Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-TEVA-468925USAoccurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10012847Date Received14/03/2014transmissiondate02/10/2014serious2Date Last Updated14/03/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age41Unit of Onset AgeyearsWeight70.37SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionNauseaOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionDizzinessOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductPLAN B ONE-STEPdrugauthorizationnumb021998drugstructuredosagenumb1.5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1.5 MILLIGRAM DAILY;drugdosageformTABLETdrugadministrationroute048drugindicationPOST COITAL CONTRACEPTIONdrugstartdateformat102drugstartdate05/02/2014drugenddateformat102drugenddate05/02/2014

openFDA Info on Medication

Application NumberNDA021998Brand NamePLAN B ONE-STEPGeneric NameLEVONORGESTRELManufacturersFoundation Consumer Healthcare LLC, Teva Women's Health, Inc.product_ndc69536-146, 69536-162, 51285-146, 51285-124, 51285-162Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLEVONORGESTRELRXCUI483325, 858079spl_id8de6d68f-7353-47ba-bbee-c2bfb37a48d9, 4bf9c544-285a-414d-b156-0941595f65d4spl_set_id6ce6b40e-14ac-47bd-a648-ddf9e452e559, e53e3f9a-d359-4c5a-aceb-d002ed367849Package NDC 69536-162-88, 69536-162-99, 69536-146-19, 51285-124-88, 51285-146-19, 51285-162- ... NUIN0000175830, M0447349, N0000175602, N0000175832Physiologic/Pharmacodynamic EffectInhibit Ovum Fertilization [PE]Chemical StructureProgesterone Congeners [CS]Established Pharmacologic ClassProgestin [EPC], Progestin-containing Intrauterine Device [EPC]UNII5W7SIA7YZW

2)

drugcharacterization2medicinalproductZOLOFTdrugindicationDEPRESSION

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

3)

drugcharacterization2medicinalproductLAMOTRIGINEdrugindicationAFFECTIVE DISORDER

openFDA Info on Medication

Application Number ANDA200672, ANDA203733, ANDA206382, ANDA090401, ANDA078956, ANDA077633, ANDA0780 ... Brand NameLAMOTRIGINE, LAMICTAL, LAMICTAL ODT, LAMOTRIGINE KIT, LAMICTAL XR, SUBVENITEGeneric NameLAMOTRIGINE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINEManufacturers Actavis Pharma, Inc., Dr. Reddys Laboratories Inc., Rising Pharmaceuticals, Inc. ... product_ndc 0228-1410, 0228-1435, 0228-1422, 0228-1453, 0228-1638, 0228-1580, 43598-550, 435 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLAMOTRIGINERXCUI 850087, 850091, 900156, 900164, 1098608, 1146690, 103968, 198430, 252478, 252479 ... spl_id 2f865cd1-cc06-4163-b331-927ac6868fee, b6835792-57b9-95b0-e053-2995a90a2e38, 584d ... spl_set_id 87beaf22-593d-4170-bb58-332c615ef90d, 54ea1ec3-876b-4d3a-a92b-1a6d70951de0, 72d2 ... Package NDC 0228-1410-03, 0228-1435-03, 0228-1422-03, 0228-1453-03, 0228-1638-03, 0228-1580- ... NUIN0000175753, N0000008486, N0000175751Established Pharmacologic ClassAnti-epileptic Agent [EPC], Mood Stabilizer [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNIIU3H27498KS

Report Duplicate

duplicatesourceTEVAduplicatenumbUS-TEVA-468925USA