Report

Version of Safety Report ID4Safety Report ID11277332primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/05/2016reporttype1serious1seriousnesshospitalization1receivedateformat102Date Received16/07/2015receiptdateformat102Date Last Updated11/02/2016fulfillexpeditecriteria1companynumbUS-LUNDBECK-DKLU2001514duplicate1

Report Duplicate

duplicatesourceLUNDBECKduplicatenumbUS-LUNDBECK-DKLU2001514

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age41Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt19.0ReactionAcute myocardial infarctionOutcomeRecovered/resolved

2)

reactionmeddraversionpt19.0ReactionDrug interactionOutcomeRecovered/resolved

3)

reactionmeddraversionpt19.0ReactionStress cardiomyopathyOutcomeRecovered/resolved

4)

reactionmeddraversionpt19.0ReactionCardiac failure congestiveOutcomeRecovered/resolved

Drug

1)

drugcharacterization3medicinalproductNORTHERAdrugauthorizationnumb203202drugstructuredosagenumb400drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute048drugindicationORTHOSTATIC HYPOTENSIONdrugenddateformat102drugenddate11/06/2015actiondrug1

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)

drugcharacterization3medicinalproductNORTHERAdrugauthorizationnumb203202drugstructuredosagenumb400drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugstartdateformat102drugstartdate17/04/2015drugenddateformat102drugenddate13/06/2015actiondrug1

activesubstance

activesubstancenameDROXIDOPA

openFDA Info on Medication

3)

drugcharacterization2medicinalproductNORTRIPTYLINEdrugstructuredosagenumb150drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationNEURALGIA

activesubstance

activesubstancenameNORTRIPTYLINE

4)

drugcharacterization2medicinalproductPROPRANOLOLdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenamePROPRANOLOL\PROPRANOLOL HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA075826Brand NamePROPRANOLOLGeneric NamePROPRANOLOL HYDROCHLORIDEManufacturersFresenius Kabi USA, LLCproduct_ndc63323-604Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsPROPRANOLOL HYDROCHLORIDERXCUI856443spl_iddb24d808-268b-4bec-bd48-7b66d2bb5951spl_set_idf14ea537-dd5c-4c78-9037-9a85e9e610efPackage NDC63323-604-01UNIIF8A3652H1V

5)

drugcharacterization2medicinalproductPLAQUENILdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameHYDROXYCHLOROQUINE SULFATE

openFDA Info on Medication

Application NumberNDA009768Brand NamePLAQUENILGeneric NameHYDROXYCHLOROQUINE SULFATEManufacturersConcordia Pharmaceuticals Inc.product_ndc59212-562Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROXYCHLOROQUINE SULFATERXCUI979092, 979094spl_idda37c8d1-331e-4549-aabc-68e2e4207df8spl_set_id34496b43-05a2-45fb-a769-52b12e099341Package NDC59212-562-10, 59212-562-60, 59212-562-11UNII8Q2869CNVH

6)

drugcharacterization2medicinalproductLYRICAdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenamePREGABALIN

openFDA Info on Medication

Application NumberNDA021446, NDA022488Brand NameLYRICAGeneric NamePREGABALINManufacturersParke-Davis Div of Pfizer Inc, U.S. Pharmaceuticalsproduct_ndc 0071-1012, 0071-1013, 0071-1014, 0071-1015, 0071-1016, 0071-1017, 0071-1019, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 607018, 607020, ... spl_idb9b1285a-2cb3-4789-8b0e-8d5e1b253534, bfdec19d-6a54-449c-95b4-908d28e5369aspl_set_id60185c88-ecfd-46f9-adb9-b97c6b00a553, ce1a4b9d-3127-4416-8bf2-fee5899fc0baPackage NDC 0071-1012-68, 0071-1013-41, 0071-1013-68, 0071-1014-41, 0071-1014-68, 0071-1015- ... UNII55JG375S6M

7)

drugcharacterization2medicinalproductCERITIZINEdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

