pharm_class_moa": [ "Angiotensin 2 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Angiotensin 2 Receptor Blocker [EPC]" ], "unii": [ "80M03YXJ7I", "17ERJ0MKGI" ] } }, { "drugcharacterization": "1", "medicinalproduct": "VALSARTAN / DIOVAN / VAL489 / CGP 48933", "drugstructuredosagenumb": "80", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "80 MG, BID", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "CARDIAC FAILURE CHRONIC", "drugstartdateformat": "102", "drugstartdate": "20150224", "actiondrug": "4", "activesubstance": { "activesubstancename": "VALSARTAN" } }, { "drugcharacterization": "1", "medicinalproduct": "DIOVAN", "drugdosagetext": "CODE NOT BROKEN", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "CARDIAC FAILURE CHRONIC", "drugstartdateformat": "102", "drugstartdate": "20150331", "actiondrug": "4", "activesubstance": { "activesubstancename": "VALSARTAN" }, "openfda": { "application_number": [ "NDA021283" ], "brand_name": [ "DIOVAN" ], "generic_name": [ "VALSARTAN" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0358", "0078-0423", "0078-1245", "0078-0359", "0078-1252", "0078-0360", "0078-1259" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "VALSARTAN" ], "rxcui": [ "349199", "349200", "349201", "349483", "351761", "351762", "352001", "352274" ], "spl_id": [ "bb542e5b-0b85-45db-8542-e203b9cd8618" ], "spl_set_id": [ "5ddba454-f3e6-43c2-a7a6-58365d297213" ], "package_ndc": [ "0078-0423-15", "0078-0358-34", "0078-1245-34", "0078-0359-34", "0078-1252-34", "0078-0360-34", "0078-1259-34" ], "nui": [ "N0000000070", "N0000175561" ], "pharm_class_moa": [ "Angiotensin 2 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Angiotensin 2 Receptor Blocker [EPC]" ], "unii": [ "80M03YXJ7I" ] } }, { "drugcharacterization": "1", "medicinalproduct": "BLINDED NO TREATMENT RECEIVED", "drugdosagetext": "CODE NOT BROKEN", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "CARDIAC FAILURE CHRONIC", "drugstartdateformat": "102", "drugstartdate": "20150331", "actiondrug": "4", "activesubstance": { "activesubstancename": "INVESTIGATIONAL PRODUCT" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20150323" } } }, { "safetyreportversion": "3", "safetyreportid": "11097946", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20160304", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20150507", "receiptdateformat": "102", "receiptdate": "20151111", "fulfillexpeditecriteria": "2", "companynumb": "US-PFIZER INC-2014350431", "duplicate": "1", "reportduplicate": { "duplicatesource": "PFIZER", "duplicatenumb": "US-PFIZER INC-2014350431" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "73", "patientonsetageunit": "801", "patientweight": "78", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "Fatigue", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "Product use issue", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "ZOLPIDEM", "drugdosagetext": "UNK", "activesubstance": { "activesubstancename": "ZOLPIDEM\\ZOLPIDEM TARTRATE" }, "openfda": { "application_number": [ "ANDA077214" ], "brand_name": [ "ZOLPIDEM" ], "generic_name": [ "ZOLPIDEM TARTRATE" ], "manufacturer_name": [ "ACI Healthcare USA, Inc" ], "product_ndc": [ "71093-155", "71093-156" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ZOLPIDEM TARTRATE" ], "rxcui": [ "854873", "854876" ], "spl_id": [ "69a3d187-578f-4e49-b8b3-109219a7bdf6" ], "spl_set_id": [ "021153ce-fe27-4ed1-8d88-b4157b0ed734" ], "package_ndc": [ "71093-155-06", "71093-155-04", "71093-156-04", "71093-156-06" ], "unii": [ "WY6W63843K" ] } }, { "drugcharacterization": "2", "medicinalproduct": "XARELTO", "drugstructuredosagenumb": "15", "drugstructuredosageunit": "003", "drugdosagetext": "15 MG, DAILY", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20150517", "activesubstance": { "activesubstancename": "RIVAROXABAN" }, "openfda": { "application_number": [ "NDA215859", "NDA022406" ], "brand_name": [ "XARELTO" ], "generic_name": [ "RIVAROXABAN" ], "manufacturer_name": [ "Janssen Pharmaceuticals, Inc." ], "product_ndc": [ "50458-575", "50458-577", "50458-580", "50458-578", "50458-579", "50458-584" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "RIVAROXABAN" ], "rxcui": [ "1114198", "1114202", "1232082", "1232084", "1232086", "1232088", "1549682", "1549683", "2059015", "2059017", "2588062", "2588066" ], "spl_id": [ "452610f0-5abb-448d-a1fc-9dd9be02bb66" ], "spl_set_id": [ "10db92f9-2300-4a80-836b-673e1ae91610" ], "package_ndc": [ "50458-577-60", "50458-577-18", "50458-577-14", "50458-577-01", "50458-577-10", "50458-580-01", "50458-580-10", "50458-580-30", "50458-580-07", "50458-580-90", "50458-578-01", "50458-578-10", "50458-578-30", "50458-578-90", "50458-578-14", "50458-578-07", "50458-579-01", "50458-579-10", "50458-579-30", "50458-579-90", "50458-579-99", "50458-579-07", "50458-579-89", "50458-584-51", "50458-584-52", "50458-575-01" ], "nui": [ "N0000175635", "N0000175637" ], "pharm_class_moa": [ "Factor Xa Inhibitors [MoA]" ], "pharm_class_epc": [ "Factor Xa Inhibitor [EPC]" ], "unii": [ "9NDF7JZ4M3" ] } }, { "drugcharacterization": "2", "medicinalproduct": "XALATAN", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "031", "drugdosagetext": "1 GTT, DAILY (EVERY EVENING)", "drugdosageform": "EYE DROPS", "drugadministrationroute": "047", "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": "LISINOPRIL.", "drugdosagetext": "UNK", "activesubstance": { "activesubstancename": "LISINOPRIL" }, "openfda": { "application_number": [ "ANDA212041", "ANDA208920", "ANDA077321", "NDA208401", "ANDA076102", "ANDA076164", "ANDA075903", "ANDA076059", "ANDA075743", "ANDA203508", "NDA019777", "ANDA077622" ], "brand_name": [ "LISINOPRIL", "QBRELIS", "ZESTRIL" ], "generic_name": [ "LISINOPRIL" ], "manufacturer_name": [ "Chartwell RX, LLC", "Quallent Pharmaceuticals Health LLC", "Azurity Pharmaceuticals, Inc.", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901)", "Solco healthcare U.S., LLC", "Camber Pharmaceuticals, Inc.", "Actavis Pharma, Inc.", "Lupin Pharmaceuticals, Inc.", "XLCare Pharmaceuticals Inc.", "Exelan Pharmaceuticals, Inc", "BluePoint Laboratories", "Exelan Pharmaceuticals Inc.", "Upsher-Smith Laboratories, LLC", "Aurobindo Pharma Limited" ], "product_ndc": [ "62135-640", "62135-641", "62135-642", "62135-643", "62135-644", "62135-645", "82009-062", "82009-063", "82009-064", "82009-065", "82009-066", "52652-3001", "23155-876", "23155-877", "23155-878", "23155-879", "23155-880", "23155-881", "43547-351", "43547-352", "43547-353", "43547-354", "43547-355", "43547-356", "31722-172", "31722-176", "31722-177", "31722-178", 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"HYPERTENSION", "drugstartdateformat": "102", "drugstartdate": "20150521", "actiondrug": "4", "activesubstance": { "activesubstancename": "METOPROLOL SUCCINATE" }, "openfda": { "application_number": [ "NDA019962" ], "brand_name": [ "TOPROL XL" ], "generic_name": [ "METOPROLOL SUCCINATE" ], "manufacturer_name": [ "Melinta Therapeutics, LLC" ], "product_ndc": [ "70842-110", "70842-113", "70842-112", "70842-111" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "METOPROLOL SUCCINATE" ], "rxcui": [ "866412", "866414", "866419", "866421", "866427", "866429", "866436", "866438" ], "spl_id": [ "a9037cc4-2d8d-45d5-9b89-2cd22c50d0a2" ], "spl_set_id": [ "496ddfaa-7c9c-4888-b747-a210249b367a" ], "package_ndc": [ "70842-113-02", "70842-112-02", "70842-111-02", "70842-110-02" ], "unii": [ "TH25PD4CCB" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20150515" } } }, { "safetyreportversion": "3", "safetyreportid": "11146368", 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"actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "activesubstance": { "activesubstancename": "ASPIRIN" }, "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 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"medicinalproduct": "HEPARIN", "drugadministrationroute": "065", "drugindication": "PROPHYLAXIS", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "HEPARIN SODIUM" } }, { "drugcharacterization": "1", "medicinalproduct": "PLACEBO", "drugdosagetext": "UNK", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20150513", "drugenddateformat": "102", "drugenddate": "20150519", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "UNSPECIFIED INGREDIENT" } }, { "drugcharacterization": "2", "medicinalproduct": "METOPROLOL.", "drugadministrationroute": "065", "drugindication": "CORONARY ARTERY DISEASE", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "METOPROLOL" }, "openfda": { "application_number": [ "ANDA078950", "ANDA091045", "ANDA202871", "ANDA090317" ], "brand_name": [ "METOPROLOL", "METOPROLOL TARTRATE" ], "generic_name": [ "METOPROLOL TARTRATE", 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"ISOSORBIDE DINITRATE" ], "manufacturer_name": [ "BluePoint Laboratories" ], "product_ndc": [ "68001-373", "68001-374", "68001-375" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ISOSORBIDE DINITRATE" ], "rxcui": [ "206842", "314055", "381056" ], "spl_id": [ "9498fa14-1614-4a8e-b872-41c11745b01e" ], "spl_set_id": [ "9498fa14-1614-4a8e-b872-41c11745b01e" ], "package_ndc": [ "68001-373-00", "68001-374-00", "68001-375-00" ], "nui": [ "N0000175415", "M0014874", "N0000009909" ], "pharm_class_epc": [ "Nitrate Vasodilator [EPC]" ], "pharm_class_cs": [ "Nitrates [CS]" ], "pharm_class_pe": [ "Vasodilation [PE]" ], "unii": [ "IA7306519N" ] } }, { "drugcharacterization": "1", "medicinalproduct": "PLACEBO", "drugdosagetext": "UNK", "drugadministrationroute": "048", "drugindication": "CARDIAC FAILURE CHRONIC", "drugstartdateformat": "102", "drugstartdate": "20150429", "drugenddateformat": "102", "drugenddate": "20150511", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "UNSPECIFIED INGREDIENT" } }, { "drugcharacterization": "2", "medicinalproduct": "OMEPRAZOLE.", "drugadministrationroute": "065", "drugindication": "GASTROOESOPHAGEAL REFLUX DISEASE", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "OMEPRAZOLE" }, "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 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}, { "drugcharacterization": "2", "medicinalproduct": "AMLODIPINE", "drugstructuredosagenumb": "5", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugcumulativedosagenumb": "595", "drugcumulativedosageunit": "003", "drugdosagetext": "5 MG, QD", "drugadministrationroute": "048", "drugindication": "HYPERTENSION", "drugstartdateformat": "102", "drugstartdate": "20150121", "drugenddateformat": "102", "drugenddate": "20150519", "actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "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: 20150510" } } }, { "safetyreportversion": "11", "safetyreportid": "11193938", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20191004", "reporttype": "2", "serious": "1", "seriousnesslifethreatening": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20150616", "receiptdateformat": "102", "receiptdate": "20190918", "fulfillexpeditecriteria": "1", "companynumb": "PHHO2015US010350", "duplicate": "1", "reportduplicate": { "duplicatesource": "SANDOZ", "duplicatenumb": "PHHO2015US010350" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "74", "patientonsetageunit": "801", "patientweight": "101.9", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "22.0", "reactionmeddrapt": "Haemorrhagic stroke", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "22.0", "reactionmeddrapt": "Subdural haematoma", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "22.0", "reactionmeddrapt": "Cerebral artery embolism", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "22.0", "reactionmeddrapt": "Headache", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "ACETYLSALICYLIC ACID", "drugauthorizationnumb": "999999", "drugstructuredosagenumb": "81", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugcumulativedosagenumb": "52326", "drugcumulativedosageunit": "003", "drugdosagetext": "81 MG, QD", "drugadministrationroute": "065", "drugindication": "PROPHYLAXIS", "drugstartdateformat": "102", "drugstartdate": "20130902", "drugenddateformat": "102", "drugenddate": "20150609", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "ASPIRIN" } }, { "drugcharacterization": "1", "medicinalproduct": "PLACEBO", "drugdosagetext": "UNK", "drugadministrationroute": "048", "drugindication": "CARDIAC FAILURE CHRONIC", "drugstartdateformat": "102", "drugstartdate": "20140825", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "UNSPECIFIED INGREDIENT" } }, { "drugcharacterization": "1", "medicinalproduct": "WARFARIN", "drugdosagetext": "VARIABLE DOSE", "drugadministrationroute": "065", "drugindication": "ATRIAL FLUTTER", "drugstartdateformat": "102", "drugstartdate": "20030305", "drugenddateformat": "102", "drugenddate": "20150609", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "WARFARIN" }, "openfda": { "application_number": [ "ANDA090935", "ANDA202202" ], "brand_name": [ "WARFARIN SODIUM" ], "generic_name": [ "WARFARIN" ], "manufacturer_name": [ "Exelan Pharmaceuticals Inc.", "Amneal Pharmaceuticals LLC" ], "product_ndc": [ "76282-327", "76282-328", "76282-329", "76282-330", "76282-331", "76282-332", "76282-333", "76282-334", "76282-335", "65162-761", "65162-762", "65162-763", "65162-764", "65162-765", "65162-766", "65162-767", "65162-768", "65162-769" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "WARFARIN SODIUM" ], "rxcui": [ "855288", "855296", "855302", "855312", "855318", "855324", "855332", "855338", "855344" ], "spl_id": [ "45e85c4e-ae91-4cf3-bd98-1d5b5aecc7c5", "caa13d7d-5a78-412c-8e5e-e03a51164e96" ], "spl_set_id": [ "c0cc4511-e656-4b6d-96cd-e02e76173b9d", "558b7a0d-5490-4c1b-802e-3ab3f1efe760" ], "package_ndc": [ "76282-327-01", "76282-327-10", "76282-328-01", "76282-328-10", "76282-329-01", "76282-329-10", "76282-330-01", "76282-330-10", "76282-331-01", "76282-331-10", "76282-332-01", "76282-332-10", "76282-333-01", "76282-333-10", "76282-334-01", "76282-335-01", "65162-761-10", "65162-761-50", "65162-761-11", "65162-762-10", "65162-762-50", "65162-762-11", "65162-763-10", "65162-763-50", "65162-763-11", "65162-764-10", "65162-764-50", "65162-764-11", "65162-765-10", "65162-765-50", "65162-765-11", "65162-766-10", "65162-766-50", "65162-766-11", "65162-767-10", "65162-767-50", "65162-767-11", "65162-768-10", "65162-768-50", "65162-768-11", "65162-769-10", "65162-769-50", "65162-769-11" ], "unii": [ "6153CWM0CL" ] } }, { "drugcharacterization": "1", "medicinalproduct": "PLAVIX", "drugstructuredosagenumb": "75", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugcumulativedosagenumb": "10875", "drugcumulativedosageunit": "003", "drugdosagetext": "75 MG, QD", "drugadministrationroute": "065", "drugindication": "PROPHYLAXIS", "drugstartdateformat": "102", "drugstartdate": "20150116", "drugenddateformat": "102", "drugenddate": "20150609", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "CLOPIDOGREL BISULFATE" }, "openfda": { "application_number": [ "NDA020839" ], "brand_name": [ "PLAVIX" ], "generic_name": [ "CLOPIDOGREL" ], "manufacturer_name": [ "Sanofi-Aventis U.S. LLC" ], "product_ndc": [ "0024-1171", "0024-1332" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CLOPIDOGREL BISULFATE" ], "rxcui": [ "213169", "309362", "749196", "749198" ], "spl_id": [ "ed60a9e7-49f4-469c-bb7a-08e1bb6057e2" ], "spl_set_id": [ "de8b0b67-eb25-4684-83b5-7ad785314227" ], "package_ndc": [ "0024-1171-90", "0024-1332-30" ], "unii": [ "08I79HTP27" ] } }, { "drugcharacterization": "1", "medicinalproduct": "ENTRESTO", "drugstructuredosagenumb": "200", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "200 MG, BID", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "CARDIAC FAILURE CHRONIC", "drugstartdateformat": "102", "drugstartdate": "20140825", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "SACUBITRIL\\VALSARTAN" }, "openfda": { "application_number": [ "NDA207620", "NDA218591" ], "brand_name": [ "ENTRESTO" ], "generic_name": [ "SACUBITRIL AND VALSARTAN" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0659", "0078-0777", "0078-9659", "0078-9777", "0078-0696", "0078-1231", "0078-1238" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SACUBITRIL", "VALSARTAN" ], "rxcui": [ "1656340", "1656346", "1656349", "1656351", "1656354", "1656356", "2679793", "2679797", "2679800", "2679802" ], "spl_id": [ "27616611-6b9c-4e50-b93b-ed29c24f9857" ], "spl_set_id": [ "000dc81d-ab91-450c-8eae-8eb74e72296f" ], "package_ndc": [ "0078-0659-20", "0078-0659-67", "0078-0659-61", "0078-0659-35", "0078-0777-20", "0078-0777-67", "0078-0777-61", "0078-0777-35", "0078-9659-50", "0078-9777-50", "0078-0696-20", "0078-0696-67", "0078-0696-61", "0078-0696-35", "0078-1231-20", "0078-1238-20" ], "nui": [ "N0000000070", "N0000175561" ], "pharm_class_moa": [ "Angiotensin 2 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Angiotensin 2 Receptor Blocker [EPC]" ], "unii": [ "80M03YXJ7I", "17ERJ0MKGI" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20150609" } } }, { "safetyreportversion": "2", "safetyreportid": "11222146", "primarysourcecountry": "FR", "occurcountry": "FR", "transmissiondateformat": "102", "transmissiondate": "20151125", "reporttype": "2", "serious": "1", "seriousnesslifethreatening": "1", "receivedateformat": "102", "receivedate": "20150626", "receiptdateformat": "102", "receiptdate": "20150727", "fulfillexpeditecriteria": "1", "companynumb": "PHHY2015FR074654", "duplicate": "1", "reportduplicate": { "duplicatesource": "NOVARTIS", "duplicatenumb": "PHHY2015FR074654" }, "primarysource": { "reportercountry": "FR", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "59", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "Ventricular tachycardia", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "ENTRESTO", "drugstructuredosagenumb": "500", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "500 MG, BID", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "CARDIAC FAILURE CHRONIC", "actiondrug": "4", "activesubstance": { "activesubstancename": "SACUBITRIL\\VALSARTAN" }, "openfda": { "application_number": [ "NDA207620", "NDA218591" ], "brand_name": [ "ENTRESTO" ], "generic_name": [ "SACUBITRIL AND VALSARTAN" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0659", "0078-0777", "0078-9659", "0078-9777", "0078-0696", "0078-1231", "0078-1238" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SACUBITRIL", "VALSARTAN" ], "rxcui": [ "1656340", "1656346", "1656349", "1656351", "1656354", "1656356", "2679793", "2679797", "2679800", "2679802" ], "spl_id": [ "27616611-6b9c-4e50-b93b-ed29c24f9857" ], "spl_set_id": [ "000dc81d-ab91-450c-8eae-8eb74e72296f" ], "package_ndc": [ "0078-0659-20", "0078-0659-67", "0078-0659-61", "0078-0659-35", "0078-0777-20", "0078-0777-67", "0078-0777-61", "0078-0777-35", "0078-9659-50", "0078-9777-50", "0078-0696-20", "0078-0696-67", "0078-0696-61", "0078-0696-35", "0078-1231-20", "0078-1238-20" ], "nui": [ "N0000000070", "N0000175561" ], "pharm_class_moa": [ "Angiotensin 2 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Angiotensin 2 Receptor Blocker [EPC]" ], "unii": [ "80M03YXJ7I", "17ERJ0MKGI" ] } }, { "drugcharacterization": "1", "medicinalproduct": "ENTRESTO", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20150603", "actiondrug": "4", "activesubstance": { "activesubstancename": "SACUBITRIL\\VALSARTAN" }, "openfda": { "application_number": [ "NDA207620", "NDA218591" ], "brand_name": [ "ENTRESTO" ], "generic_name": [ "SACUBITRIL AND VALSARTAN" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0659", "0078-0777", "0078-9659", "0078-9777", "0078-0696", "0078-1231", "0078-1238" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SACUBITRIL", "VALSARTAN" ], "rxcui": [ "1656340", "1656346", "1656349", "1656351", "1656354", "1656356", "2679793", "2679797", "2679800", "2679802" ], "spl_id": [ "27616611-6b9c-4e50-b93b-ed29c24f9857" ], "spl_set_id": [ "000dc81d-ab91-450c-8eae-8eb74e72296f" ], "package_ndc": [ "0078-0659-20", "0078-0659-67", "0078-0659-61", "0078-0659-35", "0078-0777-20", "0078-0777-67", "0078-0777-61", "0078-0777-35", "0078-9659-50", "0078-9777-50", "0078-0696-20", "0078-0696-67", "0078-0696-61", "0078-0696-35", "0078-1231-20", "0078-1238-20" ], "nui": [ "N0000000070", "N0000175561" ], "pharm_class_moa": [ "Angiotensin 2 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Angiotensin 2 Receptor Blocker [EPC]" ], "unii": [ "80M03YXJ7I", "17ERJ0MKGI" ] } }, { "drugcharacterization": "2", "medicinalproduct": "INEXIUM", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "activesubstance": { "activesubstancename": "ESOMEPRAZOLE" } }, { "drugcharacterization": "1", "medicinalproduct": "ENTRESTO", "drugstructuredosagenumb": "100", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "100 MG, BID", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20150601", "actiondrug": "4", "activesubstance": { "activesubstancename": "SACUBITRIL\\VALSARTAN" }, "openfda": { "application_number": [ "NDA207620", "NDA218591" ], "brand_name": [ "ENTRESTO" ], "generic_name": [ "SACUBITRIL AND VALSARTAN" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0659", "0078-0777", "0078-9659", "0078-9777", "0078-0696", "0078-1231", "0078-1238" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SACUBITRIL", "VALSARTAN" ], "rxcui": [ "1656340", "1656346", "1656349", "1656351", "1656354", "1656356", "2679793", "2679797", "2679800", "2679802" ], "spl_id": [ "27616611-6b9c-4e50-b93b-ed29c24f9857" ], "spl_set_id": [ "000dc81d-ab91-450c-8eae-8eb74e72296f" ], "package_ndc": [ "0078-0659-20", "0078-0659-67", "0078-0659-61", "0078-0659-35", "0078-0777-20", "0078-0777-67", "0078-0777-61", "0078-0777-35", "0078-9659-50", "0078-9777-50", "0078-0696-20", "0078-0696-67", "0078-0696-61", "0078-0696-35", "0078-1231-20", "0078-1238-20" ], "nui": [ "N0000000070", "N0000175561" ], "pharm_class_moa": [ "Angiotensin 2 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Angiotensin 2 Receptor Blocker [EPC]" ], "unii": [ "80M03YXJ7I", "17ERJ0MKGI" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PROCORALAN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "activesubstance": { "activesubstancename": "IVABRADINE" } }, { "drugcharacterization": "2", "medicinalproduct": "PREVISCAN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "activesubstance": { "activesubstancename": "FLUINDIONE" } }, { "drugcharacterization": "2", "medicinalproduct": "KARDEGIC", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "activesubstance": { "activesubstancename": "ASPIRIN LYSINE" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20150613" } } }, { "safetyreportversion": "1", "safetyreportid": "11290240", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20151125", "reporttype": "2", "serious": "1", "seriousnessdeath": "1", "receivedateformat": "102", "receivedate": "20150721", "receiptdateformat": "102", "receiptdate": "20150721", "fulfillexpeditecriteria": "1", "companynumb": "PHHO2015US007373", "duplicate": "1", "reportduplicate": { "duplicatesource": "NOVARTIS", "duplicatenumb": "PHHO2015US007373" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "58", "patientonsetageunit": "801", "patientweight": "102.4", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "Plasma cell myeloma", "reactionoutcome": "5" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "ASPIRIN.", "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", "CHEWABLE ASPIRIN", "DRUG MART EFFERVESCENT PAIN RELIEF", "ASPIRIN LOW DOSE", "ASPIRIN ENTERIC COATED", "ASPIRIN 81", "ADULT CHEWABLE ASPIRIN", "ASPIRIN 81MG", "ADULT LOW DOSE ENTERIC COATED ASPIRIN", "ASPIRIN LOW DOSE SAFETY COATED", "GERITREX ASPIRIN", "BUFFERED ASPIRIN", "ENTERIC COATED ASPIRIN", "BUFFERIN REGULAR STRENGTH PAIN RELIEF", "WISPIRIN", "EQUATE ASPIRIN", "LOW DOSE ASPIRIN", "HEB EFFERVESCENT PAIN RELIEF", "PAIN RELIEF ASPIRIN LOW DOSE", "ASPIRIN 81 MG LOW DOSE", "ASPIRIN EXTRA STRENGTH", "BAYER CHEWABLE - ASPIRIN REGIMEN LOW DOSE ASPIRIN CHERRY FLAVORED", "TRAVEL SAVVY ASPIRIN", "CHEWABLE ASPIRIN 81 MG", "TOPCARE ASPIRIN", "RAPIDOL ASPIRIN", "CAREALL ASPIRIN", "ASPIRIN REGULAR STRENGTH", "REGULAR STRENGTH ASPIRIN", "LOW DOSE MINIPRIN ENTERIC SAFETY COATED", "ASPIRIN DELAYED RELEASE", "GOOD NEIGHBOR PHARMACY ASPIRIN", "LEADER ASPIRIN", "CHEWABLE LOW DOSE ASPIRIN", "CIRCLE K ASPIRIN 325", "LOW DOSE ASPIRIN ENTERIC SAFETY COATED", "ASPIRIN 81MG ENTERIC COATED", "CHILDRENS ASPIRIN", "CVS EFFERVESCENT PAIN RELIEVER", "BASIC CARE ASPIRIN", "SIGNATURE SELECT EFFERVESCENT PAIN RELIEF", "TRI-BUFFERED ASPIRIN", "ASPIRIN ENTERIC COATED, REGULAR STRENGTH", "ASPIRIN LOW DOSE CHEWABLE", "ASPIRIN ENTERIC SAFETY COATED", "ASPIRIN 325 MG", "MEDIQUE AT HOME ASPIRIN", "REGULAR STRENGTH ENTERIC COATED ASPIRIN", "DYE-FREE ASPIRIN 81", "PUBLIX FAST RELIEF EFFERVESCENT - ORIGINAL FLAVOR", "BEST CHOICE EFFERVESCENT PAIN RELIEVER 36", "ASPIRIN 81 MG", "BAYER ASPIRIN ORIGINAL, TRAVEL BASIX", "BAYER ASPIRIN ORIGINAL, CVP HEALTH", "BAYER", "QUALITY CHOICE EFFERVESCENT PAIN RELIEF", "ASPI-COR", "UNISHIELD ASPIRIN", "FAMILY WELLNESS PAIN RELIEVER", "ASPIRINA CAPLETS", "ASPIRIN 81MG ENTERIC COATED LOW STRENGTH ASPIRIN REGIMEN", "EQUATE ASPIRIN CHEWABLE", "GOOD SENSE ASPIRIN", "BAYER ASPIRIN REGIMEN ENTERIC COATED", "RUGBY ASPIRIN", "ASPIRIN NSAID", "RIGHT REMEDIES LOW DOSE ASPIRIN 81MG", "ASPIRIN 50 CT", "SUNMARK ASPIRIN", "ASPIRIN PAIN RELIEF", "DIRECT SAFETY ASPIRIN", "ASPIRIN 81MG ENTERIC COATED DELAYED RELEASE", "FIRST AID 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. 