Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10449107primarysourcecountryUStransmissiondateformat102transmissiondate26/03/2015reporttype1serious1seriousnessdisabling1receivedateformat102Date 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)

reactionmeddraversionpt17.1ReactionHaemorrhoids

2)

reactionmeddraversionpt17.1ReactionFlatulence

3)

reactionmeddraversionpt17.1ReactionAbdominal distension

4)

reactionmeddraversionpt17.1ReactionDehydration

5)

reactionmeddraversionpt17.1ReactionDiarrhoea

6)

reactionmeddraversionpt17.1ReactionEpigastric discomfort

7)

reactionmeddraversionpt17.1ReactionWeight decreased

8)

reactionmeddraversionpt17.1ReactionDizziness

9)

reactionmeddraversionpt17.1ReactionDysentery

Drug

1)

drugcharacterization1medicinalproductLINZESSdrugbatchnumb18350drugstructuredosagenumb145drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext145 UG, 4 PILLS, 1 DAY 30 MIN BEFORE MEAL, MOUTHdrugadministrationroute048drugindicationABDOMINAL PAIN UPPERdrugstartdateformat102drugstartdate18/08/2014drugenddateformat102drugenddate25/08/2014drugrecurreadministration1drugadditional2

activesubstance

activesubstancenameLINACLOTIDE

openFDA Info on Medication

Application NumberNDA202811Brand NameLINZESSGeneric NameLINACLOTIDEManufacturersAllergan, Inc.product_ndc0456-1201, 0456-1202, 0456-1203Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLINACLOTIDERXCUI1307409, 1307415, 1307419, 1307421, 1869697, 1869699spl_id7d12c89f-0ea6-4a9b-bb75-99774445955dspl_set_id09beda19-56d6-4a56-afdc-9a77b70b2ef3Package NDC 0456-1201-30, 0456-1201-04, 0456-1202-30, 0456-1202-04, 0456-1203-30, 0456-1203- ... NUIN0000185500, N0000185499Established Pharmacologic ClassGuanylate Cyclase-C Agonist [EPC]Mechanism of ActionGuanylate Cyclase Activators [MoA]UNIIN0TXR0XR5X

2)

drugcharacterization2medicinalproductQUERCETIN-BROMELAIN

3)

drugcharacterization1medicinalproductLINZESSdrugbatchnumb18350drugstructuredosagenumb145drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext145 UG, 4 PILLS, 1 DAY 30 MIN BEFORE MEAL, MOUTHdrugadministrationroute048drugindicationWEIGHT DECREASEDdrugstartdateformat102drugstartdate18/08/2014drugenddateformat102drugenddate25/08/2014drugrecurreadministration1drugadditional2

activesubstance

activesubstancenameLINACLOTIDE

openFDA Info on Medication

Application NumberNDA202811Brand NameLINZESSGeneric NameLINACLOTIDEManufacturersAllergan, Inc.product_ndc0456-1201, 0456-1202, 0456-1203Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLINACLOTIDERXCUI1307409, 1307415, 1307419, 1307421, 1869697, 1869699spl_id7d12c89f-0ea6-4a9b-bb75-99774445955dspl_set_id09beda19-56d6-4a56-afdc-9a77b70b2ef3Package NDC 0456-1201-30, 0456-1201-04, 0456-1202-30, 0456-1202-04, 0456-1203-30, 0456-1203- ... NUIN0000185500, N0000185499Established Pharmacologic ClassGuanylate Cyclase-C Agonist [EPC]Mechanism of ActionGuanylate Cyclase Activators [MoA]UNIIN0TXR0XR5X

4)

