Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10094506serious1Date Last Updated22/04/2014receiptdateformat102companynumbUS-CELGENEUS-163-21880-14042286occurcountryUSseriousnessother1duplicate1Date Received22/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Weight90.8SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionHaemoptysisOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionDeep vein thrombosisOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionFatigueOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionDiarrhoeaOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionDehydrationOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductREVLIMIDdrugbatchnumbA0301Adrugauthorizationnumb021880drugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MILLIGRAMdrugdosageformCapsulesdrugadministrationroute048drugindicationPLASMA CELL MYELOMAdrugstartdateformat610drugstartdate/07/2008actiondrug4drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA021880Brand NameREVLIMIDGeneric NameLENALIDOMIDEManufacturersCelgene Corporationproduct_ndc59572-402, 59572-405, 59572-410, 59572-415, 59572-420, 59572-425Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLENALIDOMIDERXCUI 602910, 602912, 616114, 616116, 643712, 643714, 643720, 643722, 1242231, 1242233 ... spl_idf835baa8-4bc9-46ff-b8d5-261920a36819spl_set_id5fa97bf5-28a2-48f1-8955-f56012d296bePackage NDC 59572-402-28, 59572-402-00, 59572-405-28, 59572-405-00, 59572-410-28, 59572-410- ... NUIN0000184014Established Pharmacologic ClassThalidomide Analog [EPC]UNIIF0P408N6V4

2)

drugcharacterization1medicinalproductREVLIMIDdrugbatchnumbA0301Adrugstructuredosagenumb15drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext15 MILLIGRAMdrugdosageformCapsulesdrugadministrationroute048drugstartdateformat610drugstartdate/02/2011actiondrug4drugrecurreadministration3

openFDA Info on Medication

3)

drugcharacterization1medicinalproductREVLIMIDdrugbatchnumbA0301Adrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext25 MILLIGRAMdrugdosageformCapsulesdrugadministrationroute048drugstartdateformat610drugstartdate/08/2011actiondrug4drugrecurreadministration3

openFDA Info on Medication

4)

openFDA Info on Medication

5)

drugcharacterization2medicinalproductDRONABINOLdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

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

6)

drugcharacterization2medicinalproductSINGULAIRdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA020829, NDA020830, NDA021409Brand NameSINGULAIRGeneric NameMONTELUKAST SODIUMManufacturersMerck Sharp & Dohme Corp.product_ndc0006-9117, 0006-3841, 0006-1711, 0006-9275Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST SODIUMRXCUI153892, 153893, 200224, 242438, 261367, 311759, 351246, 404406spl_id96717981-6ea2-4720-a749-e14f1559511fspl_set_id8c166755-7711-4df9-d689-8836a1a70885Package NDC 0006-3841-30, 0006-3841-14, 0006-1711-31, 0006-1711-54, 0006-9275-31, 0006-9275- ... UNIIU1O3J18SFL

7)

drugcharacterization2medicinalproductDEXAMETHASONEdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number NDA022315, ANDA088237, NDA211379, ANDA201270, ANDA088481, ANDA088254, NDA208912, ... Brand Name OZURDEX, TAPERDEX 12-DAY, HEMADY, DEXABLISS, DEXAMETHASONE, DEXAMETHASONE 1.5 MG ... Generic NameDEXAMETHASONE, DEXAMETHASONE 1.5 MGManufacturers Allergan, Inc., Xspire Pharma, Llc, Acrotech Biopharma LLC, Levins Pharmaceutica ... product_ndc 0023-3348, 42195-149, 42195-490, 72893-015, 71905-400, 48102-045, 48102-046, 481 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVITREAL, ORAL, INTRAOCULAR, OPHTHALMIC, INTRACANALICULARActive IngredientsDEXAMETHASONERXCUI 854177, 854181, 197580, 1943550, 1998481, 2261802, 2286261, 2121587, 197577, 197 ... spl_id 04b2b881-a84c-417c-ba09-8a76cf46faea, dff2b4b8-6dba-4bf3-ac9d-3960db623d1b, 20ec ... spl_set_id 4b204f44-6e8a-4d17-803c-268f0b04679f, c3c59b82-1343-470d-bbc7-e40da3c0a28f, aec6 ... Package NDC 0023-3348-07, 0023-3348-08, 42195-149-12, 42195-490-12, 72893-015-24, 72893-015- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNII7S5I7G3JQL

