Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID11806507primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/05/2016reporttype1serious2receivedateformat102Date Received07/12/2015receiptdateformat102Date Last Updated04/02/2016fulfillexpeditecriteria2companynumbUS-LUNDBECK-DKLU2005833duplicate1

Report Duplicate

duplicatesourceLUNDBECKduplicatenumbUS-LUNDBECK-DKLU2005833

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Weight55SexFemale

Reaction

1)

reactionmeddraversionpt19.0ReactionHeart rate increasedOutcomeUnknown

2)

reactionmeddraversionpt19.0ReactionMalaiseOutcomeUnknown

3)

reactionmeddraversionpt19.0ReactionDizzinessOutcomeUnknown

4)

reactionmeddraversionpt19.0ReactionNauseaOutcomeUnknown

5)

reactionmeddraversionpt19.0ReactionFeeling abnormalOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductNORTHERAdrugauthorizationnumb203202drugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextON A TITRATION 48 HOUR TITRATION SCHEDULE, DAY 5-6drugdosageformCAPSULEdrugadministrationroute065actiondrug1

activesubstance

activesubstancenameDROXIDOPA

openFDA Info on Medication

Application NumberNDA203202Brand NameNORTHERAGeneric NameDROXIDOPAManufacturersLundbeck Pharmaceuticals LLCproduct_ndc67386-820, 67386-821, 67386-822Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDROXIDOPARXCUI1490026, 1490032, 1490034, 1490036, 1490038, 1490040spl_idc860d1c5-e572-4483-8617-c4012f2b42ebspl_set_id2179f02c-48d7-48eb-8007-5ae43d8d16bcPackage NDC67386-820-19, 67386-821-19, 67386-822-19NUIM0003647, N0000178478Chemical StructureCatecholamines [CS]Physiologic/Pharmacodynamic EffectIncreased Blood Pressure [PE]UNIIJ7A92W69L7

2)

drugcharacterization2medicinalproductCVS VITAMIN B-1drugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

3)

drugcharacterization1medicinalproductNORTHERAdrugauthorizationnumb203202drugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug1

activesubstance

activesubstancenameDROXIDOPA

openFDA Info on Medication

Application NumberNDA203202Brand NameNORTHERAGeneric NameDROXIDOPAManufacturersLundbeck Pharmaceuticals LLCproduct_ndc67386-820, 67386-821, 67386-822Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDROXIDOPARXCUI1490026, 1490032, 1490034, 1490036, 1490038, 1490040spl_idc860d1c5-e572-4483-8617-c4012f2b42ebspl_set_id2179f02c-48d7-48eb-8007-5ae43d8d16bcPackage NDC67386-820-19, 67386-821-19, 67386-822-19NUIM0003647, N0000178478Chemical StructureCatecholamines [CS]Physiologic/Pharmacodynamic EffectIncreased Blood Pressure [PE]UNIIJ7A92W69L7

4)

drugcharacterization2medicinalproductDULOXETINE HCLdrugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameDULOXETINE HYDROCHLORIDE

openFDA Info on Medication

5)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

6)

drugcharacterization2medicinalproductCYMBALTAdrugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameDULOXETINE HYDROCHLORIDE

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_id892f05de-dd11-4ae3-9a85-ce9cfcbeaaccspl_set_id2f7d4d67-10c1-4bf4-a7f2-c185fbad64baPackage NDC0002-3235-60, 0002-3240-30, 0002-3240-90, 0002-3270-30, 0002-3270-04UNII9044SC542W

