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

Adverse Event Report

Report

Primary Source

Patient

Reaction

1)

2)

3)

4)

5)

6)

7)

8)

9)

10)

11)

12)

13)

Drug

1)

activesubstance

openFDA Info on Medication

2)

activesubstance

openFDA Info on Medication

3)

activesubstance

4)

activesubstance

openFDA Info on Medication

5)

activesubstance

6)

activesubstance

openFDA Info on Medication

7)

activesubstance

openFDA Info on Medication

8)

activesubstance

9)

activesubstance

10)

activesubstance

openFDA Info on Medication

11)

activesubstance

openFDA Info on Medication

summary

Report Duplicate

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