Adverse Event Report

Report

Version of Safety Report ID4Safety Report ID11871370primarysourcecountryJPoccurcountryJPtransmissiondateformat102transmissiondate26/05/2016reporttype2serious1seriousnesshospitalization1receivedateformat102Date Received28/12/2015receiptdateformat102Date Last Updated02/03/2016fulfillexpeditecriteria1companynumbJP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2015-BI-71744BIduplicate1

Report Duplicate

duplicatesourceBOEHRINGER INGELHEIMduplicatenumbJP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2015-BI-71744BI

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age84Unit of Onset AgeyearsWeight49SexFemale

Reaction

1)

reactionmeddraversionpt19.0ReactionChest discomfortOutcomeRecovered/resolved

2)

reactionmeddraversionpt19.0ReactionGastrooesophageal reflux diseaseOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductTHYRADINE-Sdrugstructuredosagenumb75drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext75 MCGdrugadministrationroute048drugindicationHYPOTHYROIDISMdrugstartdateformat602drugstartdate//2012

2)

drugcharacterization2medicinalproductPERSANTINdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MGdrugadministrationroute048drugindicationCORONARY ARTERY STENOSIS

activesubstance

activesubstancenameDIPYRIDAMOLE

3)

drugcharacterization2medicinalproductONONdrugstructuredosagenumb112.5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext112.5 MGdrugadministrationroute048drugindicationASTHMAdrugstartdateformat602drugstartdate//2006

activesubstance

activesubstancenamePRANLUKAST

4)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MGdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate15/12/2015

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

5)

drugcharacterization2medicinalproductSENNOSIDEdrugstructuredosagenumb24drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext24 MGdrugadministrationroute048drugindicationCONSTIPATIONdrugstartdateformat602drugstartdate//1985

activesubstance

activesubstancenameSENNOSIDES

6)

drugcharacterization2medicinalproductAMLODIPINEdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MGdrugadministrationroute048drugindicationHYPERTENSIONdrugstartdateformat602drugstartdate//2009

activesubstance

activesubstancenameAMLODIPINE BESYLATE

openFDA Info on Medication

Application NumberNDA214439, NDA211340Brand NameNORLIQVA, KATERZIAGeneric NameAMLODIPINEManufacturersCMP Pharma, Inc., Azurity Pharmaceuticals, Inc.product_ndc46287-035, 52652-5001Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE, AMLODIPINE BENZOATERXCUI2599173, 2599179, 2184120, 2184126spl_id63a6bb49-fb68-4351-be5f-a6b6e8f6b540, df623dda-e184-4011-8fce-4e729b2e6b2dspl_set_idc1730a51-4383-4c61-a9a1-7e1326bd0abe, df673a4d-acb8-444c-a472-c87ab8cbd366Package NDC46287-035-15, 52652-5001-1NUIN0000000069, N0000175421, N0000175566, M0006414, N0000190114Mechanism of ActionCalcium Channel Antagonists [MoA], Cytochrome P450 3A Inhibitors [MoA]Established Pharmacologic ClassDihydropyridine Calcium Channel Blocker [EPC], Calcium Channel Blocker [EPC]Chemical StructureDihydropyridines [CS]UNII1J444QC288, XD75TQ8A2P

7)

drugcharacterization2medicinalproductBISOPROLOL FUMARATE.drugstructuredosagenumb2.5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2.5 MGdrugadministrationroute048drugindicationTACHYCARDIAdrugstartdateformat102drugstartdate16/12/2015

activesubstance

activesubstancenameBISOPROLOL FUMARATE

openFDA Info on Medication

Application NumberANDA204891, ANDA215563, ANDA077910, ANDA078635, ANDA075474Brand NameBISOPROLOL FUMARATE, BISOPROLOLGeneric NameBISOPROLOL FUMARATEManufacturers Alembic Pharmaceuticals Inc., Novitium Pharma LLC, NorthStar Rx LLC, Aurobindo P ... product_ndc 62332-603, 62332-604, 70954-455, 70954-456, 16714-529, 16714-530, 65862-086, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBISOPROLOL FUMARATERXCUI854901, 854905spl_id 918dc4a5-ef02-4ab0-8664-7c02b23e37b6, 6517d564-ea55-4084-a8ab-34fea548c24e, 4bf3 ... spl_set_id 9b2eb4ea-001e-436c-93ba-20a7f5bc5f04, 6517d564-ea55-4084-a8ab-34fea548c24e, 4bf3 ... Package NDC 62332-603-30, 62332-603-31, 62332-603-71, 62332-604-30, 62332-604-31, 62332-604- ... UNIIUR59KN573L

