Adverse Event Report

Report

reporttype1Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10144417serious1Date Last Updated18/02/2020seriousnesslifethreatening1receiptdateformat102authoritynumbGB-MHRA-ADR 22496422companynumbGB-MYLANLABS-2014S1009250occurcountryGBseriousnessother1duplicate1Date Received30/04/2014transmissiondate09/04/2020primarysourcecountryGB

Primary Source

reportercountryGBqualification3

Patient

Onset Age23Unit of Onset AgeyearsWeight88.9SexMale

Reaction

1)

reactionmeddraversionpt22.1ReactionChest discomfortOutcomeRecovering/resolving

2)

reactionmeddraversionpt22.1ReactionPhotosensitivity reactionOutcomeRecovering/resolving

3)

reactionmeddraversionpt22.1ReactionDrug interactionOutcomeUnknown

4)

reactionmeddraversionpt22.1ReactionAstheniaOutcomeRecovering/resolving

5)

reactionmeddraversionpt22.1ReactionMedication errorOutcomeRecovering/resolving

6)

reactionmeddraversionpt22.1ReactionSpeech disorderOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt22.1ReactionMemory impairmentOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt22.1ReactionAngioedemaOutcomeRecovered/resolved

9)

reactionmeddraversionpt22.1ReactionFluid retentionOutcomeRecovering/resolving

10)

reactionmeddraversionpt22.1ReactionAmnesiaOutcomeRecovering/resolving

11)

reactionmeddraversionpt22.1ReactionSleep apnoea syndromeOutcomeRecovering/resolving

12)

reactionmeddraversionpt22.1ReactionDisturbance in attentionOutcomeRecovering/resolving

13)

reactionmeddraversionpt22.1ReactionParaesthesiaOutcomeRecovering/resolving

14)

reactionmeddraversionpt22.1ReactionAbdominal painOutcomeRecovering/resolving

15)

reactionmeddraversionpt22.1ReactionDyspnoeaOutcomeRecovering/resolving

16)

reactionmeddraversionpt22.1ReactionDepressed level of consciousnessOutcomeRecovering/resolving

Drug

1)

drugcharacterization3medicinalproductPREGABALIN.drugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100MG IN MORNING 200MG IN EVENINGdrugadministrationroute048drugindicationANXIETY DISORDERdrugstartdateformat102drugstartdate01/12/2013actiondrug6

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)

drugcharacterization3medicinalproductPROPRANOLOL HYDROCHLORIDE.drugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6

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)

drugcharacterization1medicinalproductOLANZAPINE.drugauthorizationnumb202285drugdosagetextUNKdrugindicationSLEEP 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.drugdosagetextPRN, AS NECESSARY, RARELY USED.drugindicationANXIETYactiondrug6

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)

drugcharacterization2medicinalproductSERTRALINEdrugdosagetextUNKactiondrug5drugrecurreadministration3drugadditional3

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20131201

Report Duplicate

duplicatesourceMYLANduplicatenumbGB-MYLANLABS-2014S1009250

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use