Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-20378BPoccurcountryUSVersion of Safety Report ID4receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10173901Date Received15/05/2014transmissiondate26/03/2015serious2Date Last Updated30/09/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Weight45SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionPulmonary congestionOutcomeUnknown

2)

reactionmeddraversionpt17.1ReactionDysphoniaOutcomeUnknown

3)

reactionmeddraversionpt17.1ReactionOral candidiasisOutcomeUnknown

4)

reactionmeddraversionpt17.1ReactionOropharyngeal painOutcomeUnknown

5)

reactionmeddraversionpt17.1ReactionPulmonary congestionOutcomeUnknown

6)

reactionmeddraversionpt17.1ReactionProduct quality issueOutcomeUnknown

7)

reactionmeddraversionpt17.1ReactionDyspnoeaOutcomeUnknown

8)

reactionmeddraversionpt17.1ReactionProduct quality issueOutcomeUnknown

9)

reactionmeddraversionpt17.1ReactionAbdominal discomfortOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductSPIRIVAdrugbatchnumb308219A,13C3225,403056A,14C3200drugauthorizationnumb021395drugstructuredosagenumb18drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext18 MCGdrugdosageformINHALATION POWDER, HARD CAPSULEdrugadministrationroute055drugindicationCHRONIC OBSTRUCTIVE PULMONARY DISEASEdrugstartdateformat602drugstartdate//2007actiondrug4

activesubstance

activesubstancenameTIOTROPIUM BROMIDE MONOHYDRATE

openFDA Info on Medication

Application NumberNDA021395Brand NameSPIRIVA HANDIHALERGeneric NameTIOTROPIUM BROMIDEManufacturersBoehringer Ingelheim Pharmaceuticals, Inc.product_ndc0597-0075Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, RESPIRATORY (INHALATION)Active IngredientsTIOTROPIUM BROMIDE MONOHYDRATERXCUI485032, 580261spl_id61e158db-bf32-4cb5-8e5e-72acd953e493spl_set_id820839ef-e53d-47e8-a3b9-d911ff92e6a9Package NDC0597-0075-41, 0597-0075-75, 0597-0075-47UNIIL64SXO195N

2)

drugcharacterization2medicinalproductNEBULIZERdrugdosageformNEBULISER LIQUIDdrugadministrationroute055drugindicationCHRONIC OBSTRUCTIVE PULMONARY DISEASE

activesubstance

activesubstancenameUNSPECIFIED INGREDIENT

3)

drugcharacterization2medicinalproductPULMICORT TURBUHALERdrugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformInhalation solutiondrugadministrationroute055drugindicationCHRONIC OBSTRUCTIVE PULMONARY DISEASEdrugstartdateformat602drugstartdate//2013

activesubstance

activesubstancenameBUDESONIDE

4)

drugcharacterization2medicinalproductAMBIENdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MGdrugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat602drugstartdate//2012

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

5)

drugcharacterization1medicinalproductATROVENTdrugauthorizationnumb021527drugstructuredosagenumb17drugstructuredosageunit004drugdosageformInhalation solutiondrugadministrationroute055drugindicationCHRONIC OBSTRUCTIVE PULMONARY DISEASEdrugstartdateformat610drugstartdate/03/2014actiondrug4

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

6)

drugcharacterization2medicinalproductNORVASCdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MGdrugdosageformTABLETdrugadministrationroute048drugindicationHYPERTENSIONdrugstartdateformat602drugstartdate//2009

activesubstance

activesubstancenameAMLODIPINE BESYLATE

openFDA Info on Medication

Application NumberNDA019787Brand NameNORVASCGeneric NameAMLODIPINE BESYLATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0069-1520, 0069-1530, 0069-1540Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BESYLATERXCUI197361, 212542, 212549, 212575, 308135, 308136spl_id3f5ca9a3-9076-49ab-b247-669c337f3364spl_set_idabd6a2ca-40c2-485c-bc53-db1c652505edPackage NDC 0069-1520-68, 0069-1530-68, 0069-1530-41, 0069-1530-72, 0069-1540-68, 0069-1540- ... UNII864V2Q084H

