Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10333130primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate26/03/2015reporttype1serious2receivedateformat102Date Received22/07/2014receiptdateformat102Date Last Updated22/07/2014fulfillexpeditecriteria2companynumbUS-SA-2014SA012736duplicate1

Report Duplicate

duplicatesourceAVENTISduplicatenumbUS-SA-2014SA012736

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age60Unit of Onset Ageyearspatientagegroup5SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionDrug ineffectiveOutcomeUnknown

2)

reactionmeddraversionpt17.1ReactionOff label useOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductAMBIEN CRdrugbatchnumbUNKNOWNdrugauthorizationnumb021774drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformFILM-COATED TABLETdrugadministrationroute048drugindicationSLEEP DISORDERactiondrug4

activesubstance

activesubstancenameZOLPIDEM TARTRATE

openFDA Info on Medication

Application NumberNDA021774Brand NameAMBIEN CRGeneric NameZOLPIDEM TARTRATEManufacturerssanofi-aventis U.S. LLCproduct_ndc0024-5501, 0024-5521Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854880, 854882, 854894, 854896spl_id8138a0a9-168c-46d2-b13e-e7e84f27eaeespl_set_id404c858c-89ac-4c9d-8a96-8702a28e6e76Package NDC0024-5501-31, 0024-5501-10, 0024-5521-31, 0024-5521-50, 0024-5521-10UNIIWY6W63843K

2)

drugcharacterization2medicinalproductLORAZEPAM.drugindicationMENOPAUSE

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application Number ANDA076150, NDA018140, ANDA203572, ANDA074282, ANDA072755, ANDA090260, ANDA07502 ... Brand NameLORAZEPAM, LOREEV XR, ATIVANGeneric NameLORAZEPAMManufacturers International Medication Systems, Limited, Hikma Pharmaceuticals USA Inc., Aurol ... product_ndc 76329-8261, 0641-6207, 13107-083, 13107-084, 13107-085, 0409-6778, 0054-3532, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsLORAZEPAMRXCUI 238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 2569564, 25695 ... spl_id 8b30da4f-e5a1-4e8a-9971-b5c687508d81, 4f2988b1-2854-4051-962f-07cc925608ab, 66ed ... spl_set_id 7dda070d-7809-46c4-8592-eb4e4c509707, b79b38ee-c29d-4099-964f-000031f47f5a, 5b85 ... Package NDC 76329-8261-1, 0641-6207-01, 0641-6207-25, 13107-083-11, 13107-083-01, 13107-083- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

3)

drugcharacterization2medicinalproductLUNESTA

activesubstance

activesubstancenameESZOPICLONE

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