Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10062002serious1Date Last Updated10/04/2014seriousnesslifethreatening1receiptdateformat102companynumbAUR-APL-2014-04080duplicate1Date Received03/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryFR

Primary Source

reportercountryFRqualification3

Patient

Onset Age47Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionDermabrasion

2)

reactionmeddraversionpt17.0ReactionOxygen saturation decreased

3)

reactionmeddraversionpt17.0ReactionHaemophilus infection

4)

reactionmeddraversionpt17.0ReactionStreptococcal infection

5)

reactionmeddraversionpt17.0ReactionBlood alcohol increased

6)

reactionmeddraversionpt17.0ReactionHypokalaemia

7)

reactionmeddraversionpt17.0ReactionRefusal of treatment by patient

8)

reactionmeddraversionpt17.0ReactionPneumonia aspiration

9)

reactionmeddraversionpt17.0ReactionDrug interaction

10)

reactionmeddraversionpt17.0ReactionToxicity to various agents

11)

reactionmeddraversionpt17.0ReactionComa

12)

reactionmeddraversionpt17.0ReactionHypotension

13)

reactionmeddraversionpt17.0ReactionIntentional overdose

14)

reactionmeddraversionpt17.0ReactionHypertension

15)

reactionmeddraversionpt17.0ReactionDiarrhoea

Drug

1)

drugcharacterization1medicinalproductSERTRALINEdrugauthorizationnumb77206drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

2)

drugcharacterization1medicinalproductTENORMINdrugstructuredosagenumb50drugstructuredosageunit003drugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA018240Brand NameTENORMINGeneric NameATENOLOLManufacturersAlmatica Pharma LLCproduct_ndc52427-429, 52427-430, 52427-431Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATENOLOLRXCUI150750, 152414, 197379, 197380, 197381, 201322spl_id70291313-c4f6-7c2a-cd07-04fd6a07b634spl_set_id746db603-a6e1-4dc3-c2d8-92314419098cPackage NDC52427-429-90, 52427-430-90, 52427-431-90NUIN0000000161, N0000175556Mechanism of ActionAdrenergic beta-Antagonists [MoA]Established Pharmacologic Classbeta-Adrenergic Blocker [EPC]UNII50VV3VW0TI

3)

drugcharacterization1medicinalproductZOLPIDEM TARTRATEdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA078148, NDA021997, ANDA213592, ANDA076410, ANDA077214, ANDA204170, NDA021774 ... Brand Name ZOLPIDEM TARTRATE EXTENDED-RELEASE, EDLUAR, ZOLPIDEM TARTRATE, ZOLPIDEM, ZOLPIMI ... Generic NameZOLPIDEM TARTRATEManufacturers Par Pharmaceutical, Inc., Meda Pharmaceuticals, Breckenridge Pharmaceutical, Inc ... product_ndc 10370-116, 10370-117, 0037-6010, 0037-6050, 51991-981, 51991-982, 0093-0073, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, SUBLINGUALActive IngredientsZOLPIDEM TARTRATERXCUI 854880, 854894, 836641, 836645, 836647, 836649, 854873, 854876, 1232194, 1232202 ... spl_id 4df7ed76-3fcc-42c8-936c-f0cb5a15fe1b, 5f57f9b8-4244-4999-ae38-8edf6f920298, 4889 ... spl_set_id 1a32885f-7e42-4558-9142-42d441bcf23d, a32884d0-85b5-11de-8a39-0800200c9a66, cbda ... Package NDC 10370-117-10, 10370-116-10, 0037-6050-30, 0037-6010-30, 0037-6010-02, 51991-981- ... UNIIWY6W63843K

4)

drugcharacterization1medicinalproductLEXOMILdrugstructuredosagenumb2drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

5)

drugcharacterization1medicinalproductLEVOCETIRIZINEdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA211983Brand NameLEVOCETIRIZINEGeneric NameLEVOCETIRIZINE DIHYDROCHLORIDEManufacturersWalgreen Companyproduct_ndc0363-2241Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLEVOCETIRIZINE DIHYDROCHLORIDERXCUI855172spl_ide7550654-1089-4b1b-a464-14125cc1aac8spl_set_iddb38f528-6cf4-4e3c-89b9-8bbadbb1d0a1Package NDC0363-2241-76UNIISOD6A38AGA

6)

drugcharacterization1medicinalproductTHERALENEdrugstructuredosagenumb60drugstructuredosageunit031drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

7)

drugcharacterization2medicinalproductTRAMADOL (TRAMADOL)

Report Duplicate

duplicatesourceAUROBINDOduplicatenumbAUR-APL-2014-04080

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use