Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID10440157primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate26/03/2015reporttype1serious2receivedateformat102Date Received08/09/2014receiptdateformat102Date Last Updated08/09/2014fulfillexpeditecriteria2companynumbUS-BRISTOL-MYERS SQUIBB COMPANY-19436328duplicate1

Report Duplicate

duplicatesourceBRISTOL MYERS SQUIBBduplicatenumbUS-BRISTOL-MYERS SQUIBB COMPANY-19436328

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age60Unit of Onset AgeyearsWeight63.49SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionIrritabilityOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductXANAXdrugstructuredosagenumb4drugstructuredosageunit003

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0094, 0009-0029, 0009-0055, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_idf364e489-b47b-4283-a7fe-d5b15f77447e, bf933d5a-53e2-4454-a040-cacc061bca92spl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

2)

drugcharacterization1medicinalproductABILIFYdrugstructuredosagenumb2drugstructuredosageunit003drugdosageformTABLETdrugstartdateformat102drugstartdate23/07/2013

activesubstance

activesubstancenameARIPIPRAZOLE

openFDA Info on Medication

Application NumberNDA021436Brand NameABILIFYGeneric NameARIPIPRAZOLEManufacturersOtsuka America Pharmaceutical, Inc.product_ndc 59148-006, 59148-007, 59148-008, 59148-009, 59148-010, 59148-011, 59148-013, 591 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsARIPIPRAZOLERXCUI 349490, 349545, 349547, 349553, 352307, 352308, 352309, 352310, 402131, 404602, ... spl_idfa6e0346-2760-404e-bfea-23fc6403cdffspl_set_idc040bd1d-45b7-49f2-93ea-aed7220b30acPackage NDC 59148-006-13, 59148-006-92, 59148-007-13, 59148-007-35, 59148-007-94, 59148-008- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNII82VFR53I78

3)

drugcharacterization2medicinalproductCELEXAdrugstructuredosagenumb40drugstructuredosageunit003

activesubstance

activesubstancenameCITALOPRAM HYDROBROMIDE

openFDA Info on Medication

Application NumberNDA020822Brand NameCELEXAGeneric NameCITALOPRAMManufacturersAllergan, Inc.product_ndc0456-4010, 0456-4020, 0456-4040Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCITALOPRAM HYDROBROMIDERXCUI200371, 213344, 213345, 283672, 284591, 309314spl_iddbff05bb-4557-4d6c-be56-54b239bddae6spl_set_id4259d9b1-de34-43a4-85a8-41dd214e9177Package NDC 0456-4010-01, 0456-4020-01, 0456-4020-11, 0456-4020-63, 0456-4040-01, 0456-4040- ... UNIII1E9D14F36

4)

drugcharacterization2medicinalproductLUNESTA

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

5)

drugcharacterization2medicinalproductCLARITINdrugindicationHYPERSENSITIVITY

activesubstance

activesubstancenameLORATADINE

openFDA Info on Medication

Application NumberNDA020704, NDA019658, ANDA075209, NDA021952, NDA021891, NDA021993Brand NameCLARITIN REDITABS, CLARITIN, CLARITIN LIQUI-GELSGeneric NameLORATADINEManufacturersBayer Healthcare LLC., Bayer HealthCare LLC., Bayer HealthCare LLCproduct_ndc 11523-4329, 11523-7157, 11523-0007, 11523-6655, 11523-0800, 11523-1527, 11523-72 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLORATADINERXCUI311373, 744830, 206805, 311372, 828269, 836338, 665078, 668469, 672558, 904026spl_id de083f49-281f-89b3-e053-2a95a90a6fcd, de08d044-d572-48cd-e053-2a95a90a619f, d443 ... spl_set_id b681ea25-d00b-4c8a-8054-cc6f983ce337, acf2d393-53d7-062f-e053-2995a90a0d60, ac32 ... Package NDC 11523-7157-2, 11523-7157-3, 11523-7157-4, 11523-7157-7, 11523-7157-8, 11523-7157 ... UNII7AJO3BO7QN

6)

drugcharacterization2medicinalproductLOMOTILdrugstructuredosagenumb200drugstructuredosageunit003

activesubstance

activesubstancenameATROPINE SULFATE\DIPHENOXYLATE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA012462Brand NameLOMOTILGeneric NameDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0025-0061Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDERXCUI1190572, 1190641spl_id3e3a06dd-60e1-4f0b-b8e9-ab7180543762spl_set_idf170584a-1072-4fd7-b1dc-6756703483b9Package NDC0025-0061-31UNII03J5ZE7KA5, W24OD7YW48