Adverse Event Report

Report

reporttype1receiptdateformat102companynumb2014P1004667Version of Safety Report ID1receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10261250Date Received23/06/2014transmissiondate12/12/2014serious1Date Last Updated23/06/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age23Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionDiarrhoea

2)

reactionmeddraversionpt17.0ReactionAbdominal pain upper

3)

reactionmeddraversionpt17.0ReactionHaematochezia

Drug

1)

drugcharacterization1medicinalproductMYORISANdrugauthorizationnumb076485drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1X/DAYdrugindicationACNE CYSTICdrugstartdateformat102drugstartdate05/05/2014drugenddateformat102drugenddate12/05/2014drugadditional1

openFDA Info on Medication

Application NumberANDA076485Brand NameMYORISANGeneric NameISOTRETINOINManufacturersVersapharm Incorporatedproduct_ndc61748-301, 61748-302, 61748-303, 61748-304Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 1242611, 1242613, 1242615, 1663728spl_id703dd363-236a-4a17-85e9-feb1b3ae540bspl_set_id51ff6346-9256-4c01-9f52-417d13f2df05Package NDC 61748-301-13, 61748-301-11, 61748-301-01, 61748-302-13, 61748-302-11, 61748-302- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

2)

drugcharacterization2medicinalproductKETOCONAZOLE SHAMPOO

3)

drugcharacterization2medicinalproductTRIAMCINOLONE 0.1% LOTION

4)

drugcharacterization2medicinalproductCLARITIN

openFDA Info on Medication

Application NumberNDA020704, NDA019658, NDA021952, NDA021891, NDA021993Brand NameCLARITIN REDITABS, CLARITIN, CLARITIN LIQUI-GELSGeneric NameLORATADINEManufacturersBayer Healthcare LLC., Bayer HealthCare LLC., Bayer HealthCare LLCproduct_ndc 11523-4329, 11523-7157, 11523-0007, 11523-6655, 11523-1527, 11523-7237, 11523-71 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLORATADINERXCUI311373, 744830, 206805, 311372, 828269, 836338, 665078, 668469, 672558, 904026spl_id 9999c20a-a166-64be-e053-2995a90ad2ce, bb8f183a-a014-b076-e053-2995a90a1d1e, 55ed ... spl_set_id b681ea25-d00b-4c8a-8054-cc6f983ce337, acf2d393-53d7-062f-e053-2995a90a0d60, ac32 ... Package NDC 11523-7157-2, 11523-7157-3, 11523-7157-4, 11523-7157-7, 11523-7157-8, 11523-7157 ... UNII7AJO3BO7QN

5)

drugcharacterization2medicinalproductUNSPECIFIED IUD

Report Duplicate

duplicatesourceVERSAPHARMduplicatenumb2014P1004667