Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10145628serious1Date Last Updated18/06/2014receiptdateformat102companynumbUS-ACCORD-023352occurcountryUSseriousnessother1duplicate1Date Received01/05/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age42Unit of Onset AgeyearsWeight90.7SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionSyncopeOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionVertigoOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionHypertensionOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionMalaiseOutcomeRecovered/resolved

5)

reactionmeddraversionpt17.0ReactionPalpitationsOutcomeRecovered/resolved

6)

reactionmeddraversionpt17.0ReactionDyspnoeaOutcomeRecovered/resolved

7)

reactionmeddraversionpt17.0ReactionHyperhidrosisOutcomeRecovered/resolved

8)

reactionmeddraversionpt17.0ReactionNauseaOutcomeRecovered/resolved

9)

reactionmeddraversionpt17.0ReactionBack painOutcomeRecovered/resolved

10)

reactionmeddraversionpt17.0ReactionHeadacheOutcomeRecovered/resolved

11)

reactionmeddraversionpt17.0ReactionHypoaesthesiaOutcomeRecovered/resolved

12)

reactionmeddraversionpt17.0ReactionAnxietyOutcomeRecovered/resolved

13)

reactionmeddraversionpt17.0ReactionDepressionOutcomeRecovered/resolved

14)

reactionmeddraversionpt17.0ReactionDizzinessOutcomeUnknown

15)

reactionmeddraversionpt17.0ReactionVisual impairmentOutcomeUnknown

16)

reactionmeddraversionpt17.0ReactionAbdominal painOutcomeUnknown

17)

reactionmeddraversionpt17.0ReactionChest painOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductTRAMADOL/TRAMADOL HYDROCHLORIDEdrugauthorizationnumb202390drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate19/12/2013actiondrug4

2)

drugcharacterization1medicinalproductPERCOCETdrugdosagetext7.5/325 MG TIDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate19/12/2013actiondrug4

openFDA Info on Medication

Application NumberANDA040330Brand NamePERCOCETGeneric NameOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENManufacturersEndo Pharmaceuticals Inc.product_ndc63481-623, 63481-627, 63481-628, 63481-629Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDE, ACETAMINOPHENRXCUI1049214, 1049221, 1049225, 1049625, 1049635, 1049637, 1049640, 1049642spl_id8a04ce2f-d576-469f-91bc-5ed75e27e47espl_set_id4dd36cf5-8f73-404a-8b1d-3bd53bd90c25Package NDC63481-627-70, 63481-623-70, 63481-623-85, 63481-628-70, 63481-629-70UNII362O9ITL9D, C1ENJ2TE6C

3)

drugcharacterization1medicinalproductINVESTIGATIONAL DRUGdrugindicationCONSTIPATIONdrugstartdateformat102drugstartdate27/02/2014actiondrug4

4)

drugcharacterization2medicinalproductCLONAZEPAMdrugstartdateformat610drugstartdate/10/2013actiondrug4

openFDA Info on Medication

Application Number ANDA077171, ANDA074569, ANDA074869, ANDA077194, ANDA077147, ANDA074979, ANDA2110 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Par Pharmaceutical, Inc., Teva Pharmaceuticals USA, Inc., Actavis Pharma, Inc., ... product_ndc 49884-306, 49884-307, 49884-308, 49884-309, 49884-310, 0093-0832, 0093-3212, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529spl_id a95f8799-0bb3-41d6-aa27-8a291127ad54, 90dc0b61-37a3-4e54-bde3-7e4c3f7dae98, 9b58 ... spl_set_id 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069b1a0-7c06-4252-b44e-e2eef065d9b8, a58f ... Package NDC 49884-306-02, 49884-307-02, 49884-308-02, 49884-309-02, 49884-310-02, 0093-0832- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

5)

drugcharacterization2medicinalproductMETOPROLOLdrugstartdateformat602drugstartdate//2009actiondrug4

openFDA Info on Medication

Application NumberANDA078950, ANDA091045, ANDA202871Brand NameMETOPROLOL, METOPROLOL TARTRATEGeneric NameMETOPROLOL TARTRATE, METOPROLOLManufacturers Baxter Healthcare Corporation, Fresenius Kabi USA, LLC, Alembic Pharmaceuticals ... product_ndc 36000-033, 63323-660, 62332-112, 62332-113, 62332-114, 46708-290, 46708-291, 467 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsMETOPROLOL TARTRATERXCUI866508, 866511, 866514, 866924spl_id 202a1ff0-38f7-4bf2-ade7-6ede8fa64486, 94a4f468-def9-95b9-e053-2995a90a3428, bd31 ... spl_set_id 09566368-f91d-43a3-b683-30c844fb125a, be1c686e-37a5-4a53-945b-68a6ead35134, 2483 ... Package NDC 36000-033-10, 63323-660-05, 62332-112-30, 62332-112-31, 62332-112-91, 62332-113- ... UNIIW5S57Y3A5L

6)

drugcharacterization2medicinalproductSERTRALINEdrugstartdateformat610drugstartdate/10/2013actiondrug4

