Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID11061805serious1Date Last Updated26/06/2015receiptdateformat102companynumbUS-SUN PHARMACEUTICAL INDUSTRIES LTD-2015US-95722occurcountryUSseriousnessother1duplicate1Date Received24/04/2015transmissiondate21/08/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age44Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionMyalgiaOutcomeRecovering/resolving

2)

reactionmeddraversionpt18.0ReactionArthralgiaOutcomeRecovering/resolving

3)

reactionmeddraversionpt18.0ReactionColitis ulcerativeOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.0ReactionAlopeciaOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductABSORICAdrugbatchnumb14D21AAdrugauthorizationnumb021951drugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb12drugintervaldosagedefinition805drugdosagetext30 MG, BIDdrugdosageformCAPSULEdrugadministrationroute048drugindicationACNE CYSTICdrugstartdateformat102drugstartdate30/09/2014drugenddateformat102drugenddate01/02/2015actiondrug1

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberNDA021951Brand NameABSORICAGeneric NameISOTRETINOINManufacturersSun Pharmaceutical Industries, Inc.product_ndc 10631-115, 10631-116, 10631-117, 10631-118, 10631-133, 10631-134, 10631-002, 106 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI 197843, 197844, 197845, 403930, 1299203, 1300006, 1300014, 1300016, 1547561, 154 ... spl_ida8d4793a-5043-40e1-b623-35812733499fspl_set_id3ef0cff8-19c1-4441-b780-fca6c7ee1615Package NDC 10631-115-69, 10631-115-31, 10631-116-69, 10631-116-31, 10631-117-69, 10631-117- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

summary

narrativeincludeclinicalCASE EVENT DATE: 201501

Report Duplicate

duplicatesourceRANBAXYduplicatenumbUS-SUN PHARMACEUTICAL INDUSTRIES LTD-2015US-95722

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use