Adverse Event Report

Report

reporttype2Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10095286serious1Date Last Updated22/04/2014receiptdateformat102companynumbUS-ABBVIE-14P-163-1215851-00occurcountryUSseriousnessother1duplicate1Date Received22/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification1

Patient

Onset Age55Unit of Onset AgeyearsWeight59.02SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionOptic neuritisOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionHypoaesthesiaOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionPain in extremityOutcomeRecovering/resolving

4)

reactionmeddraversionpt17.0ReactionMuscular weaknessOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionParaesthesiaOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.0ReactionMusculoskeletal painOutcomeRecovering/resolving

7)

reactionmeddraversionpt17.0ReactionParaesthesiaOutcomeRecovering/resolving

8)

reactionmeddraversionpt17.0ReactionParaesthesiaOutcomeRecovering/resolving

9)

reactionmeddraversionpt17.0ReactionHypoaesthesiaOutcomeRecovering/resolving

10)

reactionmeddraversionpt17.0ReactionParaesthesiaOutcomeRecovering/resolving

11)

reactionmeddraversionpt17.0ReactionHypoaesthesiaOutcomeRecovering/resolving

12)

reactionmeddraversionpt17.0ReactionHypoaesthesiaOutcomeRecovering/resolving

13)

reactionmeddraversionpt17.0ReactionVision blurredOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumbUNKNOWNdrugauthorizationnumb125057drugstructuredosagenumb160drugstructuredosageunit003drugdosagetextONE TIME DOSEdrugdosageformSolution for injection in pre-filled pendrugindicationCROHN^S DISEASEdrugstartdateformat102drugstartdate15/02/2014drugenddateformat102drugenddate15/02/2014actiondrug1

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)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumbUNKNOWNdrugauthorizationnumb125057drugstructuredosagenumb80drugstructuredosageunit003drugdosagetextONE TIME DOSEdrugdosageformSolution for injection in pre-filled pendrugstartdateformat102drugstartdate01/03/2014drugenddateformat102drugenddate01/03/2014actiondrug1

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- ...

3)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumbUNKNOWNdrugauthorizationnumb125057drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosageformSolution for injection in pre-filled pendrugstartdateformat102drugstartdate15/03/2014actiondrug1

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- ...

4)

drugcharacterization2medicinalproductZOLOFTdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

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

5)

drugcharacterization2medicinalproductMETHOTREXATEdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number NDA011719, ANDA040385, ANDA040263, ANDA040632, ANDA201529, ANDA201530, NDA008085 ... Brand NameMETHOTREXATE, TREXALL, RASUVO, XATMEP, REDITREX, OTREXUPGeneric NameMETHOTREXATE, METHOTREXATE SODIUMManufacturers Hospira, Inc., Teva Women's Health, Inc., Fresenius Kabi USA, LLC, Hikma Pharmac ... product_ndc 61703-350, 51285-366, 51285-367, 51285-368, 51285-369, 63323-123, 0143-9830, 674 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRA-ARTERIAL, INTRAMUSCULAR, INTRAVENOUS, ORAL, INTRATHECAL, SUBCUTANEOUSActive IngredientsMETHOTREXATE SODIUM, METHOTREXATERXCUI 1946772, 105586, 283510, 283511, 283671, 284592, 284593, 284594, 284595, 311625, ... spl_id 60bbb387-0ce5-4c7e-a917-5bc4b4685616, 78d0abc0-9ade-4302-ada0-72fd6d67eff9, 46c4 ... spl_set_id 0d63ba29-b692-41b4-87e8-351265c8273f, 0e30eaef-5a09-4104-8a11-c32933eadeab, e942 ... Package NDC 61703-350-37, 61703-350-38, 61703-350-09, 61703-350-10, 51285-366-01, 51285-367- ... UNII3IG1E710ZN, YL5FZ2Y5U1NUIN0000175584, N0000000111Established Pharmacologic ClassFolate Analog Metabolic Inhibitor [EPC]Mechanism of ActionFolic Acid Metabolism Inhibitors [MoA]

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14P-163-1215851-00

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use