7)

drugcharacterization2medicinalproductZONISAMIDE.drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameZONISAMIDE

openFDA Info on Medication

Application Number ANDA077645, NDA020789, ANDA077625, ANDA077634, ANDA077869, ANDA214492, ANDA07765 ... Brand NameZONISAMIDE, ZONEGRANGeneric NameZONISAMIDEManufacturers Aurobindo Pharma Limited, Concordia Pharmaceuticals Inc., Cadila Healthcare Limi ... product_ndc 59651-378, 59651-379, 59651-380, 59212-680, 59212-681, 70771-1142, 70771-1143, 7 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZONISAMIDERXCUI314285, 403966, 403967, 284408, 404725spl_id 2de9e3a1-2be7-4e6d-9f0e-2a43cbb37dcd, 7de9d196-dab7-49de-955c-e944bfddb20a, 73e0 ... spl_set_id ab0631ca-5339-4570-bc27-f1dd92de1d6f, d12de43e-3ac3-4335-bc85-70d7366a91eb, 4a4d ... Package NDC 59651-378-03, 59651-378-60, 59651-378-01, 59651-378-05, 59651-379-03, 59651-379- ... NUIN0000175753, N0000008486, M0020790, N0000000235, N0000185503Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Chemical StructureSulfonamides [CS]Mechanism of ActionCarbonic Anhydrase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]UNII459384H98V

8)

drugcharacterization2medicinalproductCYANOCOBALAMIN.drugstructuredosagenumb1000drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformSOLUTIONdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameCYANOCOBALAMIN

openFDA Info on Medication

Application Number ANDA206503, ANDA214655, ANDA213874, ANDA209255, ANDA080515, NDA021642, ANDA08073 ... Brand Name CYANOCOBALAMIN, VITAMIN DEFICIENCY SYSTEM, COCO12, NASCOBAL, DODEX INJECTABLE, V ... Generic NameCYANOCOBALAMINManufacturers Somerset Therapeutics, LLC, Zydus Pharmaceuticals USA Inc., AuroMedics Pharma LL ... product_ndc 70069-005, 70069-172, 70710-1663, 70710-1664, 70710-1665, 55150-364, 69680-112, ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteINTRAMUSCULAR, SUBCUTANEOUS, TOPICAL, NASALActive IngredientsCYANOCOBALAMINRXCUI309594, 861113, 861115, 2598453, 797544spl_id f24e1ba1-2063-44bf-958e-d3fad248436d, 6ac6e28b-b969-4b66-bc1e-cca8a2cb66f3, 96dc ... spl_set_id 41ac0dc1-0a71-4c69-8e25-ba838f5f16a3, e6712877-ace0-441c-99a9-adf567c0b9a2, db84 ... Package NDC 70069-005-01, 70069-005-10, 70069-172-01, 70069-172-10, 70069-172-25, 70710-1663 ... NUIM0022794, N0000175951Chemical StructureVitamin B 12 [CS]Established Pharmacologic ClassVitamin B12 [EPC]UNIIP6YC3EG204

9)

drugcharacterization2medicinalproductESZOPICLONE.drugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute065drugindicationPRODUCT 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

10)

drugcharacterization2medicinalproductZIPSORdrugdosageformCAPSULEdrugadministrationroute065drugindicationMIGRAINE

activesubstance

activesubstancenameDICLOFENAC POTASSIUM

openFDA Info on Medication

Application NumberNDA022202Brand NameZIPSORGeneric NameDICLOFENAC POTASSIUMManufacturersAssertio Therapeutics, Inc.product_ndc13913-008Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDICLOFENAC POTASSIUMRXCUI858342, 858346spl_idf0e64763-d7f7-4574-b7ab-43fb104b43a4spl_set_idc982eca0-fc41-11e1-a9c8-0002a5d5c51bPackage NDC13913-008-11, 13913-008-12, 13913-008-94UNIIL4D5UA6CB4

