Adverse Event Report

Report

reporttype2Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10077743serious1Date Last Updated30/07/2014receiptdateformat102companynumbUS-ABBVIE-14P-163-1222176-00occurcountryUSseriousnessother1duplicate1Date Received14/04/2014transmissiondate26/03/2015primarysourcecountryUS

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification3

Patient

Onset Age24Unit of Onset AgeyearsWeight69.01SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionHot flushOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.1ReactionHypotensionOutcomeUnknown

3)

reactionmeddraversionpt17.1ReactionNauseaOutcomeRecovering/resolving

4)

reactionmeddraversionpt17.1ReactionLoss of consciousnessOutcomeRecovered/resolved

5)

reactionmeddraversionpt17.1ReactionWrong technique in drug usage processOutcomeRecovered/resolved

6)

reactionmeddraversionpt17.1ReactionTinnitusOutcomeRecovered/resolved

7)

reactionmeddraversionpt17.1ReactionLoss of consciousnessOutcomeRecovered/resolved

8)

reactionmeddraversionpt17.1ReactionInjection site painOutcomeRecovered/resolved

9)

reactionmeddraversionpt17.1ReactionInjection site painOutcomeRecovered/resolved

10)

reactionmeddraversionpt17.1ReactionFeeling abnormalOutcomeRecovered/resolved

11)

reactionmeddraversionpt17.1ReactionMalaiseOutcomeRecovered/resolved

12)

reactionmeddraversionpt17.1ReactionPainOutcomeUnknown

13)

reactionmeddraversionpt17.1ReactionParaesthesiaOutcomeRecovered/resolved

14)

reactionmeddraversionpt17.1ReactionHypoacusisOutcomeRecovered/resolved

15)

reactionmeddraversionpt17.1ReactionInjection site massOutcomeNot recovered/not resolved

16)

reactionmeddraversionpt17.1ReactionIncorrect dose administeredOutcomeRecovered/resolved

17)

reactionmeddraversionpt17.1ReactionInjection site erythemaOutcomeNot recovered/not resolved

18)

reactionmeddraversionpt17.1ReactionMyalgiaOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductPROGESTERONE.drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationHORMONE REPLACEMENT THERAPY

activesubstance

activesubstancenamePROGESTERONE

openFDA Info on Medication

Brand Name PROGESTERONE, PROMETRIUM, PROGESTERONE PHENOLIC, CRINONE, NATURAL PROGESTERONE, ... Generic NamePROGESTERONEManufacturers BioActive Nutritional, Inc., Fresenius Kabi USA, LLC, Bionpharma Inc., Newton La ... product_ndc 43857-0120, 63323-261, 43857-0103, 69452-148, 69452-149, 55714-6634, 69543-372, ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, VAGINALActive IngredientsPROGESTERONEspl_id d1fed1b0-6ed3-44da-a68e-e0c73097b541, 9b01a2e5-5aea-2dbe-e053-2995a90a9b54, 0fbb ... spl_set_id cddb5afa-9825-418d-acf6-cffbb0fc39c3, a479b395-1e1a-4d2a-8feb-68a15c47225f, 0de9 ... Package NDC 43857-0120-1, 63323-261-10, 43857-0103-1, 69452-148-20, 69452-149-20, 55714-6634 ... NUIM0017672, N0000175601Chemical StructureProgesterone [CS]Established Pharmacologic ClassProgesterone [EPC]UNII4G7DS2Q64YApplication Number ANDA075906, ANDA200900, NDA019781, ANDA207724, ANDA210965, ANDA211285, NDA017362 ... RXCUI 312644, 260243, 312641, 261319, 262080, 153579, 153580, 312643, 312645, 725094, ...

