Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10360767serious1Date Last Updated04/08/2014receiptdateformat102companynumbUS-GLAXOSMITHKLINE-A1083030AoccurcountryUSduplicate1Date Received04/08/2014seriousnesshospitalization1transmissiondate26/03/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

SexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionCoughOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.1ReactionDyspnoeaOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.1ReactionMemory impairmentOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.1ReactionDrug administration errorOutcomeUnknown

5)

reactionmeddraversionpt17.1ReactionDiabetes mellitusOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.1ReactionPneumoniaOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt17.1ReactionArthritisOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt17.1ReactionWeight increasedOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt17.1ReactionIll-defined disorderOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductHYDROCHLOROTHIAZIDE.

activesubstance

activesubstancenameHYDROCHLOROTHIAZIDE

openFDA Info on Medication

Application Number ANDA040780, ANDA203018, ANDA040412, ANDA085182, ANDA203561, ANDA078164, ANDA0870 ... Brand NameHYDROCHLOROTHIAZIDEGeneric NameHYDROCHLOROTHIAZIDEManufacturers Aurobindo Pharma Limited, ScieGen Pharmaceuticals, Inc., Solco Healthcare U.S., ... product_ndc 65862-133, 65862-134, 50228-111, 50228-112, 43547-397, 43547-398, 23155-008, 231 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROCHLOROTHIAZIDERXCUI197770, 310798, 199903, 429503spl_id 9d73930e-75b8-4a7b-9d12-2049f593ca9d, 5c6f4c6a-cc43-4f4d-bc16-688310c98c72, d8ce ... spl_set_id 01f1f478-5493-439f-9b99-f4f82023781c, 02e96a51-1d56-460c-8c20-3d6f37e0ce46, 60c9 ... Package NDC 65862-133-01, 65862-133-99, 65862-134-01, 65862-134-99, 50228-111-30, 50228-111- ... NUIN0000175359, N0000175419, M0471776Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Established Pharmacologic ClassThiazide Diuretic [EPC]Chemical StructureThiazides [CS]UNII0J48LPH2TH

2)

drugcharacterization2medicinalproductLEVOTHYROXINE

activesubstance

activesubstancenameLEVOTHYROXINE

openFDA Info on Medication

Brand NameLEVOTHYROXINEGeneric NameLEVOTHYROXINEManufacturersDeseret Biologicals, Inc.product_ndc43742-0955Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLEVOTHYROXINEspl_id7c431149-4f46-4c4f-a5bb-c1b1fb705283spl_set_id1a467f8b-2611-4936-af2b-098e4791d6aePackage NDC43742-0955-1NUIN0000175945, M0021504Established Pharmacologic Classl-Thyroxine [EPC]Chemical StructureThyroxine [CS]UNIIQ51BO43MG4

3)

drugcharacterization2medicinalproductATORVASTATIN

activesubstance

activesubstancenameATORVASTATIN

openFDA Info on Medication

4)

drugcharacterization1medicinalproductSEREVENTdrugbatchnumbUNKNOWNdrugauthorizationnumb020692drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1PUFF TWICE PER DAYdrugdosageformMulti dose powder inhalerdrugadministrationroute055drugindicationCHRONIC OBSTRUCTIVE PULMONARY DISEASEactiondrug4

activesubstance

activesubstancenameSALMETEROL XINAFOATE

openFDA Info on Medication

Application NumberNDA020692Brand NameSEREVENT DISKUSGeneric NameSALMETEROL XINAFOATEManufacturersGlaxoSmithKline LLCproduct_ndc0173-0520, 0173-0521Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, RESPIRATORY (INHALATION)Active IngredientsSALMETEROL XINAFOATERXCUI866044, 866047, 866048, 866049spl_id658e0021-116a-42a2-a7ac-a231d1eb611dspl_set_id12d9728e-6b5c-4aee-bfb0-745e542ed2e4Package NDC0173-0521-00, 0173-0520-00UNII6EW8Q962A5