11)

drugcharacterization1medicinalproductNORTHERAdrugauthorizationnumb203202drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextON A TITRATION 48 HOUR TITRATION SCHEDULE, DAY 1-2drugdosageformCAPSULEdrugadministrationroute065actiondrug1

activesubstance

activesubstancenameDROXIDOPA

openFDA Info on Medication

Application NumberNDA203202Brand NameNORTHERAGeneric NameDROXIDOPAManufacturersLundbeck Pharmaceuticals LLCproduct_ndc67386-820, 67386-821, 67386-822Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDROXIDOPARXCUI1490026, 1490032, 1490034, 1490036, 1490038, 1490040spl_idc860d1c5-e572-4483-8617-c4012f2b42ebspl_set_id2179f02c-48d7-48eb-8007-5ae43d8d16bcPackage NDC67386-820-19, 67386-821-19, 67386-822-19NUIM0003647, N0000178478Chemical StructureCatecholamines [CS]Physiologic/Pharmacodynamic EffectIncreased Blood Pressure [PE]UNIIJ7A92W69L7

12)

drugcharacterization2medicinalproductCYCLOBENZAPRINE HCLdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameCYCLOBENZAPRINE HYDROCHLORIDE

openFDA Info on Medication

13)

drugcharacterization2medicinalproductSUMATRIPTAN SUCCINATE.drugdosagetext6MG/0.5MLdrugdosageformSOLUTIONdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameSUMATRIPTAN SUCCINATE

openFDA Info on Medication

Application Number ANDA076847, ANDA078593, ANDA090495, NDA208223, ANDA077744, ANDA078327, NDA206099 ... Brand NameSUMATRIPTAN SUCCINATE, ZEMBRACE SYMTOUCH, SUMATRIPTAN, ONZETRA XSAILGeneric NameSUMATRIPTAN SUCCINATEManufacturers Dr. Reddy's Laboratories Limited, Wockhardt USA LLC., Upsher-Smith laboratories, ... product_ndc 55111-291, 55111-292, 55111-293, 64679-728, 55111-693, 0245-0809, 68071-4562, 03 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, SUBCUTANEOUS, NASALActive IngredientsSUMATRIPTAN SUCCINATERXCUI 313160, 313161, 315223, 313165, 1657151, 1738576, 1738581, 1739332, 1739337, 179 ... spl_id 8c734b50-3369-df0f-8a18-5bd1bdf51093, 8fed49a8-01d7-422d-bbb6-212ef36952e4, d892 ... spl_set_id ac80d018-6abf-2e41-ddea-90b4ff9e9013, e0917960-87bf-4650-b60b-64bef2ccc4d6, 4e26 ... Package NDC 55111-291-30, 55111-291-36, 55111-291-90, 55111-291-01, 55111-291-05, 55111-291- ... UNIIJ8BDZ68989

14)

drugcharacterization2medicinalproductVALACYCLOVIR HCLdrugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameVALACYCLOVIR HYDROCHLORIDE

15)

drugcharacterization1medicinalproductNORTHERAdrugauthorizationnumb203202drugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextON A TITRATION 48 HOUR TITRATION SCHEDULE, DAY 3-4drugdosageformCAPSULEdrugadministrationroute065actiondrug1

activesubstance

activesubstancenameDROXIDOPA

openFDA Info on Medication

Application NumberNDA203202Brand NameNORTHERAGeneric NameDROXIDOPAManufacturersLundbeck Pharmaceuticals LLCproduct_ndc67386-820, 67386-821, 67386-822Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDROXIDOPARXCUI1490026, 1490032, 1490034, 1490036, 1490038, 1490040spl_idc860d1c5-e572-4483-8617-c4012f2b42ebspl_set_id2179f02c-48d7-48eb-8007-5ae43d8d16bcPackage NDC67386-820-19, 67386-821-19, 67386-822-19NUIM0003647, N0000178478Chemical StructureCatecholamines [CS]Physiologic/Pharmacodynamic EffectIncreased Blood Pressure [PE]UNIIJ7A92W69L7

