Adverse Event Report

Report

reporttype1receiptdateformat102companynumb2014VER00269Version of Safety Report ID2receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10548632Date Received24/10/2014transmissiondate29/05/2015serious1Date Last Updated28/10/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age14Unit of Onset AgeyearsWeight69.8SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionMood swings

2)

reactionmeddraversionpt18.0ReactionAbdominal discomfort

3)

reactionmeddraversionpt18.0ReactionVomiting

4)

reactionmeddraversionpt18.0ReactionAlopecia

5)

reactionmeddraversionpt18.0ReactionNausea

6)

reactionmeddraversionpt18.0ReactionFatigue

Drug

1)

drugcharacterization1medicinalproductMYORISANdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK, MG, UNKdrugindicationACNEdrugstartdateformat102drugstartdate18/09/2014drugenddateformat102drugenddate06/10/2014drugadditional2

activesubstance

activesubstancenameISOTRETINOIN

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)

drugcharacterization2medicinalproductFLONASE

activesubstance

activesubstancenameFLUTICASONE PROPIONATE

openFDA Info on Medication

Application NumberNDA205434Brand NameFLONASE ALLERGY RELIEFGeneric NameFLUTICASONE PROPIONATEManufacturersGlaxoSmithKline Consumer Healthcare Holdings (US) LLCproduct_ndc0135-0576Product TypeHUMAN OTC DRUGRouteNASALActive IngredientsFLUTICASONE PROPIONATERXCUI1797907, 1797933spl_id746e63f3-5386-4e7b-811d-8cfd3e9120d8spl_set_idb6134ba0-b70a-4eac-9a82-cef64b242c1dPackage NDC 0135-0576-01, 0135-0576-02, 0135-0576-03, 0135-0576-04, 0135-0576-12, 0135-0576- ... UNIIO2GMZ0LF5W

3)

drugcharacterization1medicinalproductMYORISANdrugauthorizationnumb076485drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate15/07/2014drugenddateformat102drugenddate06/10/2014

activesubstance

activesubstancenameISOTRETINOIN

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

4)

drugcharacterization2medicinalproductFLOVENT HFA

activesubstance

activesubstancenameFLUTICASONE PROPIONATE

openFDA Info on Medication

Application NumberNDA021433Brand NameFLOVENT HFAGeneric NameFLUTICASONE PROPIONATEManufacturersGlaxoSmithKline LLCproduct_ndc0173-0718, 0173-0719, 0173-0720Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsFLUTICASONE PROPIONATERXCUI895994, 895996, 895999, 896001, 896004, 896006spl_idb5d5e68f-4588-46a7-9aa7-e26e43f14953spl_set_idb49ed7c1-123e-4b1d-fea6-0c6839fd9d6aPackage NDC0173-0718-20, 0173-0719-20, 0173-0720-20UNIIO2GMZ0LF5W

5)

drugcharacterization2medicinalproductSINGULAIR

activesubstance

activesubstancenameMONTELUKAST SODIUM

openFDA Info on Medication

Application NumberNDA020829, NDA020830, NDA021409Brand NameSINGULAIRGeneric NameMONTELUKAST SODIUMManufacturersMerck Sharp & Dohme Corp.product_ndc0006-9117, 0006-3841, 0006-1711, 0006-9275Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST SODIUMRXCUI153892, 153893, 200224, 242438, 261367, 311759, 351246, 404406spl_id96717981-6ea2-4720-a749-e14f1559511fspl_set_id8c166755-7711-4df9-d689-8836a1a70885Package NDC 0006-3841-30, 0006-3841-14, 0006-1711-31, 0006-1711-54, 0006-9275-31, 0006-9275- ... UNIIU1O3J18SFL

6)

drugcharacterization2medicinalproductALBUTEROL INHALER

activesubstance

activesubstancenameALBUTEROL

summary

narrativeincludeclinicalCASE EVENT DATE: 2014

Report Duplicate

duplicatesourceVERSAPHARMduplicatenumb2014VER00269