8)

drugcharacterization2medicinalproductFAMOTIDINE.drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameFAMOTIDINE

openFDA Info on Medication

Application Number ANDA077351, ANDA075400, ANDA206531, ANDA215767, ANDA215043, ANDA090837, ANDA0789 ... Brand Name ACID RELIEF, ACID CONTROLLER, ZANTAC 360, FAMOTIDINE, HARRIS TEETER ACID REDUCER ... Generic NameFAMOTIDINEManufacturers Rite Aid Corporation, H E B, Chattem, Inc., Camber Pharmaceuticals, Inc., Harris ... product_ndc 11822-1014, 37808-301, 41167-0360, 41167-0361, 31722-017, 31722-018, 69256-141, ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsFAMOTIDINERXCUI 310273, 199047, 284245, 310274, 204441, 1743833, 104094, 206873, 199739, 104095, ... spl_id 29a6dae5-4a6f-4a9a-b281-088340cf52a0, b6d7707b-916f-4d1d-9d99-6193cf700edc, 1193 ... spl_set_id 34034d16-dc3b-436d-8ec8-84b3c1f8e48a, 813d742f-8f3d-4f18-a6c5-03eea946f976, 89f6 ... Package NDC 11822-1014-0, 37808-301-65, 37808-301-72, 41167-0360-2, 41167-0361-0, 41167-0361 ... NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]UNII5QZO15J2Z8

9)

drugcharacterization2medicinalproductPHENTERMINE.drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenamePHENTERMINE

openFDA Info on Medication

Application NumberANDA204318Brand NamePHENTERMINEGeneric NamePHENTERMINE HYDROCHLORIDEManufacturersAurolife Pharma, LLCproduct_ndc13107-105, 13107-106Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPHENTERMINE HYDROCHLORIDERXCUI900038, 968766spl_id53dd7857-41fb-4da1-88f7-5c68a509bfb0spl_set_id737eef3b-9a6b-4ab3-a25c-49d84d2a0197Package NDC13107-105-30, 13107-105-01, 13107-106-30, 13107-106-01UNII0K2I505OTV

10)

drugcharacterization2medicinalproductSAVELLAdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationNEURALGIA

activesubstance

activesubstancenameMILNACIPRAN HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022256Brand NameSAVELLAGeneric NameMILNACIPRAN HYDROCHLORIDEManufacturersAllergan, Inc.product_ndc0456-1500, 0456-1512, 0456-1525, 0456-1550, 0456-1510Product TypeHUMAN PRESCRIPTION DRUGRouteORALRXCUI833135, 833139, 833141, 833143, 833144, 833146, 833147, 833149, 833150, 833151spl_id5cb4b5fa-97d9-4c0a-abcf-c27b8a42d797spl_set_id16a4a314-f97e-4e91-95e9-576a3773d284Package NDC 0456-1512-60, 0456-1512-11, 0456-1512-63, 0456-1525-60, 0456-1525-11, 0456-1525- ... UNIIRNZ43O5WW5Active IngredientsMILNACIPRAN HYDROCHLORIDE

11)

drugcharacterization2medicinalproductRELPAXdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameELETRIPTAN HYDROBROMIDE

openFDA Info on Medication

Application NumberNDA021016Brand NameRELPAXGeneric NameELETRIPTAN HYDROBROMIDEManufacturersRoerigproduct_ndc0049-2330, 0049-2340Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsELETRIPTAN HYDROBROMIDERXCUI359493, 359494, 404443, 404444spl_id60fa2e8b-4d0d-4546-a087-3f0efb3e7560spl_set_id85745375-fcb6-4edc-b6db-a77b4a5f3e8cPackage NDC0049-2330-79, 0049-2330-45, 0049-2340-79, 0049-2340-45, 0049-2340-05UNIIM41W832TA3

