{ "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": 252 } }, "results": [ { "safetyreportversion": "2", "safetyreportid": "23971194", "primarysourcecountry": "PL", "occurcountry": "PL", "transmissiondateformat": "102", "transmissiondate": "20240716", "reporttype": "1", "serious": "1", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "1", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "2", "receivedateformat": "102", "receivedate": "20240613", "receiptdateformat": "102", "receiptdate": "20240624", "fulfillexpeditecriteria": "1", "companynumb": "PL-Hugel Aesthetics-2158081", "primarysource": { "reportercountry": "PL" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "48", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Swelling", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Erythema", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Throat tightness", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Paraesthesia oral", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Chest discomfort", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Headache", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Migraine", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Off label use", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Histamine level increased", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Erythema", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Swelling face", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Erythema", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Chest pain", "reactionoutcome": "2" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "LETYBO", "drugauthorizationnumb": "761225", "drugstructuredosagenumb": "45", "drugstructuredosageunit": "025", "drugseparatedosagenumb": "1", "drugdosageform": "Powder for injection", "drugadministrationroute": "030", "drugstartdateformat": "102", "drugstartdate": "20240517", "drugenddateformat": "102", "drugenddate": "20240517", "drugtreatmentduration": "1", "drugtreatmentdurationunit": "804", "activesubstance": { "activesubstancename": "LETIBOTULINUMTOXINA-WLBG" }, "openfda": { "application_number": [ "BLA761225" ], "brand_name": [ "LETYBO" ], "generic_name": [ "LETIBOTULINUMTOXINA-WLBG" ], "manufacturer_name": [ "Hugel, Inc." ], "product_ndc": [ "81165-050", "81165-100" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR" ], "substance_name": [ "LETIBOTULINUMTOXINA" ], "rxcui": [ "2689290", "2689297", "2689299", "2689301" ], "spl_id": [ "2784ba3d-d3f8-1059-e063-6394a90a2ff1" ], "spl_set_id": [ "910e5d0e-4d0b-4de8-8e2d-97879a044181" ], "package_ndc": [ "81165-050-01", "81165-100-01" ], "nui": [ "N0000175771", "N0000175770", "N0000193962", "N0000175731" ], "pharm_class_epc": [ "Acetylcholine Release Inhibitor [EPC]", "Neuromuscular Blocker [EPC]" ], "pharm_class_moa": [ "Acetylcholine Release Inhibitors [MoA]" ], "pharm_class_pe": [ "Neuromuscular Blockade [PE]" ], "unii": [ "W5O50S8A59" ] } }, { "drugcharacterization": "2", "medicinalproduct": "Bilastine-Clatra", "drugseparatedosagenumb": "1", "actiondrug": "5", "drugadditional": "3" }, { "drugcharacterization": "2", "medicinalproduct": "FEXOFENADINE", "drugseparatedosagenumb": "1", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "FEXOFENADINE HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA219032" ], "brand_name": [ "FEXOFENADINE" ], "generic_name": [ "FEXOFENADINE" ], "manufacturer_name": [ "YYBA Corp" ], "product_ndc": [ "73581-012" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "FEXOFENADINE HYDROCHLORIDE" ], "rxcui": [ "997501" ], "spl_id": [ "579c7ff9-0c45-1d46-e063-6294a90aef34" ], "spl_set_id": [ "579c7ff9-0c44-1d46-e063-6294a90aef34" ], "package_ndc": [ "73581-012-01", "73581-012-06", "73581-012-02" ], "unii": [ "2S068B75ZU" ] } }, { "drugcharacterization": "2", "medicinalproduct": "DEXAMETHASONE", "drugseparatedosagenumb": "1", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "DEXAMETHASONE" }, "openfda": { "application_number": [ "ANDA216283", "NDA022315", "ANDA217695", "ANDA216282", "ANDA088481", "ANDA216284", "ANDA084754", "ANDA217001", "ANDA215106", "ANDA215604", "ANDA217696", "ANDA201270", "ANDA088149", "ANDA091188", "ANDA218372", "ANDA080399", "NDA013422", "ANDA090891", "ANDA088248", "ANDA084612", "ANDA216295", "NDA211379", "ANDA217538", "NDA208742" ], "brand_name": [ "DEXAMETHASONE", "OZURDEX", "DEXAMETHASONE 1.5 MG", "MAXIDEX", "HEMADY", "DEXTENZA" ], "generic_name": [ "DEXAMETHASONE", "DEXAMETHASONE 1.5 MG" ], "manufacturer_name": [ "Zydus Lifesciences Limited", "Allergan, Inc.", "Apotex Corp.", "Alvogen Inc.", "Viona Pharmaceuticals Inc", "Marlex Pharmaceuticals, Inc", "Bionpharma Inc.,", "Kesin Pharma Corporation", "Amneal Pharmaceuticals NY LLC", "ANI Pharmaceuticals, Inc.", "Larken Laboratories, Inc.", "Pangea Pharmaceuticals, LLC", "NorthStar Rx LLC", "Chartwell RX, LLC", "Advagen Pharma Ltd.", "Kanchan Healthcare Inc", "Prasco Laboratories", "Harrow Eye, LLC", "PD-Rx Pharmaceuticals, Inc.", "Rising Pharma Holdings, Inc.", "Hikma Pharmaceuticals USA, Inc.", "Edenbridge Pharmaceuticals LLC.", "Ocular Therapeutix, Inc." ], "product_ndc": [ "70771-1701", "0023-3348", "60505-6249", "60505-6250", "60505-6251", "60505-6252", "60505-6253", "60505-6254", "60505-6255", "70771-1699", "70771-1700", "70771-1704", "70771-1705", "70771-1707", "47781-914", "47781-916", "72578-166", "70771-1706", "10135-795", "69452-277", "69452-278", "81033-010", "60219-2043", "60219-2044", "70954-398", "70954-401", "70954-403", "70954-404", "70954-402", "70954-399", "68047-702", "81279-117", "72603-187", "72603-189", "72603-190", "72603-188", "72603-213", "72603-212", "62135-114", "72888-235", "72888-236", "72888-237", "72888-238", "72888-239", "72888-240", "72888-241", "70954-872", "85742-004", "66993-730", "82667-600", 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"70954-403-10", "70954-403-20", "70954-403-30", "70954-404-10", "70954-402-10", "70954-398-10", "70954-399-10", "68047-702-21", "68047-702-35", "68047-702-51", "81279-117-88", "72603-187-01", "72603-189-01", "72603-190-01", "72603-188-01", "72603-213-01", "72603-212-01", "62135-114-37", "72888-235-01", "72888-236-01", "72888-237-01", "72888-238-01", "72888-239-01", "72888-240-01", "72888-241-01", "70954-872-10", "85742-004-03", "66993-730-02", "66993-730-51", "66993-730-80", "68047-702-01", "82667-600-05", "72789-534-01", "72789-534-95", "72789-534-28", "72578-171-01", "72578-172-01", "72578-168-01", "72578-169-01", "72578-170-01", "64980-509-24", "0054-4179-25", "0054-4180-25", "0054-4181-25", "0054-4182-25", "0054-4182-31", "0054-4183-25", "0054-4184-25", "0054-4186-25", "0054-3176-44", "0054-3177-57", "0054-3177-63", "0054-8179-25", "0054-8180-25", "0054-8174-25", "0054-8181-25", "0054-8176-25", "0054-8175-25", "0054-8183-25", "60219-2056-1", "82111-955-01", "82111-955-02", "81279-117-60", "69452-276-20", "70382-204-88", "70382-204-01", "70382-204-10", "70382-204-99", "72578-167-01" ], "nui": [ "N0000175576", "N0000175450" ], "pharm_class_epc": [ "Corticosteroid [EPC]" ], "pharm_class_moa": [ "Corticosteroid Hormone Receptor Agonists [MoA]" ], "unii": [ "7S5I7G3JQL" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20240517" } } } ] }