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

5)

drugcharacterization2medicinalproductZYFLAMEND

6)

drugcharacterization1medicinalproductLINZESSdrugbatchnumb18350drugstructuredosagenumb145drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext145 UG, 4 PILLS, 1 DAY 30 MIN BEFORE MEAL, MOUTHdrugadministrationroute048drugindicationFLATULENCEdrugstartdateformat102drugstartdate18/08/2014drugenddateformat102drugenddate25/08/2014drugrecurreadministration1drugadditional2

activesubstance

activesubstancenameLINACLOTIDE

openFDA Info on Medication

Application NumberNDA202811Brand NameLINZESSGeneric NameLINACLOTIDEManufacturersAllergan, Inc.product_ndc0456-1201, 0456-1202, 0456-1203Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLINACLOTIDERXCUI1307409, 1307415, 1307419, 1307421, 1869697, 1869699spl_id7d12c89f-0ea6-4a9b-bb75-99774445955dspl_set_id09beda19-56d6-4a56-afdc-9a77b70b2ef3Package NDC 0456-1201-30, 0456-1201-04, 0456-1202-30, 0456-1202-04, 0456-1203-30, 0456-1203- ... NUIN0000185500, N0000185499Established Pharmacologic ClassGuanylate Cyclase-C Agonist [EPC]Mechanism of ActionGuanylate Cyclase Activators [MoA]UNIIN0TXR0XR5X

7)

drugcharacterization2medicinalproductPROSTANEX

8)

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

9)

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

10)

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

11)

drugcharacterization2medicinalproductBROMELAIN

activesubstance

activesubstancenameBROMELAINS

12)

drugcharacterization1medicinalproductLINZESSdrugbatchnumb18350drugstructuredosagenumb145drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext145 UG, 4 PILLS, 1 DAY 30 MIN BEFORE MEAL, MOUTHdrugadministrationroute048drugindicationSMALL INTESTINAL OBSTRUCTIONdrugstartdateformat102drugstartdate18/08/2014drugenddateformat102drugenddate25/08/2014drugrecurreadministration1drugadditional2

activesubstance

activesubstancenameLINACLOTIDE

openFDA Info on Medication

Application NumberNDA202811Brand NameLINZESSGeneric NameLINACLOTIDEManufacturersAllergan, Inc.product_ndc0456-1201, 0456-1202, 0456-1203Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLINACLOTIDERXCUI1307409, 1307415, 1307419, 1307421, 1869697, 1869699spl_id7d12c89f-0ea6-4a9b-bb75-99774445955dspl_set_id09beda19-56d6-4a56-afdc-9a77b70b2ef3Package NDC 0456-1201-30, 0456-1201-04, 0456-1202-30, 0456-1202-04, 0456-1203-30, 0456-1203- ... NUIN0000185500, N0000185499Established Pharmacologic ClassGuanylate Cyclase-C Agonist [EPC]Mechanism of ActionGuanylate Cyclase Activators [MoA]UNIIN0TXR0XR5X

13)

drugcharacterization1medicinalproductLINZESSdrugbatchnumb18350drugstructuredosagenumb145drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext145 UG, 4 PILLS, 1 DAY 30 MIN BEFORE MEAL, MOUTHdrugadministrationroute048drugindicationABDOMINAL DISTENSIONdrugstartdateformat102drugstartdate18/08/2014drugenddateformat102drugenddate25/08/2014drugrecurreadministration1drugadditional2

activesubstance

activesubstancenameLINACLOTIDE

openFDA Info on Medication

Application NumberNDA202811Brand NameLINZESSGeneric NameLINACLOTIDEManufacturersAllergan, Inc.product_ndc0456-1201, 0456-1202, 0456-1203Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLINACLOTIDERXCUI1307409, 1307415, 1307419, 1307421, 1869697, 1869699spl_id7d12c89f-0ea6-4a9b-bb75-99774445955dspl_set_id09beda19-56d6-4a56-afdc-9a77b70b2ef3Package NDC 0456-1201-30, 0456-1201-04, 0456-1202-30, 0456-1202-04, 0456-1203-30, 0456-1203- ... NUIN0000185500, N0000185499Established Pharmacologic ClassGuanylate Cyclase-C Agonist [EPC]Mechanism of ActionGuanylate Cyclase Activators [MoA]UNIIN0TXR0XR5X

14)

drugcharacterization2medicinalproductREPAIR VITE

summary

narrativeincludeclinicalCASE EVENT DATE: 20140818