Adverse Event Report

Report

reporttype2Version of Safety Report ID6receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10090092serious1Date Last Updated24/11/2015receiptdateformat102companynumbUS-ACTELION-A-US2013-80749occurcountryUSseriousnessother1duplicate1Date Received21/04/2014seriousnesshospitalization1transmissiondate04/03/2016primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age49Unit of Onset Ageyearspatientagegroup5SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionVomitingOutcomeUnknown

2)

reactionmeddraversionpt18.1ReactionTransfusionOutcomeUnknown

3)

reactionmeddraversionpt18.1ReactionDiverticulumOutcomeRecovering/resolving

4)

reactionmeddraversionpt18.1ReactionDyspnoeaOutcomeUnknown

5)

reactionmeddraversionpt18.1ReactionAnaemiaOutcomeRecovering/resolving

6)

reactionmeddraversionpt18.1ReactionHeadacheOutcomeUnknown

7)

reactionmeddraversionpt18.1ReactionVolume blood decreasedOutcomeRecovering/resolving

8)

reactionmeddraversionpt18.1ReactionHaemoglobin decreasedOutcomeRecovering/resolving

9)

reactionmeddraversionpt18.1ReactionAstheniaOutcomeUnknown

10)

reactionmeddraversionpt18.1ReactionErythemaOutcomeUnknown

11)

reactionmeddraversionpt18.1ReactionHaemorrhoidal haemorrhageOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductTRACLEERdrugbatchnumbIP044P010,1IP050P0101,IP052P0101drugauthorizationnumb021290drugstructuredosagenumb125drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext125 MG, BIDdrugdosageformTABLETdrugadministrationroute048drugindicationPULMONARY ARTERIAL HYPERTENSIONdrugstartdateformat102drugstartdate19/04/2013actiondrug4

activesubstance

activesubstancenameBOSENTAN

openFDA Info on Medication

Application NumberNDA021290, NDA209279Brand NameTRACLEERGeneric NameBOSENTANManufacturersActelion Pharmaceuticals US, Inc.product_ndc66215-101, 66215-102, 66215-103Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBOSENTANRXCUI349253, 352066, 656659, 656660, 1989081, 1989085spl_id93c78d0b-c8ba-4ef4-b3c9-43d6d198a70dspl_set_id749e42fb-2fe0-45dd-9268-b43bb3f4081cPackage NDC 66215-101-06, 66215-101-03, 66215-102-06, 66215-102-03, 66215-103-14, 66215-103- ... UNIIQ326023R30

2)

drugcharacterization2medicinalproductLASIXdrugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, UNKdrugrecurreadministration3

activesubstance

activesubstancenameFUROSEMIDE

openFDA Info on Medication

Application NumberNDA016273Brand NameLASIXGeneric NameFUROSEMIDEManufacturersValidus Pharmaceuticals LLCproduct_ndc30698-060, 30698-067, 30698-066Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFUROSEMIDERXCUI197732, 200801, 200809, 205732, 310429, 313988spl_id95a46760-e587-41a3-9ff3-c8dd8505f694spl_set_id2c9b4d8f-0770-482d-a9e6-9c616a440b1aPackage NDC 30698-067-01, 30698-067-10, 30698-060-01, 30698-060-10, 30698-060-50, 30698-066- ... NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

3)

drugcharacterization2medicinalproductLEVOTHYROXINE.drugstructuredosagenumb88drugstructuredosageunit004drugdosagetext88 MCG, UNKdrugstartdateformat102drugstartdate21/10/2013drugrecurreadministration3

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

4)

drugcharacterization2medicinalproductKCLdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNKdrugstartdateformat102drugstartdate13/09/2013drugrecurreadministration3

activesubstance

activesubstancenamePOTASSIUM CHLORIDE

5)

drugcharacterization2medicinalproductRANITIDINEdrugstructuredosagenumb150drugstructuredosageunit003drugdosagetext150 MG, UNKdrugstartdateformat102drugstartdate28/04/2014drugrecurreadministration3

