Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-TEVA-391861USAoccurcountryUSVersion of Safety Report ID2receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10152428Date Received05/05/2014transmissiondate12/12/2014serious2Date Last Updated05/05/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age17Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionHypertriglyceridaemiaOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.0ReactionHepatic enzyme increasedOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductCLARAVISdrugauthorizationnumb076135drugstructuredosagenumb20drugstructuredosageunit003drugdosageformCAPSULEdrugadministrationroute048drugstartdateformat102drugstartdate02/10/2012drugenddateformat102drugenddate28/12/2012actiondrug1

openFDA Info on Medication

Application NumberANDA076356, ANDA076135Brand NameCLARAVISGeneric NameISOTRETINOINManufacturersTeva Pharmaceuticals USA, Inc.product_ndc0555-1054, 0555-1055, 0555-1056, 0555-1057Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 404059, 404062, 404065, 643488spl_ide462821c-84c4-4009-a26e-da92790126bfspl_set_ida31fd109-d0fd-4ab9-ba98-a3d64333c18dPackage NDC 0555-1054-60, 0555-1054-86, 0555-1054-56, 0555-1055-60, 0555-1055-86, 0555-1055- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

2)

drugcharacterization2medicinalproductDROSPIRENONE W/ETHINYLESTRADIOL

3)

drugcharacterization2medicinalproductVENLAFAXINE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA204889, ANDA200834, ANDA090899, ANDA076690, ANDA078865, ANDA079098, ANDA0912 ... Brand NameVENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, EFFEXOR XRGeneric NameVENLAFAXINE HYDROCHLORIDE, VENLAFAXINEManufacturers Macleods Pharmaceuticals Limited, Aurobindo Pharma Limited, Torrent Pharmaceutic ... product_ndc 33342-194, 33342-195, 33342-196, 65862-527, 65862-528, 65862-697, 13668-018, 136 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVENLAFAXINE HYDROCHLORIDE, VENLAFAXINERXCUI 313581, 313583, 313585, 313580, 313582, 313584, 313586, 314277, 808744, 808748, ... spl_id aac7ed96-77bb-435a-8d54-0efb3c779ca7, ddd968b0-a0c4-47c9-88b0-be3e0e4b0f52, 947a ... spl_set_id 3e51f786-3691-4ec4-836b-7f2c9a385aa7, 85d3ce8b-8966-45d9-bdaf-f6f0475096e1, cc3c ... Package NDC 33342-194-07, 33342-194-15, 33342-194-12, 33342-194-10, 33342-194-11, 33342-195- ... UNII7D7RX5A8MO, GRZ5RCB1QGNUIN0000000102, N0000175749, N0000000109Mechanism of ActionNorepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA]Established Pharmacologic ClassSerotonin and Norepinephrine Reuptake Inhibitor [EPC]

Report Duplicate

duplicatesourceTEVAduplicatenumbUS-TEVA-391861USA