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"pharm_class_moa": [ "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]" ] } }, { "drugcharacterization": "1", "medicinalproduct": "LIPITOR", "drugauthorizationnumb": "020702", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "10 MG, 1X/DAY", "drugdosageform": "FILM-COATED TABLET", "drugadministrationroute": "048", "drugindication": "LOW DENSITY LIPOPROTEIN INCREASED", "drugstartdateformat": "102", "drugstartdate": "20001104", "drugenddateformat": "102", "drugenddate": "20040903", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "openfda": { "application_number": [ "NDA020702" ], "brand_name": [ "LIPITOR" ], "generic_name": [ "ATORVASTATIN CALCIUM" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-155", "58151-156", "58151-157", "58151-158" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATORVASTATIN CALCIUM TRIHYDRATE" ], "rxcui": [ "259255", "262095", "617310", "617311", "617312", "617314", "617318", "617320" ], "spl_id": [ "dd011a82-7356-4b83-86c4-b21cd9138fc6" ], "spl_set_id": [ "a60cc18b-0631-4cf0-b021-9f52224ece65" ], "package_ndc": [ "58151-155-77", "58151-156-77", "58151-157-77", "58151-158-77" ], "unii": [ "48A5M73Z4Q" ] } }, { "drugcharacterization": "1", "medicinalproduct": "LIPITOR", "drugauthorizationnumb": "020702", "drugstructuredosagenumb": "80", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "80 MG, 1X/DAY", "drugdosageform": "FILM-COATED TABLET", "drugadministrationroute": "048", "drugindication": "HYPERCHOLESTEROLAEMIA", "drugstartdateformat": "102", "drugstartdate": "20050406", "drugenddateformat": "102", "drugenddate": "20051215", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "openfda": { "application_number": [ "NDA020702" ], "brand_name": [ "LIPITOR" ], "generic_name": [ "ATORVASTATIN CALCIUM" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-155", "58151-156", "58151-157", "58151-158" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATORVASTATIN CALCIUM TRIHYDRATE" ], "rxcui": [ "259255", "262095", "617310", "617311", "617312", "617314", "617318", "617320" ], "spl_id": [ "dd011a82-7356-4b83-86c4-b21cd9138fc6" ], "spl_set_id": [ "a60cc18b-0631-4cf0-b021-9f52224ece65" ], "package_ndc": [ "58151-155-77", "58151-156-77", "58151-157-77", "58151-158-77" ], "unii": [ "48A5M73Z4Q" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VYTORIN", "drugdosagetext": "10/80, DAILY (EVERY BEDTIME)", "drugindication": "HYPERLIPIDAEMIA", "drugstartdateformat": "102", "drugstartdate": "20060508", "drugenddateformat": "102", "drugenddate": "20060719", "activesubstance": { "activesubstancename": "EZETIMIBE\\SIMVASTATIN" }, "openfda": { "application_number": [ "NDA021687" ], "brand_name": [ "VYTORIN" ], "generic_name": [ "EZETIMIBE AND SIMVASTATIN" ], "manufacturer_name": [ "Organon LLC" ], "product_ndc": [ "78206-174", "78206-175", "78206-176", "78206-177" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EZETIMIBE", "SIMVASTATIN" ], "rxcui": [ "476345", "476349", "476350", "476351", "1245420", "1245430", "1245441", "1245449" ], "spl_id": [ "9e668c78-ea5d-4099-ba16-b77aebbcb68a" ], "spl_set_id": [ "89b860d2-de83-468e-b7e8-76aeec2edca2" ], "package_ndc": [ "78206-174-01", "78206-174-02", "78206-175-01", "78206-175-02", "78206-176-01", "78206-176-02", "78206-177-01", "78206-177-02" ], "nui": [ "N0000175589", "N0000000121", "N0000008553", "N0000175911" ], "pharm_class_epc": [ "HMG-CoA Reductase Inhibitor [EPC]", "Dietary Cholesterol Absorption Inhibitor [EPC]" ], "pharm_class_moa": [ "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]" ], "pharm_class_pe": [ "Decreased Cholesterol Absorption [PE]" ], "unii": [ "AGG2FN16EV", "EOR26LQQ24" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20090706" } } }, { "safetyreportversion": "5", "safetyreportid": "10006110", "primarysourcecountry": "BR", "occurcountry": "BR", "transmissiondateformat": "102", "transmissiondate": "20160815", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20160427", "fulfillexpeditecriteria": "1", "companynumb": "BR-ROCHE-1364267", "duplicate": "1", "reportduplicate": { "duplicatesource": "ROCHE", "duplicatenumb": "BR-ROCHE-1364267" }, "primarysource": { "reportercountry": "BR", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "55", "patientonsetageunit": "801", "patientweight": "50", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "19.0", "reactionmeddrapt": "Erysipelas", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "19.0", "reactionmeddrapt": "Limb injury", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "19.0", "reactionmeddrapt": "Weight decreased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "19.0", "reactionmeddrapt": "Drug tolerance", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "19.0", "reactionmeddrapt": "Immunodeficiency", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "19.0", "reactionmeddrapt": "Extremity necrosis", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "19.0", "reactionmeddrapt": "Blood cholesterol increased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "19.0", "reactionmeddrapt": "Arthropathy", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "19.0", "reactionmeddrapt": "Pain", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "19.0", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "19.0", "reactionmeddrapt": "Arthralgia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "19.0", "reactionmeddrapt": "Rheumatic fever", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "ARAVA", "activesubstance": { "activesubstancename": "LEFLUNOMIDE" }, "openfda": { "application_number": [ "NDA020905" ], "brand_name": [ "ARAVA" ], "generic_name": [ "LEFLUNOMIDE" ], "manufacturer_name": [ "sanofi-aventis U.S. LLC" ], "product_ndc": [ "0088-2160", "0088-2161", "0088-2162" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LEFLUNOMIDE" ], "rxcui": [ "205284", "205285", "205286", "213377", "213379", "213380" ], "spl_id": [ "765327c7-cb5b-4637-84da-4fd9a024ad96" ], "spl_set_id": [ "320f63f2-fac3-4aee-aff8-85724e00ef52" ], "package_ndc": [ "0088-2160-30", "0088-2161-30", "0088-2162-33" ], "nui": [ "N0000175713" ], "pharm_class_epc": [ "Antirheumatic Agent [EPC]" ], "unii": [ "G162GK9U4W" ] } }, { "drugcharacterization": "2", "medicinalproduct": "NAPRIX", "activesubstance": { "activesubstancename": "RAMIPRIL" } }, { "drugcharacterization": "2", "medicinalproduct": "VYTORIN", "activesubstance": { "activesubstancename": "EZETIMIBE\\SIMVASTATIN" }, "openfda": { "application_number": [ "NDA021687" ], "brand_name": [ "VYTORIN" ], "generic_name": [ "EZETIMIBE AND SIMVASTATIN" ], "manufacturer_name": [ "Organon LLC" ], "product_ndc": [ "78206-174", "78206-175", "78206-176", "78206-177" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EZETIMIBE", "SIMVASTATIN" ], "rxcui": [ "476345", "476349", "476350", "476351", "1245420", "1245430", "1245441", "1245449" ], "spl_id": [ "9e668c78-ea5d-4099-ba16-b77aebbcb68a" ], "spl_set_id": [ "89b860d2-de83-468e-b7e8-76aeec2edca2" ], "package_ndc": [ "78206-174-01", "78206-174-02", "78206-175-01", "78206-175-02", "78206-176-01", "78206-176-02", "78206-177-01", "78206-177-02" ], "nui": [ "N0000175589", "N0000000121", "N0000008553", "N0000175911" ], "pharm_class_epc": [ "HMG-CoA Reductase Inhibitor [EPC]", "Dietary Cholesterol Absorption Inhibitor [EPC]" ], "pharm_class_moa": [ "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]" ], "pharm_class_pe": [ "Decreased Cholesterol Absorption [PE]" ], "unii": [ "AGG2FN16EV", "EOR26LQQ24" ] } }, { "drugcharacterization": "1", "medicinalproduct": "ACTEMRA", "drugauthorizationnumb": "125276", "drugdosageform": "INFUSION", "drugadministrationroute": "042", "actiondrug": "1", "activesubstance": { "activesubstancename": "TOCILIZUMAB" }, "openfda": { "application_number": [ "BLA125276", "BLA125472" ], "brand_name": [ "ACTEMRA" ], "generic_name": [ "TOCILIZUMAB" ], "manufacturer_name": [ "Genentech, Inc." ], "product_ndc": [ "50242-135", "50242-136", "50242-137", "50242-138", "50242-143" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS", "SUBCUTANEOUS" ], "substance_name": [ "TOCILIZUMAB" ], "rxcui": [ "1441527", "1441530", "1657974", "1657976", "1657979", "1657980", "1657981", "1657982", "2106073", "2106075" ], "spl_id": [ "7f1b03d3-e0e1-4d90-b588-bb8d3ecb154a" ], "spl_set_id": [ "2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13" ], "package_ndc": [ "50242-135-01", "50242-136-01", "50242-137-01", "50242-138-01", "50242-138-86", "50242-143-01", "50242-143-86" ], "nui": [ "N0000190478", "N0000190480" ], "pharm_class_moa": [ "Interleukin 6 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Interleukin-6 Receptor Antagonist [EPC]" ], "unii": [ "I031V2H011" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VYTORIN", "activesubstance": { "activesubstancename": "EZETIMIBE\\SIMVASTATIN" }, "openfda": { "application_number": [ "NDA021687" ], "brand_name": [ "VYTORIN" ], "generic_name": [ "EZETIMIBE AND SIMVASTATIN" ], "manufacturer_name": [ "Organon LLC" ], "product_ndc": [ "78206-174", "78206-175", "78206-176", "78206-177" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EZETIMIBE", "SIMVASTATIN" ], "rxcui": [ "476345", "476349", "476350", "476351", "1245420", "1245430", "1245441", "1245449" ], "spl_id": [ "9e668c78-ea5d-4099-ba16-b77aebbcb68a" ], "spl_set_id": [ "89b860d2-de83-468e-b7e8-76aeec2edca2" ], "package_ndc": [ "78206-174-01", "78206-174-02", "78206-175-01", "78206-175-02", "78206-176-01", "78206-176-02", "78206-177-01", "78206-177-02" ], "nui": [ "N0000175589", "N0000000121", "N0000008553", "N0000175911" ], "pharm_class_epc": [ "HMG-CoA Reductase Inhibitor [EPC]", "Dietary Cholesterol Absorption Inhibitor [EPC]" ], "pharm_class_moa": [ "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]" ], "pharm_class_pe": [ "Decreased Cholesterol Absorption [PE]" ], "unii": [ "AGG2FN16EV", "EOR26LQQ24" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ASA", "activesubstance": { "activesubstancename": "ASPIRIN" } }, { "drugcharacterization": "1", "medicinalproduct": "ACTEMRA", "drugauthorizationnumb": "125276", "drugdosagetext": "MOST RECENT INFUSION WAS ON 05/FEB/2014", "drugdosageform": "INFUSION", "drugadministrationroute": "042", "drugindication": "RHEUMATOID ARTHRITIS", "drugstartdateformat": "102", "drugstartdate": "20110922", "actiondrug": "1", "activesubstance": { "activesubstancename": "TOCILIZUMAB" }, "openfda": { "application_number": [ "BLA125276", "BLA125472" ], "brand_name": [ "ACTEMRA" ], "generic_name": [ "TOCILIZUMAB" ], "manufacturer_name": [ "Genentech, Inc." ], "product_ndc": [ "50242-135", "50242-136", "50242-137", "50242-138", "50242-143" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS", "SUBCUTANEOUS" ], "substance_name": [ "TOCILIZUMAB" ], "rxcui": [ "1441527", "1441530", "1657974", "1657976", "1657979", "1657980", "1657981", "1657982", "2106073", "2106075" ], "spl_id": [ "7f1b03d3-e0e1-4d90-b588-bb8d3ecb154a" ], "spl_set_id": [ "2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13" ], "package_ndc": [ "50242-135-01", "50242-136-01", "50242-137-01", "50242-138-01", "50242-138-86", "50242-143-01", "50242-143-86" ], "nui": [ "N0000190478", "N0000190480" ], "pharm_class_moa": [ "Interleukin 6 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Interleukin-6 Receptor Antagonist [EPC]" ], "unii": [ "I031V2H011" ] } }, { "drugcharacterization": "1", "medicinalproduct": "ACTEMRA", "drugauthorizationnumb": "125276", "drugdosageform": "INFUSION", "drugadministrationroute": "042", "drugstartdateformat": "610", "drugstartdate": "201109", "drugenddateformat": "610", "drugenddate": "201410", "actiondrug": "1", "activesubstance": { "activesubstancename": "TOCILIZUMAB" }, "openfda": { "application_number": [ "BLA125276", "BLA125472" ], "brand_name": [ "ACTEMRA" ], "generic_name": [ "TOCILIZUMAB" ], "manufacturer_name": [ "Genentech, Inc." ], "product_ndc": [ "50242-135", "50242-136", "50242-137", "50242-138", "50242-143" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS", "SUBCUTANEOUS" ], "substance_name": [ "TOCILIZUMAB" ], "rxcui": [ "1441527", "1441530", "1657974", "1657976", "1657979", "1657980", "1657981", "1657982", "2106073", "2106075" ], "spl_id": [ "7f1b03d3-e0e1-4d90-b588-bb8d3ecb154a" ], "spl_set_id": [ "2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13" ], "package_ndc": [ "50242-135-01", "50242-136-01", "50242-137-01", "50242-138-01", "50242-138-86", "50242-143-01", "50242-143-86" ], "nui": [ "N0000190478", "N0000190480" ], "pharm_class_moa": [ "Interleukin 6 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Interleukin-6 Receptor Antagonist [EPC]" ], "unii": [ "I031V2H011" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VASOGARD", "activesubstance": { "activesubstancename": "CILOSTAZOL" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 201401" } } }, { "safetyreportversion": "1", "safetyreportid": "10006342", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20140313", "fulfillexpeditecriteria": "2", "companynumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-09514BP", "duplicate": "1", "reportduplicate": { "duplicatesource": "BOEHRINGER INGELHEIM", "duplicatenumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-09514BP" }, "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": "Restless legs syndrome", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Off label use", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "MIRAPEX", "drugauthorizationnumb": "022421", "drugstructuredosagenumb": "2.25", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "2.25 MG", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "RESTLESS LEGS SYNDROME", "drugstartdateformat": "602", "drugstartdate": "2013", "actiondrug": "4" }, { "drugcharacterization": "2", "medicinalproduct": "LOPRESSOR", "drugadministrationroute": "048", "drugindication": "HYPERTENSION", "openfda": { "application_number": [ "NDA219373", "NDA218698", "NDA017963" ], "brand_name": [ "LOPRESSOR" ], "generic_name": [ "METOPROLOL TARTRATE" ], "manufacturer_name": [ "VALIDUS PHARMACEUTICALS LLC", "Validus Pharmaceuticals LLC" ], "product_ndc": [ "30698-464", "30698-460", "30698-458", "30698-459" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "METOPROLOL TARTRATE" ], "rxcui": [ "2712147", "2712152", "2723025", "2723027", "866511", "866513", "866514", "866516" ], "spl_id": [ "352cee93-db0d-1c05-e063-6294a90a7533", "494efa43-aa90-d6f4-e063-6294a90a11ac", "28c4fc69-5609-49ec-8fe5-4d7bc8f88288" ], "spl_set_id": [ "9f448171-9588-4a54-88b3-5d870060ce86", "b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "0283bc9d-6998-493a-824a-d4c85f704111" ], "package_ndc": [ "30698-464-30", "30698-464-31", "30698-460-03", "30698-460-01", "30698-460-10", "30698-458-01", "30698-459-01" ], "unii": [ "W5S57Y3A5L" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VYTORIN", "drugadministrationroute": "048", "drugindication": "BLOOD CHOLESTEROL INCREASED", "openfda": { "application_number": [ "NDA021687" ], "brand_name": [ "VYTORIN" ], "generic_name": [ "EZETIMIBE AND SIMVASTATIN" ], "manufacturer_name": [ "Organon LLC" ], "product_ndc": [ "78206-174", "78206-175", "78206-176", "78206-177" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EZETIMIBE", "SIMVASTATIN" ], "rxcui": [ "476345", "476349", "476350", "476351", "1245420", "1245430", "1245441", "1245449" ], "spl_id": [ "9e668c78-ea5d-4099-ba16-b77aebbcb68a" ], "spl_set_id": [ "89b860d2-de83-468e-b7e8-76aeec2edca2" ], "package_ndc": [ "78206-174-01", "78206-174-02", "78206-175-01", "78206-175-02", "78206-176-01", "78206-176-02", "78206-177-01", "78206-177-02" ], "nui": [ "N0000175589", "N0000000121", "N0000008553", "N0000175911" ], "pharm_class_epc": [ "HMG-CoA Reductase Inhibitor [EPC]", "Dietary Cholesterol Absorption Inhibitor [EPC]" ], "pharm_class_moa": [ "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]" ], "pharm_class_pe": [ "Decreased Cholesterol Absorption [PE]" ], "unii": [ "AGG2FN16EV", "EOR26LQQ24" ] } } ] } }, { "safetyreportversion": "2", "safetyreportid": "10006387", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20200122", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20191030", "fulfillexpeditecriteria": "1", "companynumb": "US-PFIZER