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

Contents

Reaction
- 1)
- 2)
- 3)
- 4)
- 5)
- 6)
- 7)
- 8)
- 9)
- 10)
- 11)
Drug
summary

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

Adverse Event Report