Adverse Event Report

Report

reporttype2Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10153036serious1Date Last Updated31/07/2014receiptdateformat102seriousnessdeath1companynumbUS-GILEAD-2014-0101095occurcountryUSseriousnessother1duplicate1Date Received05/05/2014seriousnesshospitalization1transmissiondate26/03/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification2

Patient

Onset Age32Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionBacteraemiaOutcomeFatal

2)

reactionmeddraversionpt17.1ReactionHypotensionOutcomeUnknown

3)

reactionmeddraversionpt17.1ReactionHaemoptysisOutcomeUnknown

4)

reactionmeddraversionpt17.1ReactionInfluenzaOutcomeUnknown

5)

reactionmeddraversionpt17.1ReactionRespiratory distressOutcomeUnknown

6)

reactionmeddraversionpt17.1ReactionPyrexiaOutcomeUnknown

7)

reactionmeddraversionpt17.1ReactionConfusional stateOutcomeUnknown

8)

reactionmeddraversionpt17.1ReactionMyopathyOutcomeUnknown

9)

reactionmeddraversionpt17.1ReactionAstheniaOutcomeUnknown

10)

reactionmeddraversionpt17.1ReactionBack painOutcomeUnknown

11)

reactionmeddraversionpt17.1ReactionMultiple-drug resistanceOutcomeUnknown

12)

reactionmeddraversionpt17.1ReactionBacterial sepsisOutcomeFatal

13)

reactionmeddraversionpt17.1ReactionChest painOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductSERTRALINEdrugrecurreadministration3

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

2)

drugcharacterization2medicinalproductDORNASE ALFAdrugstructuredosagenumb2.5drugstructuredosageunit003drugdosagetext2.5 MG, UNKdrugadministrationroute055drugenddateformat102drugenddate24/03/2014drugrecurreadministration3

activesubstance

activesubstancenameDORNASE ALFA

openFDA Info on Medication

Application NumberBLA103532Brand NamePULMOZYMEGeneric NameDORNASE ALFAManufacturersGenentech, Inc.product_ndc50242-100Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsDORNASE ALFARXCUI205532, 310014spl_idf9a0ca5a-1350-466c-b9d1-759b3601a6b9spl_set_idd8c78a7e-ff99-48f3-8952-643ec2ea0f86Package NDC50242-100-40NUIN0000008867, M0006007, N0000175958, M0018641Physiologic/Pharmacodynamic EffectDecreased Respiratory Secretion Viscosity [PE]Chemical StructureDeoxyribonuclease I [CS], Recombinant Proteins [CS]Established Pharmacologic ClassRecombinant Human Deoxyribonuclease 1 [EPC]UNII953A26OA1Y

3)

drugcharacterization2medicinalproductINSULINdrugdosagetextUNKdrugenddateformat102drugenddate24/03/2014drugrecurreadministration3

activesubstance

activesubstancenameINSULIN NOS

4)

drugcharacterization2medicinalproductATROVENTdrugstructuredosagenumb.5drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.5 MG, TIDdrugadministrationroute055drugrecurreadministration3

activesubstance

activesubstancenameIPRATROPIUM BROMIDE

openFDA Info on Medication

Application NumberNDA021527Brand NameATROVENT HFAGeneric NameIPRATROPIUM BROMIDEManufacturersBoehringer Ingelheim Pharmaceuticals, Inc.product_ndc0597-0087Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsIPRATROPIUM BROMIDERXCUI836343, 836368spl_id694c27b3-b662-40bb-9cfd-bf7801fe8796spl_set_id170e98ef-5560-4068-be7d-e649068eb884Package NDC0597-0087-17UNIIJ697UZ2A9J

5)

drugcharacterization1medicinalproductAZTREONAM LYSINEdrugauthorizationnumb050814drugdosagetextUNKdrugdosageformINHALATION VAPOUR, LIQUIDdrugadministrationroute055drugstartdateformat102drugstartdate04/04/2014drugenddateformat102drugenddate07/04/2014

activesubstance

activesubstancenameAZTREONAM LYSINE

6)

drugcharacterization2medicinalproductSUBOXONEdrugrecurreadministration3

activesubstance

activesubstancenameBUPRENORPHINE HYDROCHLORIDE\NALOXONE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022410Brand NameSUBOXONEGeneric NameBUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDEManufacturersIndivior Inc.product_ndc12496-1202, 12496-1204, 12496-1208, 12496-1212Product TypeHUMAN PRESCRIPTION DRUGRouteBUCCAL, SUBLINGUALActive IngredientsBUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDERXCUI1010600, 1010603, 1010604, 1010606, 1307056, 1307058, 1307061, 1307063spl_id28113af3-4448-43e7-9394-9bf2f0e5c5a7spl_set_id8a5edcf9-828c-4f97-b671-268ab13a8ecdPackage NDC 12496-1202-1, 12496-1202-3, 12496-1204-1, 12496-1204-3, 12496-1208-1, 12496-1208 ... UNII56W8MW3EN1, F850569PQR

