Adverse Event Report

Report

reporttype2Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10183879serious1Date Last Updated22/07/2014seriousnesslifethreatening1receiptdateformat102companynumbUS-ACTELION-A-NJ2014-99208occurcountryUSduplicate1Date Received20/05/2014seriousnesshospitalization1transmissiondate26/03/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age57Unit of Onset Ageyearspatientagegroup5SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionPneumoniaOutcomeUnknown

2)

reactionmeddraversionpt17.1ReactionCholecystectomyOutcomeRecovering/resolving

3)

reactionmeddraversionpt17.1ReactionSepsisOutcomeUnknown

4)

reactionmeddraversionpt17.1ReactionRespiratory failureOutcomeUnknown

5)

reactionmeddraversionpt17.1ReactionRenal failureOutcomeUnknown

6)

reactionmeddraversionpt17.1ReactionHepatic failureOutcomeRecovered/resolved

7)

reactionmeddraversionpt17.1ReactionDrug dose omissionOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductREVATIOdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, TIDdrugrecurreadministration3

activesubstance

activesubstancenameSILDENAFIL CITRATE

openFDA Info on Medication

Application NumberNDA203109, NDA022473, NDA021845Brand NameREVATIOGeneric NameSILDENAFIL CITRATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0069-0336, 0069-4190, 0069-0338Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsSILDENAFIL CITRATERXCUI577033, 581645, 882527, 882530, 1307427, 1307431spl_ideeeb2d77-bc88-45e8-afb2-f18cc8aa941espl_set_idf158fe10-d5dc-4432-b2c9-fc665401291bPackage NDC0069-4190-68, 0069-0338-01, 0069-0336-21UNIIBW9B0ZE037

2)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext200 MG, QDdrugrecurreadministration3

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

3)

drugcharacterization2medicinalproductOMEPRAZOLE.drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, QDdrugrecurreadministration3

activesubstance

activesubstancenameOMEPRAZOLE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA075757, ANDA206877, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, KIRKLAND SIGNATURE OMEPRAZOLE, OMEPRAZOLE, AC ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Costco Wholesale Company, INNOVUS PHARMACEUTICALS, INC., OHM ... product_ndc 46122-281, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 62175-136, 078 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, 8c9d9c38-9da6-4f99-9f08-26ec4693fa55, ce5c ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 48a44d0c-3502-430b-8b75-188a49d14da2, ce5c ... Package NDC 46122-281-04, 46122-281-74, 63981-915-55, 57483-740-01, 57483-740-42, 51660-029- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

4)

drugcharacterization2medicinalproductWARFARINdrugdosagetextUNK, PRNdrugrecurreadministration3

activesubstance

activesubstancenameWARFARIN

openFDA Info on Medication

Application NumberANDA090935, ANDA202202Brand NameWARFARIN SODIUMGeneric NameWARFARINManufacturersExelan Pharmaceuticals Inc., Amneal Pharmaceuticals LLCproduct_ndc 76282-327, 76282-328, 76282-329, 76282-330, 76282-331, 76282-332, 76282-333, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsWARFARIN SODIUMRXCUI855288, 855296, 855302, 855312, 855318, 855324, 855332, 855338, 855344spl_id45e85c4e-ae91-4cf3-bd98-1d5b5aecc7c5, f0ce7015-9133-4b90-a624-77fb776fbfa7spl_set_idc0cc4511-e656-4b6d-96cd-e02e76173b9d, 558b7a0d-5490-4c1b-802e-3ab3f1efe760Package NDC 76282-327-01, 76282-327-10, 76282-328-01, 76282-328-10, 76282-329-01, 76282-329- ... UNII6153CWM0CL

5)

drugcharacterization1medicinalproductVENTAVISdrugbatchnumbMA00S0F, MA00V97drugauthorizationnumb021779drugstructuredosagenumb2.5drugstructuredosageunit004drugdosagetext2.5 MCG, 6X DAILYdrugdosageformINHALATION VAPOUR, SOLUTIONdrugadministrationroute055drugindicationPULMONARY ARTERIAL HYPERTENSIONdrugstartdateformat102drugstartdate26/11/2013actiondrug4

activesubstance

activesubstancenameILOPROST

openFDA Info on Medication

Application NumberNDA021779Brand NameVENTAVISGeneric NameILOPROSTManufacturersActelion Pharmaceuticals US, Inc.product_ndc66215-302, 66215-303Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsILOPROSTRXCUI487056, 582595, 861964, 861966spl_ida8c8b2f7-d357-4a33-a56d-691bb82aa6e5spl_set_idd3bebc1c-f032-402a-bbc9-aff024276ed1Package NDC66215-302-00, 66215-302-30, 66215-303-00, 66215-303-30NUIN0000175603, M0017817Established Pharmacologic ClassProstacycline [EPC]Chemical StructureProstaglandins I [CS]UNIIJED5K35YGL

6)

drugcharacterization2medicinalproductROSUVASTATIN CALCIUMdrugstructuredosagenumb5drugstructuredosageunit003drugdosagetext5 MG, UNKdrugrecurreadministration3

activesubstance

activesubstancenameROSUVASTATIN CALCIUM

openFDA Info on Medication

Application Number ANDA206434, ANDA208898, ANDA079170, ANDA079172, ANDA210667, ANDA206465, ANDA2016 ... Brand NameROSUVASTATIN CALCIUM, ROSUVASTATIN, CRESTORGeneric NameROSUVASTATIN CALCIUMManufacturers H. J. Harkins Company Inc., Novadoz Pharmaceuticals LLC, Rising Health, LLC, Gle ... product_ndc 76519-1153, 72205-002, 72205-003, 72205-004, 72205-005, 72205-027, 57237-168, 57 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsROSUVASTATIN CALCIUMRXCUI859419, 859424, 859747, 859751, 859421, 859426, 859749, 859753spl_id 9aa182f2-7280-6b76-e053-2995a90aa64f, 8dc62d2a-9b6a-452d-9c9f-378f90fcb71a, 00e2 ... spl_set_id 60a5f95f-57e5-85ec-e053-2991aa0a8f11, d58f1f63-4bb6-413c-9730-ded3e8078618, 5c99 ... Package NDC 76519-1153-3, 72205-002-90, 72205-002-99, 72205-002-11, 72205-002-06, 72205-002- ... UNII83MVU38M7Q

