Adverse Event Report

Report

reporttype3Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10495706serious1Date Last Updated03/10/2014seriousnesslifethreatening1receiptdateformat102authoritynumbGB-MHRA-EYC 00114811companynumbGB-MYLANLABS-2014M1005538occurcountryGBseriousnessother1duplicate1Date Received03/10/2014transmissiondate28/05/2015primarysourcecountryGBseriousnessdisabling1

Primary Source

reportercountryGBqualification5

Patient

Reaction

1)

reactionmeddraversionpt18.0ReactionSuicidal behaviourOutcomeRecovering/resolving

2)

reactionmeddraversionpt18.0ReactionDepressionOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.0ReactionBone painOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.0ReactionAlopeciaOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt18.0ReactionEpiphyses premature fusionOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt18.0ReactionDry mouthOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt18.0ReactionLibido decreasedOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt18.0ReactionErectile dysfunctionOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt18.0ReactionEmotional disorderOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductISOTRETINOINdrugauthorizationnumb075945drugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, UNKdrugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate15/07/2014drugenddateformat102drugenddate04/09/2014actiondrug1drugrecurreadministration3

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20140715

Report Duplicate

duplicatesourceMYLANduplicatenumbGB-MYLANLABS-2014M1005538

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use