7)

drugcharacterization2medicinalproductAZTREONAM.drugdosagetextUNKdrugadministrationroute042drugstartdateformat610drugstartdate/02/2014drugrecurreadministration3

activesubstance

activesubstancenameAZTREONAM

openFDA Info on Medication

Application NumberANDA065439, NDA050814, NDA050580Brand NameAZTREONAM, CAYSTON, AZACTAMGeneric NameAZTREONAMManufacturersFresenius Kabi USA, LLC, Gilead Sciences, Inc., E.R. Squibb & Sons, L.L.C.product_ndc63323-401, 63323-402, 61958-0901, 0003-2560, 0003-2570Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUSActive IngredientsAZTREONAMRXCUI1664981, 1664986, 901610, 901614, 1664984, 1664988spl_id 94a3d748-6302-1b00-e053-2a95a90a62d5, 94a3c943-f01a-1397-e053-2a95a90a8bbf, 94a3 ... spl_set_id 5f5ebb63-6ac5-4fb4-bcc1-d069c123eb18, 302fd27d-0a22-44ea-91fb-1b1ffcf17a1f, c6cf ... Package NDC 63323-401-24, 63323-402-24, 63323-401-26, 63323-402-30, 63323-401-20, 63323-402- ... NUIN0000175493, M0014030Established Pharmacologic ClassMonobactam Antibacterial [EPC]Chemical StructureMonobactams [CS]UNIIG2B4VE5GH8

8)

drugcharacterization2medicinalproductALBUTEROL /00139501/drugadministrationroute055drugrecurreadministration3

activesubstance

activesubstancenameALBUTEROL

9)

drugcharacterization1medicinalproductAZTREONAM LYSINEdrugbatchnumb002380drugauthorizationnumb050814drugstructuredosagenumb75drugstructuredosageunit003drugdosagetext75 MG, UNKdrugdosageformINHALATION VAPOUR, LIQUIDdrugadministrationroute055drugindicationCYSTIC FIBROSISdrugstartdateformat102drugstartdate09/04/2010drugenddateformat102drugenddate31/01/2014

activesubstance

activesubstancenameAZTREONAM LYSINE

10)

drugcharacterization2medicinalproductAMBIENdrugrecurreadministration3

activesubstance

activesubstancenameZOLPIDEM TARTRATE

openFDA Info on Medication

Application NumberNDA021774, NDA019908Brand NameAMBIEN CR, AMBIENGeneric NameZOLPIDEM TARTRATEManufacturersSanofi-Aventis U.S. LLCproduct_ndc0024-5501, 0024-5521, 0024-5401, 0024-5421Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854880, 854882, 854894, 854896, 854873, 854875, 854876, 854878spl_id6c172483-d1e2-4203-8dab-7f8a780a02ad, e932d227-dc7a-405f-855b-4994aabb85f4spl_set_id404c858c-89ac-4c9d-8a96-8702a28e6e76, c36cadf4-65a4-4466-b409-c82020b42452Package NDC 0024-5501-31, 0024-5501-10, 0024-5521-31, 0024-5521-50, 0024-5521-10, 0024-5401- ... UNIIWY6W63843K

11)

drugcharacterization2medicinalproductPANTOPRAZOLEdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, QDdrugadministrationroute042drugenddateformat102drugenddate24/03/2014drugrecurreadministration3

activesubstance

activesubstancenamePANTOPRAZOLE SODIUM

openFDA Info on Medication

Application NumberANDA205119, ANDA077619Brand NamePANTOPRAZOLE SODIUM, PANTOPRAZOLEGeneric NamePANTOPRAZOLEManufacturersAmneal Pharmaceuticals LLC, Dr.Reddy's Laboratories Limitedproduct_ndc65162-636, 65162-637, 55111-332, 55111-333Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPANTOPRAZOLE SODIUMRXCUI251872, 314200spl_id5c7a8fef-13ea-42c4-9e13-d8bc23c8f8a4, 02f0a994-cbaa-6f9b-56bd-48e9952540ecspl_set_idf3ded82a-cf0d-4844-944a-75f9f9215ff0, 564709e8-358f-c185-4ecb-b3849c3fe59cPackage NDC 65162-636-03, 65162-636-09, 65162-637-03, 65162-637-09, 65162-637-11, 65162-637- ... UNII6871619Q5X

summary

narrativeincludeclinicalCASE EVENT DATE: 20140323

Report Duplicate

duplicatesourceGILEADduplicatenumbUS-GILEAD-2014-0101095

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use