Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10334342primarysourcecountryUStransmissiondateformat102transmissiondate26/03/2015reporttype1serious1seriousnessother1receivedateformat102Date Received21/07/2014receiptdateformat102Date Last Updated21/07/2014fulfillexpeditecriteria1companynumbADR-2014-01266duplicate1

Report Duplicate

duplicatesourceMEDTRONICduplicatenumbADR-2014-01266

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age50Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionPain

2)

reactionmeddraversionpt17.1ReactionSomnolence

3)

reactionmeddraversionpt17.1ReactionFeeling drunk

4)

reactionmeddraversionpt17.1ReactionDevice issue

Drug

1)

drugcharacterization1medicinalproductLUNESTA

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

2)

drugcharacterization1medicinalproductLIPITOR

activesubstance

activesubstancenameATORVASTATIN CALCIUM

openFDA Info on Medication

Application NumberNDA020702Brand NameLIPITORGeneric NameATORVASTATIN CALCIUMManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0155, 0071-0156, 0071-0157, 0071-0158Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATORVASTATIN CALCIUM TRIHYDRATERXCUI259255, 262095, 617310, 617311, 617312, 617314, 617318, 617320spl_idb95993d7-bc87-4d0a-9926-e3d36c5b3b4espl_set_idc6e131fe-e7df-4876-83f7-9156fc4e8228Package NDC 0071-0155-23, 0071-0155-40, 0071-0155-97, 0071-0156-23, 0071-0156-40, 0071-0156- ... UNII48A5M73Z4Q

3)

drugcharacterization1medicinalproductZOFRAN

activesubstance

activesubstancenameONDANSETRON HYDROCHLORIDE

4)

drugcharacterization1medicinalproductFLUOXETINE

activesubstance

activesubstancenameFLUOXETINE\FLUOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA090223, ANDA209695, ANDA078619, ANDA079209, ANDA210935, ANDA211282, ANDA0754 ... Brand NameFLUOXETINEGeneric NameFLUOXETINE, FLUOXETINE HYDROCHLORIDEManufacturers Alembic Pharmaceuticals Limited, Nivagen Pharmaceuticals, Inc., BluePoint Labora ... product_ndc 46708-271, 46708-272, 46708-273, 75834-148, 68001-399, 68001-400, 68001-401, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFLUOXETINE HYDROCHLORIDERXCUI310384, 310385, 313989, 1190110, 310386, 248642, 313990, 2532159, 2532163spl_id 40ef6547-f80f-45f4-8719-ebc913b4df7d, 789b1507-b5c0-4a50-bf82-f1fe9bb3c8d6, d290 ... spl_set_id 6b9c2d73-866b-44c4-8718-e7e4a9a0fb55, f4cbf9a9-1d7f-4aa0-a18d-fba50d49bd2b, f89a ... Package NDC 46708-271-30, 46708-271-31, 46708-271-71, 46708-271-91, 46708-272-30, 46708-272- ... UNIII9W7N6B1KJ

5)

drugcharacterization1medicinalproductZETIA

activesubstance

activesubstancenameEZETIMIBE

openFDA Info on Medication

Application NumberNDA021445Brand NameZETIAGeneric NameEZETIMIBEManufacturersOrganon LLCproduct_ndc78206-178Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsEZETIMIBERXCUI349556, 352304spl_id51b443ef-2feb-4db4-9175-096539adbdecspl_set_id174e45e0-45bb-48b7-9e60-8f6cfc1d22bbPackage NDC78206-178-01NUIN0000008553, N0000175911Physiologic/Pharmacodynamic EffectDecreased Cholesterol Absorption [PE]Established Pharmacologic ClassDietary Cholesterol Absorption Inhibitor [EPC]UNIIEOR26LQQ24