16)

drugcharacterization2medicinalproductMETOPROLOL SUCCINATE ERdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameMETOPROLOL SUCCINATE

openFDA Info on Medication

17)

drugcharacterization2medicinalproductMODAFINIL.drugstructuredosagenumb400drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameMODAFINIL

openFDA Info on Medication

Application Number ANDA202700, ANDA077667, ANDA202566, NDA020717, ANDA209966, ANDA078963, ANDA20719 ... Brand NameMODAFINIL, PROVIGILGeneric NameMODAFINILManufacturers Alembic Pharmaceuticals Limited, Apotex Corp., Alembic Pharmaceuticals Inc., Ris ... product_ndc 46708-385, 46708-386, 60505-2526, 60505-2527, 62332-385, 62332-386, 57237-154, 5 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMODAFINILRXCUI205324, 260218, 213471, 226426spl_id b7315903-20d7-4dce-80ea-3d33fa5f9f16, a2501635-6969-cca6-92c1-e6259d7d7708, 7aa2 ... spl_set_id 5b8496fe-b647-4ce6-aeef-71245712e46f, 944daf47-49a6-93ca-e348-4a0f1b6d937e, 41f9 ... Package NDC 46708-385-30, 46708-385-91, 46708-385-10, 46708-385-60, 46708-385-90, 46708-386- ... NUIN0000175729, N0000175651, N0000175769Physiologic/Pharmacodynamic EffectCentral Nervous System Stimulation [PE], Increased Sympathetic Activity [PE]Established Pharmacologic ClassSympathomimetic-like Agent [EPC]UNIIR3UK8X3U3D

18)

drugcharacterization1medicinalproductNORTHERAdrugauthorizationnumb203202drugstructuredosagenumb400drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute065actiondrug1

activesubstance

activesubstancenameDROXIDOPA

openFDA Info on Medication

Application NumberNDA203202Brand NameNORTHERAGeneric NameDROXIDOPAManufacturersLundbeck Pharmaceuticals LLCproduct_ndc67386-820, 67386-821, 67386-822Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDROXIDOPARXCUI1490026, 1490032, 1490034, 1490036, 1490038, 1490040spl_idc860d1c5-e572-4483-8617-c4012f2b42ebspl_set_id2179f02c-48d7-48eb-8007-5ae43d8d16bcPackage NDC67386-820-19, 67386-821-19, 67386-822-19NUIM0003647, N0000178478Chemical StructureCatecholamines [CS]Physiologic/Pharmacodynamic EffectIncreased Blood Pressure [PE]UNIIJ7A92W69L7

19)

drugcharacterization2medicinalproductMAXALTdrugdosageformTABLETdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameRIZATRIPTAN BENZOATE

openFDA Info on Medication

Application NumberNDA020864Brand NameMAXALTGeneric NameRIZATRIPTAN BENZOATEManufacturersOrganon LLCproduct_ndc78206-142, 78206-143Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRIZATRIPTAN BENZOATEspl_idde376dab-ae25-4825-9c3b-fd0e3688e41espl_set_id007b4644-e0e7-4863-9ae3-fe09676b3f5fPackage NDC78206-142-99, 78206-142-01, 78206-143-99, 78206-143-01UNIIWR978S7QHH

20)

drugcharacterization2medicinalproductTOPAMAXdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameTOPIRAMATE

openFDA Info on Medication

Application NumberNDA020505, NDA020844Brand NameTOPAMAXGeneric NameTOPIRAMATEManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-639, 50458-640, 50458-641, 50458-642, 50458-647, 50458-645Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOPIRAMATERXCUI 151226, 151227, 151228, 151229, 152855, 199888, 199889, 199890, 205315, 205316, ... spl_id095baa56-cc0a-4711-b8e4-49b1401b699espl_set_id21628112-0c47-11df-95b3-498d55d89593Package NDC 50458-639-65, 50458-640-65, 50458-641-65, 50458-642-65, 50458-647-65, 50458-645- ... NUIN0000008486, N0000185506, N0000182140Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Mechanism of ActionCytochrome P450 3A4 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNII0H73WJJ391