Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10038576serious2Date Last Updated02/03/2016receiptdateformat102authoritynumbSE-MPA-2014-002110companynumbSE-MERCK-1403SWE011537occurcountrySEduplicate1Date Received26/03/2014transmissiondate25/05/2016primarysourcecountrySE

Primary Source

reportercountrySEqualification5

Patient

Onset Age31Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt19.0ReactionMuscle atrophyOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt19.0ReactionParaesthesiaOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt19.0ReactionDry skinOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt19.0ReactionAnxietyOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt19.0ReactionSleep disorderOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt19.0ReactionFacial wastingOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductSERTRALINE HYDROCHLORIDE.drugdosagetextUNKdrugrecurreadministration3

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA077206, NDA020990, NDA019839, ANDA078861, ANDA077864, ANDA077106, ANDA076934 ... Brand NameSERTRALINE HYDROCHLORIDE, SERTRALINE, ZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturers Aurobindo Pharma Limited, Greenstone LLC, Rising Pharmaceuticals, Inc., Hikma Ph ... product_ndc 65862-011, 65862-012, 65862-013, 59762-0067, 59762-4960, 59762-4900, 59762-4910, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941, 861064, 208149, 208161, 212233, 861066spl_id 80aac5d8-bb02-46f5-a8ca-5fc9f934541c, 1ef7897d-60bb-4685-820f-21c78a097642, 96aa ... spl_set_id 39a85db1-9e59-4ab0-9e18-36757f019faa, 1a58062b-e635-431a-908d-2651c6a4a21c, af2c ... Package NDC 65862-011-30, 65862-011-50, 65862-011-60, 65862-011-90, 65862-011-01, 65862-011- ... UNIIUTI8907Y6X

2)

drugcharacterization1medicinalproductPROPECIAdrugauthorizationnumb020788drugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MG, QDdrugdosageformFILM-COATED TABLETdrugindicationALOPECIAdrugstartdateformat102drugstartdate05/03/2013drugenddateformat102drugenddate01/12/2013actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameFINASTERIDE

openFDA Info on Medication

Application NumberNDA020788Brand NamePROPECIAGeneric NameFINASTERIDEManufacturersMerck Sharp & Dohme Corp.product_ndc0006-0071Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFINASTERIDERXCUI200172, 213178spl_id52756d47-4ff2-4829-9fc4-ea346253b47cspl_set_id4e07adb4-7807-47d3-b9a9-2332a3047410Package NDC0006-0071-54, 0006-0071-31, 0006-0071-07NUIN0000175836, N0000000126Established Pharmacologic Class5-alpha Reductase Inhibitor [EPC]Mechanism of Action5-alpha Reductase Inhibitors [MoA]UNII57GNO57U7G

summary

narrativeincludeclinicalCASE EVENT DATE: 201402

Report Duplicate

duplicatesourceMERCKduplicatenumbSE-MERCK-1403SWE011537

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use