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"b78d4e8a-2261-43c6-9321-ac2539bdfd2f", "0369d423-9ef2-0191-e063-6294a90a55e7", "48bd010d-6429-906e-e063-6394a90ae8b7", "4d832ba0-8b5c-de5a-246a-a5f30e884bb4", "854ac8f7-cca5-434c-a611-9c1752260d4a", "5bcccfd7-0ae8-4fad-a535-5efa7b327550", "1de47781-9000-0fc1-e063-6294a90a8139", "11256523-425c-48e8-afe1-e3a4e28c892e", "1553d57f-414d-2c66-e063-6294a90af8e0" ], "spl_set_id": [ "871251c0-36a1-4a32-9eab-ff6c1e925ca9", "0376351b-f1a0-43e5-a0b4-533072c49f39", "3e48217f-8175-4e9b-9fd0-909be4bbba95", "5c1c694c-4b08-469e-b538-08e69df06146", "433f8a86-5ad3-43db-8e62-c0812dd3d723", "7b325108-6940-50a7-96b4-822a5206e568", "4724dbb4-3613-4e6a-948f-a43d34f97f06", "acaaab63-c9ff-44c9-8fde-9a4ea6454dd7", "2b4255a7-f9f5-4235-8dbb-b0f03acbd624", "8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "751b79c6-bba8-4d29-b69c-a2ac6453fec8" ], "package_ndc": [ "16729-005-10", "16729-005-12", "16729-005-15", "16729-005-17", "16729-006-10", "16729-006-12", "16729-006-15", "16729-006-17", "16729-007-10", "16729-007-12", "16729-007-15", "16729-007-17", "16729-156-10", "16729-156-15", "16729-156-17", "16729-004-10", "16729-004-12", "16729-004-15", "16729-004-17", "16714-681-01", "16714-681-02", "16714-682-01", "16714-682-02", "16714-682-03", "16714-683-01", "16714-683-02", "16714-683-03", "16714-684-01", "16714-684-02", "16714-684-03", "16714-685-01", "16714-685-02", "16714-685-03", "68180-482-09", "68180-482-06", "68180-482-03", "68180-482-11", "68180-478-02", "68180-478-03", "68180-478-01", "68180-479-02", "68180-479-03", "68180-479-01", "68180-480-01", "68180-480-02", "68180-480-03", "68180-481-01", "68180-481-03", "68180-481-02", "68180-464-06", "68180-464-09", "68180-464-03", "68180-465-06", "68180-465-09", "68180-465-03", "42571-010-30", "42571-010-60", "42571-010-90", "42571-010-05", "42571-010-10", "42571-005-30", "42571-005-60", "42571-005-90", "42571-005-05", "42571-005-10", "42571-020-30", "42571-020-60", "42571-020-90", "42571-020-05", "42571-020-10", "42571-040-30", "42571-040-60", "42571-040-90", "42571-040-05", "42571-040-10", "42571-080-30", "42571-080-60", "42571-080-90", "42571-080-05", "42571-080-10", "72865-305-30", "72865-305-01", "72865-305-10", "72865-305-90", "72865-306-30", "72865-306-01", "72865-306-10", "72865-306-90", "72865-307-30", "72865-307-01", "72865-307-10", "72865-307-90", "72865-307-45", "72865-308-30", "72865-308-01", "72865-308-10", "72865-308-90", "72865-308-45", "72865-309-30", "72865-309-01", "72865-309-05", "72865-309-90", "72865-309-45", "72865-309-10", "70377-001-13", "70377-001-14", "70377-001-15", "70377-001-12", "70377-002-12", "70377-002-13", "70377-002-14", "70377-002-15", "70377-003-12", "70377-003-13", "70377-003-14", "70377-003-15", "70377-004-12", "70377-004-13", "70377-004-14", "70377-004-15", "70377-005-12", "70377-005-13", "70377-005-14", "70377-005-15", "65862-050-30", "65862-050-45", "65862-050-90", "65862-050-01", "65862-050-00", "65862-050-99", "65862-050-26", "65862-051-30", "65862-051-45", "65862-051-90", "65862-051-01", "65862-051-00", "65862-051-99", "65862-051-26", "65862-052-30", "65862-052-45", "65862-052-90", "65862-052-01", "65862-052-00", "65862-052-99", "65862-052-26", "65862-053-30", "65862-053-45", "65862-053-90", "65862-053-01", "65862-053-00", "65862-053-99", "65862-053-22", "65862-054-30", "65862-054-45", "65862-054-90", "65862-054-00", "65862-054-99", "65862-054-39", "69367-374-09", "69367-374-10", "69367-375-09", "69367-375-10", "69367-376-09", "69367-376-10", "69367-377-09", "69367-377-10", "82009-013-10", "82009-012-10", "82009-014-10", "82009-015-10", "82009-016-05", "78206-182-01", "78206-182-02", "78206-181-02", "78206-181-01", "78206-180-01", "78206-180-02", "31722-510-30", "31722-510-01", "31722-510-10", "31722-510-90", "31722-511-30", "31722-511-01", "31722-511-10", "31722-511-90", "31722-512-30", "31722-512-01", "31722-512-10", "31722-512-90", "31722-513-30", "31722-513-01", "31722-513-10", "31722-513-90", "31722-514-30", "31722-514-01", "31722-514-05", "31722-514-90" ], "nui": [ "N0000175589", "N0000000121" ], "pharm_class_epc": [ "HMG-CoA Reductase Inhibitor [EPC]" ], "pharm_class_moa": [ "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]" ], "unii": [ "AGG2FN16EV" ] } }, { "drugcharacterization": "1", "medicinalproduct": "ENTRESTO", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "032", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "1 DF, (TAB)", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "CARDIAC