INC-2014066579", "duplicate": "1", "reportduplicate": { "duplicatesource": "PFIZER", "duplicatenumb": "US-PFIZER INC-2014066579" }, "primarysource": { "reportercountry": "US", "qualification": "4" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "56", "patientonsetageunit": "801", "patientweight": "82.99", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "22.1", "reactionmeddrapt": "Type 2 diabetes mellitus", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "PRAVASTATIN.", "drugstructuredosagenumb": "40", "drugstructuredosageunit": "003", "drugdosagetext": "40 MG, DAILY", "drugindication": "BLOOD CHOLESTEROL INCREASED", "drugstartdateformat": "102", "drugstartdate": "20100824", "drugenddateformat": "102", "drugenddate": "20110516", "activesubstance": { "activesubstancename": "PRAVASTATIN" } }, { "drugcharacterization": "1", "medicinalproduct": "LIPITOR", "drugauthorizationnumb": "020702", "drugdosagetext": "20 MG TO 40 MG, DAILY", "drugdosageform": "FILM-COATED TABLET", "drugadministrationroute": "048", "drugindication": "BLOOD CHOLESTEROL INCREASED", "drugstartdateformat": "102", "drugstartdate": "20000424", "drugenddateformat": "102", "drugenddate": "20100920", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "openfda": { "application_number": [ "NDA020702" ], "brand_name": [ "LIPITOR" ], "generic_name": [ "ATORVASTATIN CALCIUM" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-155", "58151-156", "58151-157", "58151-158" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATORVASTATIN CALCIUM TRIHYDRATE" ], "rxcui": [ "259255", "262095", "617310", "617311", "617312", "617314", "617318", "617320" ], "spl_id": [ "dd011a82-7356-4b83-86c4-b21cd9138fc6" ], "spl_set_id": [ "a60cc18b-0631-4cf0-b021-9f52224ece65" ], "package_ndc": [ "58151-155-77", "58151-156-77", "58151-157-77", "58151-158-77" ], "unii": [ "48A5M73Z4Q" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VYTORIN", "drugdosagetext": "10 MG TO 40 MG, DAILY", "drugindication": "BLOOD CHOLESTEROL INCREASED", "drugstartdateformat": "102", "drugstartdate": "20050511", "drugenddateformat": "102", "drugenddate": "20100306", "activesubstance": { "activesubstancename": "EZETIMIBE\\SIMVASTATIN" }, "openfda": { "application_number": [ "NDA021687" ], "brand_name": [ "VYTORIN" ], "generic_name": [ "EZETIMIBE AND SIMVASTATIN" ], "manufacturer_name": [ "Organon LLC" ], "product_ndc": [ "78206-174", "78206-175", "78206-176", "78206-177" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EZETIMIBE", "SIMVASTATIN" ], "rxcui": [ "476345", "476349", "476350", "476351", "1245420", "1245430", "1245441", "1245449" ], "spl_id": [ "9e668c78-ea5d-4099-ba16-b77aebbcb68a" ], "spl_set_id": [ "89b860d2-de83-468e-b7e8-76aeec2edca2" ], "package_ndc": [ "78206-174-01", "78206-174-02", "78206-175-01", "78206-175-02", "78206-176-01", "78206-176-02", "78206-177-01", "78206-177-02" ], "nui": [ "N0000175589", "N0000000121", "N0000008553", "N0000175911" ], "pharm_class_epc": [ "HMG-CoA Reductase Inhibitor [EPC]", "Dietary Cholesterol Absorption Inhibitor [EPC]" ], "pharm_class_moa": [ "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]" ], "pharm_class_pe": [ "Decreased Cholesterol Absorption [PE]" ], "unii": [ "AGG2FN16EV", "EOR26LQQ24" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20020625" } } }, { "safetyreportversion": "5", "safetyreportid": "10006566", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150528", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20141121", "fulfillexpeditecriteria": "1", "companynumb": "US-PFIZER INC-2014063289", "duplicate": "1", "reportduplicate": { "duplicatesource": "PFIZER", "duplicatenumb": "US-PFIZER INC-2014063289" }, "primarysource": { "reportercountry": "US", "qualification": "4" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "72", "patientonsetageunit": "801", "patientweight": "55", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Type 2 diabetes