Adverse Event Report

Report

reporttype2receiptdateformat102companynumbUS-MYLANLABS-2014M1007825occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10865298Date Received24/02/2015transmissiondate21/07/2015serious2Date Last Updated24/02/2015primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Weight57.14SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionAnxietyOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.0ReactionPanic attackOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.0ReactionInsomniaOutcomeRecovered/resolved

4)

reactionmeddraversionpt18.0ReactionWeight decreasedOutcomeRecovered/resolved

5)

reactionmeddraversionpt18.0ReactionEpistaxisOutcomeRecovered/resolved

6)

reactionmeddraversionpt18.0ReactionMood alteredOutcomeRecovered/resolved

7)

reactionmeddraversionpt18.0ReactionDepressed moodOutcomeRecovered/resolved

8)

reactionmeddraversionpt18.0ReactionSocial avoidant behaviourOutcomeRecovered/resolved

9)

reactionmeddraversionpt18.0ReactionCryingOutcomeRecovered/resolved

10)

reactionmeddraversionpt18.0ReactionDecreased appetiteOutcomeRecovered/resolved

11)

reactionmeddraversionpt18.0ReactionDecreased interestOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductAMNESTEEMdrugauthorizationnumb075945drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, QDdrugdosageformCAPSULEdrugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate09/09/2014drugenddateformat102drugenddate18/09/2014actiondrug1

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

summary

narrativeincludeclinicalCASE EVENT DATE: 2014

Report Duplicate

duplicatesourceMYLANduplicatenumbUS-MYLANLABS-2014M1007825