Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID11698799primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate04/03/2016reporttype1serious1seriousnessother1receivedateformat102Date Received04/11/2015receiptdateformat102Date Last Updated12/11/2015fulfillexpeditecriteria1companynumbUS-SUNOVION-2015SUN000779duplicate1

Report Duplicate

duplicatesourceSUNOVIONduplicatenumbUS-SUNOVION-2015SUN000779

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age55Unit of Onset AgeyearsWeight54.42SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionLoss of employment

2)

reactionmeddraversionpt18.1ReactionNauseaOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.1ReactionMalaiseOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.1ReactionDizzinessOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt18.1ReactionLoss of consciousnessOutcomeRecovered/resolved

6)

reactionmeddraversionpt18.1ReactionSomnambulismOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductZOLOFTdrugdosagetextUNKdrugindicationBIPOLAR I DISORDER

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_idca266f27-bd08-49ba-8d79-a6dba8699bd9spl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

2)

drugcharacterization2medicinalproductZOLOFTdrugdosagetextUNKdrugstartdateformat610drugstartdate/10/2015

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_idca266f27-bd08-49ba-8d79-a6dba8699bd9spl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

3)

drugcharacterization2medicinalproductALLERGYdrugdosagetextUNK

activesubstance

activesubstancenameUNSPECIFIED INGREDIENT

openFDA Info on Medication

Application Numberpart341, ANDA077421, ANDA076471, ANDA078933Brand Name ALLERGY, ALLERGY CHILDRENS, ALLERGY CHILDRENS ALLERGY, ALLERGY SOFTGEL, ALLERGY ... Generic Name DIPHENHYDRAMINE HCL, DIPHENHYDRAMINE HYDROCHLORIDE, LORATADINE, CHLORPHENIRAMINE ... Manufacturers Kroger Company, Meijer Distribution Inc, GREENBRIER INTERNATIONAL, INC., MEIJER, ... product_ndc 30142-290, 41250-379, 41250-462, 33992-0329, 41250-539, 63654-309, 55910-891, 69 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, SUBLINGUALActive Ingredients DIPHENHYDRAMINE HYDROCHLORIDE, LORATADINE, CHLORPHENIRAMINE MALEATE, ANACARDIUM ... RXCUI1049909, 1049906, 1049630, 692783, 311372, 1363309, 1014678, 1046781spl_id ce5998e0-1bc4-4531-b4f8-5a7cb6a4285e, d9ac2b0a-1934-4312-80b4-cd33bd37bb21, 6a80 ... spl_set_id 5c4ce0c7-d9ac-43ba-91e2-2c4915995d42, 622b12fa-455c-4432-a9a2-698a929bbd68, 4124 ... Package NDC 30142-290-22, 30142-290-12, 41250-379-26, 41250-379-34, 41250-462-62, 41250-462- ... UNII TC2D6JAD40, 7AJO3BO7QN, V1Q0O9OJ9Z, 4A10JR4E7E, I76KB35JEV, 7S82P3R43Z, 7556HJ75 ... NUI N0000185021, N0000175629, N0000184306, N0000185001, M0000728, M0002274, N0000185 ... Established Pharmacologic Class Standardized Insect Venom Allergenic Extract [EPC], Non-Standardized Food Allerg ... Physiologic/Pharmacodynamic Effect Increased Histamine Release [PE], Cell-mediated Immunity [PE], Increased IgG Pro ... Chemical Structure Allergens [CS], Bee Venoms [CS], Dietary Proteins [CS], Plant Proteins [CS], See ...

4)

drugcharacterization1medicinalproductLUNESTAdrugbatchnumbUNKNOWNdrugauthorizationnumb021476drugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext3 MG, HSdrugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat610drugstartdate/02/2015actiondrug4

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

5)

drugcharacterization1medicinalproductLUNESTAdrugbatchnumbUNKNOWNdrugauthorizationnumb021476drugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext3 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat610drugstartdate/10/2015actiondrug4

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: 201508