mellitus", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "ATORVASTATIN CALCIUM.", "drugauthorizationnumb": "020702", "drugstructuredosagenumb": "80", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "80 MG, 1X/DAY", "drugdosageform": "FILM-COATED TABLET", "drugadministrationroute": "048", "drugindication": "BLOOD CHOLESTEROL INCREASED", "drugstartdateformat": "602", "drugstartdate": "2009", "actiondrug": "5", "activesubstance": { "activesubstancename": 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"Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]" ] } }, { "drugcharacterization": "1", "medicinalproduct": "LIPITOR", "drugauthorizationnumb": "020702", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "20 MG, 1X/DAY", "drugdosageform": "FILM-COATED TABLET", "drugadministrationroute": "048", "drugindication": "LOW DENSITY LIPOPROTEIN INCREASED", "drugstartdateformat": "602", "drugstartdate": "2006", "drugenddateformat": "602", "drugenddate": "2009", "actiondrug": "5", "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "openfda": { "application_number": [ "NDA020702" ], "brand_name": [ "LIPITOR" ], "generic_name": [ "ATORVASTATIN CALCIUM" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-155", "58151-156", "58151-157", "58151-158" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATORVASTATIN CALCIUM TRIHYDRATE" ], "rxcui": [ "259255", "262095", "617310", "617311", "617312", "617314", "617318", "617320" ], "spl_id": [ "dd011a82-7356-4b83-86c4-b21cd9138fc6" ], "spl_set_id": [ "a60cc18b-0631-4cf0-b021-9f52224ece65" ], "package_ndc": [ "58151-155-77", "58151-156-77", "58151-157-77", "58151-158-77" ], "unii": [ "48A5M73Z4Q" ] } }, { "drugcharacterization": "1", "medicinalproduct": "LIPITOR", "drugauthorizationnumb": "020702", "drugdosageform": "FILM-COATED TABLET", "drugindication": "CARDIOVASCULAR EVENT PROPHYLAXIS", "actiondrug": "5", "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "openfda": { "application_number": [ "NDA020702" ], "brand_name": [ "LIPITOR" ], "generic_name": [ "ATORVASTATIN CALCIUM" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-155", "58151-156", "58151-157", "58151-158" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATORVASTATIN CALCIUM TRIHYDRATE" ], "rxcui": [ "259255", "262095", "617310", "617311", "617312", "617314", "617318", "617320" ], "spl_id": [ "dd011a82-7356-4b83-86c4-b21cd9138fc6" ], "spl_set_id": [ "a60cc18b-0631-4cf0-b021-9f52224ece65" ], "package_ndc": [ "58151-155-77", "58151-156-77", "58151-157-77", "58151-158-77" ], "unii": [ "48A5M73Z4Q" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VYTORIN", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "10MG OR 40 MG ONCE DAILY", "drugindication": "BLOOD CHOLESTEROL INCREASED", "drugstartdateformat": "602", "drugstartdate": "2008", "drugenddateformat": "602", "drugenddate": "2011", "activesubstance": { "activesubstancename": "EZETIMIBE\\SIMVASTATIN" }, "openfda": { "application_number": [ "NDA021687" ], "brand_name": [ "VYTORIN" ], "generic_name": [ "EZETIMIBE AND SIMVASTATIN" ], "manufacturer_name": [ "Organon LLC" ], "product_ndc": [ "78206-174", "78206-175", "78206-176", "78206-177" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EZETIMIBE", "SIMVASTATIN" ], "rxcui": [ "476345", "476349", "476350", "476351", "1245420", "1245430", "1245441", "1245449" ], "spl_id": [ "9e668c78-ea5d-4099-ba16-b77aebbcb68a" ], "spl_set_id": [ "89b860d2-de83-468e-b7e8-76aeec2edca2" ], "package_ndc": [ "78206-174-01", "78206-174-02", "78206-175-01", "78206-175-02", "78206-176-01", "78206-176-02", "78206-177-01", "78206-177-02" ], "nui": [ "N0000175589", "N0000000121", "N0000008553", "N0000175911" ], "pharm_class_epc": [ "HMG-CoA Reductase Inhibitor [EPC]", "Dietary Cholesterol Absorption Inhibitor [EPC]" ], "pharm_class_moa": [ "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]" ], "pharm_class_pe": [ "Decreased Cholesterol Absorption [PE]" ], "unii": [ "AGG2FN16EV", "EOR26LQQ24" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 