Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10009813serious1Date Last Updated09/04/2014receiptdateformat102companynumbUS-INCYTE CORPORATION-2012IN002690occurcountryUSduplicate1Date Received12/03/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification2

Patient

Onset Age74Unit of Onset AgeyearsWeight76.64SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionDyspnoeaOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.0ReactionMalaiseOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionNauseaOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionInfluenza like illnessOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionChillsOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.0ReactionPainOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt17.0ReactionHyperhidrosisOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt17.0ReactionPyrexiaOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductJAKAFIdrugbatchnumbNOT AVAILABLEdrugauthorizationnumb202192drugdosagetextNOT SPECIFIEDdrugdosageformTABLETdrugadministrationroute048drugindicationMYELOFIBROSISactiondrug1drugrecurreadministration3

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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)

drugcharacterization1medicinalproductJAKAFIdrugauthorizationnumb202192drugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, MONDAY, WEDNESDAY AND FRIDAY AFTER DIALYSISdrugdosageformTABLETdrugadministrationroute048actiondrug1drugrecurreadministration3

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3)

drugcharacterization1medicinalproductJAKAFIdrugauthorizationnumb202192drugdosagetext25 MG ON DAYS OF DIALYSISdrugdosageformTABLETdrugadministrationroute048actiondrug1drugrecurreadministration3

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4)

drugcharacterization2medicinalproductTAMSULOSIN

5)

drugcharacterization2medicinalproductFINASTERIDE

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Application Number ANDA203687, ANDA090121, ANDA091643, ANDA090061, ANDA207750, ANDA078341, NDA02078 ... Brand NameFINASTERIDE, PROPECIA, PROSCARGeneric NameFINASTERIDEManufacturers Aurobindo Pharma Limited, Rising Health, LLC, Accord Healthcare, Inc., Camber Ph ... product_ndc 65862-927, 65862-686, 57237-061, 16729-090, 16729-089, 31722-525, 67877-455, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFINASTERIDERXCUI200172, 310346, 213178, 201961spl_id 7f209776-8fde-4aac-b266-f342525ea9ca, 019ae597-49a2-40c1-b87a-e656f9c471fc, 42b2 ... spl_set_id 7d140366-2388-488e-bd86-67e6edf44345, 01b88593-99d3-4dd6-a7b6-5438c15bd7b7, adfb ... Package NDC 65862-927-30, 65862-927-90, 65862-927-99, 65862-686-30, 65862-686-90, 65862-686- ... NUIN0000175836, N0000000126Established Pharmacologic Class5-alpha Reductase Inhibitor [EPC]Mechanism of Action5-alpha Reductase Inhibitors [MoA]UNII57GNO57U7G

6)

drugcharacterization2medicinalproductROPINIROLE

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Application Number ANDA201047, ANDA090869, ANDA090135, ANDA204022, ANDA202786, ANDA077852, ANDA0788 ... Brand NameROPINIROLEGeneric NameROPINIROLEManufacturers Sandoz Inc, Actavis Pharma, Inc., Glenmark Pharmaceuticals Inc., USA, Accord Hea ... product_ndc 0781-5780, 0781-5782, 0781-5784, 0781-5786, 0781-5788, 0228-3640, 0228-3658, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsROPINIROLE HYDROCHLORIDERXCUI 799054, 799055, 799056, 824959, 848582, 283858, 312845, 312846, 312847, 312849, ... spl_id 62610145-8e1d-402e-92b2-14c6f16ce860, 84f40ca0-7fd0-4773-8c08-1cbcf7ba2c54, 7984 ... spl_set_id 2ed1aae8-ca68-41f7-8922-3662329117c4, 300946bf-2f83-471d-868d-9820b65c52bb, 8597 ... Package NDC 0781-5780-31, 0781-5780-92, 0781-5782-31, 0781-5782-92, 0781-5784-31, 0781-5786- ... UNIID7ZD41RZI9

7)

drugcharacterization2medicinalproductPANTOPRAZOLE

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Application NumberANDA205119, ANDA202882, ANDA077619Brand NamePANTOPRAZOLE SODIUM, PANTOPRAZOLEGeneric NamePANTOPRAZOLEManufacturers Amneal Pharmaceuticals LLC, Camber Pharmaceuticals, Inc., Dr.Reddy's Laboratorie ... product_ndc65162-636, 65162-637, 31722-712, 31722-713, 55111-332, 55111-333Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPANTOPRAZOLE SODIUMRXCUI251872, 314200spl_id 5c7a8fef-13ea-42c4-9e13-d8bc23c8f8a4, bbacc015-1a10-08f1-e053-2a95a90a301c, 02f0 ... spl_set_id f3ded82a-cf0d-4844-944a-75f9f9215ff0, 9daa1483-5a36-44db-9e0d-904d100da262, 5647 ... Package NDC 65162-636-03, 65162-636-09, 65162-637-03, 65162-637-09, 65162-637-11, 65162-637- ... UNII6871619Q5X

8)

drugcharacterization2medicinalproductDRONABINOL

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Application NumberANDA078292, ANDA079217, NDA018651, ANDA207421, NDA205525, ANDA201463Brand NameDRONABINOL, SYNDROS, MARINOLGeneric NameDRONABINOLManufacturers Rhodes Pharmaceuticals L.P., Akorn, Inc., Ascend Laboratories, LLC, AvKARE, Benu ... product_ndc 42858-867, 42858-868, 42858-869, 17478-761, 17478-762, 17478-763, 67877-568, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDRONABINOLRXCUI197634, 197635, 197636, 1928948, 1928954, 205641, 205642, 205645spl_id 5467a1be-b888-4f7c-9a62-5faf6c977b05, dc76bfc1-db41-459c-8401-512058213bb0, 39f1 ... spl_set_id 3c06ccda-4819-40f8-b2db-fa294bb8a2fa, a0409d82-a61e-4b9e-8717-ced299ccedb2, 0bb0 ... Package NDC 42858-867-06, 42858-868-06, 42858-869-06, 17478-761-06, 17478-762-06, 17478-763- ... NUIN0000175782, M0003267Established Pharmacologic ClassCannabinoid [EPC]Chemical StructureCannabinoids [CS]UNII7J8897W37S

9)

drugcharacterization2medicinalproductVITAMIN D

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Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturersStrides Pharma Science Limitedproduct_ndc64380-737Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36Package NDC64380-737-06, 64380-737-25NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

10)

drugcharacterization2medicinalproductSYMMETREL

11)

drugcharacterization2medicinalproductZOLOFT

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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

12)

drugcharacterization2medicinalproductPREDNISONE

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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

13)

drugcharacterization2medicinalproductFLUTICASONE

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Application NumberANDA078492Brand NameFLUTICASONEGeneric NameFLUTICASONE PROPIONATEManufacturersMorton Grove Pharmaceuticals, Inc.product_ndc60432-264Product TypeHUMAN PRESCRIPTION DRUGRouteNASALActive IngredientsFLUTICASONE PROPIONATERXCUI1797907spl_ida9e7f8b6-a38a-4128-b1c8-8a008bd15842spl_set_id7c692ed5-959e-4c48-aeec-0799d8979693Package NDC60432-264-15UNIIO2GMZ0LF5W

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duplicatesourceINCYTEduplicatenumbUS-INCYTE CORPORATION-2012IN002690

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