FAILURE CHRONIC", "drugstartdateformat": "102", "drugstartdate": "20150325", "activesubstance": { "activesubstancename": "SACUBITRIL\\VALSARTAN" }, "openfda": { "application_number": [ "NDA207620", "NDA218591" ], "brand_name": [ "ENTRESTO" ], "generic_name": [ "SACUBITRIL AND VALSARTAN" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0659", "0078-0777", "0078-9659", "0078-9777", "0078-0696", "0078-1231", "0078-1238" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SACUBITRIL", "VALSARTAN" ], "rxcui": [ "1656340", "1656346", "1656349", "1656351", "1656354", "1656356", "2679793", "2679797", "2679800", "2679802" ], "spl_id": [ "27616611-6b9c-4e50-b93b-ed29c24f9857" ], "spl_set_id": [ "000dc81d-ab91-450c-8eae-8eb74e72296f" ], "package_ndc": [ "0078-0659-20", "0078-0659-67", "0078-0659-61", "0078-0659-35", "0078-0777-20", "0078-0777-67", "0078-0777-61", "0078-0777-35", "0078-9659-50", "0078-9777-50", "0078-0696-20", "0078-0696-67", "0078-0696-61", "0078-0696-35", "0078-1231-20", "0078-1238-20" ], "nui": [ "N0000000070", "N0000175561" ], "pharm_class_moa": [ "Angiotensin 2 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Angiotensin 2 Receptor Blocker [EPC]" ], "unii": [ "80M03YXJ7I", "17ERJ0MKGI" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LASIX", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "FUROSEMIDE" }, "openfda": { "application_number": [ "NDA016273" ], "brand_name": [ "LASIX" ], "generic_name": [ "FUROSEMIDE" ], "manufacturer_name": [ "Validus Pharmaceuticals LLC" ], "product_ndc": [ "30698-060", "30698-067", "30698-066" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "FUROSEMIDE" ], "rxcui": [ "197732", "200801", "200809", "205732", "310429", "313988" ], "spl_id": [ "4002943d-0b4b-4ff0-e063-6394a90ae63b" ], "spl_set_id": [ "2c9b4d8f-0770-482d-a9e6-9c616a440b1a" ], "package_ndc": [ "30698-067-01", "30698-067-10", "30698-060-01", "30698-060-10", "30698-060-50", "30698-066-05", "30698-066-50" ], "nui": [ "N0000175366", "N0000175590" ], "pharm_class_pe": [ "Increased Diuresis at Loop of Henle [PE]" ], "pharm_class_epc": [ "Loop Diuretic [EPC]" ], "unii": [ "7LXU5N7ZO5" ] } }, { "drugcharacterization": "2", "medicinalproduct": "COUMADINE", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "WARFARIN SODIUM" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20150421" } } }, { "safetyreportversion": "1", "safetyreportid": "11313359", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20151125", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20150727", "receiptdateformat": "102", "receiptdate": "20150727", "fulfillexpeditecriteria": "2", "companynumb": "PHEH2015US014252", "duplicate": "1", "reportduplicate": { "duplicatesource": "NOVARTIS", "duplicatenumb": "PHEH2015US014252" }, "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "reaction": [ { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "Hypotension", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "ENTRESTO", "drugauthorizationnumb": "207620", "drugadministrationroute": "065", "drugindication": "CARDIAC FAILURE CHRONIC", "actiondrug": "5", "activesubstance": { "activesubstancename": "SACUBITRIL\\VALSARTAN" }, "openfda": { "application_number": [ "NDA207620", "NDA218591" ], "brand_name": [ "ENTRESTO" ], "generic_name": [ "SACUBITRIL AND VALSARTAN" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0659", "0078-0777", "0078-9659", "0078-9777", "0078-0696", "0078-1231", "0078-1238" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SACUBITRIL", "VALSARTAN" ], "rxcui": [ "1656340", "1656346", "1656349", "1656351", "1656354", "1656356", "2679793", "2679797", "2679800", "2679802" ], "spl_id": [ "27616611-6b9c-4e50-b93b-ed29c24f9857" ], "spl_set_id": [ "000dc81d-ab91-450c-8eae-8eb74e72296f" ], "package_ndc": [ "0078-0659-20", "0078-0659-67", "0078-0659-61", "0078-0659-35", "0078-0777-20", "0078-0777-67", "0078-0777-61", "0078-0777-35", "0078-9659-50", "0078-9777-50", "0078-0696-20", "0078-0696-67", "0078-0696-61", "0078-0696-35", "0078-1231-20", "0078-1238-20" ], "nui": [ "N0000000070", "N0000175561" ], "pharm_class_moa": [ "Angiotensin 2 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Angiotensin 2 Receptor Blocker [EPC]" ], "unii": [ "80M03YXJ7I", "17ERJ0MKGI" ] } } ] } } ] }