Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11808033primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate05/03/2016reporttype1serious1seriousnessdeath1seriousnesshospitalization1receivedateformat102Date Received07/12/2015receiptdateformat102Date Last Updated07/12/2015fulfillexpeditecriteria1companynumbUS-JNJFOC-20151203310duplicate1

Report Duplicate

duplicatesourceJANSSENduplicatenumbUS-JNJFOC-20151203310

Primary Source

reportercountryUSqualification3literaturereference MOWRY JB, SPYKER DA, BROOKS DE, MCMILLAN N, SCHAUBEN JL. 2014 ANNUAL REPORT OF T ...

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age62Unit of Onset Ageyearspatientagegroup5SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionToxicity to various agentsOutcomeFatal

Drug

1)

drugcharacterization1medicinalproductTRAMADOL HYDROCHLORIDE.drugauthorizationnumb020281drugdosageformUNSPECIFIEDdrugadministrationroute048drugindicationSUICIDE ATTEMPTdrugrecurreadministration2

activesubstance

activesubstancenameTRAMADOL HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA090404, ANDA205257, NDA214044, ANDA076003, ANDA091498, NDA022370, ANDA208708 ... Brand Name TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE, QDOLO, ULTRAM, ... Generic NameTRAMADOL HYDROCHLORIDEManufacturers Zydus Pharmaceuticals (USA) Inc., Cadila Healthcare Limited, Mylan Pharmaceutica ... product_ndc 68382-319, 65841-754, 0378-4152, 0378-4153, 0378-4154, 68134-402, 65162-627, 695 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTRAMADOL HYDROCHLORIDERXCUI 835603, 833709, 833711, 833713, 2395808, 1148478, 1148485, 1148489, 2179635, 194 ... spl_id 1ddd72c1-be8f-4d56-9966-f9b5c45e98b9, f3ada848-9f0a-4197-aac5-ead4675f8095, fa56 ... spl_set_id ee7179b7-6a08-4eeb-a787-5d697b02c4a2, 6f3a2ab8-f437-456f-ae35-67a965396052, c88b ... Package NDC 68382-319-01, 68382-319-05, 68382-319-10, 68382-319-30, 68382-319-77, 65841-754- ... UNII9N7R477WCK

2)

drugcharacterization1medicinalproductDIAZEPAM.drugdosageformUNSPECIFIEDdrugadministrationroute048drugindicationSUICIDE ATTEMPT

activesubstance

activesubstancenameDIAZEPAM

openFDA Info on Medication

Application Number ANDA072079, NDA020124, ANDA210363, NDA020648, NDA211635, NDA013263, ANDA071583, ... Brand NameDIAZEPAM, DIASTAT, VALTOCO, VALIUMGeneric NameDIAZEPAMManufacturers Hospira, Inc., Meridian Medical Technologies LLC, Dash Pharmaceuticals LLC, Baus ... product_ndc 0409-1273, 11704-600, 69339-136, 66490-650, 68682-650, 68682-652, 68682-655, 722 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, RECTAL, NASAL, ORALActive IngredientsDIAZEPAMRXCUI 1807459, 1807452, 2120550, 801957, 801958, 801961, 801966, 2272613, 2272619, 227 ... spl_id 14233fc1-606a-4e78-8da4-df9eedb1c793, 512dee3e-2c4c-4436-b92b-67113989cca5, 5b08 ... spl_set_id 41044928-dd1f-40bf-1fa6-709dff559124, fa352464-14c8-49e9-b8b7-5a968b1cfa93, 6b8d ... Package NDC 0409-1273-03, 0409-1273-32, 11704-600-01, 69339-136-02, 69339-136-32, 69339-136- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

3)

drugcharacterization1medicinalproductTRAZODONEdrugdosageformUNSPECIFIEDdrugadministrationroute048drugindicationSUICIDE ATTEMPT

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

openFDA Info on Medication

4)

drugcharacterization1medicinalproductESZOPICLONE.drugdosageformUNSPECIFIEDdrugadministrationroute048drugindicationSUICIDE ATTEMPT

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application Number ANDA091124, ANDA091166, ANDA091103, ANDA091113, ANDA091024, ANDA208451, ANDA2029 ... Brand NameESZOPICLONE, LUNESTAGeneric NameESZOPICLONEManufacturers Lupin Pharmaceuticals, Inc., Glenmark Pharmaceuticals Inc. USA, Sun Pharmaceutic ... product_ndc 68180-322, 68180-323, 68180-324, 68462-382, 68462-383, 68462-384, 47335-586, 473 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, OROPHARYNGEALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id c15b2322-c078-46c1-8959-9288faaab19e, 8d6002b1-95d9-445c-8ace-e6dccea36852, 95e9 ... spl_set_id 7068c455-691e-4c56-9857-b7b4e13f4784, 584dc66c-063a-4552-a056-74b811e2bc80, 8bb1 ... Package NDC 68180-322-01, 68180-322-11, 68180-322-13, 68180-323-01, 68180-323-02, 68180-323- ... UNIIUZX80K71OE