Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10445939primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate26/03/2015reporttype1serious1seriousnesshospitalization1receivedateformat102Date Received10/09/2014receiptdateformat102Date Last Updated10/09/2014fulfillexpeditecriteria1companynumbUS-CELGENEUS-163-POMAL-14091125duplicate1

Report Duplicate

duplicatesourceCELGENEduplicatenumbUS-CELGENEUS-163-POMAL-14091125

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Weight58.1SexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionNephrolithiasisOutcomeUnknown

2)

reactionmeddraversionpt17.1ReactionDehydrationOutcomeUnknown

3)

reactionmeddraversionpt17.1ReactionConstipationOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductPOMALYSTdrugbatchnumbC0029Adrugauthorizationnumb204026drugstructuredosagenumb2drugstructuredosageunit003drugdosagetext2 MILLIGRAMdrugdosageformCapsulesdrugadministrationroute048drugindicationPLASMA CELL MYELOMAdrugstartdateformat102drugstartdate08/08/2014actiondrug4drugrecurreadministration3

activesubstance

activesubstancenamePOMALIDOMIDE

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_id0e50dfc9-35ac-4b11-89f1-5c3653717c3dspl_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)

drugcharacterization2medicinalproductFLUCONAZOLE.drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameFLUCONAZOLE

openFDA Info on Medication

Application Number ANDA208963, ANDA076658, ANDA076957, ANDA077731, ANDA077253, ANDA076766, ANDA0767 ... Brand NameFLUCONAZOLE, DIFLUCANGeneric NameFLUCONAZOLEManufacturers Cadila Healthcare Limited, Dr. Reddy's Laboratories Limited, Rising Pharmaceutic ... product_ndc 70771-1063, 70771-1064, 70771-1065, 70771-1066, 55111-143, 55111-144, 55111-145, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsFLUCONAZOLERXCUI 197698, 197699, 197700, 197701, 1721314, 1721315, 310352, 310353, 201900, 201901 ... spl_id 671a4cc4-0b0f-4d27-b472-482f9901656a, 54d57030-5a06-e3d5-ea3e-902dc0b19cf9, c626 ... spl_set_id 0adb2f88-8a6f-4f33-9e2d-73f537e05313, d7fa1d79-4cd3-4a55-b74b-b31e82e616a3, 4f97 ... Package NDC 70771-1063-3, 70771-1063-1, 70771-1063-5, 70771-1063-4, 70771-1064-3, 70771-1064 ... NUIN0000175487, M0002083, N0000182140, N0000182141, N0000185504Established Pharmacologic ClassAzole Antifungal [EPC]Chemical StructureAzoles [CS]Mechanism of Action Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Cyt ... UNII8VZV102JFY

3)

drugcharacterization2medicinalproductESZOPICLONE.drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application Number ANDA091124, ANDA091166, ANDA091103, ANDA091113, ANDA091024, ANDA208451, ANDA2029 ... Brand NameESZOPICLONE, LUNESTAGeneric NameESZOPICLONEManufacturers Lupin Pharmaceuticals, Inc., Glenmark Pharmaceuticals Inc. USA, Sun Pharmaceutic ... product_ndc 68180-322, 68180-323, 68180-324, 68462-382, 68462-383, 68462-384, 47335-586, 473 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, OROPHARYNGEALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id c15b2322-c078-46c1-8959-9288faaab19e, 8d6002b1-95d9-445c-8ace-e6dccea36852, 95e9 ... spl_set_id 7068c455-691e-4c56-9857-b7b4e13f4784, 584dc66c-063a-4552-a056-74b811e2bc80, 8bb1 ... Package NDC 68180-322-01, 68180-322-11, 68180-322-13, 68180-323-01, 68180-323-02, 68180-323- ... UNIIUZX80K71OE

4)

drugcharacterization2medicinalproductBYSTOLICdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameNEBIVOLOL HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021742Brand NameBYSTOLICGeneric NameNEBIVOLOL HYDROCHLORIDEManufacturersAllergan, Inc.product_ndc0456-1402, 0456-1405, 0456-1410, 0456-1420Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsNEBIVOLOL HYDROCHLORIDERXCUI387013, 751612, 751616, 751618, 751620, 751623, 827073, 827075spl_id3f38e87f-c08a-4c22-8f31-b7d41f58b967spl_set_id8b8ad213-1dc8-454e-a524-075685c0e1a8Package NDC 0456-1402-30, 0456-1402-90, 0456-1402-01, 0456-1402-63, 0456-1405-30, 0456-1405- ... UNIIJGS34J7L9I

