Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10153311serious1Date Last Updated29/05/2014receiptdateformat102companynumbUS-CELGENEUS-163-POMAL-14045124occurcountryUSseriousnessother1duplicate1Date Received05/05/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Weight60.8SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionGlucose tolerance impairedOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionSinusitisOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionMuscle spasmsOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionNeuropathy peripheralOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionConstipationOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionDiarrhoeaOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionRenal disorderOutcomeUnknown

8)

reactionmeddraversionpt17.0ReactionNasopharyngitisOutcomeUnknown

9)

reactionmeddraversionpt17.0ReactionBronchitisOutcomeUnknown

10)

reactionmeddraversionpt17.0ReactionPneumoniaOutcomeUnknown

11)

reactionmeddraversionpt17.0ReactionBack painOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductPOMALYSTdrugbatchnumbUNKNOWNdrugauthorizationnumb204026drugstructuredosagenumb4drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext4 MILLIGRAMdrugdosageformCapsulesdrugadministrationroute048drugindicationPLASMA CELL MYELOMAdrugstartdateformat610drugstartdate/11/2013actiondrug4drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA204026Brand NamePOMALYSTGeneric NamePOMALIDOMIDEManufacturersCelgene Corporationproduct_ndc59572-501, 59572-502, 59572-503, 59572-504Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPOMALIDOMIDERXCUI1369718, 1369724, 1369726, 1369728, 1369730, 1369732, 1369734, 1369736spl_id11dd78c3-3991-4a83-ad3e-2f2262d6bd6fspl_set_id2b25ef01-5c9e-11e1-b86c-0800200c9a66Package NDC 59572-501-21, 59572-501-00, 59572-502-21, 59572-502-00, 59572-503-21, 59572-503- ... NUIN0000184014Established Pharmacologic ClassThalidomide Analog [EPC]UNIID2UX06XLB5

2)

drugcharacterization1medicinalproductPOMALYSTdrugbatchnumbUNKNOWNdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext3-4MGdrugdosageformCapsulesdrugadministrationroute048drugstartdateformat610drugstartdate/02/2014actiondrug4drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA204026Brand NamePOMALYSTGeneric NamePOMALIDOMIDEManufacturersCelgene Corporationproduct_ndc59572-501, 59572-502, 59572-503, 59572-504Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPOMALIDOMIDERXCUI1369718, 1369724, 1369726, 1369728, 1369730, 1369732, 1369734, 1369736spl_id11dd78c3-3991-4a83-ad3e-2f2262d6bd6fspl_set_id2b25ef01-5c9e-11e1-b86c-0800200c9a66Package NDC 59572-501-21, 59572-501-00, 59572-502-21, 59572-502-00, 59572-503-21, 59572-503- ... NUIN0000184014Established Pharmacologic ClassThalidomide Analog [EPC]UNIID2UX06XLB5

3)

drugcharacterization1medicinalproductPOMALYSTdrugbatchnumbUNKNOWNdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MILLIGRAMdrugdosageformCapsulesdrugadministrationroute048actiondrug4drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA204026Brand NamePOMALYSTGeneric NamePOMALIDOMIDEManufacturersCelgene Corporationproduct_ndc59572-501, 59572-502, 59572-503, 59572-504Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPOMALIDOMIDERXCUI1369718, 1369724, 1369726, 1369728, 1369730, 1369732, 1369734, 1369736spl_id11dd78c3-3991-4a83-ad3e-2f2262d6bd6fspl_set_id2b25ef01-5c9e-11e1-b86c-0800200c9a66Package NDC 59572-501-21, 59572-501-00, 59572-502-21, 59572-502-00, 59572-503-21, 59572-503- ... NUIN0000184014Established Pharmacologic ClassThalidomide Analog [EPC]UNIID2UX06XLB5

4)

drugcharacterization2medicinalproductCYMBALTAdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA021427Brand NameCYMBALTAGeneric NameDULOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3235, 0002-3240, 0002-3270Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDULOXETINE HYDROCHLORIDERXCUI596926, 596928, 596930, 596932, 596934, 615186spl_idb742d0a5-e67d-49ed-ba95-afe068f1d228spl_set_id2f7d4d67-10c1-4bf4-a7f2-c185fbad64baPackage NDC0002-3235-60, 0002-3240-30, 0002-3240-90, 0002-3270-30, 0002-3270-04UNII9044SC542W

5)

drugcharacterization2medicinalproductFENTANYLdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA022569, ANDA202097, ANDA077449, NDA021947, NDA202788, NDA019813, ANDA076258Brand NameLAZANDA, FENTANYL SYSTEM, FENTANYL, FENTORA, SUBSYS, DURAGESIC (FENTANYL SYSTEM)Generic NameFENTANYLManufacturers West Therapeutic Development LLC, Alvogen, Apotex Corp., Cephalon, Inc., Insys T ... product_ndc 71500-110, 71500-140, 71500-130, 47781-423, 47781-424, 47781-426, 47781-427, 477 ... Product TypeHUMAN PRESCRIPTION DRUGRouteNASAL, TRANSDERMAL, BUCCAL, SUBLINGUALActive IngredientsFENTANYL CITRATE, FENTANYLRXCUI 1115573, 1115575, 1115577, 1115579, 1729320, 1729322, 197696, 245134, 245135, 24 ... spl_id 9f5c9d6b-1f8a-0f2e-e053-2a95a90a1458, b9f82be8-5426-7518-e053-2995a90abd81, 4696 ... spl_set_id 73f38bde-2132-2b5a-e053-2a91aa0a6efb, 242759ef-cb6d-4e3e-9f8d-5e31efa1f289, 0ff7 ... Package NDC 71500-140-01, 71500-130-01, 71500-110-01, 47781-423-47, 47781-424-47, 47781-426- ... UNIIMUN5LYG46H, UF599785JZNUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]