7)

drugcharacterization2medicinalproductVITAMIN B12drugdosagetextFORM: INTRAMASCULARdrugadministrationroute030drugindicationSUPPLEMENTATION THERAPYdrugstartdateformat610drugstartdate/02/2014

activesubstance

activesubstancenameCYANOCOBALAMIN

8)

drugcharacterization2medicinalproductTOPROL XLdrugindicationCARDIAC DISORDER

activesubstance

activesubstancenameMETOPROLOL SUCCINATE

openFDA Info on Medication

Application NumberNDA019962Brand NameTOPROL XLGeneric NameMETOPROLOL SUCCINATEManufacturersAstraZeneca Pharmaceuticals LP, Aralez Pharmaceuticals US Inc.product_ndc 0186-1088, 0186-1090, 0186-1092, 0186-1094, 70347-025, 70347-050, 70347-100, 703 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETOPROLOL SUCCINATERXCUI866412, 866414, 866419, 866421, 866427, 866429, 866436, 866438spl_id03b2ba2e-c4b7-449d-8e07-9c0e08171f66, 259b9a5f-b63a-44a0-8d05-1bb38cfc85bdspl_set_id4a5762c6-d7a2-4e4c-10b7-8832b36fa5f4, 991fe00b-498b-400e-9e5b-921cb07d9b2cPackage NDC 0186-1088-05, 0186-1088-39, 0186-1088-30, 0186-1088-35, 0186-1090-05, 0186-1090- ... UNIITH25PD4CCB

9)

drugcharacterization2medicinalproductPREVACIDdrugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext30 MGdrugdosageformCAPSULEdrugadministrationroute048drugindicationGASTROOESOPHAGEAL REFLUX DISEASEdrugstartdateformat602drugstartdate//2013

activesubstance

activesubstancenameLANSOPRAZOLE

openFDA Info on Medication

Application NumberNDA020406, NDA022327Brand NamePREVACID, PREVACID 24 HRGeneric NameLANSOPRAZOLEManufacturers Takeda Pharmaceuticals America, Inc., GlaxoSmithKline Consumer Healthcare Holdin ... product_ndc64764-046, 64764-541, 64764-543, 64764-544, 0067-6286Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsLANSOPRAZOLERXCUI206205, 206206, 311277, 351260, 351261, 596843, 596918, 866152spl_ide9cb8e8b-589a-4d5d-9615-4bbd8dda0033, f2b830fb-0c23-494a-9d4c-76748dd7e1c6spl_set_id71ba78cb-7e46-43eb-9425-fa130f537f84, fd4629d5-b876-4ae9-bb32-c3560ad416a9Package NDC 64764-541-30, 64764-541-19, 64764-541-11, 64764-541-05, 64764-046-13, 64764-046- ... NUIN0000175525, N0000000147, N0000009724Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA]Physiologic/Pharmacodynamic EffectInhibition Gastric Acid Secretion [PE]UNII0K5C5T2QPG

10)

drugcharacterization2medicinalproductLIPITORdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MGdrugdosageformTABLETdrugadministrationroute048drugindicationBLOOD CHOLESTEROL INCREASEDdrugstartdateformat602drugstartdate//2011

activesubstance

activesubstancenameATORVASTATIN CALCIUM

openFDA Info on Medication

Application NumberNDA020702Brand NameLIPITORGeneric NameATORVASTATIN CALCIUMManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0155, 0071-0156, 0071-0157, 0071-0158Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATORVASTATIN CALCIUM TRIHYDRATERXCUI259255, 262095, 617310, 617311, 617312, 617314, 617318, 617320spl_id0ba214c6-250e-42a0-aea8-5e44aba04882spl_set_idc6e131fe-e7df-4876-83f7-9156fc4e8228Package NDC 0071-0155-23, 0071-0155-40, 0071-0155-10, 0071-0155-97, 0071-0156-23, 0071-0156- ... UNII48A5M73Z4Q

11)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MGdrugdosageformTABLETdrugadministrationroute048drugindicationDEPRESSIONdrugstartdateformat602drugstartdate//2011

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

12)

drugcharacterization2medicinalproductHYDRALAZINEdrugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1000 MGdrugdosageformTABLETdrugadministrationroute048drugindicationCARDIAC DISORDERdrugstartdateformat602drugstartdate//2012

activesubstance

activesubstancenameHYDRALAZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA203845Brand NameHYDRALAZINEGeneric NameHYDRALAZINE HYDROCHLORIDEManufacturersNivagen Pharmaceuticals, Inc.product_ndc75834-126, 75834-127, 75834-128Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDRALAZINE HYDROCHLORIDERXCUI905222, 905225, 905395spl_id7bb9db08-2d7a-476a-a1c2-a2b2834c632fspl_set_id1fd8cf42-66ae-4af5-a5ae-7c9679a0e532Package NDC 75834-126-01, 75834-126-00, 75834-127-01, 75834-127-00, 75834-128-01, 75834-128- ... UNIIFD171B778Y