6)

drugcharacterization1medicinalproductLASIX

activesubstance

activesubstancenameFUROSEMIDE

openFDA Info on Medication

Application NumberNDA016273Brand NameLASIXGeneric NameFUROSEMIDEManufacturersValidus Pharmaceuticals LLCproduct_ndc30698-060, 30698-067, 30698-066Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFUROSEMIDERXCUI197732, 200801, 200809, 205732, 310429, 313988spl_id95a46760-e587-41a3-9ff3-c8dd8505f694spl_set_id2c9b4d8f-0770-482d-a9e6-9c616a440b1aPackage NDC 30698-067-01, 30698-067-10, 30698-060-01, 30698-060-10, 30698-060-50, 30698-066- ... NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

7)

drugcharacterization1medicinalproductDILAUDIDdrugstructuredosagenumb7.502drugstructuredosageunit003

activesubstance

activesubstancenameHYDROMORPHONE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA019034, NDA019892, NDA019891Brand NameDILAUDIDGeneric NameHYDROMORPHONE HYDROCHLORIDEManufacturersFresenius Kabi USA, LLC, Rhodes Pharmaceuticals L.P.product_ndc76045-009, 76045-010, 76045-121, 42858-122, 42858-234, 42858-338, 42858-416Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, ORALActive IngredientsHYDROMORPHONE HYDROCHLORIDERXCUI 897756, 897757, 1433251, 1872265, 1872269, 1872752, 2277368, 2277370, 897657, 89 ... spl_id 91e4f1a1-03b1-4625-b4d4-19ab7667ee4c, f89754d5-a3d4-44c9-b175-1bf0581e18da, 6cac ... spl_set_id 9eebd88a-5632-460f-b7b6-26c8a180540d, 4d77772f-874f-9c87-2d80-ca467c7690a1, d6b4 ... Package NDC 76045-009-96, 76045-009-06, 76045-009-01, 76045-009-11, 76045-010-01, 76045-010- ... UNIIL960UP2KRW

8)

drugcharacterization1medicinalproductFENOFIBRATE.

activesubstance

activesubstancenameFENOFIBRATE

openFDA Info on Medication

Application Number ANDA211080, ANDA209950, ANDA207378, ANDA211122, ANDA210606, ANDA090715, NDA02169 ... Brand NameFENOFIBRATE, FENOFIBRATE FILM COATED, ANTARA, TRICOR, LIPOFEN, FENOGLIDEGeneric NameFENOFIBRATEManufacturers Solco Healthcare US, LLC, Amneal Pharmaceuticals NY LLC, Northstar Rx LLC, Gravi ... product_ndc 43547-430, 43547-431, 69238-1262, 69238-1263, 16714-739, 16714-740, 16714-741, 6 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFENOFIBRATERXCUI 477560, 477562, 349287, 351133, 200311, 310288, 310289, 483425, 483427, 1442163, ... spl_id 165e6912-1ca0-4fad-8c3c-97a927d0d249, eabb010f-d348-4d41-afac-20c21ef60800, 502b ... spl_set_id 085109a6-f006-44f0-a170-980d8899a365, 7e79d495-5d59-485e-b3c2-7c31ba044948, e47b ... Package NDC 43547-430-09, 43547-430-50, 43547-431-09, 43547-431-50, 69238-1262-9, 69238-1263 ... NUIN0000175596, N0000175375, M0199111Established Pharmacologic ClassPeroxisome Proliferator Receptor alpha Agonist [EPC]Mechanism of ActionPeroxisome Proliferator-activated Receptor alpha Agonists [MoA]Chemical StructurePPAR alpha [CS]UNIIU202363UOS

9)

drugcharacterization1medicinalproductVISTARIL

activesubstance

activesubstancenameHYDROXYZINE PAMOATE

openFDA Info on Medication

Application NumberNDA011459Brand NameVISTARILGeneric NameHYDROXYZINE PAMOATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0069-5410, 0069-5420, 0069-5440Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROXYZINE PAMOATERXCUI995253, 995255, 995274, 995276, 995278, 995280spl_id2fb74df1-48cd-43c5-b99f-6967faf02da2spl_set_idc271f97f-040e-492b-9194-2c8b74675a95Package NDC0069-5410-66, 0069-5420-66, 0069-5440-93, 0069-5440-97UNIIM20215MUFR

