Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-ABBVIE-14P-163-1207497-00occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10129299Date Received28/04/2014transmissiondate12/12/2014serious2Date Last Updated28/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age60Unit of Onset AgeyearsWeight136.2SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionBack painOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionBack painOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductANDROGELdrugbatchnumb920520drugauthorizationnumb022309drugstructuredosagenumb40.5drugstructuredosageunit003drugdosagetext2 PUMPS DAILYdrugdosageformGELdrugadministrationroute061drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate24/01/2014actiondrug4

openFDA Info on Medication

Application NumberNDA022309, NDA021015Brand NameANDROGELGeneric NameTESTOSTERONEManufacturersAbbVie Inc.product_ndc0051-8462, 0051-8425, 0051-8488, 0051-8450Product TypeHUMAN PRESCRIPTION DRUGRouteTRANSDERMALActive IngredientsTESTOSTERONERXCUI 1597075, 1597076, 1597120, 1597121, 1597126, 1597127, 1596780, 1597074, 1597123, ... spl_id82f7abad-fc55-fb9a-dd1a-a7078ed950b1, 98c4655b-0eb4-e920-a954-2143fda23603spl_set_id8677ba5b-8374-46cb-854c-403972e9ddf3, c506aaa3-04f8-4eb1-8dc4-e964cdd08e7fPackage NDC 0051-8462-33, 0051-8462-12, 0051-8462-31, 0051-8462-01, 0051-8462-30, 0051-8488- ... NUIN0000175824, N0000000146, M0001109Established Pharmacologic ClassAndrogen [EPC]Mechanism of ActionAndrogen Receptor Agonists [MoA]Chemical StructureAndrostanes [CS]UNII3XMK78S47O

2)

drugcharacterization2medicinalproductENALAPRILdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

3)

drugcharacterization2medicinalproductZOLOFTdrugindicationPRODUCT 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

4)

drugcharacterization2medicinalproductMETFORMINdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA200690, ANDA209674, ANDA209313Brand NameMETFORMIN HYDROCHLORIDE, METFORMINGeneric NameMETFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MGManufacturers Mylan Pharmaceuticals Inc., Ingenus Pharmaceuticals, LLC, Granules Pharmaceutica ... product_ndc0378-6001, 0378-6002, 50742-633, 50742-634, 70010-491, 70010-492Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETFORMIN HYDROCHLORIDERXCUI1807894, 1807917, 860975, 860981spl_id b1d71739-26c3-43d3-9088-60bef3689e74, d7e2ad60-7a17-4c65-b836-e56644be754d, a353 ... spl_set_id 7e41818c-60e9-4bcf-9586-7bb8d33d5e89, 49a0b5c2-ebaf-4c4c-905f-dfd1962ac647, 6d6e ... Package NDC 0378-6002-91, 0378-6001-91, 50742-633-60, 50742-633-90, 50742-633-10, 50742-634- ... UNII786Z46389E

5)

drugcharacterization2medicinalproductLASIXdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA016273Brand NameLASIXGeneric NameFUROSEMIDEManufacturersValidus Pharmaceuticals LLCproduct_ndc30698-060, 30698-067, 30698-066Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFUROSEMIDERXCUI197732, 200801, 200809, 205732, 310429, 313988spl_id95a46760-e587-41a3-9ff3-c8dd8505f694spl_set_id2c9b4d8f-0770-482d-a9e6-9c616a440b1aPackage NDC 30698-067-01, 30698-067-10, 30698-060-01, 30698-060-10, 30698-060-50, 30698-066- ... NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

6)

drugcharacterization2medicinalproductINSULINdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

7)

drugcharacterization2medicinalproductUROCIT-KdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA019071Brand NameUROCIT-KGeneric NamePOTASSIUM CITRATEManufacturersMission Pharmacal Companyproduct_ndc0178-0600, 0178-0610, 0178-0615Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPOTASSIUM CITRATERXCUI199376, 199381, 603281, 603282, 898490, 898517spl_idba857427-5c50-0eca-e053-2995a90ab33aspl_set_id72cdea1b-2240-41db-987d-86d5c6aaa978Package NDC0178-0600-01, 0178-0610-01, 0178-0615-01UNIIEE90ONI6FF

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14P-163-1207497-00