Adverse Event Report

Report

reporttype2Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10357973serious1Date Last Updated01/10/2014receiptdateformat102companynumbUS-ACTELION-A-US2014-102605occurcountryUSseriousnessother1duplicate1Date Received01/08/2014transmissiondate28/05/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age57Unit of Onset Ageyearspatientagegroup5SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionBlood glucose increasedOutcomeRecovering/resolving

2)

reactionmeddraversionpt18.0ReactionInfectionOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionDiabetes mellitusOutcomeRecovering/resolving

Drug

1)

drugcharacterization2medicinalproductSILDENAFIL.drugrecurreadministration3

activesubstance

activesubstancenameSILDENAFIL

openFDA Info on Medication

Application Number ANDA203988, ANDA204883, ANDA201171, ANDA203962, ANDA202025, ANDA203623, ANDA2064 ... Brand NameSILDENAFIL, SILDENAFIL CITRATEGeneric NameSILDENAFIL CITRATE, SILDENAFIL, SILDINAFILManufacturers AuroMedics Pharma LLC, TruPharma LLC, Mylan Pharmaceuticals Inc., Aurobindo Phar ... product_ndc 55150-166, 52817-295, 0378-1658, 0378-1659, 0378-1660, 65862-689, 65862-690, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsSILDENAFIL CITRATE, SILDENAFILRXCUI882527, 577033, 312950, 314228, 314229, 1307427spl_id fa662b74-7d1b-4784-8a4c-0e2fc1ae2ddb, a8abd38f-2334-34e3-e053-2a95a90acb7d, 1d0e ... spl_set_id bb92d686-a81e-4b91-8048-693af0534cb3, c8864c64-22ad-402b-a1e8-cfb53fa02e80, cad6 ... Package NDC 55150-166-13, 52817-295-90, 52817-295-00, 0378-1658-93, 0378-1658-01, 0378-1658- ... UNIIBW9B0ZE037, 3M7OB98Y7HNUIN0000175599, N0000020026Established Pharmacologic ClassPhosphodiesterase 5 Inhibitor [EPC]Mechanism of ActionPhosphodiesterase 5 Inhibitors [MoA]

2)

drugcharacterization2medicinalproductZOCORdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, QDdrugrecurreadministration3

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

3)

drugcharacterization2medicinalproductAMLODIPINEdrugrecurreadministration3

activesubstance

activesubstancenameAMLODIPINE BESYLATE

openFDA Info on Medication

Application NumberNDA211340Brand NameKATERZIAGeneric NameAMLODIPINEManufacturersAzurity Pharmaceuticals, Inc.product_ndc52652-5001Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BENZOATERXCUI2184120, 2184126spl_id33926064-be3f-4380-b051-ac4136524317spl_set_iddf673a4d-acb8-444c-a472-c87ab8cbd366Package NDC52652-5001-1UNIIXD75TQ8A2P

4)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, QDdrugrecurreadministration3

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

5)

drugcharacterization2medicinalproductTRAZODONEdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, TIDdrugrecurreadministration3

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

6)

drugcharacterization1medicinalproductTRACLEERdrugauthorizationnumb021290drugstructuredosagenumb62.5drugstructuredosageunit003drugdosagetext62.5 MG, UNKdrugdosageformTABLETdrugadministrationroute048drugindicationPULMONARY ARTERIAL HYPERTENSIONdrugstartdateformat102drugstartdate20/03/2014actiondrug1

activesubstance

activesubstancenameBOSENTAN\BOSENTAN MONOHYDRATE

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

7)

drugcharacterization2medicinalproductMETFORMINdrugstructuredosagenumb1000drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1000 MG, BIDdrugindicationESSENTIAL HYPERTENSIONdrugrecurreadministration3

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

8)

drugcharacterization2medicinalproductHYDROCODONEdrugseparatedosagenumb4drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext7.50 UNK, QIDdrugrecurreadministration3

activesubstance

activesubstancenameHYDROCODONE

summary

narrativeincludeclinicalCASE EVENT DATE: 20140714

Report Duplicate

duplicatesourceACTELIONduplicatenumbUS-ACTELION-A-US2014-102605

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use