Adverse Event Report

Report

reporttype1receiptdateformat102companynumb2014P1004136Version of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10203695Date Received23/05/2014transmissiondate12/12/2014serious2Date Last Updated23/05/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age21Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionDry skin

2)

reactionmeddraversionpt17.0ReactionAlopecia

3)

reactionmeddraversionpt17.0ReactionMood swings

4)

reactionmeddraversionpt17.0ReactionEmotional disorder

5)

reactionmeddraversionpt17.0ReactionAnxiety

6)

reactionmeddraversionpt17.0ReactionParanoia

7)

reactionmeddraversionpt17.0ReactionBack pain

8)

reactionmeddraversionpt17.0ReactionSomnolence

9)

reactionmeddraversionpt17.0ReactionDepression

10)

reactionmeddraversionpt17.0ReactionDisturbance in attention

Drug

1)

drugcharacterization1medicinalproductMYORISANdrugstructuredosagenumb20drugstructuredosageunit003drugindicationACNEdrugstartdateformat102drugstartdate22/01/2014drugenddateformat102drugenddate06/05/2014

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)

drugcharacterization1medicinalproductADDERALLdrugstructuredosagenumb7.5drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugenddateformat102drugenddate01/05/2014

openFDA Info on Medication

Application NumberANDA040422, NDA021303Brand NameADDERALL, ADDERALL XRGeneric Name DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, ... ManufacturersTeva Pharmaceuticals USA, Inc., Takeda Pharmaceuticals America, Inc.product_ndc 57844-105, 57844-117, 57844-110, 57844-112, 57844-115, 57844-120, 57844-130, 540 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive Ingredients DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMI ... RXCUI 541363, 541365, 541878, 541879, 541892, 541894, 577957, 577960, 577961, 577962, ... spl_ide9cd0754-917c-4545-8963-e0b5b8fe544a, 05c01190-093d-41b3-8fe6-4ad8d6e2aee3spl_set_idf22635fe-821d-4cde-aa12-419f8b53db81, aff45863-ffe1-4d4f-8acf-c7081512a6c0Package NDC 57844-105-01, 57844-117-01, 57844-110-01, 57844-112-01, 57844-115-01, 57844-120- ... UNII6DPV8NK46S, G83415V073, O1ZPV620O4, JJ768O327N

Report Duplicate

duplicatesourceVERSAPHARMduplicatenumb2014P1004136