Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10834601primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/07/2015reporttype2serious2receivedateformat102Date Received19/02/2015receiptdateformat102Date Last Updated19/02/2015fulfillexpeditecriteria2companynumbUS-ABBVIE-14P-163-1206215-00duplicate1

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14P-163-1206215-00

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age73Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionAphoniaOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionNasopharyngitisOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductZOCORdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameSIMVASTATIN

openFDA Info on Medication

Application NumberNDA019766Brand NameZOCORGeneric NameSIMVASTATINManufacturersOrganon LLCproduct_ndc78206-179, 78206-182, 78206-181, 78206-180Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSIMVASTATINRXCUI104490, 104491, 152923, 198211, 200345, 213319, 312961, 314231spl_id50f92ae8-00c3-4467-8482-237a5ee3aaf6spl_set_id8f55d5de-5a4f-4a39-8c84-c53976dd6af9Package NDC 78206-179-01, 78206-179-02, 78206-182-01, 78206-182-02, 78206-181-02, 78206-181- ... NUIN0000175589, N0000000121Established Pharmacologic ClassHMG-CoA Reductase Inhibitor [EPC]Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]UNIIAGG2FN16EV

2)

drugcharacterization2medicinalproductPREMARINdrugdosageformVAGINAL CREAMdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameESTROGENS, CONJUGATED

openFDA Info on Medication

Application NumberNDA020216, NDA010402, NDA004782Brand NamePREMARIN VAGINAL, PREMARINGeneric NameCONJUGATED ESTROGENS, ESTROGENS, CONJUGATEDManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0046-0872, 0046-0749, 0046-1100, 0046-1101, 0046-1102, 0046-1104, 0046-1103Product TypeHUMAN PRESCRIPTION DRUGRouteVAGINAL, INTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsESTROGENS, CONJUGATEDRXCUI 688240, 688242, 211975, 310203, 150840, 197660, 197661, 197662, 202301, 208513, ... spl_id b54269c0-58cc-40b9-80fe-91740e9ed83f, 73618f81-e08d-4f94-807c-8a58395ec2a2, 9cd6 ... spl_set_id 96609623-528e-4aba-cabe-7254aed816d5, 87e2da8d-432c-4ed5-67a1-dc26294b2295, 258e ... Package NDC 0046-0872-04, 0046-0872-21, 0046-0749-05, 0046-1101-81, 0046-1102-81, 0046-1102- ... NUIN0000175825, N0000000100, M0007792Established Pharmacologic ClassEstrogen [EPC]Mechanism of ActionEstrogen Receptor Agonists [MoA]Chemical StructureEstrogens, Conjugated (USP) [CS]UNIIIU5QR144QX

3)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumbUNKNOWNdrugauthorizationnumb125057drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosageformSOLUTION FOR INJECTION IN PRE-FILLED PENdrugadministrationroute058drugindicationRHEUMATOID ARTHRITISdrugstartdateformat102drugstartdate11/02/2013actiondrug1

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)

drugcharacterization2medicinalproductADVAIR HFAdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameFLUTICASONE PROPIONATE\SALMETEROL XINAFOATE

openFDA Info on Medication

Application NumberNDA021254Brand NameADVAIR HFAGeneric NameFLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEManufacturersGlaxoSmithKline LLCproduct_ndc0173-0715, 0173-0716, 0173-0717Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsFLUTICASONE PROPIONATE, SALMETEROL XINAFOATERXCUI 896231, 896235, 896236, 896237, 896239, 896243, 896244, 896245, 896267, 896271, ... spl_id717071a8-e206-47f6-8e3f-c395d532ebd3spl_set_iddfaca6f9-3277-47b2-319d-1377917cb54cPackage NDC 0173-0715-20, 0173-0715-22, 0173-0716-20, 0173-0716-22, 0173-0717-20, 0173-0717- ... UNII6EW8Q962A5, O2GMZ0LF5W

5)

drugcharacterization2medicinalproductPROAIR HFAdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameALBUTEROL SULFATE

openFDA Info on Medication

Application NumberNDA021457Brand NamePROAIR HFAGeneric NameALBUTEROL SULFATEManufacturersTeva Respiratory, LLCproduct_ndc59310-579Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsALBUTEROL SULFATERXCUI745752, 2123072spl_id07738d64-2ab5-4f96-bce1-f92bbb93ef18spl_set_id8e701d71-1dcb-4b84-bada-84e4f04f5e62Package NDC59310-579-22, 59310-579-23UNII021SEF3731

6)

drugcharacterization2medicinalproductBENICARdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameOLMESARTAN MEDOXOMIL

openFDA Info on Medication

Application NumberNDA021286Brand NameBENICARGeneric NameOLMESARTAN MEDOXOMILManufacturersCosette Pharmaceuticals, Inc., Daiichi Sankyo, Inc.product_ndc0713-0860, 0713-0861, 0713-0862, 65597-101, 65597-103, 65597-104Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOLMESARTAN MEDOXOMILspl_ide1e58027-cc06-6f64-e053-2995a90a9309, 9a1acd82-0655-4e72-9177-12ddf31c4b1bspl_set_id5b6f8a18-8f8a-4521-81c3-3a39c73c6646, 33770d80-754f-11de-8dba-0002a5d5c51bPackage NDC 0713-0860-30, 0713-0861-30, 0713-0862-30, 65597-101-30, 65597-103-03, 65597-103- ... UNII6M97XTV3HDRXCUI349373, 349401, 349405, 352199, 352200, 352201

7)

drugcharacterization2medicinalproductACIPROdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

8)

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

9)

drugcharacterization2medicinalproductNEXIUMdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameESOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMRXCUI 606726, 606728, 606730, 606731, 692576, 692578, 861568, 861570, 861576, 861583, ... spl_id84c822de-ebe2-4a39-9944-7e38e1961dde, 24d37125-c3cf-48e0-9e50-75cbc818e7c1spl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43H

summary

narrativeincludeclinicalCASE EVENT DATE: 20140217