12)

drugcharacterization1medicinalproductNORTHERAdrugauthorizationnumb203202drugdosageformCAPSULEdrugadministrationroute048drugindicationAUTONOMIC NEUROPATHYdrugstartdateformat610drugstartdate/05/2015actiondrug1

activesubstance

activesubstancenameDROXIDOPA

openFDA Info on Medication

13)

drugcharacterization2medicinalproductNUCYNTAdrugstructuredosagenumb75drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb6drugintervaldosagedefinition805drugadministrationroute048drugindicationNEURALGIA

activesubstance

activesubstancenameTAPENTADOL HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA200533, NDA022304Brand NameNUCYNTA ER, NUCYNTAGeneric NameTAPENTADOL HYDROCHLORIDEManufacturersCollegium Pharmaceutical, Inc.product_ndc 24510-058, 24510-116, 24510-174, 24510-232, 24510-291, 24510-050, 24510-075, 245 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTAPENTADOL HYDROCHLORIDERXCUI 1148797, 1148800, 1148803, 1148807, 1148809, 1149367, 1149370, 1149373, 1149376, ... spl_idcbee26ee-fbdd-4dee-ada8-101ed4a40eed, e5283782-fa09-4c2c-8505-23bc8789e146spl_set_idc3d04d70-0155-4147-9ce4-a3b1fad4b373, 80938c30-9fe3-4c7d-9d9c-5476638cfb2dPackage NDC 24510-058-60, 24510-058-01, 24510-116-60, 24510-116-01, 24510-174-60, 24510-174- ... UNII71204KII53

14)

drugcharacterization2medicinalproductMIDODRINEdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameMIDODRINE

openFDA Info on Medication

15)

drugcharacterization2medicinalproductFIORICET/BUTALBITAL/CAFFEINEdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

16)

drugcharacterization2medicinalproductLINZESSdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameLINACLOTIDE

openFDA Info on Medication

Application NumberNDA202811Brand NameLINZESSGeneric NameLINACLOTIDEManufacturersAllergan, Inc.product_ndc0456-1201, 0456-1202, 0456-1203Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLINACLOTIDERXCUI1307409, 1307415, 1307419, 1307421, 1869697, 1869699spl_id7d12c89f-0ea6-4a9b-bb75-99774445955dspl_set_id09beda19-56d6-4a56-afdc-9a77b70b2ef3Package NDC 0456-1201-30, 0456-1201-04, 0456-1202-30, 0456-1202-04, 0456-1203-30, 0456-1203- ... NUIN0000185500, N0000185499Established Pharmacologic ClassGuanylate Cyclase-C Agonist [EPC]Mechanism of ActionGuanylate Cyclase Activators [MoA]UNIIN0TXR0XR5X

17)

drugcharacterization3medicinalproductNOREPINEPHRINE REUPTAKE BLOCKERSdrugadministrationroute065drugindicationNEURALGIAactiondrug5

activesubstance

activesubstancenameUNSPECIFIED INGREDIENT

18)

drugcharacterization2medicinalproductALPRAZOLAM.drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA074174 ... Brand NameALPRAZOLAM, XANAX XR, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZOLAM XRGeneric NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia & Upjohn Comp ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 687022, 687023, ... spl_id 94163352-f78e-400a-b7da-b3075e9213eb, 35398b0f-4f2a-4504-b254-bb6010a4101e, f364 ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

19)

drugcharacterization2medicinalproductLUNESTAdrugadministrationroute065drugindicationPRODUCT 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

summary

narrativeincludeclinicalCASE EVENT DATE: 20150613

Adverse Event Report

Report

Report Duplicate

Primary Source

Sender

Receiver

Patient

Reaction

1)

2)

3)

4)

Drug

1)

activesubstance

openFDA Info on Medication

2)

activesubstance

openFDA Info on Medication

3)

activesubstance

4)

activesubstance

openFDA Info on Medication

5)

activesubstance

openFDA Info on Medication

6)

activesubstance

openFDA Info on Medication

7)

8)

activesubstance

openFDA Info on Medication

9)

activesubstance

openFDA Info on Medication

10)

activesubstance

openFDA Info on Medication

11)

activesubstance

openFDA Info on Medication

12)

activesubstance

openFDA Info on Medication

13)

activesubstance

openFDA Info on Medication

14)

activesubstance

openFDA Info on Medication

15)

16)

activesubstance

openFDA Info on Medication

17)

activesubstance

18)

activesubstance

openFDA Info on Medication

19)

activesubstance

openFDA Info on Medication

summary

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