Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11021444primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/08/2015reporttype1serious2receivedateformat102Date Received13/04/2015receiptdateformat102Date Last Updated13/04/2015fulfillexpeditecriteria2companynumbUS-UPSHER-SMITH LABORATORIES, INC.-14000874duplicate1

Report Duplicate

duplicatesourceUPSHER-SMITHduplicatenumbUS-UPSHER-SMITH LABORATORIES, INC.-14000874

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age81Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionDyspepsiaOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNKdrugindicationINSOMNIAdrugrecurreadministration3

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

2)

drugcharacterization2medicinalproductPROBIOTIC ACIDOPHILUSdrugdosagetextUNKdrugrecurreadministration3

activesubstance

activesubstancenameLACTOBACILLUS ACIDOPHILUS

3)

drugcharacterization1medicinalproductPREVALITEdrugauthorizationnumb073263drugstructuredosagenumb4drugstructuredosageunit002drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext4 G, QDdrugdosageformPOWDERdrugadministrationroute048drugindicationCOLITISdrugstartdateformat102drugstartdate27/03/2014actiondrug4

activesubstance

activesubstancenameCHOLESTYRAMINE

openFDA Info on Medication

Application NumberANDA073263Brand NamePREVALITEGeneric NameCHOLESTYRAMINEManufacturersUpsher-Smith Laboratories, LLCproduct_ndc0245-0036Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCHOLESTYRAMINERXCUI848951, 1801279spl_id9b6744b4-a5bb-4b5c-a92e-c11b0329cba9spl_set_iddd434ef8-8af3-434c-a0a0-9a0b18459ba0Package NDC0245-0036-89, 0245-0036-42, 0245-0036-60, 0245-0036-23NUIN0000180292, N0000175365Established Pharmacologic ClassBile Acid Sequestrant [EPC]Mechanism of ActionBile-acid Binding Activity [MoA]UNII4B33BGI082

4)

drugcharacterization2medicinalproductMULTIVITAMINdrugdosagetextUNKdrugrecurreadministration3

activesubstance

activesubstancenameVITAMINS

summary

narrativeincludeclinicalCASE EVENT DATE: 20140329