Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11022908primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/08/2015reporttype1serious2receivedateformat102Date Received13/04/2015receiptdateformat102Date Last Updated13/04/2015fulfillexpeditecriteria1companynumbUS-GLAXOSMITHKLINE-US2015048522duplicate1

Report Duplicate

duplicatesourceGLAXOSMITHKLINEduplicatenumbUS-GLAXOSMITHKLINE-US2015048522

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionDyspnoeaOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.0ReactionDrug ineffectiveOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionPalpitationsOutcomeUnknown

4)

reactionmeddraversionpt18.0ReactionChest painOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductLISINOPRIL.actiondrug5

activesubstance

activesubstancenameLISINOPRIL

openFDA Info on Medication

Application Number ANDA076063, ANDA077321, ANDA077622, NDA208401, ANDA078402, ANDA208920, ANDA21204 ... Brand NameLISINOPRIL, QBRELIS, ZESTRILGeneric NameLISINOPRILManufacturers Hikma Pharmaceuticals USA Inc., International Laboratories, LLC, Rising Pharma H ... product_ndc 0143-9713, 0143-9715, 0143-9714, 54458-872, 54458-877, 54458-874, 54458-873, 165 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISINOPRILRXCUI 311354, 314076, 314077, 197884, 205326, 311353, 1806884, 1806890, 104375, 104376 ... spl_id 533f6e0f-04a0-4ef7-81b8-0a7be07ddd1a, b685bb45-44a6-4afc-bb3e-940bce536bda, c031 ... spl_set_id b70933da-55b2-4025-a00e-63ce3e6b7fdf, 6eef83b4-ce4c-462b-bcfa-eefa525e682d, c031 ... Package NDC 0143-9715-01, 0143-9715-10, 0143-9715-99, 0143-9714-01, 0143-9714-10, 0143-9714- ... UNIIE7199S1YWR

2)

drugcharacterization2medicinalproductLUNESTAactiondrug5

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

3)

drugcharacterization2medicinalproductCOQ10actiondrug5

activesubstance

activesubstancenameUBIDECARENONE

4)

drugcharacterization2medicinalproductPRAMIPEXOLEactiondrug5

activesubstance

activesubstancenamePRAMIPEXOLE

openFDA Info on Medication

Application NumberANDA203855, ANDA202206Brand NamePRAMIPEXOLE, PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASEGeneric NamePRAMIPEXOLEManufacturersCamber Pharmaceuticals, Inc., Par Pharmaceutical, Inc.product_ndc 31722-906, 31722-907, 31722-908, 31722-909, 31722-910, 31722-911, 10370-251, 103 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPRAMIPEXOLE DIHYDROCHLORIDERXCUI 858625, 859033, 859040, 859044, 859048, 859052, 901534, 901541, 901546, 901550, ... spl_id540a17f8-b64d-41e1-a96b-d55bc8c48f3d, 4b42cbf3-6700-4c2d-95a2-edb74067858aspl_set_ida7405a56-de1c-4875-b57f-210c991474ba, 79d73ae4-beaf-4a99-b0f3-d66438c122bdPackage NDC 31722-906-90, 31722-906-10, 31722-906-05, 31722-907-90, 31722-907-10, 31722-907- ... UNII3D867NP06J

5)

drugcharacterization1medicinalproductANORO ELLIPTAdrugbatchnumbR682350drugauthorizationnumb203975drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK, QDdrugdosageformINHALATION POWDERdrugadministrationroute055drugindicationCHRONIC OBSTRUCTIVE PULMONARY DISEASEactiondrug4

activesubstance

activesubstancenameUMECLIDINIUM BROMIDE\VILANTEROL TRIFENATATE

openFDA Info on Medication

Application NumberNDA203975Brand NameANORO ELLIPTAGeneric NameUMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATEManufacturersGlaxoSmithKline LLCproduct_ndc0173-0869Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsUMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATERXCUI1487519, 1487524, 1487527, 1487528spl_id704f01d5-f085-4276-839e-81a30f2f85aaspl_set_id2dbd0671-c565-40c5-bf0f-e324db26799cPackage NDC0173-0869-10, 0173-0869-06, 0173-0869-61UNII7AN603V4JV, 40AHO2C6DG

6)

drugcharacterization1medicinalproductALBUTEROL.drugbatchnumbUNKNOWNdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenameALBUTEROL

openFDA Info on Medication

Application Number ANDA210948, ANDA213657, ANDA211397, ANDA208804, ANDA072894, ANDA207046, ANDA2088 ... Brand NameALBUTEROLGeneric NameALBUTEROL SULFATE, ALBUTEROLManufacturers Nivagen Pharmaceuticals Inc, Aurobindo Pharma Limited, Virtus Pharmaceuticals LL ... product_ndc 75834-273, 75834-274, 59651-333, 59651-334, 69543-290, 69543-291, 69238-1344, 69 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALBUTEROL SULFATERXCUI197316, 197318spl_id 5b89a3bb-e3bb-421d-89f7-f180e01a1b4d, d3cb4534-a60a-4476-928c-6eb52ac01cf8, b9cd ... spl_set_id b735e92d-eb1a-6fc1-e053-2995a90afce2, ff9b287b-e4a4-4c12-ad2f-6b7d55b20dc6, 3f81 ... Package NDC 75834-273-01, 75834-274-01, 59651-333-01, 59651-333-05, 59651-334-01, 59651-334- ... UNII021SEF3731

7)

drugcharacterization2medicinalproductSIMVASTATIN.actiondrug5

activesubstance

activesubstancenameSIMVASTATIN

openFDA Info on Medication

Application Number NDA206679, ANDA078155, ANDA077691, ANDA078103, ANDA090383, ANDA078034, ANDA20089 ... Brand NameFLOLIPID, SIMVASTATIN, ZOCORGeneric NameSIMVASTATINManufacturers Salerno Pharmaceuticals Co., Accord Healthcare, Inc., NorthStar Rx LLC, Lupin Ph ... product_ndc 29273-401, 29273-402, 16729-004, 16729-005, 16729-006, 16729-007, 16729-156, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSIMVASTATINRXCUI 1790679, 1944262, 1944264, 1944266, 198211, 200345, 312961, 312962, 314231, 1044 ... spl_id d733a50e-32b3-2d73-e053-2a95a90a6106, cfc99fa8-c0c7-72ef-e053-2a95a90a6a03, 8ba4 ... spl_set_id 6ee17d10-6eb1-452a-99e8-02381368b3fe, 871251c0-36a1-4a32-9eab-ff6c1e925ca9, 0376 ... Package NDC 29273-401-04, 29273-402-04, 16729-005-10, 16729-005-12, 16729-005-15, 16729-005- ... NUIN0000175589, N0000000121Established Pharmacologic ClassHMG-CoA Reductase Inhibitor [EPC]Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]UNIIAGG2FN16EV

8)

drugcharacterization1medicinalproductCOMBIVENTdrugbatchnumbUNKNOWNdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenameALBUTEROL SULFATE\IPRATROPIUM BROMIDE

9)

drugcharacterization2medicinalproductASPIRIN (BABY)actiondrug5