Adverse Event Report

Report

reporttype1Version of Safety Report ID5receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10101424serious1Date Last Updated02/12/2016receiptdateformat102companynumbTR-RANBAXY-2014R1-80530occurcountryTRseriousnessother1duplicate1Date Received24/04/2014seriousnesshospitalization1transmissiondate06/02/2017primarysourcecountryTR

Primary Source

reportercountryGBqualification3

Patient

Onset Age26Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt19.1ReactionLip dryOutcomeUnknown

2)

reactionmeddraversionpt19.1ReactionDry skinOutcomeUnknown

3)

reactionmeddraversionpt19.1ReactionPericardial effusionOutcomeRecovering/resolving

4)

reactionmeddraversionpt19.1ReactionAtrial tachycardiaOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductISOTRETINOINdrugauthorizationnumb76041drugstructuredosagenumb.5drugstructuredosageunit007drugdosagetext0.5 MG/KG, DAILYdrugadministrationroute048drugindicationACNEactiondrug1drugadditional1

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-2014R1-80530

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use