2009" } } }, { "safetyreportversion": "5", "safetyreportid": "10007594", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150720", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20150217", "fulfillexpeditecriteria": "1", "companynumb": "US-PFIZER INC-2014069973", "duplicate": "1", "reportduplicate": { "duplicatesource": "PFIZER", "duplicatenumb": "US-PFIZER INC-2014069973" }, "primarysource": { "reportercountry": "US", "qualification": "4" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "67", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Type 2 diabetes mellitus", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "LOPID", "drugauthorizationnumb": "018422", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugdosagetext": "20 MG, DAILY", "drugdosageform": "FILM-COATED TABLET", "drugindication": "BLOOD CHOLESTEROL INCREASED", "drugstartdateformat": "602", "drugstartdate": "1985", "drugenddateformat": "602", "drugenddate": "1990", "activesubstance": { "activesubstancename": "GEMFIBROZIL" }, "openfda": { "application_number": [ "NDA018422" ], "brand_name": [ "LOPID" ], "generic_name": [ "GEMFIBROZIL" ], "manufacturer_name": [ "Parke-Davis Div of Pfizer Inc" ], "product_ndc": [ "0071-0737" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "GEMFIBROZIL" ], "rxcui": [ "205751", "310459" ], "spl_id": [ "c2888455-2200-497a-8e5a-10515dcb4f66" ], "spl_set_id": [ "c48855b7-215e-453b-b3b1-a0f9dee7221f" ], "package_ndc": [ "0071-0737-20", "0071-0737-30" ], "nui": [ "N0000175596", "N0000175375", "M0543661" ], "pharm_class_epc": [ "Peroxisome Proliferator Receptor alpha Agonist [EPC]" ], "pharm_class_moa": [ "Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]" ], "pharm_class_cs": [ "Fibric Acids [CS]" ], "unii": [ "Q8X02027X3" ] } }, { "drugcharacterization": "1", "medicinalproduct": "LIPITOR", "drugauthorizationnumb": "020702", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugdosagetext": "20 MG, DAILY, AS DIRECTED", "drugdosageform": "FILM-COATED TABLET", "drugadministrationroute": "048", "drugindication": "LOW DENSITY LIPOPROTEIN INCREASED", "drugstartdateformat": "602", "drugstartdate": "1998", "drugenddateformat": "610", "drugenddate": "200208", "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "openfda": { "application_number": [ "NDA020702" ], "brand_name": [ "LIPITOR" ], "generic_name": [ "ATORVASTATIN CALCIUM" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-155", "58151-156", "58151-157", "58151-158" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATORVASTATIN CALCIUM TRIHYDRATE" ], "rxcui": [ "259255", "262095", "617310", "617311", "617312", "617314", "617318", "617320" ], "spl_id": [ "dd011a82-7356-4b83-86c4-b21cd9138fc6" ], "spl_set_id": [ "a60cc18b-0631-4cf0-b021-9f52224ece65" ], "package_ndc": [ "58151-155-77", "58151-156-77", "58151-157-77", "58151-158-77" ], "unii": [ "48A5M73Z4Q" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VYTORIN", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugdosagetext": "20 MG, UNK", "drugindication": "BLOOD CHOLESTEROL INCREASED", "drugstartdateformat": "610", "drugstartdate": "200208", "drugenddateformat": "602", "drugenddate": "2014", "activesubstance": { "activesubstancename": "EZETIMIBE\\SIMVASTATIN" }, "openfda": { "application_number": [ "NDA021687" ], "brand_name": [ "VYTORIN" ], "generic_name": [ "EZETIMIBE AND SIMVASTATIN" ], "manufacturer_name": [ "Organon LLC" ], "product_ndc": [ "78206-174", "78206-175", "78206-176", "78206-177" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EZETIMIBE", "SIMVASTATIN" ], "rxcui": [ "476345", "476349", "476350", "476351", "1245420", "1245430", "1245441", "1245449" ], "spl_id": [ "9e668c78-ea5d-4099-ba16-b77aebbcb68a" ], "spl_set_id": [ "89b860d2-de83-468e-b7e8-76aeec2edca2" ], "package_ndc": [ "78206-174-01", "78206-174-02", "78206-175-01", "78206-175-02", "78206-176-01", "78206-176-02", "78206-177-01", "78206-177-02" ], "nui": [ "N0000175589", "N0000000121", "N0000008553", "N0000175911" ], "pharm_class_epc": [ "HMG-CoA Reductase Inhibitor [EPC]", "Dietary Cholesterol Absorption Inhibitor [EPC]" ], "pharm_class_moa": [ "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]" ], "pharm_class_pe": [ "Decreased Cholesterol Absorption [PE]" ], "unii": [ "AGG2FN16EV", "EOR26LQQ24" ] } }, { "drugcharacterization": "1", "medicinalproduct": "LIPITOR", "drugauthorizationnumb": "020702", "drugdosageform": "FILM-COATED TABLET", "drugindication": "CARDIOVASCULAR EVENT PROPHYLAXIS", "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "openfda": { "application_number": [ "NDA020702" ], "brand_name": [ "LIPITOR" ], "generic_name": [ "ATORVASTATIN CALCIUM" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-155", "58151-156", "58151-157", "58151-158" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATORVASTATIN CALCIUM TRIHYDRATE" ], "rxcui": [ "259255", "262095", "617310", "617311", "617312", "617314", "617318", "617320" ], "spl_id": [ "dd011a82-7356-4b83-86c4-b21cd9138fc6" ], "spl_set_id": [ "a60cc18b-0631-4cf0-b021-9f52224ece65" ], "package_ndc": [ "58151-155-77", "58151-156-77", "58151-157-77", "58151-158-77" ], "unii": [ "48A5M73Z4Q" ] } }, { "drugcharacterization": "1", "medicinalproduct": "LIPITOR", "drugauthorizationnumb": "020702", "drugdosageform": "FILM-COATED TABLET", "drugindication": "BLOOD TRIGLYCERIDES INCREASED", "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "openfda": { "application_number": [ "NDA020702" ], "brand_name": [ "LIPITOR" ], "generic_name": [ "ATORVASTATIN CALCIUM" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-155", "58151-156", "58151-157", "58151-158" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATORVASTATIN CALCIUM TRIHYDRATE" ], "rxcui": [ "259255", "262095", "617310", "617311", "617312", "617314", "617318", "617320" ], "spl_id": [ "dd011a82-7356-4b83-86c4-b21cd9138fc6" ], "spl_set_id": [ "a60cc18b-0631-4cf0-b021-9f52224ece65" ], "package_ndc": [ "58151-155-77", "58151-156-77", "58151-157-77", "58151-158-77" ], "unii": [ "48A5M73Z4Q" ] } }, { "drugcharacterization": "1", "medicinalproduct": "LIPITOR", "drugauthorizationnumb": "020702", "drugdosageform": "FILM-COATED TABLET", "drugindication": "BLOOD CHOLESTEROL INCREASED", "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "openfda": { "application_number": [ "NDA020702" ], "brand_name": [ "LIPITOR" ], "generic_name": [ "ATORVASTATIN CALCIUM" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-155", "58151-156", "58151-157", "58151-158" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATORVASTATIN CALCIUM TRIHYDRATE" ], "rxcui": [ "259255", "262095", "617310", "617311", "617312", "617314", "617318", "617320" ], "spl_id": [ "dd011a82-7356-4b83-86c4-b21cd9138fc6" ], "spl_set_id": [ "a60cc18b-0631-4cf0-b021-9f52224ece65" ], "package_ndc": [ "58151-155-77", "58151-156-77", "58151-157-77", "58151-158-77" ], "unii": [ "48A5M73Z4Q" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20031208" } } }, { "safetyreportversion": "4", "safetyreportid": "10008077", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150720", 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}, { "drugcharacterization": "1", "medicinalproduct": "LIPITOR", "drugauthorizationnumb": "020702", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugdosagetext": "10 MG, DAILY", "drugdosageform": "FILM-COATED TABLET", "drugadministrationroute": "048", "drugindication": "LOW DENSITY LIPOPROTEIN INCREASED", "drugstartdateformat": "610", "drugstartdate": "200203", "drugenddateformat": "610", "drugenddate": "200611", "actiondrug": "5", "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "openfda": { "application_number": [ "NDA020702" ], "brand_name": [ "LIPITOR" ], "generic_name": [ "ATORVASTATIN CALCIUM" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-155", "58151-156", "58151-157", "58151-158" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATORVASTATIN CALCIUM TRIHYDRATE" ], "rxcui": [ "259255", "262095", "617310", "617311", "617312", "617314", "617318", "617320" ], 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