Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID12414855serious1Date Last Updated14/06/2017receiptdateformat102companynumbUS-MYLANLABS-2016M1021866occurcountryUSseriousnessother1duplicate1Date Received29/05/2016transmissiondate30/08/2017primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Reaction

1)

reactionmeddraversionpt20.0ReactionInflammatory bowel diseaseOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt20.0ReactionEmotional distressOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt20.0ReactionPainOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt20.0ReactionSuicidal ideationOutcomeRecovered/resolved

5)

reactionmeddraversionpt20.0ReactionRenal injuryOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt20.0ReactionMyalgiaOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt20.0ReactionFatigueOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt20.0ReactionUrinary incontinenceOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt20.0ReactionRectal haemorrhageOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt20.0ReactionBlood glucose increasedOutcomeNot recovered/not resolved

11)

reactionmeddraversionpt20.0ReactionRenal disorderOutcomeNot recovered/not resolved

12)

reactionmeddraversionpt20.0ReactionHypertensionOutcomeUnknown

13)

reactionmeddraversionpt20.0ReactionMuscle disorderOutcomeRecovered/resolved

14)

reactionmeddraversionpt20.0ReactionHallucination, auditoryOutcomeUnknown

15)

reactionmeddraversionpt20.0ReactionPyrexiaOutcomeNot recovered/not resolved

16)

reactionmeddraversionpt20.0ReactionAstheniaOutcomeNot recovered/not resolved

17)

reactionmeddraversionpt20.0ReactionDyscheziaOutcomeNot recovered/not resolved

18)

reactionmeddraversionpt20.0ReactionAnxietyOutcomeNot recovered/not resolved

19)

reactionmeddraversionpt20.0ReactionDepressionOutcomeNot recovered/not resolved

20)

reactionmeddraversionpt20.0ReactionAlopeciaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductISOTRETINOINdrugauthorizationnumb075945drugdosagetextUNKdrugdosageformCAPSULEdrugstartdateformat610drugstartdate/04/2014drugenddateformat610drugenddate/07/2014actiondrug1drugadditional1

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

2)

drugcharacterization1medicinalproductACCUTANEdrugdosagetextUNKdrugadministrationroute065actiondrug1drugrecurreadministration3drugadditional1

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA202099Brand NameACCUTANEGeneric NameISOTRETINOINManufacturersJG Pharma Inc.product_ndc72143-231, 72143-232, 72143-234, 72143-233Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 206880, 206883, 206902, 403930, 2473107spl_ida599c5e2-aeaa-4667-b6fa-ddc56bbb71daspl_set_ida41ceb83-aaca-4f9d-ae33-c53b1ca71e41Package NDC 72143-231-10, 72143-231-30, 72143-232-10, 72143-232-30, 72143-234-10, 72143-234- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

Report Duplicate

duplicatesourceMYLANduplicatenumbUS-MYLANLABS-2016M1021866

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use