Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10166458serious1Date Last Updated12/05/2014receiptdateformat102companynumbAU-ELI_LILLY_AND_COMPANY-AU201404010013occurcountryAUseriousnessother1duplicate1Date Received12/05/2014transmissiondate12/12/2014primarysourcecountryAU

Primary Source

reportercountryAUqualification5

Patient

SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionSerotonin syndromeOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionPyrexiaOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionIncreased upper airway secretionOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionHypothermiaOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionDizzinessOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionParaesthesiaOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionTinnitusOutcomeUnknown

8)

reactionmeddraversionpt17.0ReactionConfusional stateOutcomeUnknown

9)

reactionmeddraversionpt17.0ReactionAstheniaOutcomeUnknown

10)

reactionmeddraversionpt17.0ReactionPollakiuriaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductCYMBALTAdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetextUNK, UNKNOWNdrugdosageformCAPSULEdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA021427Brand NameCYMBALTAGeneric NameDULOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3235, 0002-3240, 0002-3270Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDULOXETINE HYDROCHLORIDERXCUI596926, 596928, 596930, 596932, 596934, 615186spl_idb742d0a5-e67d-49ed-ba95-afe068f1d228spl_set_id2f7d4d67-10c1-4bf4-a7f2-c185fbad64baPackage NDC0002-3235-60, 0002-3240-30, 0002-3240-90, 0002-3270-30, 0002-3270-04UNII9044SC542W

2)

drugcharacterization1medicinalproductZYPREXAdrugauthorizationnumb020592drugstructuredosagenumb1drugstructuredosageunit032drugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA020592, NDA021086, NDA021253, NDA022173Brand NameZYPREXA, ZYPREXA ZYDIS, ZYPREXA INTRAMUSCULAR, ZYPREXA RELPREVVGeneric NameOLANZAPINE, OLANZAPINE PAMOATEManufacturersEli Lilly and Companyproduct_ndc 0002-4112, 0002-4115, 0002-4116, 0002-4117, 0002-4415, 0002-4420, 0002-4453, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULARActive IngredientsOLANZAPINERXCUI 153046, 153047, 153048, 200034, 212405, 261337, 283639, 284514, 312076, 312077, ... spl_idab87dd62-b7a0-4b0c-92e3-a14eac38b76e, 1510c949-be2b-4de1-a10a-edb597fe51e2spl_set_idd5051fbc-846b-4946-82df-341fb1216341, f9a73185-88de-4d7b-b3c0-bbf231483241Package NDC 0002-4112-30, 0002-4115-30, 0002-4116-30, 0002-4117-30, 0002-4415-30, 0002-4420- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIN7U69T4SZR

3)

drugcharacterization1medicinalproductAROPAXdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

4)

drugcharacterization1medicinalproductCELEBREXdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA020998Brand NameCELEBREXGeneric NameCELECOXIBManufacturersG.D. Searle LLC Division of Pfizer Incproduct_ndc0025-1515, 0025-1520, 0025-1525, 0025-1530Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCELECOXIBRXCUI205322, 205323, 213468, 213469, 349514, 352314, 686379, 686381spl_idd2a1146b-f1a6-4467-9ba8-b10f94494f8espl_set_id8d52185d-421f-4e34-8db7-f7676db2a226Package NDC 0025-1515-01, 0025-1520-31, 0025-1520-51, 0025-1520-34, 0025-1525-31, 0025-1525- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIJCX84Q7J1L

5)

drugcharacterization1medicinalproductCIPRAMIL /00582602/drugstructuredosagenumb1drugstructuredosageunit032drugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

6)

drugcharacterization1medicinalproductEFEXORdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

7)

drugcharacterization1medicinalproductENDEPdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

8)

drugcharacterization1medicinalproductENDONEdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

9)

drugcharacterization1medicinalproductLEXAPROdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA021323Brand NameLEXAPROGeneric NameESCITALOPRAM OXALATEManufacturersAllergan, Inc.product_ndc0456-2005, 0456-2010, 0456-2020, 0456-2101Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESCITALOPRAM OXALATERXCUI349332, 351249, 351250, 351285, 352272, 352273, 404408, 404420spl_idf7659260-4527-4446-9aa5-15a2895c5b0espl_set_id13bb8267-1cab-43e5-acae-55a4d957630aPackage NDC 0456-2005-01, 0456-2010-01, 0456-2010-11, 0456-2010-63, 0456-2020-01, 0456-2020- ... UNII5U85DBW7LO

10)

drugcharacterization1medicinalproductMOGADONdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

11)

drugcharacterization1medicinalproductNAPROXENdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA091416, NDA018965, ANDA204872, ANDA091432, ANDA075927, ANDA091305, ANDA21270 ... Brand NameNAPROXEN, NAPROSYN, BACK AND MUSCLE PAIN, EC-NAPROXEN, EC-NAPROSYNGeneric NameNAPROXEN, NAPROXEN SODIUMManufacturers MARKSANS PHARMA LIMITED, Allegis Holdings, LLC, Amerisource Bergen, Virtus Pharm ... product_ndc 25000-138, 25000-139, 25000-140, 71297-200, 46122-564, 69543-425, 69543-426, 461 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsNAPROXEN, NAPROXEN SODIUMRXCUI 198012, 198013, 198014, 311913, 849574, 311915, 603103, 207093, 849398, 849431, ... spl_id 6fa09e97-8e2d-4d74-9490-3eb2169820f6, b61f4f8a-87e2-3fa6-e053-2995a90a0b2e, 7543 ... spl_set_id 1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8, bc979c90-5853-4a95-8402-ba6b57100b17, 1e2e ... Package NDC 25000-138-03, 25000-138-14, 25000-138-21, 25000-138-31, 25000-138-98, 25000-139- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNII57Y76R9ATQ, 9TN87S3A3C

12)

drugcharacterization1medicinalproductOXYCONTINdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA022272Brand NameOXYCONTINGeneric NameOXYCODONE HYDROCHLORIDEManufacturersPurdue Pharma LPproduct_ndc59011-410, 59011-480, 59011-415, 59011-420, 59011-430, 59011-440, 59011-460Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDERXCUI 1049504, 1049545, 1049565, 1049576, 1049586, 1049595, 1049601, 1860127, 1860129, ... spl_id21ec1aed-af99-6d71-bc44-4755651ecd9espl_set_idbfdfe235-d717-4855-a3c8-a13d26dadedePackage NDC 59011-480-20, 59011-480-10, 59011-410-10, 59011-410-20, 59011-415-10, 59011-415- ... UNIIC1ENJ2TE6C

13)

drugcharacterization1medicinalproductPANADEINE /00116401/drugstructuredosagenumb1drugstructuredosageunit032drugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

14)

drugcharacterization1medicinalproductSEREPAXdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

15)

drugcharacterization1medicinalproductVALIUM /00017001/drugstructuredosagenumb1drugstructuredosageunit032drugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

16)

drugcharacterization1medicinalproductZOLOFTdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

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

Report Duplicate

duplicatesourceELI LILLY AND COduplicatenumbAU-ELI_LILLY_AND_COMPANY-AU201404010013

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use