Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10117341serious1Date Last Updated22/07/2015receiptdateformat102companynumbUS-BMSGILMSD-2012-0060645occurcountryUSseriousnessother1duplicate1Date Received25/04/2014seriousnesshospitalization1transmissiondate25/11/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age47Unit of Onset Ageyearspatientagegroup5SexMale

Reaction

1)

reactionmeddraversionpt18.1ReactionSuicide attemptOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductATRIPLAdrugauthorizationnumb021937drugdosagetextUNKdrugdosageformTABLETdrugindicationHIV INFECTIONdrugstartdateformat102drugstartdate21/10/2010actiondrug1

activesubstance

activesubstancenameEFAVIRENZ\EMTRICITABINE\TENOFOVIR DISOPROXIL FUMARATE

openFDA Info on Medication

Application NumberNDA021937Brand NameATRIPLAGeneric NameEFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATEManufacturersGilead Sciences, LLCproduct_ndc15584-0101Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsEFAVIRENZ, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATERXCUI643066, 643070spl_idb670fd52-7f65-e416-e053-2a95a90ac7b7spl_set_id2e97aa6d-09f7-46df-9499-63db7e9bac35Package NDC15584-0101-1NUI N0000175463, N0000175460, N0000009948, N0000190118, N0000187064, N0000185504, N0 ... Established Pharmacologic Class Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhib ... Mechanism of Action Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Cytochrome P450 3A Induce ... Chemical StructureNucleoside Analog [Chemical/Ingredient]UNIIJE6H2O27P8, G70B4ETF4S, OTT9J7900I

2)

drugcharacterization2medicinalproductAMBIENdrugdosagetextUNKdrugstartdateformat102drugstartdate10/08/2011drugrecurreadministration3

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

3)

drugcharacterization2medicinalproductAZELEXdrugdosagetextUNKdrugstartdateformat102drugstartdate21/09/2011drugrecurreadministration3

activesubstance

activesubstancenameAZELAIC ACID

openFDA Info on Medication

Application NumberNDA020428Brand NameAZELEXGeneric NameAZELAIC ACIDManufacturersAlmirall, LLCproduct_ndc16110-869Product TypeHUMAN PRESCRIPTION DRUGRouteCUTANEOUSActive IngredientsAZELAIC ACIDRXCUI1041520, 1043753spl_id4e21d6b6-e1de-4601-b80e-0e8bd1c859ddspl_set_idebdfcaf7-b5d6-47e1-be87-ccaba4b97e75Package NDC16110-869-30, 16110-869-50NUIN0000008841, N0000009982Physiologic/Pharmacodynamic EffectDecreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]UNIIF2VW3D43YT

4)

drugcharacterization2medicinalproductAZITHROMYCINdrugdosagetextUNKdrugstartdateformat102drugstartdate29/11/2012drugrecurreadministration3

activesubstance

activesubstancenameAZITHROMYCIN ANHYDROUS

openFDA Info on Medication

Application Number ANDA211791, ANDA065179, ANDA203294, ANDA065511, ANDA209045, ANDA209044, NDA05069 ... Brand NameAZITHROMYCINGeneric Name AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, AZITHROMYCIN FOR ... Manufacturers Alembic Pharmaceuticals Limited, Fresenius Kabi USA, LLC, AuroMedics Pharma LLC, ... product_ndc 46708-057, 63323-398, 55150-174, 0409-0144, 0527-2370, 0527-2395, 59762-3051, 59 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUS, PARENTERALActive IngredientsAZITHROMYCIN DIHYDRATE, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN ANHYDROUSRXCUI308460, 749783, 1668238, 248656, 749780, 204844, 861416, 141963, 308459spl_id deea1a56-84ed-4ce4-9d11-03271510c0a1, 94a38ec5-e40e-dd25-e053-2995a90a2525, 93f2 ... spl_set_id deea1a56-84ed-4ce4-9d11-03271510c0a1, 62f6f327-3fef-49f0-ae90-078356d002b5, b699 ... Package NDC 46708-057-30, 46708-057-06, 63323-398-12, 63323-398-01, 63323-398-10, 55150-174- ... UNII5FD1131I7S, JTE4MNN1MD, J2KLZ20U1MNUIN0000175935, M0028311Established Pharmacologic ClassMacrolide Antimicrobial [EPC]Chemical StructureMacrolides [CS]

5)

drugcharacterization2medicinalproductSERTRALINEdrugdosagetextUNKdrugstartdateformat102drugstartdate11/08/2011drugrecurreadministration3

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

6)

drugcharacterization2medicinalproductTEMAZEPAM.drugdosagetextUNKdrugstartdateformat102drugstartdate15/09/2011drugrecurreadministration3

activesubstance

activesubstancenameTEMAZEPAM

openFDA Info on Medication

Application Number ANDA203482, ANDA071620, ANDA211542, ANDA071456, ANDA071457, ANDA078581, ANDA0711 ... Brand NameTEMAZEPAM, RESTORILGeneric NameTEMAZEPAMManufacturers Amneal Pharmaceuticals LLC, Actavis Pharma, Inc., Alembic Pharmaceuticals Limite ... product_ndc 65162-556, 65162-583, 65162-584, 65162-557, 0228-2076, 0228-2077, 46708-379, 467 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTEMAZEPAMRXCUI198241, 198242, 198243, 485489, 208463, 208464, 208465, 539384spl_id c21455f5-1c17-442d-b1d1-69d27d290d48, eac383e8-6227-4439-b72d-c1b1794ee031, 2676 ... spl_set_id be68c6e0-17ad-40fe-9bc1-58abe24b53f6, a4370eb4-b00d-4247-af8d-980e59fbbec6, db83 ... Package NDC 65162-583-03, 65162-583-10, 65162-583-50, 65162-583-11, 65162-556-03, 65162-556- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIICHB1QD2QSS

