Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10424461primarysourcecountryUStransmissiondateformat102transmissiondate26/03/2015reporttype1serious2receivedateformat102Date Received22/07/2014receiptdateformat102Date Last Updated22/07/2014fulfillexpeditecriteria2companynumb163-10004-14050473duplicate1

Report Duplicate

duplicatesourceCELGENEduplicatenumb163-10004-14050473

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age43Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionDiarrhoea

2)

reactionmeddraversionpt17.1ReactionDepression

Drug

1)

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

2)

drugcharacterization1medicinalproductOTEZLAdrugbatchnumbNSCPdrugauthorizationnumb205437drugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationPSORIATIC ARTHROPATHYdrugstartdateformat102drugstartdate24/03/2014drugenddateformat102drugenddate30/04/2014drugrecurreadministration3drugadditional3

activesubstance

activesubstancenameAPREMILAST

openFDA Info on Medication

Application NumberNDA205437Brand NameOTEZLAGeneric NameAPREMILASTManufacturersCelgene Corporation, Amgen Incproduct_ndc59572-630, 59572-631, 59572-632, 55513-137, 55513-369, 55513-485Product TypeHUMAN PRESCRIPTION DRUGRouteORALRXCUI 1492732, 1492738, 1492740, 1492742, 1492744, 1492746, 1492747, 1492748, 1605454, ... spl_id4b03ba80-afc7-4904-8c87-ef84b8fd25ea, f761de70-1a50-433e-9a3c-243644a6ae59spl_set_id3acf6751-827d-11e2-9e96-0800200c9a66, f6b1f516-4972-4d82-bced-113e47b41cc5Package NDC 59572-630-27, 59572-630-99, 59572-631-06, 59572-631-28, 59572-632-55, 55513-137- ... UNIIUP7QBP99PNActive IngredientsAPREMILAST

3)

drugcharacterization2medicinalproductCELEBREX

activesubstance

activesubstancenameCELECOXIB

openFDA Info on Medication

Application NumberNDA020998Brand NameCELEBREXGeneric NameCELECOXIBManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0025-1515, 0025-1520, 0025-1525, 0025-1530Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCELECOXIBRXCUI205322, 205323, 213468, 213469, 349514, 352314, 686379, 686381spl_idaa50b33d-5037-4cd8-968a-b0f64f8fb490spl_set_id8d52185d-421f-4e34-8db7-f7676db2a226Package NDC 0025-1515-01, 0025-1520-31, 0025-1520-51, 0025-1520-34, 0025-1525-31, 0025-1525- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIJCX84Q7J1L

summary

narrativeincludeclinicalCASE EVENT DATE: 20140430