Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10100692serious1Date Last Updated30/03/2015receiptdateformat102companynumbTR-MYLANLABS-2014S1008519occurcountryTRseriousnessother1duplicate1Date Received23/04/2014seriousnesshospitalization1transmissiondate20/07/2015primarysourcecountryTR

Primary Source

reportercountryTRqualification3literaturereference GULER E, GULER GB, YAVUZ C, KIZILIRMAK F. AN UNKNOWN SIDE EFFECT OF ISOTRETINOIN ...

Patient

Reaction

1)

reactionmeddraversionpt18.0ReactionPericardial effusionOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.0ReactionDry skinOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionAtrial tachycardiaOutcomeRecovered/resolved

4)

reactionmeddraversionpt18.0ReactionLip dryOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductISOTRETINOINdrugauthorizationnumb075945drugdosagetext0.5MG/KG/DAYdrugadministrationroute048drugindicationACNEactiondrug1

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

duplicatesourceMYLANduplicatenumbTR-MYLANLABS-2014S1008519

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use