5)

drugcharacterization2medicinalproductTIZANIDINEdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameTIZANIDINE

openFDA Info on Medication

Application NumberANDA076416, ANDA211798, ANDA208187, ANDA076533, ANDA076286, ANDA091283Brand NameTIZANIDINEGeneric NameTIZANIDINEManufacturers Sun Pharmaceutical Industries, Inc., Ascend Laboratories, LLC, Cadila Healthcare ... product_ndc 57664-502, 57664-503, 67877-613, 67877-614, 70771-1335, 70771-1336, 60505-0251, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTIZANIDINE HYDROCHLORIDERXCUI313412, 313413spl_id 5e8ef5b3-9f58-46a7-833c-31ef018ea9a0, 4904688c-ba48-4db8-8720-4e6e99a6460e, 1723 ... spl_set_id 4659df31-8b89-4eff-9d86-7b7e38de416b, 72f25135-1333-4e52-83f5-7df7d90e68bb, 8910 ... Package NDC 57664-502-89, 57664-502-18, 57664-503-89, 57664-503-18, 67877-613-15, 67877-613- ... UNIIB53E3NMY5C

6)

drugcharacterization2medicinalproductHYDROCODONE/ACETAMINOPHENdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameACETAMINOPHEN\HYDROCODONE

7)

drugcharacterization2medicinalproductAMLODIPINEdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameAMLODIPINE BESYLATE

openFDA Info on Medication

Application NumberNDA214439, NDA211340Brand NameNORLIQVA, KATERZIAGeneric NameAMLODIPINEManufacturersCMP Pharma, Inc., Azurity Pharmaceuticals, Inc.product_ndc46287-035, 52652-5001Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE, AMLODIPINE BENZOATERXCUI2599173, 2599179, 2184120, 2184126spl_id63a6bb49-fb68-4351-be5f-a6b6e8f6b540, df623dda-e184-4011-8fce-4e729b2e6b2dspl_set_idc1730a51-4383-4c61-a9a1-7e1326bd0abe, df673a4d-acb8-444c-a472-c87ab8cbd366Package NDC46287-035-15, 52652-5001-1NUIN0000000069, N0000175421, N0000175566, M0006414, N0000190114Mechanism of ActionCalcium Channel Antagonists [MoA], Cytochrome P450 3A Inhibitors [MoA]Established Pharmacologic ClassDihydropyridine Calcium Channel Blocker [EPC], Calcium Channel Blocker [EPC]Chemical StructureDihydropyridines [CS]UNII1J444QC288, XD75TQ8A2P

8)

drugcharacterization2medicinalproductASPIRIN.drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameASPIRIN

openFDA Info on Medication

Application Numberpart343, NDA203697Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN TABLET 325MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 36800-545, 0363-0587, 70000-0218, 63 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 260847, 198471, 825180 ... spl_id 70f66f99-a450-4ab6-a3b9-c5d9207e0a79, da59962f-0c77-5c08-e053-2a95a90aaee7, 1b00 ... spl_set_id 2826d84d-b135-4e20-aeea-271e9f74f431, 356e4ff4-a7f1-4a50-9b86-2555e232b300, 4c30 ... Package NDC 49035-914-32, 47682-456-50, 47682-456-47, 42961-044-01, 42961-044-02, 42961-044- ... NUIN0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]UNIIR16CO5Y76E, H0G9379FGK

9)

drugcharacterization2medicinalproductMOTRINdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameIBUPROFEN

openFDA Info on Medication

Application NumberNDA020603, ANDA079113Brand NameMOTRIN INFANTS, MOTRIN PMGeneric NameIBUPROFEN, IBUPROFEN AND DIPHENHYDRAMINE CITRATEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-198, 50580-563Product TypeHUMAN OTC DRUGRouteORALActive IngredientsIBUPROFEN, DIPHENHYDRAMINE CITRATERXCUI204442, 854762, 895664, 895666spl_iddb6d94a1-21f2-3c69-e053-2995a90a9ee5, d189154b-2808-ac7a-e053-2995a90af834spl_set_idc57f6ded-c0bd-45ae-823a-4c02ce334d98, 55403f19-58ae-450b-8a7b-0bc544088f20Package NDC 50580-198-50, 50580-198-51, 50580-198-52, 50580-563-20, 50580-563-40, 50580-563- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIWK2XYI10QM, 4OD433S209

