Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10256271primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate12/12/2014reporttype1serious2receivedateformat102Date Received24/06/2014receiptdateformat102Date Last Updated24/06/2014fulfillexpeditecriteria2companynumbUS-ZOGENIX, INC.-2012ZX000123duplicate1

Report Duplicate

duplicatesourceZOGENIXduplicatenumbUS-ZOGENIX, INC.-2012ZX000123

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age52Unit of Onset AgeyearsWeight68.1SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionInjection site painOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionInjection site haemorrhageOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionDrug ineffectiveOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductSUMAVEL DOSEPROdrugbatchnumb061431,061431drugauthorizationnumb022239drugdosageformINJECTIONdrugindicationMIGRAINEdrugrecurreadministration2

2)

drugcharacterization1medicinalproductSUMAVEL DOSEPROdrugbatchnumb061431,061431drugauthorizationnumb022239drugdosageformINJECTIONdrugstartdateformat102drugstartdate31/03/2012drugenddateformat102drugenddate31/03/2012drugrecurreadministration2

3)

drugcharacterization2medicinalproductWELLBUTRIN XLdrugindicationDEPRESSION

openFDA Info on Medication

Application NumberNDA021515Brand NameWELLBUTRIN XLGeneric NameBUPROPION HYDROCHLORIDEManufacturersBausch Health US LLCproduct_ndc0187-0730, 0187-0731Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBUPROPION HYDROCHLORIDERXCUI993541, 993545, 993557, 993564spl_id63046e0c-233f-4dc1-b3eb-f9d27872bd25spl_set_ida435da9d-f6e8-4ddc-897d-8cd2bf777b21Package NDC0187-0730-30, 0187-0730-90, 0187-0730-07, 0187-0731-30, 0187-0731-07UNIIZG7E5POY8O

4)

drugcharacterization2medicinalproductLUNESTAdrugindicationSLEEP DISORDER

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

5)

drugcharacterization2medicinalproductATIVANdrugindicationANXIETY

openFDA Info on Medication

Application NumberNDA017794, NDA018140Brand NameATIVANGeneric NameLORAZEPAMManufacturersBausch Health US LLC, Hikma Pharmaceuticals USA Inc.product_ndc0187-0063, 0187-0064, 0187-0065, 0641-6000, 0641-6001, 0641-6003, 0641-6002Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsLORAZEPAMRXCUI 104719, 197900, 197901, 197902, 206821, 206828, 206819, 206820, 238100, 238101, ... spl_id0c599118-4213-4a51-bd2d-a162ac18a940, 2d4cea58-1dfe-4bc0-bd5a-415ced5420dbspl_set_id89057c93-8155-4040-acec-64e877bd2b4c, 5fc0e987-61c9-40c4-b0d5-fcea07c8733ePackage NDC 0187-0063-01, 0187-0063-50, 0187-0063-10, 0187-0064-01, 0187-0064-50, 0187-0064- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

6)

drugcharacterization2medicinalproductSOMAdrugindicationPAIN

openFDA Info on Medication

Application NumberNDA011792Brand NameSOMAGeneric NameCARISOPRODOLManufacturersMeda Pharmaceuticalsproduct_ndc0037-2001, 0037-2250Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCARISOPRODOLRXCUI197446, 213695, 730794, 730918spl_idf1040579-1917-4488-9df8-ca3424ebd03bspl_set_id6297cf20-830a-11dc-94c8-0002a5d5c51bPackage NDC0037-2250-10, 0037-2250-30, 0037-2001-01NUIN0000175730, N0000175737Physiologic/Pharmacodynamic EffectCentrally-mediated Muscle Relaxation [PE]Established Pharmacologic ClassMuscle Relaxant [EPC]UNII21925K482H