Adverse Event Report

Report

reporttype1receiptdateformat102companynumb2014VER00314Version of Safety Report ID1receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10609813Date Received24/11/2014transmissiondate29/05/2015serious1Date Last Updated24/11/2014primarysourcecountryIN

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryIN

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age27Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionPersecutory delusion

2)

reactionmeddraversionpt18.0ReactionSleep disorder

3)

reactionmeddraversionpt18.0ReactionPsychotic disorder

4)

reactionmeddraversionpt18.0ReactionFeeling abnormal

Drug

1)

drugcharacterization1medicinalproductISOTRETINOINdrugauthorizationnumb076485drugindicationACNEdrugadditional1

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

duplicatesourceVERSAPHARMduplicatenumb2014VER00314