{ "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": 1, "total": 1 } }, "results": [ { "safetyreportversion": "4", "safetyreportid": "14336626", "primarysourcecountry": "CA", "occurcountry": "CA", "transmissiondateformat": "102", "transmissiondate": "20181010", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20171229", "receiptdateformat": "102", "receiptdate": "20180904", "fulfillexpeditecriteria": "1", "companynumb": "CA-CELLTRION INC.-2017CA014322", "duplicate": "1", "reportduplicate": { "duplicatesource": "CELLTRION", "duplicatenumb": "CA-CELLTRION INC.-2017CA014322" }, "primarysource": { "reportercountry": "CA", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "reaction": [ { "reactionmeddraversionpt": "21.0", "reactionmeddrapt": "Blood pressure fluctuation", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "21.0", "reactionmeddrapt": "Blood pressure fluctuation", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "21.0", "reactionmeddrapt": "Fatigue", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.0", "reactionmeddrapt": "Hypertension", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.0", "reactionmeddrapt": "Muscle spasms", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.0", "reactionmeddrapt": "Migraine", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.0", "reactionmeddrapt": "Somnolence", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.0", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.0", "reactionmeddrapt": "Arthralgia", "reactionoutcome": "6" } ], "drug": [ { 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"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" ] } }, { "drugcharacterization": "1", "medicinalproduct": "INFLECTRA", "drugbatchnumb": "245087", "drugstructuredosagenumb": "810", "drugstructuredosageunit": "003", "drugdosagetext": "810 MG, CYCLIC (EVERY 0, 2, 6, WEEKS, THEN EVERY 8 WEEKS)", "drugdosageform": "POWDER FOR INJECTION", "drugadministrationroute": "042", "drugindication": "ANKYLOSING SPONDYLITIS", "drugstartdateformat": "102", "drugstartdate": "20171006", "drugenddateformat": "102", "drugenddate": "20171116", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "INFLIXIMAB-DYYB" }, "openfda": { "application_number": [ "BLA125544" ], "brand_name": [ "INFLECTRA" ], "generic_name": [ "INFLIXIMAB-DYYB" ], "manufacturer_name": [ "Pfizer Laboratories Div Pfizer Inc" ], "product_ndc": [ "0069-0809" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "INFLIXIMAB" ], "rxcui": [ "1790541", "1790546" ], "spl_id": [ "248ec8d1-8b3d-480f-8cdc-dbda1f130d17" ], "spl_set_id": [ "37eaca10-d812-48bc-8b8e-b836bfa9968f" ], "package_ndc": [ "0069-0809-01" ], "nui": [ "N0000175610", "N0000175451" ], "pharm_class_epc": [ "Tumor Necrosis Factor Blocker [EPC]" ], "pharm_class_moa": [ "Tumor Necrosis Factor Receptor Blocking Activity [MoA]" ], "unii": [ "B72HH48FLU" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CELEBREX", "drugstructuredosagenumb": "200", "drugstructuredosageunit": "003", "drugdosagetext": "200 MG, 2X/DAY", "drugadministrationroute": "065", "activesubstance": { "activesubstancename": "CELECOXIB" }, "openfda": { "application_number": [ "NDA020998" ], "brand_name": [ "CELEBREX" ], "generic_name": [ "CELECOXIB" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-082", "58151-083", "58151-084", "58151-085" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CELECOXIB" ], "rxcui": [ "205322", "205323", "213468", "213469", "349514", "352314", "686379", "686381" ], "spl_id": [ "0c321a7b-89e4-48cc-ab0b-1bd7620d7799" ], "spl_set_id": [ "2d6675e4-5859-4be2-8037-a20ce9f707aa" ], "package_ndc": [ "58151-082-91", "58151-083-01", "58151-083-05", "58151-083-32", "58151-083-88", "58151-084-01", "58151-084-05", "58151-084-32", "58151-084-88", "58151-085-91", "58151-085-32", "58151-085-88" ], "nui": [ "N0000000160", "M0001335", "N0000175722" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]" ], "unii": [ "JCX84Q7J1L" ] } }, { "drugcharacterization": "2", "medicinalproduct": "NAPROSYN", "drugadministrationroute": "065", "activesubstance": { "activesubstancename": "NAPROXEN" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20171006" } } } ] }