Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10183234serious1Date Last Updated27/05/2014receiptdateformat102companynumbAU-MYLANLABS-2014S1010694occurcountryAUseriousnessother1duplicate1Date Received20/05/2014transmissiondate12/12/2014primarysourcecountryAU

Primary Source

reportercountryAUqualification5

Patient

Onset Age43Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionDrug withdrawal syndromeOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionVision blurredOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionHypokinesiaOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionHeadacheOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionDizzinessOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.0ReactionFatigueOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt17.0ReactionMemory impairmentOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt17.0ReactionLibido disorderOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt17.0ReactionAnxietyOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt17.0ReactionDepressionOutcomeNot recovered/not resolved

11)

reactionmeddraversionpt17.0ReactionTremorOutcomeNot recovered/not resolved

12)

reactionmeddraversionpt17.0ReactionWeight increasedOutcomeNot recovered/not resolved

13)

reactionmeddraversionpt17.0ReactionNasal drynessOutcomeNot recovered/not resolved

14)

reactionmeddraversionpt17.0ReactionDry mouthOutcomeNot recovered/not resolved

15)

reactionmeddraversionpt17.0ReactionHyporeflexiaOutcomeNot recovered/not resolved

16)

reactionmeddraversionpt17.0ReactionHypopnoeaOutcomeNot recovered/not resolved

17)

reactionmeddraversionpt17.0ReactionDiarrhoeaOutcomeNot recovered/not resolved

18)

reactionmeddraversionpt17.0ReactionYellow skinOutcomeNot recovered/not resolved

19)

reactionmeddraversionpt17.0ReactionChange of bowel habitOutcomeNot recovered/not resolved

20)

reactionmeddraversionpt17.0ReactionParaesthesiaOutcomeNot recovered/not resolved

21)

reactionmeddraversionpt17.0ReactionHypoaesthesiaOutcomeNot recovered/not resolved

22)

reactionmeddraversionpt17.0ReactionMyalgiaOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductKALMAdrugauthorizationnumb074215drugstructuredosagenumb3drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugindicationPANIC DISORDERactiondrug2

2)

drugcharacterization1medicinalproductKALMAdrugauthorizationnumb074215drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugindicationPANIC DISORDERactiondrug2

3)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 TABLETS OF 100MG AT NIGHTdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

4)

drugcharacterization2medicinalproductCAVSTATdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 TABLET AT NIGHTdrugindicationBLOOD CHOLESTEROL

5)

drugcharacterization2medicinalproductMINAXdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 TABLET IN THE MORNING AND 1 AT THE NIGHTdrugindicationHYPERTENSION

Report Duplicate

duplicatesourceMYLANduplicatenumbAU-MYLANLABS-2014S1010694

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use