Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10104610primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate12/12/2014reporttype2serious1seriousnesshospitalization1seriousnessother1receivedateformat102Date Received24/04/2014receiptdateformat102Date Last Updated24/04/2014fulfillexpeditecriteria1companynumbUS-ABBVIE-14P-163-1226708-00duplicate1

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14P-163-1226708-00

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionPortal vein thrombosisOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.0ReactionSplenic vein thrombosisOutcomeRecovering/resolving

3)

reactionmeddraversionpt17.0ReactionMesenteric vein thrombosisOutcomeRecovering/resolving

4)

reactionmeddraversionpt17.0ReactionAbdominal painOutcomeRecovering/resolving

5)

reactionmeddraversionpt17.0ReactionAbdominal distensionOutcomeRecovering/resolving

6)

reactionmeddraversionpt17.0ReactionArterial injuryOutcomeRecovering/resolving

7)

reactionmeddraversionpt17.0ReactionArterial haemorrhageOutcomeRecovering/resolving

8)

reactionmeddraversionpt17.0ReactionDepressionOutcomeUnknown

9)

reactionmeddraversionpt17.0ReactionDiarrhoeaOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt17.0ReactionLaboratory test abnormalOutcomeNot recovered/not resolved

11)

reactionmeddraversionpt17.0ReactionWeight decreasedOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumbUNKNOWNdrugauthorizationnumb125057drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosageformSolution for injection in pre-filled pendrugindicationCROHN^S DISEASEdrugstartdateformat602drugstartdate//2009actiondrug4

openFDA Info on Medication

Application NumberBLA125057Brand NameHUMIRAGeneric NameADALIMUMABManufacturersAbbVie Inc.product_ndc 0074-0067, 0074-3799, 0074-6347, 0074-4339, 0074-9374, 0074-0243, 0074-0554, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 351290, 352334, 727703, 727705, 763564, 763565, 797544, 825169, 825170, 1551887, ... spl_id1b259c93-37f5-4845-92ff-224dacfe1d50spl_set_id608d4f0d-b19f-46d3-749a-7159aa5f933dPackage NDC 0074-3799-02, 0074-3799-71, 0074-3799-06, 0074-3799-03, 0074-6347-02, 0074-4339- ...

2)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextAT BEDTIMEdrugindicationINSOMNIA

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)

drugcharacterization2medicinalproductLUNESTAdrugindicationINSOMNIA

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

4)

drugcharacterization2medicinalproductAMBIENdrugindicationINSOMNIA

openFDA Info on Medication

Application NumberNDA021774, NDA019908Brand NameAMBIEN CR, AMBIENGeneric NameZOLPIDEM TARTRATEManufacturerssanofi-aventis U.S. LLCproduct_ndc0024-5501, 0024-5521, 0024-5401, 0024-5421Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854880, 854882, 854894, 854896, 854873, 854875, 854876, 854878spl_id8138a0a9-168c-46d2-b13e-e7e84f27eaee, c8f05d12-bc35-43cb-8b65-588bec02c73dspl_set_id404c858c-89ac-4c9d-8a96-8702a28e6e76, c36cadf4-65a4-4466-b409-c82020b42452Package NDC 0024-5501-31, 0024-5501-10, 0024-5521-31, 0024-5521-50, 0024-5521-10, 0024-5401- ... UNIIWY6W63843K

5)

drugcharacterization2medicinalproductAMBIENdrugindicationINSOMNIA

openFDA Info on Medication

Application NumberNDA021774, NDA019908Brand NameAMBIEN CR, AMBIENGeneric NameZOLPIDEM TARTRATEManufacturerssanofi-aventis U.S. LLCproduct_ndc0024-5501, 0024-5521, 0024-5401, 0024-5421Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854880, 854882, 854894, 854896, 854873, 854875, 854876, 854878spl_id8138a0a9-168c-46d2-b13e-e7e84f27eaee, c8f05d12-bc35-43cb-8b65-588bec02c73dspl_set_id404c858c-89ac-4c9d-8a96-8702a28e6e76, c36cadf4-65a4-4466-b409-c82020b42452Package NDC 0024-5501-31, 0024-5501-10, 0024-5521-31, 0024-5521-50, 0024-5521-10, 0024-5401- ... UNIIWY6W63843K