Adverse Event Report

Report

reporttype1receiptdateformat102Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10729826Date Received21/01/2015transmissiondate21/07/2015serious2Date Last Updated21/01/2015primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age26Unit of Onset AgeyearsWeight68.04SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionSensory disturbance

2)

reactionmeddraversionpt18.0ReactionMale orgasmic disorder

3)

reactionmeddraversionpt18.0ReactionErectile dysfunction

4)

reactionmeddraversionpt18.0ReactionTinnitus

Drug

1)

drugcharacterization1medicinalproductAMNESTEEMdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextTAKEN BY MOUTHdrugindicationACNEdrugstartdateformat102drugstartdate11/01/2015drugenddateformat102drugenddate16/01/2015drugadditional2

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20150120