Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10104894serious1Date Last Updated24/04/2014receiptdateformat102companynumbUS-ABBVIE-14P-163-1227996-00occurcountryUSseriousnessother1duplicate1Date Received24/04/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age69Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionConvulsionOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionLoss of consciousnessOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionAtrial fibrillationOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductSYNTHROIDdrugbatchnumbUNKNOWNdrugauthorizationnumb021402drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA021402Brand NameSYNTHROIDGeneric NameLEVOTHYROXINE SODIUMManufacturersAbbVie Inc.product_ndc 0074-3727, 0074-7149, 0074-4341, 0074-4552, 0074-5182, 0074-6624, 0074-6594, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOTHYROXINE SODIUMRXCUI 892246, 892251, 892255, 966158, 966171, 966185, 966191, 966201, 966205, 966218, ... spl_iddb21fc0c-4a2d-9922-39bd-8128e429bebcspl_set_id1e11ad30-1041-4520-10b0-8f9d30d30fccPackage NDC 0074-7149-90, 0074-7149-19, 0074-4341-13, 0074-4341-90, 0074-4341-19, 0074-4341- ... UNII9J765S329G

2)

drugcharacterization2medicinalproductXARELTOdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA202439, NDA022406Brand NameXARELTOGeneric NameRIVAROXABANManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-577, 50458-580, 50458-578, 50458-579, 50458-584Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRIVAROXABANRXCUI 1114198, 1114202, 1232082, 1232084, 1232086, 1232088, 1549682, 1549683, 2059015, ... spl_idbc8e9efa-638a-11ea-9dc6-12fbfb2ca371spl_set_id10db92f9-2300-4a80-836b-673e1ae91610Package NDC 50458-577-60, 50458-577-18, 50458-577-14, 50458-577-01, 50458-577-10, 50458-580- ... NUIN0000175635, N0000175637Mechanism of ActionFactor Xa Inhibitors [MoA]Established Pharmacologic ClassFactor Xa Inhibitor [EPC]UNII9NDF7JZ4M3

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)

drugcharacterization2medicinalproductESOMEPRAZOLE MAGNESIUMdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA209647, ANDA209339, ANDA209716, ANDA202784, ANDA207193, NDA204655, ANDA20363 ... Brand Name ESOMEPRAZOLE MAGNESIUM, PHARMAPURERX ESOMEP-EZS, NEXIUM 24HR, NEXIUM 24HR CLEARM ... Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLEManufacturers Amneal Pharmaceuticals LLC, Harris Teeter, P & L Development, LLC, Camber Pharma ... product_ndc 65162-644, 65162-645, 72036-800, 59726-912, 31722-572, 31722-573, 49035-980, 639 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM DIHYDRATE, ESOMEPRAZOLERXCUI 606726, 606730, 606728, 861568, 606731, 692576, 692578, 861570, 861576, 861583, ... spl_id 0682b963-c90c-42a4-a29b-5bb6bd4fd233, f2cfc048-bed4-4d79-8545-c7ceadf39b1e, 141b ... spl_set_id d9c8bc29-9b3b-41bc-a802-02cd85c95a11, 38b79d0d-d99e-4011-8a14-a56a3f75d8c3, 777e ... Package NDC 65162-644-03, 65162-644-09, 65162-644-50, 65162-644-11, 65162-645-03, 65162-645- ... UNIIR6DXU4WAY9, 36H71644EQ, N3PA6559FTNUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]

5)

drugcharacterization2medicinalproductPRAVASTATIN SODIUMdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA209869, ANDA207068, ANDA076056, ANDA077793, ANDA076714, ANDA077917, ANDA2033 ... Brand NamePRAVASTATIN SODIUM, PRAVACHOLGeneric NamePRAVASTATIN SODIUMManufacturers BIOCON PHARMA INC.,, Accord Healthcare Inc., Teva Pharmaceuticals USA, Inc., Dr. ... product_ndc 70377-045, 70377-046, 70377-047, 70377-048, 16729-008, 16729-009, 16729-010, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPRAVASTATIN SODIUMRXCUI904458, 904467, 904475, 904481, 904469, 904477spl_id 35751ea8-7d0f-5334-0e36-df438b2b9202, 96d49c2d-3263-3692-e053-2995a90ac8f4, c288 ... spl_set_id 9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb, 6c011348-a236-47d3-bbef-3e0b956dd080, 99e0 ... Package NDC 70377-045-11, 70377-045-12, 70377-045-14, 70377-046-11, 70377-046-12, 70377-046- ... UNII3M8608UQ61

6)

drugcharacterization2medicinalproductAMLODIPINEdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA211340Brand NameKATERZIAGeneric NameAMLODIPINEManufacturersAzurity Pharmaceuticals, Inc.product_ndc52652-5001Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BENZOATERXCUI2184120, 2184126spl_id33926064-be3f-4380-b051-ac4136524317spl_set_iddf673a4d-acb8-444c-a472-c87ab8cbd366Package NDC52652-5001-1UNIIXD75TQ8A2P

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14P-163-1227996-00

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use