Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10297406serious1Date Last Updated23/07/2014receiptdateformat102companynumbUS-TEVA-493077USAoccurcountryUSseriousnessother1duplicate1Date Received11/07/2014transmissiondate26/03/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionMajor depressionOutcomeUnknown

2)

reactionmeddraversionpt17.1ReactionConfusional stateOutcomeUnknown

3)

reactionmeddraversionpt17.1ReactionHypoaesthesiaOutcomeUnknown

4)

reactionmeddraversionpt17.1ReactionDyspnoeaOutcomeUnknown

5)

reactionmeddraversionpt17.1ReactionArthralgiaOutcomeUnknown

6)

reactionmeddraversionpt17.1ReactionHyperhidrosisOutcomeUnknown

7)

reactionmeddraversionpt17.1ReactionAbdominal pain upperOutcomeUnknown

8)

reactionmeddraversionpt17.1ReactionParaesthesiaOutcomeUnknown

9)

reactionmeddraversionpt17.1ReactionDizzinessOutcomeUnknown

10)

reactionmeddraversionpt17.1ReactionPainOutcomeUnknown

11)

reactionmeddraversionpt17.1ReactionGait disturbanceOutcomeUnknown

12)

reactionmeddraversionpt17.1ReactionAlopeciaOutcomeUnknown

13)

reactionmeddraversionpt17.1ReactionPanic attackOutcomeUnknown

14)

reactionmeddraversionpt17.1ReactionHeadacheOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductCLARAVISdrugauthorizationnumb076135drugstructuredosagenumb1drugstructuredosageunit032drugdosagetext20 MG AND 40 MGdrugindicationACNEdrugstartdateformat102drugstartdate24/06/2014drugenddateformat102drugenddate03/07/2014actiondrug1

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA076356, ANDA076135Brand NameCLARAVISGeneric NameISOTRETINOINManufacturersTeva Pharmaceuticals USA, Inc.product_ndc0555-1054, 0555-1055, 0555-1056, 0555-1057Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 404059, 404062, 404065, 643488spl_ide462821c-84c4-4009-a26e-da92790126bfspl_set_ida31fd109-d0fd-4ab9-ba98-a3d64333c18dPackage NDC 0555-1054-60, 0555-1054-86, 0555-1054-56, 0555-1055-60, 0555-1055-86, 0555-1055- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

Report Duplicate

duplicatesourceTEVAduplicatenumbUS-TEVA-493077USA

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use