8)

drugcharacterization2medicinalproductPLAVIXdrugstructuredosagenumb75drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext75 MGdrugadministrationroute048drugindicationCORONARY ARTERY STENOSISdrugstartdateformat102drugstartdate13/11/2015

activesubstance

activesubstancenameCLOPIDOGREL BISULFATE

openFDA Info on Medication

Application NumberNDA020839Brand NamePLAVIXGeneric NameCLOPIDOGRELManufacturerssanofi-aventis U.S. LLC, Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnershipproduct_ndc0024-1171, 0024-1332, 63653-1171, 63653-1332Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLOPIDOGREL BISULFATERXCUI213169, 309362, 749196, 749198spl_id4e097e4e-304d-4830-a350-d617662aa303, fdbc18a6-b364-4f85-9fd1-71d04b3a7ab1spl_set_idde8b0b67-eb25-4684-83b5-7ad785314227, 01b14603-8f29-4fa3-8d7e-9d523f802e0bPackage NDC 0024-1171-90, 0024-1332-30, 63653-1171-6, 63653-1171-1, 63653-1171-3, 63653-1171 ... UNII08I79HTP27

9)

drugcharacterization1medicinalproductDABIGATRANdrugauthorizationnumb022512drugstructuredosagenumb110drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext220 MGdrugdosageformCAPSULEdrugadministrationroute048drugindicationATRIAL FIBRILLATIONdrugstartdateformat102drugstartdate13/11/2015actiondrug4

activesubstance

activesubstancenameDABIGATRAN

10)

drugcharacterization2medicinalproductNEXIUMdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MGdrugadministrationroute048drugindicationPROPHYLAXIS AGAINST GASTROINTESTINAL ULCERdrugstartdateformat102drugstartdate23/10/2015

activesubstance

activesubstancenameESOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMRXCUI 606726, 606728, 606730, 606731, 692576, 692578, 861568, 861570, 861576, 861583, ... spl_id84c822de-ebe2-4a39-9944-7e38e1961dde, 24d37125-c3cf-48e0-9e50-75cbc818e7c1spl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43H

11)

drugcharacterization2medicinalproductOLMETECdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MGdrugadministrationroute048drugindicationHYPERTENSIONdrugstartdateformat602drugstartdate//2006

activesubstance

activesubstancenameOLMESARTAN MEDOXOMIL

12)

drugcharacterization2medicinalproductCIBENOLdrugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext300 MGdrugadministrationroute048drugindicationHYPERTROPHIC CARDIOMYOPATHYdrugstartdateformat102drugstartdate06/10/2015

activesubstance

activesubstancenameCIFENLINE

13)

drugcharacterization2medicinalproductCRESTORdrugstructuredosagenumb2.5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2.5 MGdrugadministrationroute048drugindicationHYPERLIPIDAEMIAdrugstartdateformat602drugstartdate//2005

activesubstance

activesubstancenameROSUVASTATIN CALCIUM

openFDA Info on Medication

Application NumberNDA021366Brand NameCRESTORGeneric NameROSUVASTATIN CALCIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0310-7560, 0310-7570, 0310-7580, 0310-7590, 0310-0751, 0310-0755, 0310-0752, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsROSUVASTATIN CALCIUMRXCUI859419, 859421, 859424, 859426, 859747, 859749, 859751, 859753spl_id08039402-2a60-4599-83b5-1c63b85ead70, d9298e4d-e35f-4ba4-9fdf-1a8d0358707fspl_set_id325a5d0e-9a72-4015-9fcd-1655fb504cee, bb0f3b5e-4bc6-41c9-66b9-6257e2513512Package NDC 0310-7560-90, 0310-7570-90, 0310-7580-90, 0310-7590-30, 0310-0755-90, 0310-0751- ... UNII83MVU38M7Q

14)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 MGdrugadministrationroute048drugstartdateformat102drugstartdate15/12/2015

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20151214