Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10157693primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate12/12/2014reporttype1serious2receivedateformat102Date Received07/05/2014receiptdateformat102Date Last Updated07/05/2014fulfillexpeditecriteria2companynumbUS-009507513-1404USA015511duplicate1

Report Duplicate

duplicatesourceMERCKduplicatenumbUS-009507513-1404USA015511

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age85Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionDrug ineffectiveOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductOXYTROL FOR WOMENdrugbatchnumb3E13WSdrugauthorizationnumb202211drugdosagetextUNK, UNKNOWNdrugdosageformTRANSDERMAL PATCHdrugadministrationroute062drugindicationNOCTURIA

openFDA Info on Medication

Application NumberNDA202211Brand NameOXYTROL FOR WOMENGeneric NameOXYBUTYNINManufacturersAllergan, Inc.product_ndc0023-9637Product TypeHUMAN OTC DRUGRouteTRANSDERMALActive IngredientsOXYBUTYNINRXCUI403799, 404448spl_id54be9aae-fd23-43aa-9e76-2ae94a41bfcaspl_set_id8cdc5b4d-ff8d-4010-97d7-313422a0b868Package NDC0023-9637-04, 0023-9637-08NUIN0000175700, N0000000125Established Pharmacologic ClassCholinergic Muscarinic Antagonist [EPC]Mechanism of ActionCholinergic Muscarinic Antagonists [MoA]UNIIK9P6MC7092

2)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNK, UNKNOWNdrugindicationSLEEP DISORDERactiondrug5drugrecurreadministration3

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