6)

drugcharacterization2medicinalproductOXYCODONEdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA203638, NDA208090, ANDA211748, ANDA211749Brand NameOXYCODONE HYDROCHLORIDE, XTAMPZA ER, OXYCODONEGeneric NameOXYCODONEManufacturers Amneal Pharmaceuticals LLC, Collegium Pharmaceutical, Inc., Ascend Laboratories, ... product_ndc 65162-047, 65162-048, 65162-049, 65162-050, 65162-051, 24510-110, 24510-115, 245 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDE, OXYCODONERXCUI 1049611, 1049618, 1049621, 1049683, 1049686, 1790527, 1790533, 1791558, 1791560, ... spl_id faecea25-bf41-43c2-99de-89ba81a21162, 424fa63c-5bd6-457d-b65e-c40ddfc48d6c, d906 ... spl_set_id 094b64b3-cd32-4de5-afb6-ea00d9caad74, b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c, 08b2 ... Package NDC 65162-047-03, 65162-047-10, 65162-047-25, 65162-047-50, 65162-048-03, 65162-048- ... UNIIC1ENJ2TE6C, CD35PMG570NUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]

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)

drugcharacterization2medicinalproductSYNTHROIDdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

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

9)

drugcharacterization2medicinalproductNEURONTINdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA020882, NDA020235, NDA021129Brand NameNEURONTINGeneric NameGABAPENTINManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0401, 0071-0803, 0071-0805, 0071-0806, 0071-0513, 0071-2012Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 105028, 105029, 105030, 261280, 261281, 283523, 310430, 310431, 310432, 310433, ... spl_id597965f8-e2d2-4010-b57b-482f6e59a810spl_set_idee9ad9ed-6d9f-4ee1-9d7f-cfad438df388Package NDC 0071-0803-24, 0071-0803-40, 0071-0805-24, 0071-0805-40, 0071-0806-24, 0071-0806- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

10)

drugcharacterization2medicinalproductLORAZEPAMdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA076150, NDA018140, ANDA203572, ANDA074282, ANDA072755, ANDA090260, ANDA07502 ... Brand NameLORAZEPAM, ATIVANGeneric NameLORAZEPAMManufacturers International Medication Systems, Limited, West-Ward Pharmaceuticals Corp., Auro ... product_ndc 76329-8261, 0641-6207, 13107-083, 13107-084, 13107-085, 0409-6778, 0054-3532, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsLORAZEPAMRXCUI 238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 763028, 763029 ... spl_id decb713d-bc45-4bf5-8f61-c0e2f23051b0, eb500b8e-b94e-4900-bc8a-8217fc718704, e1fa ... spl_set_id 7dda070d-7809-46c4-8592-eb4e4c509707, b79b38ee-c29d-4099-964f-000031f47f5a, 5b85 ... Package NDC 76329-8261-1, 0641-6207-01, 0641-6207-25, 13107-083-10, 13107-083-01, 13107-083- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

11)

drugcharacterization2medicinalproductVIAGRAdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA020895Brand NameVIAGRAGeneric NameSILDENAFIL CITRATEManufacturersU.S. Pharmaceuticals, Pfizer Laboratories Div Pfizer Incproduct_ndc63539-421, 63539-422, 0069-4200, 0069-4210, 0069-4220Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSILDENAFIL CITRATERXCUI213270, 213271, 312950, 314229, 213269, 314228spl_id44077f94-92ff-4cd3-ae7d-3913bd41d97a, 825327ae-a572-4b15-b9dd-1221249a7ac8spl_set_id442a09ee-e7de-4d53-a32e-07c7530cdede, 0b0be196-0c62-461c-94f4-9a35339b4501Package NDC 63539-421-97, 63539-422-02, 63539-422-03, 0069-4200-30, 0069-4210-30, 0069-4210- ... UNIIBW9B0ZE037

12)

drugcharacterization2medicinalproductTRAZADONEdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

13)

drugcharacterization2medicinalproductVENLAFAXINEdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA211323, ANDA079098, ANDA206250, ANDA078627, ANDA078932, ANDA090555, ANDA0776 ... Brand NameVENLAFAXINE, VENLAFAXINE HYDROCHLORIDEGeneric NameVENLAFAXINE, VENLAFAXINE HYDROCHLORIDEManufacturers Cadila Pharmaceuticals Limited, Amneal Pharmaceuticals LLC, Sun Pharmaceutical I ... product_ndc 71209-087, 71209-088, 71209-089, 65162-300, 65162-302, 65162-306, 65162-307, 651 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVENLAFAXINE HYDROCHLORIDERXCUI808744, 808748, 808753, 313580, 313582, 313584, 313586, 314277, 808751spl_id f0cda912-3f9e-4f18-a55e-a5cc80bd2e7a, 11f387e7-a398-4a1f-90d8-7454e9bd499d, a3b2 ... spl_set_id 516e7566-35c2-4a25-88d8-54d9dbc8f6be, 62c02cdb-ea65-41ff-a531-4d9ea498f705, 2ed6 ... Package NDC 71209-087-01, 71209-087-04, 71209-087-11, 71209-088-01, 71209-088-04, 71209-088- ... UNII7D7RX5A8MO

14)

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

Report Duplicate

duplicatesourceCELGENEduplicatenumbUS-CELGENEUS-163-POMAL-14045124

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use