10)

drugcharacterization2medicinalproductTYLENOLdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameACETAMINOPHEN

openFDA Info on Medication

Application Numberpart341, part343Brand Name TYLENOL COLD PLUS HEAD CONGESTION SEVERE, TYLENOL REGULAR STRENGTH, TYLENOL EXTR ... Generic NameACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHENManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc 50580-566, 50580-495, 50580-458, 50580-487, 50580-496, 50580-451, 50580-600, 505 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDERXCUI1243679, 209387, 313782, 198436, 1738139, 198440, 209459spl_id da433eb1-9a1d-276e-e053-2a95a90a7794, dfd72ee1-40ac-6983-e053-2995a90a4d94, da40 ... spl_set_id ce43e5c2-fe96-4462-882c-d7479318b33d, de5c6654-56c5-40d3-a286-f04ed47ac7c8, 01f4 ... Package NDC 50580-566-25, 50580-495-01, 50580-458-11, 50580-458-50, 50580-458-10, 50580-487- ... NUIN0000193956, N0000008867, N0000009560Established Pharmacologic ClassExpectorant [EPC]Physiologic/Pharmacodynamic Effect Decreased Respiratory Secretion Viscosity [PE], Increased Respiratory Secretions ... UNII362O9ITL9D, 495W7451VQ, 04JA59TNSJ

11)

drugcharacterization2medicinalproductNYSTATIN.drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameNYSTATIN

openFDA Info on Medication

Application Number ANDA203621, ANDA064142, ANDA211838, ANDA062124, ANDA208581, ANDA062838, ANDA0651 ... Brand NameNYSTATIN, NYAMYC, NYSTOPGeneric NameNYSTATIN, NYSTATIN ORAL SUSPENSION, NYSTATIN OINTMENT, NYSTATIN CREAMManufacturers Pharmaceutical Associates, Inc., VistaPharm, Inc., Torrent Pharmaceuticals Limit ... product_ndc 0121-0810, 0121-4810, 66689-037, 13668-534, 0168-0007, 70771-1585, 53489-400, 80 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, TOPICALActive IngredientsNYSTATINRXCUI312055, 884308, 646456, 312059, 584414, 543546, 261178spl_id d57cde69-0eb9-180d-e053-2995a90a33aa, 91e9fe62-a1e7-46e6-8357-cdc2a93cc62f, d61b ... spl_set_id 31e3da10-5a7b-4bc5-8a4f-3e786b64c13a, 41034d7b-33a1-4d6d-b425-9cfefff8d518, 4949 ... Package NDC 0121-0810-02, 0121-0810-16, 0121-4810-05, 0121-4810-40, 0121-4810-00, 0121-4810- ... NUIN0000175498, M0017172Established Pharmacologic ClassPolyene Antifungal [EPC]Chemical StructurePolyenes [CS]UNIIBDF1O1C72E

12)

drugcharacterization2medicinalproductTRAMADOLdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameTRAMADOL

13)

drugcharacterization2medicinalproductCYCLOPHOSPHAMIDE.drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameCYCLOPHOSPHAMIDE

openFDA Info on Medication

Application Number ANDA211608, NDA212501, ANDA040745, ANDA210046, ANDA209872, ANDA204555, NDA012141 ... Brand NameCYCLOPHOSPHAMIDEGeneric NameCYCLOPHOSPHAMIDEManufacturers Cipla USA Inc., Athenex Pharmaceutical Division, LLC., Baxter Healthcare Corpora ... product_ndc 69097-516, 69097-517, 70860-218, 10019-943, 10019-944, 10019-945, 70121-1238, 70 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsCYCLOPHOSPHAMIDE ANHYDROUS, CYCLOPHOSPHAMIDERXCUI 1437968, 1437969, 2386859, 1734917, 1734919, 1734921, 197549, 197550, 2568661, 2 ... spl_id f57dbebf-f145-4e3c-bfef-b7907f6e01eb, 7eaabaf5-ac12-406b-8432-8e01db8e519d, 0eb9 ... spl_set_id 0e1cb955-99c8-4fe5-89d1-399c8e52174e, a0e99679-f939-4fb3-9d38-dfdb824f89bc, cef0 ... Package NDC 69097-516-07, 69097-517-07, 70860-218-03, 70860-218-05, 70860-218-10, 10019-943- ... NUIN0000000236, N0000175558Mechanism of ActionAlkylating Activity [MoA]Established Pharmacologic ClassAlkylating Drug [EPC]UNII6UXW23996M, 8N3DW7272P

14)

drugcharacterization2medicinalproductOXYCODONE/ACETAMINOPHENdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameACETAMINOPHEN\OXYCODONE\OXYCODONE HYDROCHLORIDE

summary

narrativeincludeclinicalCASE EVENT DATE: 2014