{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-07-30", "results": { "skip": 0, "limit": 10, "total": 703413 } }, "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" }, 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"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", 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"0074-0616-71", "0074-0616-02", "0074-0817-02" ] } } ] } }, { "safetyreportversion": "1", "safetyreportid": "10003548", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "2", "serious": "2", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "2", "companynumb": "US-ABBVIE-13P-163-1154207-00", "duplicate": "1", "reportduplicate": { "duplicatesource": "ABBVIE", "duplicatenumb": "US-ABBVIE-13P-163-1154207-00" }, "primarysource": { "reportercountry": "COUNTRY NOT SPECIFIED", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Urticaria", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", 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