Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10210788serious1Date Last Updated02/06/2014receiptdateformat102companynumbGB-MYLANLABS-2014S1012028occurcountryGBseriousnessother1duplicate1Date Received02/06/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryGB

Primary Source

reportercountryGBqualification2

Patient

Onset Age20Unit of Onset AgeyearsWeight69SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionType 1 diabetes mellitusOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.0ReactionPolyuriaOutcomeRecovering/resolving

3)

reactionmeddraversionpt17.0ReactionPolydipsiaOutcomeRecovering/resolving

4)

reactionmeddraversionpt17.0ReactionWeight decreasedOutcomeRecovering/resolving

5)

reactionmeddraversionpt17.0ReactionInfluenza like illnessOutcomeRecovering/resolving

6)

reactionmeddraversionpt17.0ReactionBlood triglycerides increasedOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductISOTRETINOINdrugauthorizationnumb075945drugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationACNEdrugstartdateformat610drugstartdate/03/2014drugenddateformat102drugenddate07/05/2014actiondrug2drugrecurreadministration3

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

2)

drugcharacterization1medicinalproductISOTRETINOINdrugauthorizationnumb075945drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate07/05/2014drugenddateformat102drugenddate07/05/2014actiondrug2drugrecurreadministration3

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

duplicatesourceMYLANduplicatenumbGB-MYLANLABS-2014S1012028

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use