{ "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": "1", "safetyreportid": "22621709", "primarysourcecountry": "CA", "occurcountry": "CA", "transmissiondateformat": "102", "transmissiondate": "20230721", "reporttype": "2", "serious": "1", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "1", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "2", "receivedateformat": "102", "receivedate": "20230620", "receiptdateformat": "102", "receiptdate": "20230620", "fulfillexpeditecriteria": "1", "companynumb": "CA-PFIZER INC-202300222504", "duplicate": "1", "reportduplicate": { "duplicatesource": "Health Canada", "duplicatenumb": "E2B_05929643" }, "primarysource": { "reportercountry": "CA", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "69", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "26.0", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "26.0", "reactionmeddrapt": "Lung disorder", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "26.0", "reactionmeddrapt": "Pain in extremity", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "METHOTREXATE SODIUM", "drugauthorizationnumb": "011719", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "METHOTREXATE SODIUM" }, "openfda": { "application_number": [ "ANDA040263", "ANDA201749", "ANDA040266", "ANDA216453", "ANDA040054" ], "brand_name": [ "METHOTREXATE", "METHOTREXATE SODIUM" ], "generic_name": [ "METHOTREXATE SODIUM" ], "manufacturer_name": [ "Fresenius Kabi USA, LLC", "Sun Pharmaceutical Industries, Inc.", "Elite Laboratories, Inc.", "Hikma Pharmaceuticals USA Inc." ], "product_ndc": [ "63323-123", "47335-235", "63323-122", "64850-330", "0054-4550", "0054-8550" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRA-ARTERIAL", "INTRAMUSCULAR", "INTRAVENOUS", "ORAL", "INTRATHECAL" ], "substance_name": [ "METHOTREXATE SODIUM" ], "rxcui": [ "1946772", "105585", "311625" ], "spl_id": [ "880c2caa-1b11-45ce-a54e-a3733da367f0", "524f657e-d138-9c87-e063-6294a90a93ad", "3d21237a-ef53-4592-bf06-0c739696203d", "030a6bcf-d482-4c98-9d27-423235cdb930", "09f7cdcb-241e-4916-a68c-b4c452d3d640" ], "spl_set_id": [ "b585f621-f6c9-4735-ab61-bd1b401f3df0", "8f1260de-b60c-4f0e-8af6-0e957b0a281b", "ec476b11-0b3c-4139-b1eb-a3daa76bc271", "89c05ea3-3be1-46dd-b112-29c436fd7289", "d71b1856-99d8-4a9e-9189-f87b6675f80a" ], "package_ndc": [ "63323-123-10", "47335-235-96", "47335-235-83", "63323-122-50", "64850-330-01", "0054-4550-25", "0054-4550-15", "0054-8550-25" ], "unii": [ "3IG1E710ZN" ] } }, { "drugcharacterization": "1", "medicinalproduct": "ORENCIA", "drugstructuredosagenumb": "125", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosagetext": "125 MG, WEEKLY", "drugadministrationroute": "058", "drugindication": "Rheumatoid arthritis", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "ABATACEPT" }, "openfda": { "application_number": [ "BLA125118" ], "brand_name": [ "ORENCIA" ], "generic_name": [ "ABATACEPT" ], "manufacturer_name": [ "E.R. 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SODIUM", "activesubstance": { "activesubstancename": "DICLOFENAC SODIUM" }, "openfda": { "application_number": [ "ANDA212506", "ANDA209903", "ANDA206116", "ANDA208021", "ANDA212351", "ANDA208098", "ANDA210986", "ANDA211253", "ANDA208198", "ANDA205878", "ANDA208301", "ANDA217646", "ANDA219945", "ANDA077600", "ANDA203818", "ANDA208077", "ANDA204306", "ANDA213040", "NDA022122", "ANDA076201", "ANDA078031", "ANDA203383", "ANDA078792", "ANDA076152", "ANDA075185", "ANDA074514", "ANDA216548", "ANDA077863", "ANDA090066", "ANDA210893", "ANDA216275", "ANDA206298", "ANDA075281", "ANDA075492", "ANDA206493" ], "brand_name": [ "DICLOFENAC SODIUM", "ARTHRITIS PAIN RELIEVER", "ASPERCREME ARTHRITIS", "TOPCARE ATHRITIS PAIN RELIEVER", "TOPCARE ARTHRITIS PAIN RELIEVER", "GOOD SENSE ARTHRITIS PAIN", "SALONPAS", "VOLTAREN ARTHRITIS PAIN", "EQUATE ARTHRITIS PAIN", "ARTHRITIS PAIN RELIEVING", "DG HEALTH ARTHRITIS PAIN", "KIRKLAND SIGNATURE ARTHRITIS PAIN RELIEF", "DICLOFENAC SODIUM TOPICAL 1%", "DICLOFENAC", "MOTRIN ARTHRITIS PAIN", "UP AND UP ARTHRITIS PAIN RELIEVER", "MEMBERS MARK ARTHRITIS PAIN RELIEVER", "DICLOFENAC SODIUM DELAYED RELEASE", "DICLOFENAC SODIUM TOPICAL", "BERKLEY AND JENSEN ARTHRITIS PAIN", "FOSTER AND THRIVE ARTHRITIS PAIN", "AMAZON BASIC CARE ARTHRITIS PAIN", "GENCARE-ARTHRITIS PAIN RELIEF", "ARTHRITIS PAIN RELIEF", "CURIST ARTHRITIS RELIEF", "CAREONE ARTHRITIS PAIN RELIEF", "EQUALINE ARTHRITIS PAIN RELIEVING", "BASIC CARE ARTHRITIS PAIN", "ALEVE ARTHRITIS PAIN GEL" ], "generic_name": [ "DICLOFENAC SODIUM", "DICLOFENAC SODIUM TOPICAL", "DICLOFENAC SODIUM TOPICAL GEL, 1%", "DICLOFENAC", "DICLOFENAC SODIUM 1%" ], "manufacturer_name": [ "Alembic Pharmaceuticals Inc.", "EXELAN PHARMACEUTICALS INC.", "SOLA Pharmaceuticals, LLC", "Lupin Pharmaceuticals, Inc.", "Cipla USA Inc.", "Alembic Pharmaceuticals Limited", "Sun Pharmaceutical Industries, Inc.", "BluePoint Laboratories", "Publix Super Markets Inc", "Amneal Pharmaceuticals LLC", "Encube Ethicals, Inc.", "Chattem, Inc.", 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