Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10799654primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/07/2015reporttype2serious2receivedateformat102Date Received16/02/2015receiptdateformat102Date Last Updated16/02/2015fulfillexpeditecriteria2companynumbUS-ABBVIE-14K-163-1243197-00duplicate1

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14K-163-1243197-00

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age54Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionInjection site painOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductGABAPENTIN.drugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationNEURALGIA

activesubstance

activesubstancenameGABAPENTIN

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 59afc809-201f-4cf8-95f6-67ae52c0a327, 4553 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

2)

drugcharacterization2medicinalproductVITAMIN Edrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancename.ALPHA.-TOCOPHEROL

3)

drugcharacterization2medicinalproductVITAMIN Cdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameASCORBIC ACID

4)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationINSOMNIA

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

5)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1015229drugauthorizationnumb125057drugstructuredosagenumb40drugstructuredosageunit003drugdosageformSOLUTION FOR INJECTION IN PRE-FILLED PENdrugstartdateformat102drugstartdate28/05/2014actiondrug4

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- ...

6)

drugcharacterization2medicinalproductVITAMIN Adrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameVITAMIN A

openFDA Info on Medication

Application Numberpart347Brand NameSKINEEZGeneric NameVITAMIN AManufacturersCAUSE FOR CHANGE LLCproduct_ndc73238-001Product TypeHUMAN OTC DRUGRouteTOPICALActive IngredientsVITAMIN Aspl_idcee2e772-ac94-a91d-e053-2995a90a47a1spl_set_idbbdd2c15-deca-4c8f-a727-6f531a87beacPackage NDC73238-001-01NUIM0022788, N0000175950Chemical StructureVitamin A [CS]Established Pharmacologic ClassVitamin A [EPC]UNII81G40H8B0T

7)

drugcharacterization2medicinalproductVITAMIN Ddrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameCHOLECALCIFEROL

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturers Strides Pharma Science Limited, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmac ... product_ndc64380-737, 23155-809Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725, 9c09c2d2-ef29-4654-be7d-ed3b2b508f43spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36, 96da2c1e-6c5e-4df0-8166-3de53c08a701Package NDC64380-737-06, 64380-737-25, 23155-809-01NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

8)

drugcharacterization2medicinalproductOMEPRAZOLE.drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationGASTROOESOPHAGEAL REFLUX DISEASE

activesubstance

activesubstancenameOMEPRAZOLE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA206877, ANDA075757, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, EQUALINE OMEPRAZOLE DELAYED RELEASE, KIRKLAND ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Supervalu Inc, Costco Wholesale Company, INNOVUS PHARMACEUTI ... product_ndc 46122-281, 41163-614, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 621 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, bd28c8a0-73e5-4c81-bc0e-b2c1504a88c3, 8c9d ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 16bf0c57-0376-48b3-90e5-502d61d1b6eb, 48a4 ... Package NDC 46122-281-04, 46122-281-74, 41163-614-01, 63981-915-55, 57483-740-01, 57483-740- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

9)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1015229drugauthorizationnumb125057drugstructuredosagenumb160drugstructuredosageunit003drugdosageformSOLUTION FOR INJECTION IN PRE-FILLED PENdrugindicationCROHN^S DISEASEdrugstartdateformat102drugstartdate30/04/2014drugenddateformat102drugenddate30/04/2014actiondrug4

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- ...

10)

drugcharacterization2medicinalproductGEMFIBROZIL.drugstructuredosagenumb600drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationBLOOD TRIGLYCERIDES INCREASED

