Report

reporttype2Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10051659serious1Date Last Updated01/04/2014receiptdateformat102companynumbUS-ABBVIE-14P-163-1215977-00occurcountryUSseriousnessother1duplicate1Date Received01/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification1

Patient

Onset Age14Unit of Onset AgeyearsWeight71.3SexMale

Contents

Reaction
- 1)
- 2)
- 3)
- 4)
- 5)
- 6)
- 7)
- 8)
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- 14)
Drug

Reaction

1)

reactionmeddraversionpt17.0ReactionIntestinal obstructionOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionAppendicitisOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionInfectionOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionOff label useOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionInjection site painOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.0ReactionInjection site painOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionAbdominal painOutcomeRecovered/resolved

8)

reactionmeddraversionpt17.0ReactionIntestinal mucosal hypertrophyOutcomeRecovered/resolved

9)

reactionmeddraversionpt17.0ReactionEnteritisOutcomeRecovered/resolved

10)

reactionmeddraversionpt17.0ReactionLocalised intraabdominal fluid collectionOutcomeRecovered/resolved

11)

reactionmeddraversionpt17.0ReactionIleusOutcomeRecovered/resolved

12)

reactionmeddraversionpt17.0ReactionNauseaOutcomeRecovered/resolved

13)

reactionmeddraversionpt17.0ReactionVomitingOutcomeRecovered/resolved

14)

reactionmeddraversionpt17.0ReactionCrohn^s diseaseOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1009150drugauthorizationnumb125057drugstructuredosagenumb40drugstructuredosageunit003drugdosageformSolution for injection in pre-filled pendrugindicationCROHN^S DISEASEdrugstartdateformat610drugstartdate/05/2013actiondrug1

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_id7a967019-f452-7b99-ba3d-e9b3ac703363spl_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)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1009150drugauthorizationnumb125057drugstructuredosagenumb160drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformSolution for injection in pre-filled pendrugstartdateformat102drugstartdate14/06/2013drugenddateformat102drugenddate14/06/2013actiondrug1

openFDA Info on Medication

3)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1009150drugauthorizationnumb125057drugstructuredosagenumb80drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformSolution for injection in pre-filled pendrugstartdateformat102drugstartdate27/08/2013actiondrug1

openFDA Info on Medication

4)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1009150drugauthorizationnumb125057drugstructuredosagenumb40drugstructuredosageunit003drugdosageformSolution for injection in pre-filled pendrugstartdateformat102drugstartdate10/09/2013actiondrug1

openFDA Info on Medication

5)

drugcharacterization2medicinalproductZOLOFTdrugindicationDEPRESSION

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14P-163-1215977-00

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use

Adverse Event Report

Report

Primary Source

Patient

Reaction

1)

2)

3)

4)

5)

6)

7)

8)

9)

10)

11)

12)

13)

14)

Drug

1)

openFDA Info on Medication

2)

openFDA Info on Medication

3)

openFDA Info on Medication

4)

openFDA Info on Medication

5)

openFDA Info on Medication

Report Duplicate

Receiver

Sender

Media

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