{ "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": "2026-04-28", "results": { "skip": 0, "limit": 1, "total": 699271 } }, "results": [ { "safetyreportversion": "3", "safetyreportid": "10003532", "primarysourcecountry": "GB", "occurcountry": "GB", "transmissiondateformat": "102", "transmissiondate": "20150821", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20150602", "fulfillexpeditecriteria": "1", "companynumb": "GB-ABBVIE-14P-167-1209507-00", "duplicate": "1", "reportduplicate": { "duplicatesource": "ABBVIE", "duplicatenumb": "GB-ABBVIE-14P-167-1209507-00" }, "primarysource": { "reportercountry": "COUNTRY NOT SPECIFIED", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "59", "patientonsetageunit": "801", "patientweight": "105", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Chest pain", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Oedema peripheral", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Gastrooesophageal reflux disease", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "HUMIRA", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "125057", "drugstructuredosagenumb": "40", "drugstructuredosageunit": "003", "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", "1594352", "1594357", "1594358", "1655726", "1655728", "1656703", "1801277", "1801278", "1855523", "1855524", "1855526", "1855527", "1872983", "1872984", "1872985", "1872986", "1873086", "1873087", "1921244", "1921245", "1921467", "1921468", "2531133", "2531134" ], "spl_id": [ "5fe81b1a-cc31-444e-a0f1-1ea4f7334b89", "8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a" ], "spl_set_id": [ "4977567e-3525-44ac-9ff5-f1e74b053950", "608d4f0d-b19f-46d3-749a-7159aa5f933d" ], "package_ndc": [ "83457-554-02", "83457-553-01", "83457-927-01", "83457-124-02", "83457-123-01", "83457-243-02", "83457-242-01", "83457-616-02", "83457-615-01", "83457-817-02", "83457-816-01", "0074-3799-02", "0074-3799-71", "0074-3799-06", "0074-3799-03", "0074-4339-02", "0074-4339-07", "0074-4339-71", "0074-4339-73", "0074-4339-01", "0074-4339-74", "0074-9374-71", "0074-0243-02", "0074-0243-71", "0074-0554-01", "0074-0554-02", "0074-0554-04", "0074-0554-06", "0074-0554-71", "0074-0554-74", "0074-0554-73", "0074-0067-02", "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" } } } ] }