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

7)

drugcharacterization2medicinalproductALBUTEROLdrugstartdateformat602drugstartdate//1981actiondrug4

openFDA Info on Medication

Application Number ANDA210948, ANDA213657, ANDA211397, ANDA208804, ANDA207046, ANDA072894, ANDA2088 ... Brand NameALBUTEROLGeneric NameALBUTEROL SULFATE, ALBUTEROLManufacturers Nivagen Pharmaceuticals Inc, Aurobindo Pharma Limited, Virtus Pharmaceuticals LL ... product_ndc 75834-273, 75834-274, 59651-333, 59651-334, 69543-290, 69543-291, 69238-1344, 69 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALBUTEROL SULFATERXCUI197316, 197318spl_id b736135f-6e13-3e29-e053-2a95a90a67f4, ff9b287b-e4a4-4c12-ad2f-6b7d55b20dc6, b9cd ... spl_set_id b735e92d-eb1a-6fc1-e053-2995a90afce2, ff9b287b-e4a4-4c12-ad2f-6b7d55b20dc6, 3f81 ... Package NDC 75834-273-01, 75834-274-01, 59651-333-01, 59651-333-05, 59651-334-01, 59651-334- ... UNII021SEF3731

8)

drugcharacterization2medicinalproductZESTORETICdrugstartdateformat602drugstartdate//2009actiondrug4

openFDA Info on Medication

Application NumberNDA019888Brand NameZESTORETICGeneric NameLISINOPRIL AND HYDROCHLOROTHIAZIDEManufacturersAlmatica Pharma Inc.product_ndc52427-435, 52427-436, 52427-437Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISINOPRIL, HYDROCHLOROTHIAZIDERXCUI197885, 197886, 197887, 823971, 823982, 823986spl_id5f9e6622-20be-9e82-1406-9119c661db2bspl_set_id0d3a966f-f937-05a8-a90f-5aa52ebbd613Package NDC52427-435-90, 52427-436-90, 52427-437-90NUIN0000175359, N0000175419, M0471776Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Established Pharmacologic ClassThiazide Diuretic [EPC]Chemical StructureThiazides [CS]UNII0J48LPH2TH, E7199S1YWR

9)

drugcharacterization2medicinalproductLORATADINEdrugstartdateformat602drugstartdate//2010actiondrug4

openFDA Info on Medication

Application Number ANDA210722, ANDA076471, ANDA076301, ANDA202538, ANDA076805, ANDA075209, ANDA0757 ... Brand Name LORATADINE, ALLERGY RELIEF, CHILDRENS LORATADINE SUGAR FREE, COUNTERACT ALLERGY, ... Generic NameLORATADINE, LORATADINE ORALManufacturers Granules India Ltd, Geri-Care Pharmaceutical Corp, Shopko Stores Operating Co., ... product_ndc 62207-787, 57896-788, 37012-612, 69452-211, 69842-540, 54473-166, 36800-608, 036 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLORATADINE, FAMOTIDINERXCUI 311372, 828269, 692783, 1087051, 311373, 665078, 744830, 206805, 1020126, 755478 ... spl_id 9aadc2f2-d0ea-5297-e053-2995a90ac51e, 9aa07ca9-ee19-89c7-e053-2a95a90ae9b5, 105d ... spl_set_id 0dee9036-d51f-4d7f-b5e2-4f6940249eef, 41fab408-35cb-47cc-bd4e-bba4ec10f6c7, 47b0 ... Package NDC 62207-787-51, 62207-787-59, 57896-788-03, 57896-788-09, 37012-612-65, 37012-612- ... UNII7AJO3BO7QN, 5QZO15J2Z8NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]

10)

drugcharacterization2medicinalproductMETHOCARBAMOLdrugstartdateformat610drugstartdate/11/2013actiondrug4

openFDA Info on Medication

Application Number ANDA208116, ANDA200958, ANDA207522, ANDA204404, ANDA208507, ANDA211504, ANDA0404 ... Brand NameMETHOCARBAMOL, ROBAXIN, METHOCARB 500-EZSGeneric NameMETHOCARBAMOL INJECTION, METHOCARBAMOL, METHOCARBAMOL TABLETSManufacturers Renaissance Lakewood LLC, Westminster Pharmaceuticals, LLC, Somerset Therapeutic ... product_ndc 49396-0711, 69367-255, 69367-256, 70069-101, 67457-273, 76385-123, 76385-124, 43 ... Product TypeHUMAN PRESCRIPTION DRUGRoutePARENTERAL, ORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsMETHOCARBAMOLRXCUI238175, 197943, 197944, 207014, 207016, 1010654spl_id 7d658860-a6e3-cb2f-e053-2991aa0a9461, ae9df131-66a3-0ec7-e053-2995a90a02e4, f868 ... spl_set_id 4a9d9920-c79a-4396-e054-00144ff8d46c, 2199b810-fb84-4dac-b787-ade2b5f67e92, 68dd ... Package NDC 49396-0711-1, 69367-256-01, 69367-256-05, 69367-255-01, 69367-255-05, 70069-101- ... NUIN0000175730, N0000175737Physiologic/Pharmacodynamic EffectCentrally-mediated Muscle Relaxation [PE]Established Pharmacologic ClassMuscle Relaxant [EPC]UNII125OD7737X

Report Duplicate

duplicatesourceACCORDduplicatenumbUS-ACCORD-023352

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use