Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10148733primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate12/12/2014reporttype1serious1seriousnessother1receivedateformat102Date Received02/05/2014receiptdateformat102Date Last Updated02/05/2014fulfillexpeditecriteria1companynumbUS-ELI_LILLY_AND_COMPANY-US201404007385duplicate1

Report Duplicate

duplicatesourceELI LILLY AND COduplicatenumbUS-ELI_LILLY_AND_COMPANY-US201404007385

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionPneumothoraxOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionTooth lossOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionEye painOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionAbdominal pain upperOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionGastrointestinal painOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionLip disorderOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionToothacheOutcomeUnknown

8)

reactionmeddraversionpt17.0ReactionCoughOutcomeUnknown

9)

reactionmeddraversionpt17.0ReactionUrinary tract infectionOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductZYPREXAdrugauthorizationnumb020592drugdosagetextUNK, UNKNOWNdrugdosageformTABLETdrugadministrationroute065drugindicationPRODUCT 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_id7184cd07-6f72-4413-9d11-daa74ef14b03, b222aade-353e-401c-b7d4-cb0da936e374spl_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

2)

drugcharacterization1medicinalproductABILIFYdrugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

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)

drugcharacterization1medicinalproductREMERONdrugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA020415Brand NameREMERONGeneric NameMIRTAZAPINEManufacturersOrganon LLCproduct_ndc78206-160, 78206-161, 78206-156, 78206-158, 78206-159Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMIRTAZAPINEspl_id3dc49c6b-23a6-41ed-909e-98b5c179130fspl_set_id98ad1917-a094-44f5-a28f-a64a8cfcd887Package NDC 78206-160-01, 78206-161-01, 78206-156-99, 78206-156-01, 78206-158-99, 78206-158- ... UNIIA051Q2099Q

4)

drugcharacterization1medicinalproductLUNESTAdrugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

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)

drugcharacterization1medicinalproductCLOZARILdrugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA019758Brand NameCLOZARILGeneric NameCLOZAPINEManufacturersHLS Therapeutics (USA), Inc.product_ndc69809-0126, 69809-0127, 69809-0130, 69809-0135Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLOZAPINERXCUI104775, 104776, 197535, 197536, 309374, 429212, 2269079, 2269081spl_id29feed9f-c971-4c63-bcfc-0776c12215cfspl_set_id90876802-0e3a-44c9-9ff7-1754dfbe736aPackage NDC69809-0126-5, 69809-0127-5, 69809-0130-5, 69809-0135-5NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIJ60AR2IKIC