10)

drugcharacterization1medicinalproductMETFORMIN

activesubstance

activesubstancenameMETFORMIN HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA200690, ANDA209674, ANDA209313Brand NameMETFORMIN HYDROCHLORIDE, METFORMINGeneric NameMETFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MGManufacturers Mylan Pharmaceuticals Inc., Ingenus Pharmaceuticals, LLC, Granules Pharmaceutica ... product_ndc0378-6001, 0378-6002, 50742-633, 50742-634, 70010-491, 70010-492Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETFORMIN HYDROCHLORIDERXCUI1807894, 1807917, 860975, 860981spl_id b1d71739-26c3-43d3-9088-60bef3689e74, d7e2ad60-7a17-4c65-b836-e56644be754d, d164 ... spl_set_id 7e41818c-60e9-4bcf-9586-7bb8d33d5e89, 49a0b5c2-ebaf-4c4c-905f-dfd1962ac647, 6d6e ... Package NDC 0378-6002-91, 0378-6001-91, 50742-633-60, 50742-633-90, 50742-633-10, 50742-634- ... UNII786Z46389E

11)

drugcharacterization1medicinalproductBACLOFEN INTRATHECAL 95.0 MCG/MLdrugauthorizationnumb20075drugstructuredosagenumb24.944drugstructuredosageunit004drugindicationPAINdrugenddateformat102drugenddate09/07/2014

activesubstance

activesubstancenameBACLOFEN

12)

drugcharacterization1medicinalproductBACLOFEN.

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA209102, ANDA215885, ANDA209594, ANDA074584, ANDA2100 ... Brand NameBACLOFEN, BACLOFEN (INTRATHECAL), LYVISPAH, OZOBAX, FLEQSUVYGeneric NameBACLOFENManufacturers Northstar RxLLC, TruPharma LLC, Lifestar Pharma LLC, Mylan Institutional LLC, Up ... product_ndc 16714-071, 16714-072, 52817-319, 52817-320, 52817-321, 70756-085, 70756-288, 707 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 430902, 1300890, 308517, 1666613, 2586589, 2586595, 2586596, 258 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, b8da4a75-4c34-1d06-e053-2a95a90a7886, f4a6 ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 68aa591e-ea98-4438-9a4a-4f7e9ea2b285, f9dd ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 52817-319-10, 52817-320- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

13)

drugcharacterization1medicinalproductMIRALAX

activesubstance

activesubstancenamePOLYETHYLENE GLYCOL 3350

openFDA Info on Medication

Application NumberNDA022015Brand NameMIRALAXGeneric NamePOLYETHYLENE GLYCOL 3350ManufacturersBayer HealthCare LLC.product_ndc11523-4357, 11523-7268, 11523-7234, 11523-7341Product TypeHUMAN OTC DRUGRouteORALActive IngredientsPOLYETHYLENE GLYCOL 3350RXCUI876193, 876195spl_idd7a274a0-b5a1-1a00-e053-2a95a90a0387spl_set_idd69ce3d4-7ca4-4fe3-b49e-6655e48d6963Package NDC 11523-7268-3, 11523-7268-8, 11523-7268-7, 11523-7268-4, 11523-7268-9, 11523-7234 ... NUIN0000010288, N0000175811, N0000009871Mechanism of ActionOsmotic Activity [MoA]Established Pharmacologic ClassOsmotic Laxative [EPC]Physiologic/Pharmacodynamic EffectStimulation Large Intestine Fluid/Electrolyte Secretion [PE]UNIIG2M7P15E5P

14)

drugcharacterization1medicinalproductLEVOTHYROXINE

activesubstance

activesubstancenameLEVOTHYROXINE

openFDA Info on Medication

Brand NameLEVOTHYROXINEGeneric NameLEVOTHYROXINEManufacturersDeseret Biologicals, Inc.product_ndc43742-0955Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLEVOTHYROXINEspl_id7c431149-4f46-4c4f-a5bb-c1b1fb705283spl_set_id1a467f8b-2611-4936-af2b-098e4791d6aePackage NDC43742-0955-1NUIN0000175945, M0021504Established Pharmacologic Classl-Thyroxine [EPC]Chemical StructureThyroxine [CS]UNIIQ51BO43MG4

