Adverse Event Report

Report

reporttype3Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10064284serious1Date Last Updated08/04/2014receiptdateformat102companynumbGB-LUPIN PHARMACEUTICALS INC.-E2B_00001898occurcountryGBseriousnessother1duplicate1Date Received08/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryGBseriousnessdisabling1

Primary Source

reportercountryGB

Patient

Onset Age35Unit of Onset AgeyearsWeight98SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionExtrasystolesOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionHallucination, visualOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionPanic attackOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionDrug interactionOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionChronic fatigue syndromeOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.0ReactionDepressed level of consciousnessOutcomeRecovered/resolved

7)

reactionmeddraversionpt17.0ReactionDepressionOutcomeRecovered/resolved

8)

reactionmeddraversionpt17.0ReactionDrug ineffectiveOutcomeUnknown

9)

reactionmeddraversionpt17.0ReactionAnxietyOutcomeRecovered/resolved

10)

reactionmeddraversionpt17.0ReactionPalpitationsOutcomeRecovered/resolved

11)

reactionmeddraversionpt17.0ReactionHyperhidrosisOutcomeRecovered/resolved

12)

reactionmeddraversionpt17.0ReactionHeadacheOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductSERTRALINEdrugbatchnumbUNKNOWNdrugauthorizationnumb077670drugstructuredosagenumb50drugstructuredosageunit003drugadministrationroute048drugindicationDEPRESSED MOODdrugstartdateformat102drugstartdate22/11/2013actiondrug1drugrecurreadministration3

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

2)

drugcharacterization1medicinalproductSERTRALINEdrugbatchnumbUNKNOWNdrugauthorizationnumb077670drugstructuredosagenumb150drugstructuredosageunit003drugadministrationroute048drugenddateformat102drugenddate07/02/2014actiondrug1drugrecurreadministration3

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

3)

drugcharacterization1medicinalproductAMITRIPTYLINE HYDROCHLORIDEdrugbatchnumbUNKNOWNdrugstructuredosagenumb50drugstructuredosageunit003drugadministrationroute048drugindicationNEURALGIAdrugstartdateformat102drugstartdate24/09/2013drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA085969, ANDA085966, ANDA085968, ANDA085971, ANDA085967, ANDA085970, ANDA2024 ... Brand NameAMITRIPTYLINE HYDROCHLORIDEGeneric NameAMITRIPTYLINE HYDROCHLORIDEManufacturers Northstar RxLLC, Accord Healthcare Inc., Mylan Pharmaceuticals Inc., Sandoz Inc, ... product_ndc 16714-446, 16714-447, 16714-448, 16714-449, 16714-450, 16714-451, 16729-171, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMITRIPTYLINE HYDROCHLORIDERXCUI856762, 856773, 856783, 856834, 856845, 856853spl_id 2cd883f4-4d52-43f6-82be-a78c417f3578, 958ff135-0d53-c264-e053-2a95a90a8c92, 2534 ... spl_set_id 23521590-ec42-4845-aab4-600f6b79e084, 1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd, 61d2 ... Package NDC 16714-446-01, 16714-446-02, 16714-447-01, 16714-447-02, 16714-448-01, 16714-448- ... UNII26LUD4JO9K

4)

drugcharacterization1medicinalproductAMITRIPTYLINE HYDROCHLORIDEdrugbatchnumbUNKNOWNdrugstructuredosagenumb70drugstructuredosageunit003drugadministrationroute048drugenddateformat102drugenddate14/02/2014drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA085969, ANDA085966, ANDA085968, ANDA085971, ANDA085967, ANDA085970, ANDA2024 ... Brand NameAMITRIPTYLINE HYDROCHLORIDEGeneric NameAMITRIPTYLINE HYDROCHLORIDEManufacturers Northstar RxLLC, Accord Healthcare Inc., Mylan Pharmaceuticals Inc., Sandoz Inc, ... product_ndc 16714-446, 16714-447, 16714-448, 16714-449, 16714-450, 16714-451, 16729-171, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMITRIPTYLINE HYDROCHLORIDERXCUI856762, 856773, 856783, 856834, 856845, 856853spl_id 2cd883f4-4d52-43f6-82be-a78c417f3578, 958ff135-0d53-c264-e053-2a95a90a8c92, 2534 ... spl_set_id 23521590-ec42-4845-aab4-600f6b79e084, 1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd, 61d2 ... Package NDC 16714-446-01, 16714-446-02, 16714-447-01, 16714-447-02, 16714-448-01, 16714-448- ... UNII26LUD4JO9K

5)

drugcharacterization2medicinalproductDIAZEPAMdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate29/01/2014drugenddateformat102drugenddate07/02/2014

openFDA Info on Medication

Application Number ANDA072079, ANDA071134, ANDA071135, ANDA071136, NDA020124, ANDA210363, NDA020648 ... Brand NameDIAZEPAM, DIASTAT, VALTOCO, VALIUMGeneric NameDIAZEPAMManufacturers Hospira, Inc., Mayne Pharma, Meridian Medical Technologies, Inc., Dash Pharmaceu ... product_ndc 0409-1273, 51862-062, 51862-063, 51862-064, 11704-600, 69339-136, 66490-650, 686 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORAL, RECTAL, NASALActive IngredientsDIAZEPAMRXCUI 1807459, 197589, 197590, 197591, 1807452, 2120550, 801957, 801961, 801966, 22726 ... spl_id c2374258-57c6-4be5-89df-27d6cf5dc832, 49cd2631-74e5-4291-a491-b15b2fa31ee3, 8861 ... spl_set_id 41044928-dd1f-40bf-1fa6-709dff559124, 7d81850c-ad3f-4e2e-ac41-ed9c567aea4b, fa35 ... Package NDC 0409-1273-03, 0409-1273-32, 51862-062-01, 51862-062-05, 51862-062-10, 51862-063- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

Report Duplicate

duplicatesourceLUPINduplicatenumbGB-LUPIN PHARMACEUTICALS INC.-E2B_00001898

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use