Adverse Event Report

Report

reporttype2Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10865591serious1Date Last Updated24/02/2015receiptdateformat102companynumbUS-MYLANLABS-2014S1013990occurcountryUSseriousnessother1duplicate1Date Received24/02/2015seriousnesshospitalization1transmissiondate21/07/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age31Unit of Onset AgeyearsWeight97.52SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionColitis ulcerativeOutcomeRecovering/resolving

Drug

1)

drugcharacterization2medicinalproductPROTONIXdrugdosagetextUNK

activesubstance

activesubstancenamePANTOPRAZOLE SODIUM

openFDA Info on Medication

Application NumberNDA020988, NDA020987, NDA022020Brand NamePROTONIX I.V., PROTONIX DELAYED-RELEASEGeneric NamePANTOPRAZOLE SODIUMManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0008-0923, 0008-2001, 0008-4001, 0008-0841, 0008-0843, 0008-0844Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsPANTOPRAZOLE SODIUMRXCUI283669, 885257, 251872, 284400, 314200, 352125, 763306, 763308spl_id b326d5db-8b20-4ec4-ac25-78190fb3ac36, 1e8fa399-506d-4bcd-9097-dbf7850147bf, 7bdf ... spl_set_id 51e4144a-489e-436c-609a-39305f8f56ba, 5b5ddedd-d429-41a7-8573-10c3e9ad4e52, f39b ... Package NDC 0008-0923-51, 0008-0923-60, 0008-0923-55, 0008-2001-01, 0008-2001-25, 0008-2001- ... UNII6871619Q5X

2)

drugcharacterization1medicinalproductAMNESTEEMdrugauthorizationnumb075945drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG,QDdrugdosageformCAPSULEdrugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate02/05/2014drugenddateformat102drugenddate19/05/2014actiondrug1

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA075945Brand NameAMNESTEEMGeneric NameISOTRETINOINManufacturersMylan Pharmaceuticals Inc.product_ndc0378-6611, 0378-6612, 0378-6614Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 404058, 404061, 404064spl_id47bb51b9-0613-4708-905f-e950dbfa5127spl_set_idb2cb63c9-f825-4991-9a2c-6260f1bbcc2cPackage NDC 0378-6611-85, 0378-6611-93, 0378-6612-85, 0378-6612-93, 0378-6614-85, 0378-6614- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

3)

drugcharacterization2medicinalproductMOBICdrugdosagetextUNK

activesubstance

activesubstancenameMELOXICAM

openFDA Info on Medication

Application NumberNDA020938Brand NameMOBICGeneric NameMELOXICAMManufacturersBoehringer Ingelheim Pharmaceuticals, Inc.product_ndc0597-0029, 0597-0030Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMELOXICAMRXCUI152695, 152697, 152698, 311486spl_iddb60b4e8-6f69-436d-9fd4-ff6e0a931fdcspl_set_id676e73fb-51d2-449a-8749-1a7bcc257b11Package NDC0597-0029-01, 0597-0029-94, 0597-0030-01, 0597-0030-56NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIVG2QF83CGL

summary

narrativeincludeclinicalCASE EVENT DATE: 20140519

Report Duplicate

duplicatesourceMYLANduplicatenumbUS-MYLANLABS-2014S1013990

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use