15)

drugcharacterization1medicinalproductTRIAZOLAM.

activesubstance

activesubstancenameTRIAZOLAM

openFDA Info on Medication

Application NumberANDA214219, NDA017892, ANDA074224Brand NameTRIAZOLAM, HALCIONGeneric NameTRIAZOLAMManufacturers Ingenus Pharmaceuticals, LLC, Pharmacia & Upjohn Company LLC, Greenstone LLC, Hi ... product_ndc50742-645, 50742-646, 0009-0017, 59762-3717, 59762-3718, 0054-4858, 0054-4859Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTRIAZOLAMRXCUI198317, 198318, 208681spl_id c8ac1484-0706-4629-9563-1e6b7dac89d8, 35f32dcf-f1d8-4656-b982-02f5a9ede2c4, 21b4 ... spl_set_id a0c99f0b-4122-4611-9b53-80fadfceacb6, a0da0dba-a56d-486b-a45b-e8a7cdfbeac6, 5add ... Package NDC 50742-645-01, 50742-646-01, 50742-646-05, 0009-0017-55, 0009-0017-58, 59762-3717 ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII1HM943223R

16)

drugcharacterization1medicinalproductBUMETANIDE.

activesubstance

activesubstancenameBUMETANIDE

openFDA Info on Medication

Application Number ANDA074225, NDA018225, ANDA209916, ANDA074441, ANDA202900, ANDA079196, ANDA20972 ... Brand NameBUMETANIDE, BUMEXGeneric NameBUMETANIDEManufacturers Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Validus Pharmaceu ... product_ndc 14539-700, 14539-701, 14539-702, 30698-630, 30698-631, 30698-632, 0832-0540, 083 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsBUMETANIDERXCUI197417, 197418, 197419, 205488, 205489, 205490, 282486, 1727569spl_id 138f8bdd-34a5-49c6-832f-0d343aa95c7b, a8cdbcbb-2436-4157-9929-e1138035de53, a2d6 ... spl_set_id a51d798c-5847-49b2-ba94-434131848199, 32dfbea3-eb2b-4070-8605-57ce3e6d5a2f, ff5d ... Package NDC 14539-700-01, 14539-700-05, 14539-700-10, 14539-701-01, 14539-701-05, 14539-701- ... NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII0Y2S3XUQ5H

17)

drugcharacterization1medicinalproductXANAX

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0094, 0009-0029, 0009-0055, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_idf364e489-b47b-4283-a7fe-d5b15f77447e, bf933d5a-53e2-4454-a040-cacc061bca92spl_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

18)

drugcharacterization1medicinalproductPROTONIX

activesubstance

activesubstancenamePANTOPRAZOLE SODIUM

openFDA Info on Medication

Application NumberNDA020988, NDA020987, NDA022020Brand NamePROTONIX I.V., PROTONIX DELAYED-RELEASEGeneric NamePANTOPRAZOLE SODIUMManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0008-0923, 0008-2001, 0008-4001, 0008-0841, 0008-0843, 0008-0844Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsPANTOPRAZOLE SODIUMRXCUI283669, 885257, 251872, 284400, 314200, 352125, 763306, 763308spl_id 027ca15a-8c9f-422a-8e8d-374f68db15cc, ffc4c349-c863-49bf-b179-caa42b759898, 9dd8 ... spl_set_id 51e4144a-489e-436c-609a-39305f8f56ba, 5b5ddedd-d429-41a7-8573-10c3e9ad4e52, f39b ... Package NDC 0008-0923-51, 0008-0923-60, 0008-0923-55, 0008-2001-01, 0008-2001-25, 0008-2001- ... UNII6871619Q5X

19)

drugcharacterization1medicinalproductPOTASSIUM

activesubstance

activesubstancenamePOTASSIUM

20)

drugcharacterization1medicinalproductLEVOTHROID

activesubstance

activesubstancenameLEVOTHYROXINE SODIUM