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"route": [ "ORAL" ], "substance_name": [ "ESCITALOPRAM OXALATE" ], "rxcui": [ "349332", "351249", "351250", "351285", "352272", "352273", "404408", "404420" ], "spl_id": [ "9ff46a66-0f97-4a78-9d18-ec576f63bae7" ], "spl_set_id": [ "13bb8267-1cab-43e5-acae-55a4d957630a" ], "package_ndc": [ "0456-2005-01", "0456-2010-01", "0456-2010-11", "0456-2010-63", "0456-2020-01", "0456-2020-11", "0456-2020-63", "0456-2101-08" ], "unii": [ "5U85DBW7LO" ] } } ] } }, { "safetyreportversion": "2", "safetyreportid": "10081510", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140416", "receiptdateformat": "102", "receiptdate": "20140620", "fulfillexpeditecriteria": "1", "companynumb": "US-ALLERGAN-1407354US", "duplicate": "1", "reportduplicate": { "duplicatesource": "ALLERGAN", "duplicatenumb": "US-ALLERGAN-1407354US" }, 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"drugcharacterization": "2", "medicinalproduct": "NYQUIL", "drugrecurreadministration": "3" } ] } }, { "safetyreportversion": "1", "safetyreportid": "10084896", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140417", "receiptdateformat": "102", "receiptdate": "20140417", "fulfillexpeditecriteria": "1", "companynumb": "US-ALLERGAN-1407598US", "duplicate": "1", "reportduplicate": { "duplicatesource": "ALLERGAN", "duplicatenumb": "US-ALLERGAN-1407598US" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "70", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Endocarditis", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Fungal endocarditis", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "BOTOX COSMETIC", "drugauthorizationnumb": "1145103000", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "UNK, SINGLE", "drugdosageform": "POWDER FOR INJECTION", "drugadministrationroute": "030", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "BLA103000" ], "brand_name": [ "BOTOX COSMETIC" ], "generic_name": [ "ONABOTULINUMTOXINA" ], "manufacturer_name": [ "Allergan, Inc." ], "product_ndc": [ "0023-3919", "0023-9232" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR" ], "substance_name": [ "BOTULINUM TOXIN TYPE A" ], "rxcui": [ "860192", "1726293", "1726296", "1726313" ], "spl_id": [ 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"duplicatenumb": "US-ALLERGAN-1408922US" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "55", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Lymphoma", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "BOTOX COSMETIC", "drugauthorizationnumb": "1145103000", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "UNK, SINGLE", "drugdosageform": "POWDER FOR INJECTION", "drugindication": "SKIN WRINKLING", "drugstartdateformat": "610", "drugstartdate": "201309", "drugenddateformat": "610", "drugenddate": "201309", "activesubstance": { "activesubstancename": "ONABOTULINUMTOXINA" }, "openfda": { "application_number": [ 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"reactionmeddrapt": "Botulism", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Facial pain", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Influenza like illness", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Myalgia", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Rash", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Muscular weakness", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Feeling abnormal", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Night sweats", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Oral mucosal exfoliation", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Palpitations", "reactionoutcome": "6" }, { "reactionmeddraversionpt": 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"reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Paraesthesia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Hypoaesthesia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Headache", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "BOTOX COSMETIC", "drugauthorizationnumb": "1145103000", "drugdosagetext": "UNK", "drugdosageform": "POWDER FOR INJECTION", "drugindication": "SKIN WRINKLING", "drugstartdateformat": "102", "drugstartdate": "20130806", "drugenddateformat": "102", "drugenddate": "20130806", "drugrecurreadministration": "1", "activesubstance": { "activesubstancename": "ONABOTULINUMTOXINA" }, "openfda": { "application_number": [ "BLA103000" ], "brand_name": [ "BOTOX COSMETIC" ], "generic_name": [ "ONABOTULINUMTOXINA" ], 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"drugintervaldosagedefinition": "804", "drugdosagetext": "1000 MG, QD", "drugindication": "HERPES SIMPLEX", "drugstartdateformat": "102", "drugstartdate": "20061013", "actiondrug": "4", "activesubstance": { "activesubstancename": "VALACYCLOVIR HYDROCHLORIDE" }, "openfda": { "application_number": [ "NDA020487" ], "brand_name": [ "VALTREX" ], "generic_name": [ "VALACYCLOVIR HYDROCHLORIDE" ], "manufacturer_name": [ "GlaxoSmithKline LLC" ], "product_ndc": [ "0173-0565", "0173-0933" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "VALACYCLOVIR HYDROCHLORIDE" ], "rxcui": [ "108780", "212448", "313564", "313565" ], "spl_id": [ "861c5801-9c12-4a6b-9bf4-aacb183a58b0" ], "spl_set_id": [ "f8e0d8f8-cb73-4206-a484-88f5c4fbd719" ], "package_ndc": [ "0173-0933-08", "0173-0933-10", "0173-0565-04", "0173-0565-10" ], "unii": [ "G447S0T1VC" ] } }, { "drugcharacterization": "1", "medicinalproduct": "JUVEDERM ULTRA XC", "drugbatchnumb": "H24LA20055", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "012", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "1 ML, SINGLE", "drugindication": "SKIN WRINKLING", "actiondrug": "5", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "HYALURONIC ACID\\LIDOCAINE HYDROCHLORIDE" } }, { "drugcharacterization": "1", "medicinalproduct": "BOTOX COSMETIC", "drugauthorizationnumb": "1145103000", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "20 UNITS, SINGLE", "drugdosageform": "POWDER FOR INJECTION", "drugindication": "SKIN WRINKLING", "drugstartdateformat": "102", "drugstartdate": "20130222", "drugenddateformat": "102", "drugenddate": "20130222", "drugrecurreadministration": "1", "activesubstance": { "activesubstancename": "ONABOTULINUMTOXINA" }, "openfda": { "application_number": [ "BLA103000" ], "brand_name": [ "BOTOX COSMETIC" ], "generic_name": [ "ONABOTULINUMTOXINA" ], "manufacturer_name": [ "Allergan, Inc." ], "product_ndc": [ "0023-3919", "0023-9232" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR" ], "substance_name": [ "BOTULINUM TOXIN TYPE A" ], "rxcui": [ "860192", "1726293", "1726296", "1726313" ], "spl_id": [ "265710db-c7b9-42ff-9fc8-c24a936c1d87" ], "spl_set_id": [ "485d9b71-6881-42c5-a620-a4360c7192ab" ], "package_ndc": [ "0023-3919-50", "0023-3919-51", "0023-9232-02", "0023-9232-01" ], "nui": [ "N0000175771", "N0000193962", "N0000175731", "N0000175770" ], "pharm_class_epc": [ "Acetylcholine Release Inhibitor [EPC]", "Neuromuscular Blocker [EPC]" ], "pharm_class_pe": [ "Neuromuscular Blockade [PE]" ], "pharm_class_moa": [ "Acetylcholine Release Inhibitors [MoA]" ], "unii": [ "E211KPY694" ] } }, { "drugcharacterization": "1", "medicinalproduct": "BOTOX COSMETIC", "drugauthorizationnumb": "1145103000", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "4 UNITS, SINGLE", "drugdosageform": "POWDER FOR INJECTION", "drugindication": "SKIN WRINKLING", "drugstartdateformat": "102", "drugstartdate": "20130222", "drugenddateformat": "102", "drugenddate": "20130222", "drugrecurreadministration": "1", "activesubstance": { "activesubstancename": "ONABOTULINUMTOXINA" }, "openfda": { "application_number": [ "BLA103000" ], "brand_name": [ "BOTOX COSMETIC" ], "generic_name": [ "ONABOTULINUMTOXINA" ], "manufacturer_name": [ "Allergan, Inc." ], "product_ndc": [ "0023-3919", "0023-9232" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR" ], "substance_name": [ "BOTULINUM TOXIN TYPE A" ], "rxcui": [ "860192", "1726293", "1726296", "1726313" ], "spl_id": [ "265710db-c7b9-42ff-9fc8-c24a936c1d87" ], "spl_set_id": [ "485d9b71-6881-42c5-a620-a4360c7192ab" ], "package_ndc": [ "0023-3919-50", "0023-3919-51", "0023-9232-02", "0023-9232-01" ], "nui": [ "N0000175771", "N0000193962", "N0000175731", "N0000175770" ], "pharm_class_epc": [ "Acetylcholine Release Inhibitor [EPC]", "Neuromuscular Blocker [EPC]" ], "pharm_class_pe": [ "Neuromuscular Blockade [PE]" ], "pharm_class_moa": [ "Acetylcholine Release Inhibitors [MoA]" ], "unii": [ "E211KPY694" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 201303" } } } ] }