Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10061215serious1Date Last Updated07/04/2014receiptdateformat102companynumbPHHY2014GB036823occurcountryGBseriousnessother1duplicate1Date Received07/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryGBseriousnessdisabling1

Primary Source

reportercountryGBqualification3

Patient

Onset Age35Unit of Onset AgeyearsWeight98SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionDepressionOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionPanic attackOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionAnxietyOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionPalpitationsOutcomeRecovered/resolved

5)

reactionmeddraversionpt17.0ReactionExtrasystolesOutcomeRecovered/resolved

6)

reactionmeddraversionpt17.0ReactionHallucination, visualOutcomeRecovered/resolved

7)

reactionmeddraversionpt17.0ReactionDrug interactionOutcomeUnknown

8)

reactionmeddraversionpt17.0ReactionChronic fatigue syndromeOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt17.0ReactionHyperhidrosisOutcomeRecovered/resolved

10)

reactionmeddraversionpt17.0ReactionHeadacheOutcomeRecovered/resolved

11)

reactionmeddraversionpt17.0ReactionFatigueOutcomeNot recovered/not resolved

12)

reactionmeddraversionpt17.0ReactionDepressed level of consciousnessOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductAMITRIPTYLINE HYDROCHLORIDE SANDOZdrugauthorizationnumb085966drugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50MG SELF TAPERING UP TO 70MGdrugadministrationroute048drugindicationNEURALGIAdrugstartdateformat102drugstartdate24/09/2013drugrecurreadministration3

2)

drugcharacterization3medicinalproductAMITRIPTYLINE HYDROCHLORIDE SANDOZdrugauthorizationnumb085966drugstructuredosagenumb70drugstructuredosageunit003drugdosagetext50MG SELF TAPERING UP TO 70MGdrugadministrationroute048drugenddateformat102drugenddate14/02/2014drugrecurreadministration3

3)

drugcharacterization3medicinalproductSERTRALINE HYDROCHLORIDEdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50MG INCREASED EVERY FEW WEEKS TO 150 MGdrugadministrationroute048drugindicationDEPRESSED MOODdrugstartdateformat102drugstartdate22/11/2013drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA077206, NDA020990, NDA019839, ANDA078861, ANDA077864, ANDA077106, ANDA076934 ... Brand NameSERTRALINE HYDROCHLORIDE, SERTRALINE, ZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturers Aurobindo Pharma Limited, Greenstone LLC, Rising Pharmaceuticals, Inc., Hikma Ph ... product_ndc 65862-011, 65862-012, 65862-013, 59762-0067, 59762-4960, 59762-4900, 59762-4910, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941, 861064, 208149, 208161, 212233, 861066spl_id 80aac5d8-bb02-46f5-a8ca-5fc9f934541c, 1ef7897d-60bb-4685-820f-21c78a097642, 96aa ... spl_set_id 39a85db1-9e59-4ab0-9e18-36757f019faa, 1a58062b-e635-431a-908d-2651c6a4a21c, af2c ... Package NDC 65862-011-30, 65862-011-50, 65862-011-60, 65862-011-90, 65862-011-01, 65862-011- ... UNIIUTI8907Y6X

4)

drugcharacterization3medicinalproductSERTRALINE HYDROCHLORIDEdrugstructuredosagenumb150drugstructuredosageunit003drugdosagetext50MG INCREASED EVERY FEW WEEKS TO 150 MGdrugadministrationroute048drugenddateformat102drugenddate07/02/2014drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA077206, NDA020990, NDA019839, ANDA078861, ANDA077864, ANDA077106, ANDA076934 ... Brand NameSERTRALINE HYDROCHLORIDE, SERTRALINE, ZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturers Aurobindo Pharma Limited, Greenstone LLC, Rising Pharmaceuticals, Inc., Hikma Ph ... product_ndc 65862-011, 65862-012, 65862-013, 59762-0067, 59762-4960, 59762-4900, 59762-4910, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941, 861064, 208149, 208161, 212233, 861066spl_id 80aac5d8-bb02-46f5-a8ca-5fc9f934541c, 1ef7897d-60bb-4685-820f-21c78a097642, 96aa ... spl_set_id 39a85db1-9e59-4ab0-9e18-36757f019faa, 1a58062b-e635-431a-908d-2651c6a4a21c, af2c ... Package NDC 65862-011-30, 65862-011-50, 65862-011-60, 65862-011-90, 65862-011-01, 65862-011- ... UNIIUTI8907Y6X

5)

drugcharacterization2medicinalproductDIAZEPAMdrugstartdateformat102drugstartdate29/01/2014drugenddateformat102drugenddate07/02/2014

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

duplicatesourceSANDOZduplicatenumbPHHY2014GB036823

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use