Adverse Event Report

Report

reporttype1receiptdateformat102companynumb2014VER00271Version of Safety Report ID2receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10548192Date Received24/10/2014transmissiondate20/07/2015serious1Date Last Updated27/02/2015primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age19Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionPregnancy test positive

2)

reactionmeddraversionpt18.0ReactionInappropriate schedule of drug administration

3)

reactionmeddraversionpt18.0ReactionMaternal exposure before pregnancy

4)

reactionmeddraversionpt18.0ReactionAbortion induced

Drug

1)

drugcharacterization1medicinalproductMIDOL

activesubstance

activesubstancenameIBUPROFEN

openFDA Info on Medication

2)

drugcharacterization1medicinalproductMYORISANdrugauthorizationnumb076485drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugstartdateformat102drugstartdate09/09/2014drugenddateformat102drugenddate10/10/2014drugadditional2

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

3)

drugcharacterization2medicinalproductUNSPECIFIED BIRTH CONTROL PILLS

activesubstance

activesubstancenameUNSPECIFIED INGREDIENT

4)

drugcharacterization2medicinalproductEFFEXOR

activesubstance

activesubstancenameVENLAFAXINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020699Brand NameEFFEXOR XRGeneric NameVENLAFAXINE HYDROCHLORIDEManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0008-0833, 0008-0837, 0008-0836Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVENLAFAXINE HYDROCHLORIDERXCUI313581, 313583, 313585, 729929, 729931, 729932spl_id0a5ea9cc-56af-4474-a69e-443eed935fc8spl_set_id53c3e7ac-1852-4d70-d2b6-4fca819acf26Package NDC 0008-0837-20, 0008-0837-21, 0008-0837-22, 0008-0837-02, 0008-0837-03, 0008-0833- ... UNII7D7RX5A8MO

summary

narrativeincludeclinicalCASE EVENT DATE: 2014

Report Duplicate

duplicatesourceAKORNduplicatenumb2014VER00271