Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11572711primarysourcecountryDKoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious1seriousnessother1receivedateformat102Date Received29/09/2015receiptdateformat102Date Last Updated29/09/2015fulfillexpeditecriteria1companynumbUS-FRI-1000079852duplicate1

Report Duplicate

duplicatesourceFORESTduplicatenumbUS-FRI-1000079852

Primary Source

reportercountryDKqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age68Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionLogorrhoeaOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.1ReactionInsomniaOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.1ReactionDry eyeOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.1ReactionDrug interactionOutcomeRecovered/resolved

5)

reactionmeddraversionpt18.1ReactionAgitationOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt18.1ReactionCorneal abrasionOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt18.1ReactionSerotonin syndromeOutcomeUnknown

8)

reactionmeddraversionpt18.1ReactionArthralgiaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductBRINTELLIXdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MG, QDdrugdosageformTABLETdrugadministrationroute048drugindicationANXIETYdrugstartdateformat102drugstartdate05/09/2015drugenddateformat102drugenddate13/09/2015actiondrug1

activesubstance

activesubstancenameVORTIOXETINE HYDROBROMIDE

2)

drugcharacterization1medicinalproductTRAZODONEdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate05/09/2015actiondrug5

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

openFDA Info on Medication

3)

drugcharacterization1medicinalproductCITALOPRAMdrugauthorizationnumb020822drugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugenddateformat102drugenddate05/09/2015actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameCITALOPRAM HYDROBROMIDE

openFDA Info on Medication

Application Number ANDA077048, ANDA077043, NDA215428, ANDA077534, ANDA077042, ANDA077031, ANDA07728 ... Brand NameCITALOPRAM, CITALOPRAM HYDROBROMIDE, CELEXAGeneric NameCITALOPRAM TABLETS, CITALOPRAM TABLET, CITALOPRAM, CITALOPRAM HYDROBROMIDEManufacturers Cosette Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Almatica Pharma L ... product_ndc 0713-4740, 0713-4741, 0713-4742, 0054-0062, 52427-691, 69097-822, 69097-823, 690 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsCITALOPRAM HYDROBROMIDE, CITALOPRAMRXCUI200371, 283672, 309314, 309313, 2591786, 213344, 213345, 284591spl_id 8eadc3e4-81a3-4b3b-aa1c-1dc65151f94c, 3b571c67-5234-44ad-8276-e29b1ceabec3, bde4 ... spl_set_id cf7b6823-108b-ebff-8f41-91f8b8325e3a, 29408d84-7b00-4cee-969c-8095f8083ff5, 2f81 ... Package NDC 0713-4740-01, 0713-4740-05, 0713-4741-01, 0713-4741-05, 0713-4742-01, 0713-4742- ... UNIII1E9D14F36, 0DHU5B8D6VNUIN0000175696, N0000000109Established Pharmacologic ClassSerotonin Reuptake Inhibitor [EPC]Mechanism of ActionSerotonin Uptake Inhibitors [MoA]

4)

drugcharacterization1medicinalproductBRINTELLIXdrugdosageformTABLETactiondrug1

activesubstance

activesubstancenameVORTIOXETINE HYDROBROMIDE

5)

drugcharacterization1medicinalproductCITALOPRAMdrugauthorizationnumb020822drugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 UNK,drugadministrationroute065drugstartdateformat102drugstartdate05/09/2015actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameCITALOPRAM HYDROBROMIDE

openFDA Info on Medication

Application Number ANDA077048, ANDA077043, NDA215428, ANDA077534, ANDA077042, ANDA077031, ANDA07728 ... Brand NameCITALOPRAM, CITALOPRAM HYDROBROMIDE, CELEXAGeneric NameCITALOPRAM TABLETS, CITALOPRAM TABLET, CITALOPRAM, CITALOPRAM HYDROBROMIDEManufacturers Cosette Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Almatica Pharma L ... product_ndc 0713-4740, 0713-4741, 0713-4742, 0054-0062, 52427-691, 69097-822, 69097-823, 690 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsCITALOPRAM HYDROBROMIDE, CITALOPRAMRXCUI200371, 283672, 309314, 309313, 2591786, 213344, 213345, 284591spl_id 8eadc3e4-81a3-4b3b-aa1c-1dc65151f94c, 3b571c67-5234-44ad-8276-e29b1ceabec3, bde4 ... spl_set_id cf7b6823-108b-ebff-8f41-91f8b8325e3a, 29408d84-7b00-4cee-969c-8095f8083ff5, 2f81 ... Package NDC 0713-4740-01, 0713-4740-05, 0713-4741-01, 0713-4741-05, 0713-4742-01, 0713-4742- ... UNIII1E9D14F36, 0DHU5B8D6VNUIN0000175696, N0000000109Established Pharmacologic ClassSerotonin Reuptake Inhibitor [EPC]Mechanism of ActionSerotonin Uptake Inhibitors [MoA]

6)

drugcharacterization2medicinalproductCLONAZEPAM.drugstructuredosagenumb1drugstructuredosageunit003drugdosagetext1 MG, UNKdrugadministrationroute065drugindicationANXIETYactiondrug5

activesubstance

activesubstancenameCLONAZEPAM

openFDA Info on Medication

Application Number ANDA077194, ANDA077171, ANDA074569, ANDA077147, ANDA211033, ANDA077856, NDA01753 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Teva Pharmaceuticals USA, Inc., Par Pharmaceutical, Inc., Accord Healthcare Inc. ... product_ndc 0093-9290, 0093-9291, 0093-9292, 0093-9293, 0093-9294, 49884-306, 49884-307, 498 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI 349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529, 206157, 206159, ... spl_id 0a290597-0942-4e2e-bcf7-7486bf8b933e, a95f8799-0bb3-41d6-aa27-8a291127ad54, e7a6 ... spl_set_id cb2e209e-e69b-422b-8abb-34df2bc92caa, 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069 ... Package NDC 0093-9290-67, 0093-9291-67, 0093-9292-67, 0093-9293-67, 0093-9294-67, 49884-306- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

7)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugdosagetext3 MG, UNKdrugadministrationroute065drugindicationINSOMNIAactiondrug5

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

summary

narrativeincludeclinicalCASE EVENT DATE: 201509