2)

drugcharacterization2medicinalproductESTROGENdrugdosagetext2 PUMPS DAILYdrugdosageformGELdrugindicationHORMONE REPLACEMENT THERAPY

activesubstance

activesubstancenameESTRONE\SUS SCROFA OVARY

openFDA Info on Medication

Brand NameESTROGENGeneric Name FOLLICULINUM, OOPHORINUM (SUIS), FOLLICULINUM, OOPHORINUM,, FOLLICULINUM, OOPHOR ... ManufacturersBioActive Nutritional, Inc., Deseret Biologicals, Inc.product_ndc43857-0150, 43742-0066, 43857-0074Product TypeHUMAN OTC DRUGRouteORALActive IngredientsESTRONE, SUS SCROFA OVARYspl_id f57f2fdf-83fd-4400-9f42-28710cda6fba, 9f8595be-f24f-433b-9368-6347e67033dd, 04f4 ... spl_set_id 4e194dcd-83d4-4783-b4a2-0c50bcd7f359, b440d0b5-8c4e-4ff9-936b-4776a8474349, 0c72 ... Package NDC43857-0150-1, 43742-0066-1, 43857-0074-1UNII2DI9HA706A, S7YTV04R8O

3)

drugcharacterization2medicinalproductZOLOFTdrugindicationANXIETY

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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

4)

drugcharacterization2medicinalproductPRILOSECdrugdosagetext50 OR 25 MG TWICE DAILYdrugindicationULCER

activesubstance

activesubstancenameOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022056Brand NamePRILOSECGeneric NameOMEPRAZOLE MAGNESIUMManufacturersCovis Pharmaproduct_ndc70515-610, 70515-625Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE MAGNESIUMRXCUI797058, 797061, 797063, 797065spl_id1bd73b0f-b2c2-4409-94ce-1955c6ab119bspl_set_idb6761f84-53ac-4745-a8c8-1e5427d7e179Package NDC70515-625-01, 70515-610-01UNII426QFE7XLK

5)

drugcharacterization2medicinalproductTOPAMAXdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationMIGRAINE

activesubstance

activesubstancenameTOPIRAMATE

openFDA Info on Medication

Application NumberNDA020505, NDA020844Brand NameTOPAMAXGeneric NameTOPIRAMATEManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-639, 50458-640, 50458-641, 50458-642, 50458-647, 50458-645Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOPIRAMATERXCUI 151226, 151227, 151228, 151229, 152855, 199888, 199889, 199890, 205315, 205316, ... spl_id97a88b90-639a-11ea-a5cc-2737fc2ca371spl_set_id21628112-0c47-11df-95b3-498d55d89593Package NDC 50458-639-65, 50458-640-65, 50458-641-65, 50458-642-65, 50458-647-65, 50458-645- ... NUIN0000008486, N0000185506, N0000182140Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Mechanism of ActionCytochrome P450 3A4 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNII0H73WJJ391

6)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1007967drugauthorizationnumb125057drugstructuredosagenumb80drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformSolution for injection in pre-filled pendrugindicationCROHN^S DISEASEdrugstartdateformat102drugstartdate04/04/2014drugenddateformat102drugenddate04/04/2014actiondrug5

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_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- ...

7)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1007967drugauthorizationnumb125057drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosageformSolution for injection in pre-filled penactiondrug5

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_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- ...

8)

drugcharacterization2medicinalproductPREDNISONE.drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenamePREDNISONE

openFDA Info on Medication

Application Number NDA202020, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA040584, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., GeneYork Pharmaceuticals Group LLC, Mylan Pharma ... product_ndc 75987-020, 75987-021, 75987-022, 71329-106, 0378-0640, 0378-0641, 0378-0642, 060 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id be29c86d-242b-42a7-9488-ecf6f76426cd, 4384c1d1-059b-4689-9f3d-1078de814ce8, 88a6 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, be50449f-3aa8-46b7-9246-2dbd5f04f2b1, fec0 ... Package NDC 75987-020-02, 75987-020-01, 75987-020-70, 75987-021-02, 75987-021-01, 75987-021- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIVB0R961HZT

9)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationDEPRESSION

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20140404

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14P-163-1222176-00

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use