8)

drugcharacterization2medicinalproductALBUTEROLdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA210948, ANDA077788, ANDA213657, ANDA211397, ANDA208804, ANDA207046, ANDA0728 ... Brand NameALBUTEROL, ALBUTEROL SULFATEGeneric NameALBUTEROL SULFATE, ALBUTEROLManufacturers Nivagen Pharmaceuticals Inc, VistaPharm, Inc., Aurobindo Pharma Limited, Virtus ... product_ndc 75834-273, 75834-274, 66689-100, 59651-333, 59651-334, 69543-290, 69543-291, 692 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALBUTEROL SULFATERXCUI197316, 197318, 755497spl_id b736135f-6e13-3e29-e053-2a95a90a67f4, 737932ca-a391-48c3-96c5-14de8ae1000e, ff9b ... spl_set_id b735e92d-eb1a-6fc1-e053-2995a90afce2, c7713a63-af2a-40d3-8deb-cbb92d5f1cd3, ff9b ... Package NDC 75834-273-01, 75834-274-01, 66689-100-16, 66689-100-08, 59651-333-01, 59651-333- ... UNII021SEF3731

9)

drugcharacterization2medicinalproductVALACYCLOVIRdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA090682, ANDA079137, ANDA203047, ANDA078518, ANDA076588, ANDA209553Brand NameVALACYCLOVIR, VALACYCLOVIR HYDROCHLORIDEGeneric NameVALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIRManufacturers ACETRIS HEALTH, LLC, Cadila Healthcare Limited, Camber Pharmaceuticals, Inc., My ... product_ndc 52343-051, 52343-052, 65841-629, 65841-630, 31722-704, 31722-705, 0378-4275, 037 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVALACYCLOVIR HYDROCHLORIDERXCUI313564, 313565spl_id d6adb9f0-31da-4a25-aaaf-443f16660755, cdbeb2ec-2bbe-4af0-8a7e-c54b7d607a24, 08e1 ... spl_set_id 1cd5d77f-6478-4176-b703-6bfb3f5cb305, 91832fd8-0d76-4408-9d26-9d5f52c47670, 7f5e ... Package NDC 52343-051-30, 52343-051-90, 52343-052-30, 52343-052-90, 65841-629-06, 65841-629- ... UNIIG447S0T1VC

10)

drugcharacterization2medicinalproductMULTIVITAMINSdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

11)

drugcharacterization2medicinalproductASPIRINEdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

12)

drugcharacterization2medicinalproductVICODINdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

13)

drugcharacterization2medicinalproductLISINOPRILdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA076063, ANDA077321, NDA208401, ANDA078402, ANDA212041, ANDA076180, ANDA07616 ... Brand NameLISINOPRIL, QBRELIS, PRINIVIL, ZESTRILGeneric NameLISINOPRILManufacturers Hikma Pharmaceuticals USA Inc., International Laboratories, LLC, Azurity Pharmac ... product_ndc 0143-9713, 0143-9715, 0143-9714, 54458-872, 54458-877, 54458-874, 54458-873, 526 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISINOPRILRXCUI 311354, 314076, 314077, 197884, 1806884, 1806890, 205326, 311353, 206764, 206765 ... spl_id 533f6e0f-04a0-4ef7-81b8-0a7be07ddd1a, b685bb45-44a6-4afc-bb3e-940bce536bda, 2fdc ... spl_set_id b70933da-55b2-4025-a00e-63ce3e6b7fdf, 6eef83b4-ce4c-462b-bcfa-eefa525e682d, 9f6e ... Package NDC 0143-9715-01, 0143-9715-10, 0143-9715-99, 0143-9714-01, 0143-9714-10, 0143-9714- ... UNIIE7199S1YWR

14)

drugcharacterization2medicinalproductGABAPENTINdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 6e41ce47-a6cc-4c34-84f1-305747df38c2, 5fc4 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

15)

drugcharacterization2medicinalproductVELCADEdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA021602Brand NameVELCADEGeneric NameBORTEZOMIBManufacturersMillennium Pharmaceuticals, Inc.product_ndc63020-049Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, SUBCUTANEOUSActive IngredientsBORTEZOMIBRXCUI402243, 402244spl_idbe1071a2-48b4-4e50-8414-f53d498d48eespl_set_id1521d321-e724-4ffc-adad-34bf4f44fac7Package NDC63020-049-01NUIN0000175604, N0000175075Established Pharmacologic ClassProteasome Inhibitor [EPC]Mechanism of ActionProteasome Inhibitors [MoA]UNII69G8BD63PP

