Adverse Event Report

Report

reporttype1receiptdateformat102Version of Safety Report ID1receivedateformat102seriousnessother1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10932817Date Received19/03/2015seriousnesshospitalization1transmissiondate21/07/2015serious1Date Last Updated19/03/2015seriousnesslifethreatening1primarysourcecountryUSseriousnessdisabling1

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age18Unit of Onset AgeyearsWeight80.29SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionDyspnoea

2)

reactionmeddraversionpt18.0ReactionHeadache

3)

reactionmeddraversionpt18.0ReactionFatigue

4)

reactionmeddraversionpt18.0ReactionChills

5)

reactionmeddraversionpt18.0ReactionArthralgia

6)

reactionmeddraversionpt18.0ReactionUrticaria

7)

reactionmeddraversionpt18.0ReactionAnaphylactic reaction

8)

reactionmeddraversionpt18.0ReactionTinnitus

9)

reactionmeddraversionpt18.0ReactionDizziness

10)

reactionmeddraversionpt18.0ReactionTremor

11)

reactionmeddraversionpt18.0ReactionGait disturbance

Drug

1)

drugcharacterization1medicinalproductCLARAVISdrugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextBY MOUTHdrugindicationACNEdrugstartdateformat102drugstartdate20/01/2015drugenddateformat102drugenddate19/02/2015drugadditional2

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20150219