7)

drugcharacterization2medicinalproductISENTRESSdrugdosagetextUNKdrugstartdateformat102drugstartdate15/09/2011drugrecurreadministration3

activesubstance

activesubstancenameRALTEGRAVIR POTASSIUM

openFDA Info on Medication

Application NumberNDA022145, NDA203045, NDA205786Brand NameISENTRESSGeneric NameRALTEGRAVIRManufacturersMerck Sharp & Dohme Corp.product_ndc0006-0227, 0006-0477, 0006-0473, 0006-3603, 0006-3080Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRALTEGRAVIR POTASSIUMRXCUI 744842, 744846, 1235588, 1235591, 1235593, 1235595, 1486838, 1486841, 1924313, 1 ... spl_id9434823c-41b1-4536-91eb-45bb4094fdf8spl_set_id89a5ec53-d956-4329-8004-0f40f51c88a3Package NDC 0006-0227-61, 0006-0477-61, 0006-0473-61, 0006-3603-01, 0006-3603-60, 0006-3603- ... UNII43Y000U234

8)

drugcharacterization2medicinalproductAZITHROMYCINdrugdosagetextUNKdrugstartdateformat102drugstartdate02/12/2011drugrecurreadministration3

activesubstance

activesubstancenameAZITHROMYCIN ANHYDROUS

openFDA Info on Medication

Application Number ANDA211791, ANDA065179, ANDA203294, ANDA065511, ANDA209045, ANDA209044, NDA05069 ... Brand NameAZITHROMYCINGeneric Name AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, AZITHROMYCIN FOR ... Manufacturers Alembic Pharmaceuticals Limited, Fresenius Kabi USA, LLC, AuroMedics Pharma LLC, ... product_ndc 46708-057, 63323-398, 55150-174, 0409-0144, 0527-2370, 0527-2395, 59762-3051, 59 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUS, PARENTERALActive IngredientsAZITHROMYCIN DIHYDRATE, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN ANHYDROUSRXCUI308460, 749783, 1668238, 248656, 749780, 204844, 861416, 141963, 308459spl_id deea1a56-84ed-4ce4-9d11-03271510c0a1, 94a38ec5-e40e-dd25-e053-2995a90a2525, 93f2 ... spl_set_id deea1a56-84ed-4ce4-9d11-03271510c0a1, 62f6f327-3fef-49f0-ae90-078356d002b5, b699 ... Package NDC 46708-057-30, 46708-057-06, 63323-398-12, 63323-398-01, 63323-398-10, 55150-174- ... UNII5FD1131I7S, JTE4MNN1MD, J2KLZ20U1MNUIN0000175935, M0028311Established Pharmacologic ClassMacrolide Antimicrobial [EPC]Chemical StructureMacrolides [CS]

9)

drugcharacterization2medicinalproductTRUVADAdrugdosagetextUNKdrugdosageformTABLETdrugstartdateformat102drugstartdate15/09/2011drugrecurreadministration3

activesubstance

activesubstancenameEMTRICITABINE\TENOFOVIR DISOPROXIL FUMARATE

openFDA Info on Medication

Application NumberNDA021752Brand NameTRUVADAGeneric NameEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEManufacturersGilead Sciences, Incproduct_ndc61958-0701, 61958-0703, 61958-0704, 61958-0705Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsEMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATERXCUI476556, 639888, 1744001, 1744003, 1744005, 1744007, 1744009, 1744011spl_idb6ffaad2-76e6-3927-e053-2995a90a73faspl_set_id54e82b13-a037-49ed-b4b3-030b37c0ecddPackage NDC61958-0701-1, 61958-0703-1, 61958-0704-1, 61958-0705-1NUIN0000175462, N0000175459, N0000009947Established Pharmacologic Class Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [ ... Chemical StructureNucleoside Analog [Chemical/Ingredient]Mechanism of ActionNucleoside Reverse Transcriptase Inhibitors [MoA]UNIIOTT9J7900I, G70B4ETF4S

10)

drugcharacterization2medicinalproductALPRAZOLAM.drugdosagetextUNKdrugstartdateformat102drugstartdate10/08/2011drugrecurreadministration3

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA078088 ... Brand Name ALPRAZOLAM, XANAX XR, ALPRAZOLAM ER, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZO ... Generic NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia and Upjohn Co ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 687022, 687023, ... spl_id 05c4e062-e29d-4e46-a6f0-302025edd596, 84ebf58b-deef-4f35-ba5e-e901288c2997, dfdd ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

summary

narrativeincludeclinicalCASE EVENT DATE: 201205

Report Duplicate

duplicatesourceGILEADduplicatenumbUS-BMSGILMSD-2012-0060645

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use