13)

drugcharacterization2medicinalproductXOPENEXdrugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextSTRENGTH: 0.63 MG/3ML AND DAILY DOS:1.89drugdosageformInhalation solutiondrugadministrationroute055drugindicationCHRONIC OBSTRUCTIVE PULMONARY DISEASE

activesubstance

activesubstancenameLEVALBUTEROL HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020837Brand NameXOPENEXGeneric NameLEVALBUTEROL HYDROCHLORIDEManufacturersAkorn, Inc.product_ndc17478-172, 17478-173, 17478-174, 17478-171Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsLEVALBUTEROL HYDROCHLORIDERXCUI242754, 261136, 311286, 349590, 352132, 833470, 1855389, 1855391spl_id37feff22-df96-43eb-9d66-d15edb1c6faa, 2d495cb9-f9e7-4069-9d7f-c4c664bcaf40spl_set_id7e2644e6-36c5-4988-8e52-bec90e2cd2f0, 0c47c47d-45f7-4eb4-b1f8-7d6c633a1f69Package NDC 17478-172-12, 17478-172-24, 17478-173-12, 17478-173-24, 17478-174-12, 17478-174- ... UNIIWDQ1526QJM

14)

drugcharacterization2medicinalproductSINGULAIRdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MGdrugadministrationroute048drugindicationCHRONIC OBSTRUCTIVE PULMONARY DISEASE

activesubstance

activesubstancenameMONTELUKAST SODIUM

openFDA Info on Medication

Application NumberNDA020829, NDA020830, NDA021409Brand NameSINGULAIRGeneric NameMONTELUKAST SODIUMManufacturersMerck Sharp & Dohme Corp.product_ndc0006-9117, 0006-3841, 0006-1711, 0006-9275Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST SODIUMRXCUI153892, 153893, 200224, 242438, 261367, 311759, 351246, 404406spl_id96717981-6ea2-4720-a749-e14f1559511fspl_set_id8c166755-7711-4df9-d689-8836a1a70885Package NDC 0006-3841-30, 0006-3841-14, 0006-1711-31, 0006-1711-54, 0006-9275-31, 0006-9275- ... UNIIU1O3J18SFL

15)

drugcharacterization2medicinalproductPERFORMISTdrugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformInhalation solutiondrugadministrationroute055drugindicationCHRONIC OBSTRUCTIVE PULMONARY DISEASE

16)

drugcharacterization2medicinalproductTOPROL XLdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MGdrugdosageformTABLETdrugadministrationroute048drugindicationHYPERTENSIONdrugstartdateformat602drugstartdate//2009

activesubstance

activesubstancenameMETOPROLOL SUCCINATE

openFDA Info on Medication

Application NumberNDA019962Brand NameTOPROL XLGeneric NameMETOPROLOL SUCCINATEManufacturersAstraZeneca Pharmaceuticals LP, Aralez Pharmaceuticals US Inc.product_ndc 0186-1088, 0186-1090, 0186-1092, 0186-1094, 70347-025, 70347-050, 70347-100, 703 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETOPROLOL SUCCINATERXCUI866412, 866414, 866419, 866421, 866427, 866429, 866436, 866438spl_id03b2ba2e-c4b7-449d-8e07-9c0e08171f66, 259b9a5f-b63a-44a0-8d05-1bb38cfc85bdspl_set_id4a5762c6-d7a2-4e4c-10b7-8832b36fa5f4, 991fe00b-498b-400e-9e5b-921cb07d9b2cPackage NDC 0186-1088-05, 0186-1088-39, 0186-1088-30, 0186-1088-35, 0186-1090-05, 0186-1090- ... UNIITH25PD4CCB

17)

drugcharacterization2medicinalproductXOPENEXdrugdosageformInhalation solutiondrugadministrationroute055drugstartdateformat602drugstartdate//2013

activesubstance

activesubstancenameLEVALBUTEROL HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020837Brand NameXOPENEXGeneric NameLEVALBUTEROL HYDROCHLORIDEManufacturersAkorn, Inc.product_ndc17478-172, 17478-173, 17478-174, 17478-171Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsLEVALBUTEROL HYDROCHLORIDERXCUI242754, 261136, 311286, 349590, 352132, 833470, 1855389, 1855391spl_id37feff22-df96-43eb-9d66-d15edb1c6faa, 2d495cb9-f9e7-4069-9d7f-c4c664bcaf40spl_set_id7e2644e6-36c5-4988-8e52-bec90e2cd2f0, 0c47c47d-45f7-4eb4-b1f8-7d6c633a1f69Package NDC 17478-172-12, 17478-172-24, 17478-173-12, 17478-173-24, 17478-174-12, 17478-174- ... UNIIWDQ1526QJM

summary

narrativeincludeclinicalCASE EVENT DATE: 2013

Report Duplicate

duplicatesourceBOEHRINGER INGELHEIMduplicatenumbUS-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-20378BP