Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11272221primarysourcecountryUStransmissiondateformat102transmissiondate21/08/2015reporttype1serious2receivedateformat102Date Received25/06/2015receiptdateformat102Date Last Updated25/06/2015fulfillexpeditecriteria2companynumbA-US2014-106974duplicate1

Report Duplicate

duplicatesourceACTELIONduplicatenumbA-US2014-106974

Primary Source

reportercountryUSqualification2

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age67Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionPyrexia

2)

reactionmeddraversionpt18.0ReactionAbdominal discomfort

3)

reactionmeddraversionpt18.0ReactionDyspepsia

4)

reactionmeddraversionpt18.0ReactionPeripheral swelling

5)

reactionmeddraversionpt18.0ReactionChest pain

6)

reactionmeddraversionpt18.0ReactionDyspnoea

Drug

1)

drugcharacterization1medicinalproductOPSUMITdrugauthorizationnumb204410drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationPULMONARY ARTERIAL HYPERTENSIONdrugstartdateformat102drugstartdate25/09/2014drugenddateformat102drugenddate11/12/2014drugadditional1

activesubstance

activesubstancenameMACITENTAN

openFDA Info on Medication

Application NumberNDA204410Brand NameOPSUMITGeneric NameMACITENTANManufacturersActelion Pharmaceuticals US, Inc.product_ndc66215-501Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMACITENTANRXCUI1442137, 1442143spl_id7e422256-207c-4f3b-b5e0-8e94c33b1eccspl_set_id1e484a50-55db-4b85-8c57-6cd1b0353abdPackage NDC66215-501-30, 66215-501-15NUIN0000175581, N0000175364Established Pharmacologic ClassEndothelin Receptor Antagonist [EPC]Mechanism of ActionEndothelin Receptor Antagonists [MoA]UNIIZ9K9Y9WMVL

2)

drugcharacterization2medicinalproductLUNESTA

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

3)

drugcharacterization2medicinalproductADVIR (FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE)

4)

drugcharacterization2medicinalproductSPIRIVA

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_id74c01ed6-9299-467e-bda9-8043c8d887fbspl_set_id820839ef-e53d-47e8-a3b9-d911ff92e6a9Package NDC0597-0075-41, 0597-0075-75, 0597-0075-47UNIIL64SXO195N

5)

drugcharacterization2medicinalproductACETYLCYSTEINE (ACETYLCYSTEINE SODIUM)

6)

drugcharacterization2medicinalproductASPIRIN (ACETYLSALICYLIC ACID)

activesubstance

activesubstancenameASPIRIN

7)

drugcharacterization2medicinalproductREVATIO (SILDENAFIL CITRATE)

8)

drugcharacterization2medicinalproductPROAIR (FLUTICASONE PROPIONATE)

activesubstance

activesubstancenameFLUTICASONE PROPIONATE

9)

drugcharacterization2medicinalproductMETOPROLOL SUCCINATE (METOPROLOL SUCCINATE0

10)

drugcharacterization2medicinalproductDIOVAN

activesubstance

activesubstancenameVALSARTAN

openFDA Info on Medication

Application NumberNDA021283Brand NameDIOVANGeneric NameVALSARTANManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0358, 0078-0423, 0078-0359, 0078-0360Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVALSARTANRXCUI349199, 349200, 349201, 349483, 351761, 351762, 352001, 352274spl_idac202414-fac4-4db2-8e6d-8c797f74232aspl_set_id5ddba454-f3e6-43c2-a7a6-58365d297213Package NDC0078-0423-15, 0078-0358-34, 0078-0359-34, 0078-0360-34NUIN0000000070, N0000175561Mechanism of ActionAngiotensin 2 Receptor Antagonists [MoA]Established Pharmacologic ClassAngiotensin 2 Receptor Blocker [EPC]UNII80M03YXJ7I

11)

drugcharacterization2medicinalproductNORVASC

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_id80f34426-dbf5-41e4-9aaa-75526d0f3cf0spl_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

summary

narrativeincludeclinicalCASE EVENT DATE: 20141001