Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10348748serious1Date Last Updated29/07/2014receiptdateformat102companynumbES-MYLAN-2014S1016723occurcountryESseriousnessother1duplicate1Date Received29/07/2014transmissiondate26/03/2015primarysourcecountryES

Primary Source

reportercountryESqualification3literaturereference ASCALA PARTERA JA DEPRESSION AND PANIC ATTACK IN ACNE TREATED WITH ISOTRETINOIN ...

Patient

Reaction

1)

reactionmeddraversionpt17.1ReactionApathyOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.1ReactionInsomniaOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.1ReactionDizzinessOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.1ReactionDepressionOutcomeRecovered/resolved

5)

reactionmeddraversionpt17.1ReactionDepressed moodOutcomeRecovered/resolved

6)

reactionmeddraversionpt17.1ReactionLethargyOutcomeRecovered/resolved

7)

reactionmeddraversionpt17.1ReactionApparent deathOutcomeRecovered/resolved

8)

reactionmeddraversionpt17.1ReactionDisturbance in attentionOutcomeRecovered/resolved

9)

reactionmeddraversionpt17.1ReactionPanic attackOutcomeRecovered/resolved

10)

reactionmeddraversionpt17.1ReactionSuicidal ideationOutcomeRecovered/resolved

11)

reactionmeddraversionpt17.1ReactionVision blurredOutcomeRecovered/resolved

12)

reactionmeddraversionpt17.1ReactionDecreased appetiteOutcomeRecovered/resolved

13)

reactionmeddraversionpt17.1ReactionFeeling abnormalOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductISOTRETINOINdrugauthorizationnumb075945drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG,QDdrugadministrationroute048drugindicationACNEactiondrug1

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

duplicatesourceMYLANduplicatenumbES-MYLAN-2014S1016723

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use