Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10449098primarysourcecountryUStransmissiondateformat102transmissiondate26/03/2015reporttype1serious1seriousnessdisabling1receivedateformat102Date Received11/09/2014receiptdateformat102Date Last Updated11/09/2014fulfillexpeditecriteria2

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age71Unit of Onset AgeyearsWeight87.09SexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionCondition aggravated

2)

reactionmeddraversionpt17.1ReactionDizziness

3)

reactionmeddraversionpt17.1ReactionAbdominal distension

4)

reactionmeddraversionpt17.1ReactionFlatulence

5)

reactionmeddraversionpt17.1ReactionAbdominal pain upper

6)

reactionmeddraversionpt17.1ReactionDiscomfort

7)

reactionmeddraversionpt17.1ReactionInsomnia

8)

reactionmeddraversionpt17.1ReactionPain

9)

reactionmeddraversionpt17.1ReactionBalance disorder

10)

reactionmeddraversionpt17.1ReactionMental impairment

11)

reactionmeddraversionpt17.1ReactionFeeling abnormal

Drug

1)

drugcharacterization2medicinalproductREPAIR-VITE

2)

drugcharacterization2medicinalproductPROSTANOL

3)

drugcharacterization2medicinalproductLUNESTA

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

4)

drugcharacterization2medicinalproductQUERCETIN-BROMELAIN

5)

drugcharacterization1medicinalproductAMITIZAdrugstructuredosagenumb8drugstructuredosageunit004drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationSMALL INTESTINAL OBSTRUCTIONdrugstartdateformat102drugstartdate22/08/2014drugenddateformat102drugenddate23/08/2014drugadditional2

activesubstance

activesubstancenameLUBIPROSTONE

openFDA Info on Medication

Application NumberNDA021908Brand NameAMITIZAGeneric NameLUBIPROSTONEManufacturersTakeda Pharmaceuticals America, Inc.product_ndc64764-080, 64764-240Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLUBIPROSTONERXCUI616578, 617768, 794639, 794641spl_id66132fab-c36d-4f07-9593-4352fa5380bfspl_set_idd474ac6a-444d-4aa6-9986-24be6fcf811dPackage NDC64764-080-60, 64764-080-40, 64764-240-60, 64764-240-10, 64764-240-40NUIN0000175573, N0000175456Established Pharmacologic ClassChloride Channel Activator [EPC]Mechanism of ActionChloride Channel Activators [MoA]UNII7662KG2R6K

6)

drugcharacterization2medicinalproductCIALIS

activesubstance

activesubstancenameTADALAFIL

openFDA Info on Medication

Application NumberNDA021368Brand NameCIALISGeneric NameTADALAFILManufacturersEli Lilly and Companyproduct_ndc0002-4462, 0002-4465, 0002-4463, 0002-4464Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTADALAFILRXCUI402019, 402096, 402097, 403957, 404711, 484814, 757707, 762660spl_id05dbd8b6-1b9d-436a-a67c-8a16713f753fspl_set_idbcd8f8ab-81a2-4891-83db-24a0b0e25895Package NDC 0002-4465-79, 0002-4465-34, 0002-4462-30, 0002-4462-79, 0002-4462-34, 0002-4463- ... NUIN0000175599, N0000020026Established Pharmacologic ClassPhosphodiesterase 5 Inhibitor [EPC]Mechanism of ActionPhosphodiesterase 5 Inhibitors [MoA]UNII742SXX0ICT

7)

drugcharacterization2medicinalproductVITAMIN D3

activesubstance

activesubstancenameCHOLECALCIFEROL

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturers Strides Pharma Science Limited, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmac ... product_ndc64380-737, 23155-809Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725, 9c09c2d2-ef29-4654-be7d-ed3b2b508f43spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36, 96da2c1e-6c5e-4df0-8166-3de53c08a701Package NDC64380-737-06, 64380-737-25, 23155-809-01NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

8)

drugcharacterization2medicinalproductASPIRIN.

activesubstance

activesubstancenameASPIRIN

openFDA Info on Medication

Application Numberpart343, NDA203697Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN TABLET 325MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 36800-545, 0363-0587, 70000-0218, 63 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 260847, 198471, 825180 ... spl_id 70f66f99-a450-4ab6-a3b9-c5d9207e0a79, da59962f-0c77-5c08-e053-2a95a90aaee7, 1b00 ... spl_set_id 2826d84d-b135-4e20-aeea-271e9f74f431, 356e4ff4-a7f1-4a50-9b86-2555e232b300, 4c30 ... Package NDC 49035-914-32, 47682-456-50, 47682-456-47, 42961-044-01, 42961-044-02, 42961-044- ... NUIN0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]UNIIR16CO5Y76E, H0G9379FGK

summary

narrativeincludeclinicalCASE EVENT DATE: 20140822