Report

reporttype1Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10149972serious1Date Last Updated14/11/2018seriousnesslifethreatening1receiptdateformat102authoritynumbGB-MHRA-ADR 22496422companynumbGB-TEVA-477404ISRoccurcountryGBseriousnessother1duplicate1Date Received02/05/2014transmissiondate04/02/2019primarysourcecountryGB

Primary Source

reportercountryGBqualification5

Patient

Onset Age23Unit of Onset AgeyearsWeight88.9SexMale

Reaction

1)

reactionmeddraversionpt21.1ReactionAmnesiaOutcomeRecovering/resolving

2)

reactionmeddraversionpt21.1ReactionAbdominal painOutcomeRecovering/resolving

3)

reactionmeddraversionpt21.1ReactionDyspnoeaOutcomeRecovering/resolving

4)

reactionmeddraversionpt21.1ReactionDrug interactionOutcomeUnknown

5)

reactionmeddraversionpt21.1ReactionAngioedemaOutcomeRecovering/resolving

6)

reactionmeddraversionpt21.1ReactionSleep apnoea syndromeOutcomeRecovering/resolving

7)

reactionmeddraversionpt21.1ReactionSpeech disorderOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt21.1ReactionMemory impairmentOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt21.1ReactionAstheniaOutcomeRecovering/resolving

10)

reactionmeddraversionpt21.1ReactionChest discomfortOutcomeRecovering/resolving

11)

reactionmeddraversionpt21.1ReactionDisturbance in attentionOutcomeRecovering/resolving

12)

reactionmeddraversionpt21.1ReactionParaesthesiaOutcomeRecovering/resolving

13)

reactionmeddraversionpt21.1ReactionFluid retentionOutcomeRecovering/resolving

14)

reactionmeddraversionpt21.1ReactionPhotosensitivity reactionOutcomeRecovering/resolving

15)

reactionmeddraversionpt21.1ReactionDepressed level of consciousnessOutcomeRecovering/resolving

16)

reactionmeddraversionpt21.1ReactionMedication errorOutcomeRecovering/resolving

Drug

1)

drugcharacterization2medicinalproductSERTRALINEdrugadministrationroute065

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)

drugcharacterization1medicinalproductCLONAZEPAM.drugauthorizationnumb74569drugdosagetextRARELY USED.drugadministrationroute065drugindicationANXIETYactiondrug5drugrecurreadministration3drugadditional3

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 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

3)

drugcharacterization3medicinalproductOLANZAPINE.drugauthorizationnumb076000drugadministrationroute065drugindicationSLEEP DISORDERactiondrug5drugrecurreadministration3drugadditional3

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)

drugcharacterization1medicinalproductPROPRANOLOLdrugauthorizationnumb070550drugadministrationroute065actiondrug5drugrecurreadministration3drugadditional3

activesubstance

activesubstancenamePROPRANOLOL HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA075826Brand NamePROPRANOLOLGeneric NamePROPRANOLOL HYDROCHLORIDEManufacturersFresenius Kabi USA, LLCproduct_ndc63323-604Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsPROPRANOLOL HYDROCHLORIDERXCUI856443spl_iddb24d808-268b-4bec-bd48-7b66d2bb5951spl_set_idf14ea537-dd5c-4c78-9037-9a85e9e610efPackage NDC63323-604-01UNIIF8A3652H1V

5)

drugcharacterization3medicinalproductPREGABALIN.drugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext300 MILLIGRAM DAILY; 100MG IN THE MORNING 200MG IN THE EVENINGdrugadministrationroute048drugindicationANXIETY DISORDERdrugstartdateformat102drugstartdate01/12/2013actiondrug5drugrecurreadministration3drugadditional3

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

duplicatesourceTEVAduplicatenumbGB-TEVA-477404ISR

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use

Adverse Event Report

Report

Primary Source

Patient

Reaction

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Drug

1)

activesubstance

openFDA Info on Medication

2)

activesubstance

openFDA Info on Medication

3)

activesubstance

openFDA Info on Medication

4)

activesubstance

openFDA Info on Medication

5)

activesubstance

openFDA Info on Medication

summary

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