Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10084266serious1Date Last Updated02/02/2015receiptdateformat102authoritynumbGB-MHRA-EYC 00110095companynumbGB-PFIZER INC-2014103246occurcountryGBseriousnessother1duplicate1Date Received17/04/2014transmissiondate20/07/2015primarysourcecountryGB

Primary Source

reportercountryGBqualification5

Patient

Onset Age22Unit of Onset AgeyearsWeight88.9SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionConfusional stateOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.0ReactionFace oedemaOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.0ReactionCondition aggravatedOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.0ReactionFluid retentionOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt18.0ReactionEye swellingOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt18.0ReactionOedema peripheralOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt18.0ReactionMemory impairmentOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductPREGABALIN.drugauthorizationnumb021446drugstructuredosagenumb600drugstructuredosageunit003drugdosagetext600 MG, UNKdrugdosageformCAPSULE, HARDdrugadministrationroute048drugindicationANXIETY DISORDERdrugstartdateformat102drugstartdate01/12/2013actiondrug2drugrecurreadministration3

activesubstance

activesubstancenamePREGABALIN

openFDA Info on Medication

Application Number ANDA209357, ANDA206912, NDA209501, ANDA203459, ANDA212865, ANDA091157, ANDA20762 ... Brand NamePREGABALIN, LYRICA CR, LYRICAGeneric NamePREGABALINManufacturers MSN LABORATORIES PRIVATE LIMITED, Camber Pharmaceuticals, Inc., Parke-Davis Div ... product_ndc 69539-011, 69539-012, 69539-013, 69539-014, 69539-015, 69539-016, 69539-017, 695 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 1988974, 1988977 ... spl_id 6a062096-6569-45c1-9184-11e9973cc3c8, 241c4b7e-f719-4828-8639-ea613b8a6583, df98 ... spl_set_id 993bedd3-2f7c-40ff-87dc-8a55c6c7a3c7, 241c4b7e-f719-4828-8639-ea613b8a6583, 2d83 ... Package NDC 69539-011-90, 69539-011-99, 69539-011-11, 69539-011-06, 69539-012-90, 69539-012- ... UNII55JG375S6M

2)

drugcharacterization2medicinalproductPROPRANOLOL HYDROCHLORIDE.drugdosagetextUNK

activesubstance

activesubstancenamePROPRANOLOL HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA090321, ANDA070979, ANDA070690, ANDA212026, ANDA078494, NDA018553, ANDA07776 ... Brand Name PROPRANOLOL HYDROCHLORIDE, INDERAL LA, INNOPRAN XL, HEMANGEOL, PROPRANOLOL HYDRO ... Generic NamePROPRANOLOL HYDROCHLORIDEManufacturers Zydus Pharmaceuticals (USA) Inc., West Ward Pharmaceuticals Corp., Lannett Compa ... product_ndc 68382-161, 68382-162, 68382-163, 68382-164, 0054-3727, 0054-3730, 0527-4116, 052 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsPROPRANOLOL HYDROCHLORIDERXCUI 856460, 856481, 856535, 856569, 856724, 856733, 856462, 856483, 856537, 856571, ... spl_id c3cf9407-83ca-40fa-9794-623ee06074d0, 27888d2b-acfc-4b6e-8082-62cbdd4b7f9a, fb2e ... spl_set_id 5a7858eb-9d2d-44d9-9f81-c78ba3ce1815, 8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e, 5229 ... Package NDC 68382-161-16, 68382-161-01, 68382-161-05, 68382-161-10, 68382-161-30, 68382-161- ... UNIIF8A3652H1V

3)

drugcharacterization2medicinalproductOLANZAPINE.drugdosagetextUNK

activesubstance

activesubstancenameOLANZAPINE

openFDA Info on Medication

Application Number ANDA204319, ANDA201588, ANDA076255, NDA020592, NDA021086, NDA021253, ANDA090798, ... Brand NameOLANZAPINE, ZYPREXA, ZYPREXA ZYDIS, ZYPREXA INTRAMUSCULARGeneric NameOLANZAPINEManufacturers Virtus Pharmaceuticals, LLC, Sandoz Inc, Dr. Reddy's Laboratories Inc., Eli Lill ... product_ndc 69543-380, 69543-381, 69543-382, 69543-383, 69543-384, 69543-385, 0781-9105, 435 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULARActive IngredientsOLANZAPINERXCUI 200034, 283639, 312077, 312078, 312079, 314154, 485968, 153046, 153047, 153048, ... spl_id a6c0f6d1-1550-41e3-e053-2a95a90aa46f, a0f9cb84-1dee-4dc5-96b7-ce259903b940, 55da ... spl_set_id 6a5db723-0f21-417e-a95c-cf0c438e8b44, c44a96cc-817d-4eb5-a13a-00977f76e666, d474 ... Package NDC 69543-380-30, 69543-380-90, 69543-381-30, 69543-381-90, 69543-382-30, 69543-382- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIN7U69T4SZR

4)

drugcharacterization2medicinalproductSERTRALINE HYDROCHLORIDE.drugdosagetextUNK

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20131201

Report Duplicate

duplicatesourcePFIZERduplicatenumbGB-PFIZER INC-2014103246

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use