Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID10744444primarysourcecountryJPoccurcountryJPtransmissiondateformat102transmissiondate21/08/2015reporttype1serious2receivedateformat102Date Received28/01/2015receiptdateformat102Date Last Updated14/04/2015fulfillexpeditecriteria2companynumbJP-EISAI-201407779duplicate1

Report Duplicate

duplicatesourceSUNOVIONduplicatenumbJP-EISAI-201407779

Primary Source

reportercountryJPqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age82Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionRestlessnessOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.0ReactionMental status changes

3)

reactionmeddraversionpt18.0ReactionAbnormal behaviourOutcomeRecovered/resolved

4)

reactionmeddraversionpt18.0ReactionIrritability

5)

reactionmeddraversionpt18.0ReactionSomnambulism

6)

reactionmeddraversionpt18.0ReactionHallucinationOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductMAINTATE

activesubstance

activesubstancenameBISOPROLOL FUMARATE

2)

drugcharacterization2medicinalproductCARDENALIN

activesubstance

activesubstancenameDOXAZOSIN MESYLATE

3)

drugcharacterization2medicinalproductMAGLAX

activesubstance

activesubstancenameMAGNESIUM OXIDE

4)

drugcharacterization1medicinalproductLUNESTAdrugauthorizationnumb021476drugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate06/01/2015drugenddateformat102drugenddate08/01/2015actiondrug1

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)

drugcharacterization2medicinalproductIRBESARTAN.

activesubstance

activesubstancenameIRBESARTAN

openFDA Info on Medication

Application Number ANDA202910, ANDA206194, NDA020757, ANDA079213, ANDA203071, ANDA203081, ANDA20302 ... Brand NameIRBESARTAN, AVAPROGeneric NameIRBESARTANManufacturers Camber Pharmaceuticals, Inc., Hisun Pharmaceuticals USA Inc., Sanofi-Aventis U.S ... product_ndc 31722-729, 31722-730, 31722-731, 42658-121, 42658-122, 42658-123, 0024-5850, 002 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsIRBESARTANRXCUI200094, 200095, 200096, 153665, 153666, 153667spl_id afbb61d8-a033-487e-a556-d6e85337bdba, d05d838a-88eb-7e1b-e053-2995a90a5177, cf3c ... spl_set_id 33416f1e-adee-4a45-b6fe-1fc39044e307, 61ab1b6e-c849-49ca-a3f0-150774db649d, 7885 ... Package NDC 31722-729-30, 31722-729-90, 31722-729-05, 31722-729-31, 31722-730-30, 31722-730- ... NUIN0000000070, N0000175561Mechanism of ActionAngiotensin 2 Receptor Antagonists [MoA]Established Pharmacologic ClassAngiotensin 2 Receptor Blocker [EPC]UNIIJ0E2756Z7N

6)

drugcharacterization2medicinalproductALL OTHER THERAPEUTIC PRODUCTS

activesubstance

activesubstancenameUNSPECIFIED INGREDIENT

7)

drugcharacterization2medicinalproductLASIX

activesubstance

activesubstancenameFUROSEMIDE

openFDA Info on Medication

Application NumberNDA016273Brand NameLASIXGeneric NameFUROSEMIDEManufacturersValidus Pharmaceuticals LLCproduct_ndc30698-060, 30698-067, 30698-066Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFUROSEMIDERXCUI197732, 200801, 200809, 205732, 310429, 313988spl_id95a46760-e587-41a3-9ff3-c8dd8505f694spl_set_id2c9b4d8f-0770-482d-a9e6-9c616a440b1aPackage NDC 30698-067-01, 30698-067-10, 30698-060-01, 30698-060-10, 30698-060-50, 30698-066- ... NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

8)

drugcharacterization2medicinalproductAMLODIPINE

activesubstance

activesubstancenameAMLODIPINE BESYLATE

openFDA Info on Medication

Application NumberNDA214439, NDA211340Brand NameNORLIQVA, KATERZIAGeneric NameAMLODIPINEManufacturersCMP Pharma, Inc., Azurity Pharmaceuticals, Inc.product_ndc46287-035, 52652-5001Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE, AMLODIPINE BENZOATERXCUI2599173, 2599179, 2184120, 2184126spl_id63a6bb49-fb68-4351-be5f-a6b6e8f6b540, df623dda-e184-4011-8fce-4e729b2e6b2dspl_set_idc1730a51-4383-4c61-a9a1-7e1326bd0abe, df673a4d-acb8-444c-a472-c87ab8cbd366Package NDC46287-035-15, 52652-5001-1NUIN0000000069, N0000175421, N0000175566, M0006414, N0000190114Mechanism of ActionCalcium Channel Antagonists [MoA], Cytochrome P450 3A Inhibitors [MoA]Established Pharmacologic ClassDihydropyridine Calcium Channel Blocker [EPC], Calcium Channel Blocker [EPC]Chemical StructureDihydropyridines [CS]UNII1J444QC288, XD75TQ8A2P

9)

drugcharacterization2medicinalproductPANALDINE

activesubstance

activesubstancenameTICLOPIDINE HYDROCHLORIDE

10)

drugcharacterization2medicinalproductRABEPRAZOLE

activesubstance

activesubstancenameRABEPRAZOLE

openFDA Info on Medication

Application NumberANDA204179Brand NameRABEPRAZOLE SODIUMGeneric NameRABEPRAZOLEManufacturersAmneal Pharmaceuticals LLCproduct_ndc65162-724Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRABEPRAZOLE SODIUMRXCUI854868spl_idd9030269-5b52-4b36-8ef9-5a0d2a0fcd1cspl_set_id951caefe-6e18-48ff-9567-beb545b09c25Package NDC65162-724-03, 65162-724-09, 65162-724-50, 65162-724-11UNII3L36P16U4R

11)

drugcharacterization2medicinalproductMOSAPRIDE

activesubstance

activesubstancenameMOSAPRIDE

summary

narrativeincludeclinicalCASE EVENT DATE: 20150106