activesubstance

activesubstancenameRANITIDINE\RANITIDINE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA091429, NDA021698, ANDA076195, ANDA200172, ANDA207579, ANDA207578, ANDA07865 ... Brand Name COOL MINT ACID REDUCER, ZANTAC MAXIMUM STRENGTH 150 COOL MINT, HARRIS TEETER ACI ... Generic NameRANITIDINE, RANITIDINE HYDROCHLORIDEManufacturers Rite Aid Corporation, Boehringer Ingelheim Pharmaceuticals Inc., Harris Teeter, ... product_ndc 11822-0950, 0597-0120, 69256-876, 37808-303, 69842-293, 41520-609, 58602-733, 58 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsRANITIDINE HYDROCHLORIDE, RANITIDINERXCUI 198191, 827189, 312773, 198193, 1090518, 705610, 643046, 198190, 198192, 827183, ... spl_id 0ebab972-16c7-4733-b1bc-e063d53f9e87, 97cb5218-4c7e-5ae5-e053-2995a90af3f2, a43a ... spl_set_id 4784c5b2-58eb-4b7c-b6e9-13dde7610a37, 888d9feb-fc9b-49cc-8361-30b5da86ea05, a43a ... Package NDC 11822-0950-1, 11822-0950-0, 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120- ... UNIIBK76465IHM, 884KT10YB7NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]

6)

drugcharacterization2medicinalproductDEMADEXdrugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKdrugrecurreadministration3

activesubstance

activesubstancenameTORSEMIDE

7)

drugcharacterization2medicinalproductZOCORdrugdosagetextUNKdrugstartdateformat610drugstartdate/10/2013drugrecurreadministration3

activesubstance

activesubstancenameSIMVASTATIN

openFDA Info on Medication

Application NumberNDA019766Brand NameZOCORGeneric NameSIMVASTATINManufacturersMerck Sharp & Dohme Corp.product_ndc0006-0543, 0006-0749, 0006-0740, 0006-0735Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSIMVASTATINRXCUI104490, 104491, 152923, 198211, 200345, 213319, 312961, 314231spl_id41a60de3-6740-43c7-a8d7-7dbfd0a8d6a0spl_set_idfdbfe194-b845-42c5-bb87-a48118bc72e7Package NDC 0006-0543-31, 0006-0543-54, 0006-0749-31, 0006-0749-54, 0006-0740-54, 0006-0740- ... NUIN0000175589, N0000000121Established Pharmacologic ClassHMG-CoA Reductase Inhibitor [EPC]Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]UNIIAGG2FN16EV

8)

drugcharacterization1medicinalproductTRACLEERdrugbatchnumbEP105P0101drugauthorizationnumb021290drugstructuredosagenumb62.5drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext62.5 MG, BIDdrugdosageformTABLETdrugadministrationroute048actiondrug4

activesubstance

activesubstancenameBOSENTAN

openFDA Info on Medication

Application NumberNDA021290, NDA209279Brand NameTRACLEERGeneric NameBOSENTANManufacturersActelion Pharmaceuticals US, Inc.product_ndc66215-101, 66215-102, 66215-103Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBOSENTANRXCUI349253, 352066, 656659, 656660, 1989081, 1989085spl_id93c78d0b-c8ba-4ef4-b3c9-43d6d198a70dspl_set_id749e42fb-2fe0-45dd-9268-b43bb3f4081cPackage NDC 66215-101-06, 66215-101-03, 66215-102-06, 66215-102-03, 66215-103-14, 66215-103- ... UNIIQ326023R30

9)

drugcharacterization2medicinalproductADCIRCAdrugrecurreadministration3

activesubstance

activesubstancenameTADALAFIL

openFDA Info on Medication

Application NumberNDA022332Brand NameADCIRCAGeneric NameTADALAFILManufacturersUnited Therapeutics Corporationproduct_ndc66302-467Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTADALAFILRXCUI849866, 2123194spl_id29f1af17-9d06-4338-afd6-632dcbcff287spl_set_idff61b237-be8e-461b-8114-78c52a8ad0aePackage NDC66302-467-60, 66302-467-61NUIN0000175599, N0000020026Established Pharmacologic ClassPhosphodiesterase 5 Inhibitor [EPC]Mechanism of ActionPhosphodiesterase 5 Inhibitors [MoA]UNII742SXX0ICT

10)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb100drugstructuredosageunit003drugdosagetext100 MG, UNKdrugstartdateformat610drugstartdate/04/2013drugrecurreadministration3

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

11)

drugcharacterization2medicinalproductTREPROSTINIL DIOLAMINdrugadministrationroute048drugrecurreadministration3

activesubstance

activesubstancenameTREPROSTINIL DIOLAMINE

summary

narrativeincludeclinicalCASE EVENT DATE: 201407

Report Duplicate

duplicatesourceACTELIONduplicatenumbUS-ACTELION-A-US2013-80749

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use