16)

drugcharacterization2medicinalproductSERTRALINEdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

17)

drugcharacterization2medicinalproductCOLACEdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Numberpart334Brand NameCOLACEGeneric NameDOCUSATE SODIUM, DOCUSATE SODIUM - SENNOSIDESManufacturersAvrio Health L.P.product_ndc67618-101, 67618-110, 67618-111Product TypeHUMAN OTC DRUGRouteORALActive IngredientsDOCUSATE SODIUM, SENNOSIDESRXCUI1115005, 1247756, 998740, 1872920, 1247759, 1247761spl_id 008f0cb3-8a9a-42f6-b985-a3dbc0deabc0, 7ec009a7-4793-524b-5e6d-202f324d81fd, f8b2 ... spl_set_id 7793fced-e8ee-44e2-b212-dd2a59a5f462, 9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b, a159 ... Package NDC 67618-101-10, 67618-101-30, 67618-101-60, 67618-101-52, 67618-110-10, 67618-110- ... UNIIF05Q2T2JA0, 3FYP5M0IJX

18)

drugcharacterization2medicinalproductADVAIRdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

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Application NumberNDA021077Brand NameADVAIR DISKUSGeneric NameFLUTICASONE PROPIONATE AND SALMETEROLManufacturersGlaxoSmithKline LLCproduct_ndc0173-0695, 0173-0696, 0173-0697Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsSALMETEROL XINAFOATE, FLUTICASONE PROPIONATERXCUI 896161, 896165, 896184, 896185, 896186, 896190, 896209, 896212, 896218, 896222, ... spl_idc03442a4-17dc-4c49-ae07-3f8f7f26e0dfspl_set_id4eeb5f6a-593f-4a9e-9692-adefa2caf8fcPackage NDC 0173-0695-00, 0173-0695-04, 0173-0696-00, 0173-0696-04, 0173-0697-00, 0173-0697- ... UNIIO2GMZ0LF5W, 6EW8Q962A5

19)

drugcharacterization2medicinalproductPRILOSECdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

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

20)

drugcharacterization2medicinalproductFERROUS SULFATEdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Brand NameFERROUS SULFATE, FERRUM SULPHURICUMGeneric NameFERROUS SULFATE, IRON SUPPLEMENT THERAPYManufacturers Richmond Pharmaceuticals, Inc., Boiron, Healthlife of USA, Washington Homeopathi ... product_ndc54738-963, 0220-2111, 69517-133, 68428-941, 71919-293Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFERROUS SULFATERXCUI310325spl_id 9a63ba0a-0ded-744b-e053-2a95a90a9344, 8723d1f8-ed45-3373-e053-2991aa0a81d7, 655e ... spl_set_id 58dd4f30-980b-44bc-9f8e-8d4626854b91, 7a4087d8-d054-bbdc-e053-2991aa0ae8cf, 3810 ... Package NDC 54738-963-01, 54738-963-03, 0220-2111-41, 69517-133-30, 68428-941-03, 68428-941- ... UNII39R4TAN1VT

21)

drugcharacterization2medicinalproductCYCLOBENZAPRINEdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA090478, ANDA071611Brand NameCYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINEGeneric NameCYCLOBENZAPRINE, CYCLOBENZAPRINE HYDROCHLORIDEManufacturersCipla USA Inc., Rising Health, LLCproduct_ndc69097-845, 69097-846, 57237-266Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCYCLOBENZAPRINE HYDROCHLORIDERXCUI828320, 828348, 828299spl_idfb272847-c855-4abb-b9dd-0d7a4b92bef0, 09330886-13f8-44cc-98d2-883f3e0514b4spl_set_id575a31fb-04c5-4001-88a7-c33adbacc6a8, b12fb4ea-182e-462b-b6ed-cfd2f6bb71e8Package NDC69097-845-07, 69097-845-15, 69097-846-07, 69097-846-15, 57237-266-01UNII0VE05JYS2P

22)

drugcharacterization2medicinalproductXANAXdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia and Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_iddfdda989-af0a-4c14-871c-b26b7b6da50e, d95506a3-aba6-47f4-83c4-443a4cce678bspl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

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