Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11705584primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate04/03/2016reporttype1serious2receivedateformat102Date Received06/11/2015receiptdateformat102Date Last Updated06/11/2015fulfillexpeditecriteria2companynumbUS-WARNER CHILCOTT, LLC-1043868duplicate1

Report Duplicate

duplicatesourceWARNER CHILCOTTduplicatenumbUS-WARNER CHILCOTT, LLC-1043868

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age80Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionOedema peripheralOutcomeRecovering/resolving

Drug

1)

drugcharacterization2medicinalproductMULTIVIT

activesubstance

activesubstancenameVITAMINS

2)

drugcharacterization2medicinalproductCALCIUM

activesubstance

activesubstancenameCALCIUM

openFDA Info on Medication

Brand Name P D ALL, 7030 CALCIUM PREMIUM, ONLYCAL, RESTO L, P D M, RESTORATION TREATMENT, A ... Generic NameCALCIUMManufacturerscoexleaders co.,ltd., Apexel Co., Ltd, APEXEL CO., LTD.product_ndc 81445-0002, 55259-0002, 81445-0005, 81445-0006, 81445-0003, 81445-0001, 55259-00 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCALCIUMspl_id bcb38a08-7ca8-1e46-e053-2a95a90afef6, bdc7c088-83ef-20ce-e053-2995a90abd2f, bcb3 ... spl_set_id b9e7d869-d218-d60c-e053-2995a90af542, bdc7c833-daf7-48f9-e053-2995a90ad88e, b9eb ... Package NDC 81445-0002-1, 55259-0002-1, 81445-0005-1, 81445-0006-1, 81445-0003-1, 81445-0001 ... NUIM0003153, N0000175901, N0000175597, N0000020074Chemical StructureCalcium [CS]Established Pharmacologic ClassCalcium [EPC], Phosphate Binder [EPC]Mechanism of ActionPhosphate Chelating Activity [MoA]UNIISY7Q814VUP

3)

drugcharacterization1medicinalproductENABLEXdrugbatchnumb519666A / 09/2015drugauthorizationnumb021513drugstructuredosagenumb7.5drugstructuredosageunit003drugdosageformMODIFIED-RELEASE TABLETdrugadministrationroute048drugindicationHYPERTONIC BLADDERdrugstartdateformat102drugstartdate08/01/2015drugenddateformat102drugenddate08/01/2015actiondrug1

activesubstance

activesubstancenameDARIFENACIN\DARIFENACIN HYDROBROMIDE

4)

drugcharacterization2medicinalproductVITAMIN D

activesubstance

activesubstancenameCHOLECALCIFEROL

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturers Strides Pharma Science Limited, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmac ... product_ndc64380-737, 23155-809Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725, 9c09c2d2-ef29-4654-be7d-ed3b2b508f43spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36, 96da2c1e-6c5e-4df0-8166-3de53c08a701Package NDC64380-737-06, 64380-737-25, 23155-809-01NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

5)

drugcharacterization2medicinalproductENTOCORT EC

activesubstance

activesubstancenameBUDESONIDE

6)

drugcharacterization2medicinalproductLIPITOR

activesubstance

activesubstancenameATORVASTATIN CALCIUM

openFDA Info on Medication

Application NumberNDA020702Brand NameLIPITORGeneric NameATORVASTATIN CALCIUMManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0155, 0071-0156, 0071-0157, 0071-0158Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATORVASTATIN CALCIUM TRIHYDRATERXCUI259255, 262095, 617310, 617311, 617312, 617314, 617318, 617320spl_idb95993d7-bc87-4d0a-9926-e3d36c5b3b4espl_set_idc6e131fe-e7df-4876-83f7-9156fc4e8228Package NDC 0071-0155-23, 0071-0155-40, 0071-0155-97, 0071-0156-23, 0071-0156-40, 0071-0156- ... UNII48A5M73Z4Q

7)

drugcharacterization2medicinalproductATACAND

activesubstance

activesubstancenameCANDESARTAN CILEXETIL

openFDA Info on Medication

Application NumberNDA020838Brand NameATACANDGeneric NameCANDESARTAN CILEXETILManufacturersANI Pharmaceuticals, Inc.product_ndc62559-640, 62559-641, 62559-642, 62559-643Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCANDESARTAN CILEXETILRXCUI153822, 153823, 577776, 577785, 577787, 639537, 639539, 639543spl_id690e8be9-d5c7-457b-a24e-9f5479d63562spl_set_id94a59260-d2b6-464a-b5b9-bbc599e57e10Package NDC 62559-640-30, 62559-641-30, 62559-642-30, 62559-642-90, 62559-643-30, 62559-643- ... UNIIR85M2X0D68

8)

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