Adverse Event Report

Report

reporttype1Version of Safety Report ID6receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10086383serious1Date Last Updated20/01/2020seriousnesslifethreatening1receiptdateformat102authoritynumbGB-MHRA-ADR 22496422companynumbGB-PFIZER INC-2014109035occurcountryGBseriousnessother1duplicate1Date Received18/04/2014transmissiondate09/04/2020primarysourcecountryGB

Primary Source

reportercountryGBqualification5

Patient

Onset Age23Unit of Onset AgeyearsWeight88.9SexMale

Reaction

1)

reactionmeddraversionpt22.1ReactionDrug interactionOutcomeUnknown

2)

reactionmeddraversionpt22.1ReactionDisturbance in attentionOutcomeRecovering/resolving

3)

reactionmeddraversionpt22.1ReactionMemory impairmentOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt22.1ReactionSleep apnoea syndromeOutcomeRecovering/resolving

5)

reactionmeddraversionpt22.1ReactionAmnesiaOutcomeRecovering/resolving

6)

reactionmeddraversionpt22.1ReactionDyspnoeaOutcomeRecovering/resolving

7)

reactionmeddraversionpt22.1ReactionDepressed level of consciousnessOutcomeRecovering/resolving

8)

reactionmeddraversionpt22.1ReactionSpeech disorderOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt22.1ReactionAstheniaOutcomeRecovering/resolving

10)

reactionmeddraversionpt22.1ReactionChest discomfortOutcomeRecovering/resolving

11)

reactionmeddraversionpt22.1ReactionMedication errorOutcomeRecovering/resolving

12)

reactionmeddraversionpt22.1ReactionFluid retentionOutcomeRecovering/resolving

13)

reactionmeddraversionpt22.1ReactionAngioedemaOutcomeRecovered/resolved

14)

reactionmeddraversionpt22.1ReactionParaesthesiaOutcomeRecovering/resolving

15)

reactionmeddraversionpt22.1ReactionAbdominal painOutcomeRecovering/resolving

16)

reactionmeddraversionpt22.1ReactionPhotosensitivity reactionOutcomeRecovering/resolving

Drug

1)

drugcharacterization2medicinalproductSERTRALINEdrugdosagetextUNK

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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)

drugcharacterization3medicinalproductPROPRANOLOL HYDROCHLORIDE.drugdosagetextUNKactiondrug5drugadditional3

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)

drugcharacterization3medicinalproductOLANZAPINE.drugdosagetextUNKdrugindicationSLEEP DISORDERactiondrug1drugadditional1

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, 06a3 ... 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)

drugcharacterization3medicinalproductCLONAZEPAM.drugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 DF, AS NEEDED RARELY USEDdrugindicationANXIETYactiondrug5drugadditional3

activesubstance

activesubstancenameCLONAZEPAM

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 IngredientsCLONAZEPAMRXCUI 349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529, 206157, 206159, ... spl_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)

drugcharacterization1medicinalproductPREGABALIN.drugauthorizationnumb021446drugstructuredosagenumb300drugstructuredosageunit003drugdosagetext300 MG, DAILY 100MG IN THE MORNING AND 200MG IN THE EVENINGdrugadministrationroute048drugindicationANXIETY DISORDERdrugstartdateformat102drugstartdate01/12/2013actiondrug5drugadditional3

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20131201

Report Duplicate

duplicatesourcePFIZERduplicatenumbGB-PFIZER INC-2014109035

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use