activesubstance

activesubstancenameGEMFIBROZIL

openFDA Info on Medication

Application Number ANDA203266, NDA018422, ANDA204189, ANDA079072, ANDA202726, ANDA214603, ANDA07783 ... Brand NameGEMFIBROZIL, LOPIDGeneric NameGEMFIBROZILManufacturers Cadila Pharmaceuticals Limited, Parke-Davis Div of Pfizer Inc, Cadila Healthcare ... product_ndc 71209-008, 0071-0737, 70771-1431, 16714-101, 16571-784, 72865-186, 76282-225, 75 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGEMFIBROZILRXCUI310459, 205751spl_id a402785a-71fa-48a3-9495-9ea594939044, ef2b3c7e-b287-4cae-9bc3-86fb6ccbe9ae, d1d0 ... spl_set_id 0b50849a-66b6-4e8f-9f45-5425a875d366, c48855b7-215e-453b-b3b1-a0f9dee7221f, e6bc ... Package NDC 71209-008-03, 71209-008-08, 71209-008-10, 0071-0737-20, 0071-0737-30, 70771-1431 ... NUIN0000175596, N0000175375, M0199111Established Pharmacologic ClassPeroxisome Proliferator Receptor alpha Agonist [EPC]Mechanism of ActionPeroxisome Proliferator-activated Receptor alpha Agonists [MoA]Chemical StructurePPAR alpha [CS]UNIIQ8X02027X3

11)

drugcharacterization2medicinalproductZINCdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameZINC\ZINC CHLORIDE

openFDA Info on Medication

Brand NameZINCUM METALLICUM, NEURALGIA HEADACHE, ZINC, ZINCUM METALLICUM KIT REFILLGeneric NameZINC, ZINC SOAP, ZINC GLUCONATE, ZINC CHLORIDEManufacturers Boiron, Natural Health Supply, Washington Homeopathic Products, Seroyal USA, Mei ... product_ndc 0220-5434, 64117-052, 68428-712, 62106-5367, 78565-007, 49035-881, 0409-4090, 68 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, TOPICAL, INTRAVENOUSActive IngredientsZINC, PYRITHIONE ZINC, ZINC GLUCONATE, ZINC CHLORIDEspl_id 857e20b3-10c6-5551-e053-2a91aa0a4509, 71c93143-bfd1-416e-ab5d-6a97b7540ba0, 75e4 ... spl_set_id 857e20b3-10c5-5551-e053-2a91aa0a4509, e13c7e77-5b07-43af-a74d-43e84232254f, 88ab ... Package NDC 0220-5434-41, 64117-052-01, 64117-052-02, 68428-712-03, 68428-712-05, 68428-712- ... UNIIJ41CSQ7QDS, R953O2RHZ5, U6WSN5SQ1Z, 86Q357L16BApplication Numberpart358H, NDA018959RXCUI283707, 237508

12)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1015229drugauthorizationnumb125057drugstructuredosagenumb80drugstructuredosageunit003drugdosageformSOLUTION FOR INJECTION IN PRE-FILLED PENdrugstartdateformat102drugstartdate14/05/2014drugenddateformat102drugenddate14/05/2014actiondrug4

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- ...

13)

drugcharacterization2medicinalproductIRONdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameIRON

openFDA Info on Medication

Brand NameFERRUM METALLICUM, BILIOUSNESS DIARRHEAGeneric NameIRONManufacturersBoiron, Natural Health Supply, Washington Homeopathic Products, Seroyal USAproduct_ndc 0220-2055, 0220-2085, 0220-2051, 0220-2050, 0220-2047, 64117-791, 0220-2046, 022 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsIRONspl_id 8591b12c-51c9-9839-e053-2a91aa0aa937, 87372ec7-ead0-90b1-e053-2a91aa0afadf, 8591 ... spl_set_id 8591b12c-51c8-9839-e053-2a91aa0aa937, 87372ec7-eacf-90b1-e053-2a91aa0afadf, 8591 ... Package NDC 0220-2055-41, 0220-2085-41, 0220-2051-41, 0220-2050-41, 0220-2047-41, 64117-791- ... UNIIE1UOL152H7

14)

drugcharacterization2medicinalproductCALCIUM+MAGNESIUMdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationPRODUCT USED FOR UNKNOWN INDICATION

15)

drugcharacterization2medicinalproductSULFAMETHIZOLEdrugstructuredosagenumb800drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationACNE

activesubstance

activesubstancenameSULFAMETHIZOLE

summary

narrativeincludeclinicalCASE EVENT DATE: 20140430