Adverse Event Report

Report

reporttype1receiptdateformat102Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID11009358Date Received09/04/2015transmissiondate21/08/2015serious1Date Last Updated09/04/2015primarysourcecountryUSseriousnessdisabling1

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age44Unit of Onset AgeyearsWeight56.7SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionArthralgia

2)

reactionmeddraversionpt18.0ReactionAlopecia

3)

reactionmeddraversionpt18.0ReactionColitis ulcerative

4)

reactionmeddraversionpt18.0ReactionRectal haemorrhage

5)

reactionmeddraversionpt18.0ReactionMyalgia

Drug

1)

drugcharacterization2medicinalproductPERCOCET

activesubstance

activesubstancenameACETAMINOPHEN\OXYCODONE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA040330Brand NamePERCOCETGeneric NameOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENManufacturersEndo Pharmaceuticals Inc.product_ndc63481-623, 63481-627, 63481-628, 63481-629Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDE, ACETAMINOPHENRXCUI1049214, 1049221, 1049225, 1049625, 1049635, 1049637, 1049640, 1049642spl_id8a04ce2f-d576-469f-91bc-5ed75e27e47espl_set_id4dd36cf5-8f73-404a-8b1d-3bd53bd90c25Package NDC63481-627-70, 63481-623-70, 63481-623-85, 63481-628-70, 63481-629-70UNIIC1ENJ2TE6C, 362O9ITL9D

2)

drugcharacterization2medicinalproductSUMATROPIN

3)

drugcharacterization2medicinalproductCANASA

activesubstance

activesubstancenameMESALAMINE

openFDA Info on Medication

Application NumberNDA021252Brand NameCANASAGeneric NameMESALAMINEManufacturersAllergan, Inc.product_ndc58914-501Product TypeHUMAN PRESCRIPTION DRUGRouteRECTALActive IngredientsMESALAMINERXCUI248420, 583257spl_ida7db5020-05fe-4018-9685-02bfa2f95c8espl_set_id89d91601-152b-4398-bebe-af1c023e9935Package NDC58914-501-33, 58914-501-42, 58914-501-56NUIN0000175781, M0000971Established Pharmacologic ClassAminosalicylate [EPC]Chemical StructureAminosalicylic Acids [CS]UNII4Q81I59GXC

4)

drugcharacterization2medicinalproductSPIRONOLACTONE.

activesubstance

activesubstancenameSPIRONOLACTONE

openFDA Info on Medication

Application Number ANDA091426, ANDA040750, ANDA203512, ANDA203253, NDA012151, ANDA089424, ANDA20593 ... Brand NameSPIRONOLACTONE, ALDACTONEGeneric NameSPIRONOLACTONEManufacturers Amneal Pharmaceuticals LLC, Oxford Pharmaceuticals, LLC, Accord Healthcare, Inc. ... product_ndc 65162-511, 65162-514, 65162-515, 69584-852, 69584-853, 69584-854, 16729-225, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSPIRONOLACTONERXCUI198222, 198223, 313096, 200817, 200820, 200825spl_id 5c663162-67fb-4890-977c-70db2561d387, db73b6cc-b152-4ec1-8566-f4ead6f9ae6d, 9590 ... spl_set_id fb66327e-8261-46ae-b39a-4fa79d520844, 852684dc-e1c6-4caa-bccb-10ac90bbb3bb, 8a96 ... Package NDC 65162-511-03, 65162-511-06, 65162-511-09, 65162-511-10, 65162-511-11, 65162-511- ... NUIN0000175557, N0000011310Established Pharmacologic ClassAldosterone Antagonist [EPC]Mechanism of ActionAldosterone Antagonists [MoA]UNII27O7W4T232

5)

drugcharacterization2medicinalproductZOLPIDEM

activesubstance

activesubstancenameZOLPIDEM\ZOLPIDEM TARTRATE

openFDA Info on Medication

Application NumberANDA077214Brand NameZOLPIDEMGeneric NameZOLPIDEM TARTRATEManufacturersACI Healthcare USA, Incproduct_ndc71093-155, 71093-156Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854873, 854876spl_idad76e67e-f0d0-4f39-b3d8-68d43560b07fspl_set_id021153ce-fe27-4ed1-8d88-b4157b0ed734Package NDC71093-155-06, 71093-155-04, 71093-156-04, 71093-156-06UNIIWY6W63843K

6)

drugcharacterization2medicinalproductLIALDA

activesubstance

activesubstancenameMESALAMINE

openFDA Info on Medication

Application NumberNDA022000Brand NameLIALDAGeneric NameMESALAMINEManufacturersTakeda Pharmaceuticals America, Inc.product_ndc54092-476Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMESALAMINERXCUI686429, 686433spl_idfae5a172-e372-429b-a06f-65b9906ae707spl_set_id3098a080-be86-4265-9818-7fc4beab77b7Package NDC54092-476-08, 54092-476-01, 54092-476-12, 54092-476-02NUIN0000175781, M0000971Established Pharmacologic ClassAminosalicylate [EPC]Chemical StructureAminosalicylic Acids [CS]UNII4Q81I59GXC

7)

drugcharacterization1medicinalproductABSORICAdrugbatchnumb14D21AAdrugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextTAKEN BY MOUTH, 1 PILLdrugdosageformPILLULESdrugindicationACNE CYSTICdrugtreatmentduration5drugtreatmentdurationunit802drugadditional2

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberNDA021951Brand NameABSORICAGeneric NameISOTRETINOINManufacturersSun Pharmaceutical Industries, Inc.product_ndc 10631-115, 10631-116, 10631-117, 10631-118, 10631-133, 10631-134, 10631-002, 106 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI 197843, 197844, 197845, 403930, 1299203, 1300006, 1300014, 1300016, 1547561, 154 ... spl_ida8d4793a-5043-40e1-b623-35812733499fspl_set_id3ef0cff8-19c1-4441-b780-fca6c7ee1615Package NDC 10631-115-69, 10631-115-31, 10631-116-69, 10631-116-31, 10631-117-69, 10631-117- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

8)

drugcharacterization2medicinalproductPREDN ISONE

summary

narrativeincludeclinicalCASE EVENT DATE: 20150408