Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10361957serious1Date Last Updated05/08/2014receiptdateformat102companynumbTR-RANBAXY-2013R1-76140occurcountryTRseriousnessother1duplicate1Date Received05/08/2014transmissiondate26/03/2015primarysourcecountryTR

Primary Source

reportercountryTRqualification3literaturereference GUNGOR S, GOKDEMIR G. ANAL FISSURE AND RECTAL BLEEDING AS A COMPLICATION OF SYST ...

Patient

Onset Age15Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionAnal fissureOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.1ReactionCheilitisOutcomeRecovering/resolving

3)

reactionmeddraversionpt17.1ReactionXerosisOutcomeRecovering/resolving

4)

reactionmeddraversionpt17.1ReactionEpistaxisOutcomeRecovering/resolving

5)

reactionmeddraversionpt17.1ReactionRectal haemorrhageOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductISOTRETINOINdrugauthorizationnumb021951drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb12drugintervaldosagedefinition805drugdosagetext40 MG, BIDdrugadministrationroute065drugindicationACNEactiondrug1

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application Number NDA211913, NDA021951, ANDA202099, ANDA076356, ANDA076135, ANDA075945, ANDA076485 ... Brand Name ABSORICA LD, ABSORICA, ZENATANE, ACCUTANE, CLARAVIS, ISOTRETINOIN, AMNESTEEM, MY ... Generic NameISOTRETINOINManufacturers Sun Pharmaceutical Industries, Inc., Dr. Reddy's Laboratories Limited, JG Pharma ... product_ndc 10631-002, 10631-115, 10631-116, 10631-117, 10631-118, 10631-133, 10631-134, 106 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI 197843, 197844, 197845, 403930, 1299203, 1300006, 1300014, 1300016, 1547561, 154 ... spl_id a8d4793a-5043-40e1-b623-35812733499f, 1f5178c1-0f6f-824d-d0ee-1b973377ccc6, a599 ... spl_set_id 3ef0cff8-19c1-4441-b780-fca6c7ee1615, 27b3cf26-f22e-5b70-1c24-009933b7c6ee, a41c ... Package 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

Report Duplicate

duplicatesourceRANBAXYduplicatenumbTR-RANBAXY-2013R1-76140

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use