Adverse Event Report

Report

Version of Safety Report ID3Safety Report ID10274655primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate26/03/2015reporttype2serious1seriousnesshospitalization1seriousnessother1receivedateformat102Date Received02/07/2014receiptdateformat102Date Last Updated21/07/2014fulfillexpeditecriteria1companynumbUS-ABBVIE-14P-163-1253510-00duplicate1

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14P-163-1253510-00

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age27Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionRectal perforationOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.1ReactionShockOutcomeRecovering/resolving

3)

reactionmeddraversionpt17.1ReactionPyrexiaOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.1ReactionWeight decreasedOutcomeUnknown

5)

reactionmeddraversionpt17.1ReactionDiarrhoeaOutcomeUnknown

6)

reactionmeddraversionpt17.1ReactionGastrointestinal inflammationOutcomeUnknown

7)

reactionmeddraversionpt17.1ReactionBlood pressure decreasedOutcomeRecovered/resolved

8)

reactionmeddraversionpt17.1ReactionSepsisOutcomeUnknown

9)

reactionmeddraversionpt17.1ReactionCrohn^s diseaseOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt17.1ReactionHeart rate increasedOutcomeRecovered/resolved

11)

reactionmeddraversionpt17.1ReactionAbdominal adhesionsOutcomeUnknown

12)

reactionmeddraversionpt17.1ReactionFistulaOutcomeUnknown

13)

reactionmeddraversionpt17.1ReactionIncreased appetiteOutcomeUnknown

14)

reactionmeddraversionpt17.1ReactionMuscle spasmsOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductCELEXAdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameCITALOPRAM HYDROBROMIDE

openFDA Info on Medication

Application NumberNDA020822Brand NameCELEXAGeneric NameCITALOPRAMManufacturersAllergan, Inc.product_ndc0456-4010, 0456-4020, 0456-4040Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCITALOPRAM HYDROBROMIDERXCUI200371, 213344, 213345, 283672, 284591, 309314spl_iddbff05bb-4557-4d6c-be56-54b239bddae6spl_set_id4259d9b1-de34-43a4-85a8-41dd214e9177Package NDC 0456-4010-01, 0456-4020-01, 0456-4020-11, 0456-4020-63, 0456-4040-01, 0456-4040- ... UNIII1E9D14F36

2)

drugcharacterization2medicinalproductKLONOPINdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameCLONAZEPAM

openFDA Info on Medication

Application NumberNDA017533Brand NameKLONOPINGeneric NameCLONAZEPAMManufacturersH2-Pharma, LLC, Genentech, Inc.product_ndc61269-605, 61269-610, 61269-620, 0004-0058, 0004-0068, 0004-0098Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI197527, 197528, 197529, 206157, 206159, 206160spl_id65d5607d-3926-4b60-97dc-18509af3f271, 0d423291-6115-4522-88db-dcd1096bd432spl_set_idcfa0d79a-843c-4b88-95a1-e9511d649ca1, 542f22e8-dad2-47a8-93b6-30936715d73bPackage NDC 61269-605-10, 61269-610-10, 61269-620-10, 0004-0068-01, 0004-0058-01, 0004-0098- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

3)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumbUNKNWONdrugauthorizationnumb125057drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosageformSolution for injection in pre-filled pendrugindicationCROHN^S DISEASEdrugstartdateformat610drugstartdate/02/2014actiondrug4

activesubstance

activesubstancenameADALIMUMAB

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- ...

4)

drugcharacterization2medicinalproductLUNESTAdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

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

summary

narrativeincludeclinicalCASE EVENT DATE: 201402