Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-INCYTE CORPORATION-2012IN001206occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10008985Date Received13/03/2014transmissiondate02/10/2014serious2Date Last Updated13/03/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age52Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionArthralgiaOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionHypoaesthesiaOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionParaesthesiaOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductJAKAFIdrugbatchnumbA81294Pdrugstructuredosagenumb15drugstructuredosageunit003drugdosagetext15 MG, BIDdrugdosageformTABLETdrugadministrationroute048drugindicationSPLENOMEGALYactiondrug4

openFDA Info on Medication

Application NumberNDA202192Brand NameJAKAFIGeneric NameRUXOLITINIBManufacturersIncyte Corporationproduct_ndc50881-005, 50881-010, 50881-015, 50881-020, 50881-025Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRUXOLITINIBRXCUI 1193331, 1193337, 1193339, 1193341, 1193343, 1193345, 1193347, 1193349, 1193351, ... spl_id1cf98918-4377-4b1b-8b2f-1ae23681d1d2spl_set_idf1c82580-87ae-11e0-bc84-0002a5d5c51bPackage NDC 50881-005-60, 50881-010-01, 50881-010-60, 50881-015-60, 50881-020-60, 50881-025- ... NUIN0000175605, N0000175076Established Pharmacologic ClassKinase Inhibitor [EPC]Mechanism of ActionProtein Kinase Inhibitors [MoA]UNII82S8X8XX8H

2)

drugcharacterization2medicinalproductCOUMADINdrugstructuredosagenumb6drugstructuredosageunit003drugdosagetext6 MG, QD

openFDA Info on Medication

3)

drugcharacterization2medicinalproductNADOLOLdrugstructuredosagenumb120drugstructuredosageunit003drugdosagetext120 MG, QD

openFDA Info on Medication

Application Number ANDA203455, ANDA208832, ANDA210786, ANDA207761, ANDA210955, NDA018063, ANDA07417 ... Brand NameNADOLOL, CORGARDGeneric NameNADOLOLManufacturers Cipla USA Inc., Amneal Pharmaceuticals NY LLC, Ingenus Pharmaceuticals, LLC, Zyd ... product_ndc 69097-867, 69097-868, 69097-869, 69238-1123, 69238-1124, 69238-1125, 50742-178, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsNADOLOLRXCUI198006, 198007, 198008, 201337, 201338, 206961spl_id 04cca80e-cd0b-467d-9017-32fe1380e044, 282480d1-518b-419a-ae33-692ffbb1db78, adaa ... spl_set_id c899eedb-4113-45da-acc3-8e181250a7d8, e2e24b14-0169-4028-828a-894ad3c2ba55, 9d26 ... Package NDC 69097-867-07, 69097-867-15, 69097-867-02, 69097-868-02, 69097-868-07, 69097-868- ... NUIN0000000161, N0000175556Mechanism of ActionAdrenergic beta-Antagonists [MoA]Established Pharmacologic Classbeta-Adrenergic Blocker [EPC]UNIIFEN504330V

4)

drugcharacterization2medicinalproductLEVOTHYROXINE SODIUMdrugdosagetext175 MCG, QD

openFDA Info on Medication

Application Number ANDA209713, NDA021924, NDA021292, ANDA212399, NDA202231, NDA021342, ANDA208749, ... Brand Name LEVOTHYROXINE SODIUM, EUTHYROX, TIROSINT, LEVO-T, THYQUIDITY, LEVOXYL, UNITHROID ... Generic NameLEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUSManufacturers Lupin Pharmaceuticals, Inc., Lannett Company, Inc., Provell Pharmaceuticals, LLC ... product_ndc 68180-965, 68180-966, 68180-967, 68180-968, 68180-969, 68180-970, 68180-971, 681 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsLEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUSRXCUI 892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966248, 966249, ... spl_id 9c2dfcdd-dc8c-4b32-9e9c-19087205679f, 8c338424-2ed3-45de-87cd-cef28456c4c1, 0b57 ... spl_set_id 18717e58-89fb-4e2f-93b6-d6ac3e988d37, 686ba2cf-7651-44de-9b4d-eeaaf2a0e364, bc3c ... Package NDC 68180-965-01, 68180-965-02, 68180-965-03, 68180-965-09, 68180-966-01, 68180-966- ... UNII9J765S329G, 054I36CPMN

5)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb200drugstructuredosageunit003drugdosagetext200 MG, QD

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

Report Duplicate

duplicatesourceINCYTEduplicatenumbUS-INCYTE CORPORATION-2012IN001206