5)

drugcharacterization2medicinalproductASPIRIN.

activesubstance

activesubstancenameASPIRIN

openFDA Info on Medication

Application Numberpart343Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN 81MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 0363-0587, 70000-0218, 70000-0170, 6 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 198471, 825180, 198464 ... spl_id a1833a99-76cc-47fb-80fb-3a6507a2db3e, acc2acbd-b310-e26a-e053-2a95a90a1874, 1b00 ... spl_set_id 2826d84d-b135-4e20-aeea-271e9f74f431, 356e4ff4-a7f1-4a50-9b86-2555e232b300, 4c30 ... Package NDC 49035-914-32, 47682-456-50, 47682-456-47, 42961-044-01, 42961-044-02, 42961-044- ... NUIN0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]UNIIR16CO5Y76E, H0G9379FGK

6)

drugcharacterization2medicinalproductMETFORMIN

activesubstance

activesubstancenameMETFORMIN HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA200690, ANDA209674, ANDA209313Brand NameMETFORMIN HYDROCHLORIDE, METFORMINGeneric NameMETFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MGManufacturers Mylan Pharmaceuticals Inc., Ingenus Pharmaceuticals, LLC, Granules Pharmaceutica ... product_ndc0378-6001, 0378-6002, 50742-633, 50742-634, 70010-491, 70010-492Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETFORMIN HYDROCHLORIDERXCUI1807894, 1807917, 860975, 860981spl_id b1d71739-26c3-43d3-9088-60bef3689e74, d7e2ad60-7a17-4c65-b836-e56644be754d, a353 ... spl_set_id 7e41818c-60e9-4bcf-9586-7bb8d33d5e89, 49a0b5c2-ebaf-4c4c-905f-dfd1962ac647, 6d6e ... Package NDC 0378-6002-91, 0378-6001-91, 50742-633-60, 50742-633-90, 50742-633-10, 50742-634- ... UNII786Z46389E

7)

drugcharacterization2medicinalproductDITROPAN XL

activesubstance

activesubstancenameOXYBUTYNIN CHLORIDE

openFDA Info on Medication

Application NumberNDA020897Brand NameDITROPAN XLGeneric NameOXYBUTYNIN CHLORIDEManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-805, 50458-810Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYBUTYNIN CHLORIDERXCUI863619, 863622, 863636, 863638spl_id3208919a-639a-11ea-84ff-3a1efc2ca371spl_set_id36cc9115-bef3-48fa-93ff-bcda24cf26e2Package NDC50458-805-01, 50458-810-01UNIIL9F3D9RENQ

8)

drugcharacterization2medicinalproductLANTUS

activesubstance

activesubstancenameINSULIN GLARGINE

openFDA Info on Medication

Application NumberBLA021081Brand NameLANTUSGeneric NameINSULIN GLARGINEManufacturerssanofi-aventis U.S. LLCproduct_ndc0088-2220, 0088-2219, 0088-5021, 0088-5020Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsINSULIN GLARGINERXCUI285018, 311041, 847230, 847232spl_id0a57f187-f101-4268-851f-7f20c7f708f9, 4e455ace-94f4-4fa3-85eb-0152e5a06239spl_set_idd5e07a0c-7e14-4756-9152-9fea485d654a, 6328c99d-d75f-43ef-b19e-7e71f91e57f6Package NDC 0088-2220-33, 0088-2220-34, 0088-2219-00, 0088-2219-01, 0088-2219-05, 0088-5021- ... NUIN0000004931, N0000175453Chemical StructureInsulin [Chemical/Ingredient]Established Pharmacologic ClassInsulin Analog [EPC]UNII2ZM8CX04RZ

9)

drugcharacterization2medicinalproductSERTRALINE

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

Report Duplicate

duplicatesourceGLAXOSMITHKLINEduplicatenumbUS-GLAXOSMITHKLINE-A1083030A

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use