7)

drugcharacterization2medicinalproductLETAIRISdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, QDdrugrecurreadministration3

activesubstance

activesubstancenameAMBRISENTAN

openFDA Info on Medication

Application NumberNDA022081Brand NameLETAIRISGeneric NameAMBRISENTANManufacturersGilead Sciences, Incproduct_ndc61958-0801, 61958-0802Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMBRISENTANRXCUI722116, 722120, 722122, 722124spl_idb6b19f3a-0619-cb36-e053-2995a90a5254spl_set_id725d4e73-6c83-477a-adc6-0ae4a133a844Package NDC 61958-0801-2, 61958-0801-3, 61958-0801-1, 61958-0801-5, 61958-0801-4, 61958-0801 ... NUIN0000175581, N0000175364Established Pharmacologic ClassEndothelin Receptor Antagonist [EPC]Mechanism of ActionEndothelin Receptor Antagonists [MoA]UNIIHW6NV07QEC

8)

drugcharacterization2medicinalproductOXYBUTINdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MG, TIDdrugrecurreadministration3

activesubstance

activesubstancenameOXYBUTYNIN

9)

drugcharacterization2medicinalproductADVAIR HFAdrugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext500-50 MCG, BIDdrugrecurreadministration3

activesubstance

activesubstancenameFLUTICASONE PROPIONATE\SALMETEROL XINAFOATE

openFDA Info on Medication

Application NumberNDA021254Brand NameADVAIR HFAGeneric NameFLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEManufacturersGlaxoSmithKline LLCproduct_ndc0173-0715, 0173-0716, 0173-0717Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsFLUTICASONE PROPIONATE, SALMETEROL XINAFOATERXCUI 896231, 896235, 896236, 896237, 896239, 896243, 896244, 896245, 896267, 896271, ... spl_id499c58ac-7a9c-488d-ab84-74e90b8b7dc7spl_set_iddfaca6f9-3277-47b2-319d-1377917cb54cPackage NDC 0173-0715-20, 0173-0715-22, 0173-0716-20, 0173-0716-22, 0173-0717-20, 0173-0717- ... UNIIO2GMZ0LF5W, 6EW8Q962A5

10)

drugcharacterization2medicinalproductLEFLUNOMIDE.drugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 MG, QDdrugrecurreadministration3

activesubstance

activesubstancenameLEFLUNOMIDE

openFDA Info on Medication

Application Number ANDA091369, ANDA211863, ANDA077086, ANDA212308, ANDA212453, NDA020905, ANDA07709 ... Brand NameLEFLUNOMIDE, ARAVAGeneric NameLEFLUNOMIDEManufacturers Alembic Pharmaceuticals Limited, Lupin Pharmaceuticals, Inc., Heritage Pharmaceu ... product_ndc 46708-436, 46708-437, 70748-129, 70748-130, 23155-043, 23155-044, 62332-061, 623 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEFLUNOMIDERXCUI205284, 205285, 205286, 213377, 213379, 213380spl_id e61a8fad-d513-4d27-aba0-e1a55b49c164, e2b15ca2-d8c1-421a-b175-3ed40ba80cec, 92c9 ... spl_set_id f6a4107e-b393-45ed-8e5a-70af5bd53826, 5d48fded-b43b-461a-8488-ca1da5c41a03, 40dd ... Package NDC 46708-436-30, 46708-436-60, 46708-436-31, 46708-436-71, 46708-437-30, 46708-437- ... NUIN0000175713Established Pharmacologic ClassAntirheumatic Agent [EPC]UNIIG162GK9U4W

11)

drugcharacterization2medicinalproductDIPHENHYDRAMINEdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext25 MG, QDdrugrecurreadministration3

activesubstance

activesubstancenameDIPHENHYDRAMINE

openFDA Info on Medication

Application Numberpart341, ANDA205723, ANDA040466Brand NameNIGHTIME SLEEP AID, DIPHENHYDRAMINEGeneric NameDIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HCLManufacturers Velocity Pharma, AAA Pharmaceutical, Inc., Safetec of America, Inc., Micro Labs ... product_ndc76168-065, 57344-090, 61010-4409, 42571-169, 42571-337, 68196-929, 63323-664Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsDIPHENHYDRAMINE HYDROCHLORIDERXCUI1020477, 1049630, 1049909, 1723740spl_id 6cbc010f-0449-cb45-e053-2a91aa0a1ec6, 94e265d8-7fba-2ee9-e053-2a95a90a4993, 8909 ... spl_set_id 9c44e54f-d8bc-4451-8382-40d2e8e03b42, 76724432-ff3c-404f-ba1f-5af68e3ab8c4, ef6b ... Package NDC 76168-065-37, 57344-090-02, 57344-090-03, 61010-4409-0, 61010-4409-1, 61010-4409 ... UNIITC2D6JAD40

summary

narrativeincludeclinicalCASE EVENT DATE: 20140430

Report Duplicate

duplicatesourceACTELIONduplicatenumbUS-ACTELION-A-NJ2014-99208

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use