Adverse Event Report

Report

reporttype1Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10089519serious1Date Last Updated17/01/2020seriousnesslifethreatening1receiptdateformat102companynumbGB-DRREDDYS-GER/UKI/14/0039773occurcountryGBseriousnessother1duplicate1Date Received21/04/2014transmissiondate09/04/2020primarysourcecountryGB

Primary Source

reportercountryGBqualification5

Patient

Onset Age23Unit of Onset AgeyearsWeight88.9SexMale

Reaction

1)

reactionmeddraversionpt22.1ReactionSpeech disorderOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt22.1ReactionAstheniaOutcomeRecovered/resolved

3)

reactionmeddraversionpt22.1ReactionAbdominal painOutcomeRecovered/resolved

4)

reactionmeddraversionpt22.1ReactionMedication errorOutcomeRecovering/resolving

5)

reactionmeddraversionpt22.1ReactionDrug interactionOutcomeUnknown

6)

reactionmeddraversionpt22.1ReactionSleep apnoea syndromeOutcomeRecovering/resolving

7)

reactionmeddraversionpt22.1ReactionDepressed level of consciousnessOutcomeRecovered/resolved

8)

reactionmeddraversionpt22.1ReactionDisturbance in attentionOutcomeRecovered/resolved

9)

reactionmeddraversionpt22.1ReactionParaesthesiaOutcomeRecovered/resolved

10)

reactionmeddraversionpt22.1ReactionMemory impairmentOutcomeNot recovered/not resolved

11)

reactionmeddraversionpt22.1ReactionAmnesiaOutcomeRecovered/resolved

12)

reactionmeddraversionpt22.1ReactionQuality of life decreasedOutcomeRecovered/resolved

13)

reactionmeddraversionpt22.1ReactionDyspnoeaOutcomeRecovered/resolved

14)

reactionmeddraversionpt22.1ReactionChest discomfortOutcomeRecovered/resolved

15)

reactionmeddraversionpt22.1ReactionFluid retentionOutcomeRecovered/resolved

16)

reactionmeddraversionpt22.1ReactionPhotosensitivity reactionOutcomeRecovered/resolved

17)

reactionmeddraversionpt22.1ReactionAngioedemaOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductCLONAZEPAM.drugbatchnumbUNKNOWNdrugindicationANXIETYactiondrug5drugrecurreadministration3drugadditional3

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

2)

drugcharacterization1medicinalproductPREGABALIN.drugbatchnumbUNKNOWNdrugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100MG 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

3)

drugcharacterization2medicinalproductSERTRALINEdrugbatchnumbUNKNOWNdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

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, 6dce ... 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

4)

drugcharacterization1medicinalproductPROPRANOLOL HYDROCHLORIDE.drugbatchnumbUNKNOWNdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3drugadditional3

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

5)

drugcharacterization1medicinalproductOLANZAPINE.drugbatchnumbUNKNOWN,UNKNOWNdrugauthorizationnumb076133drugindicationSLEEP 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, 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

summary

narrativeincludeclinicalCASE EVENT DATE: 20131201

Report Duplicate

duplicatesourceDR REDDYSduplicatenumbGB-DRREDDYS-GER/UKI/14/0039773

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use