Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11338183primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious2receivedateformat102Date Received03/08/2015receiptdateformat102Date Last Updated03/08/2015fulfillexpeditecriteria2companynumbUS-ELI_LILLY_AND_COMPANY-US201007004034duplicate1

Report Duplicate

duplicatesourceELI LILLY AND COduplicatenumbUS-ELI_LILLY_AND_COMPANY-US201007004034

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexMale

Reaction

1)

reactionmeddraversionpt18.1ReactionFeeling abnormalOutcomeUnknown

2)

reactionmeddraversionpt18.1ReactionRestlessnessOutcomeUnknown

3)

reactionmeddraversionpt18.1ReactionFatigueOutcomeUnknown

4)

reactionmeddraversionpt18.1ReactionAkathisiaOutcomeUnknown

5)

reactionmeddraversionpt18.1ReactionInsomniaOutcomeUnknown

6)

reactionmeddraversionpt18.1ReactionAnxietyOutcomeUnknown

7)

reactionmeddraversionpt18.1ReactionSleep apnoea syndromeOutcomeUnknown

8)

reactionmeddraversionpt18.1ReactionLimb discomfortOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductEFFEXOR XRdrugstructuredosagenumb150drugstructuredosageunit003drugdosagetext150 MG, UNKactiondrug1

activesubstance

activesubstancenameVENLAFAXINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020699Brand NameEFFEXOR XRGeneric NameVENLAFAXINE HYDROCHLORIDEManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0008-0833, 0008-0837, 0008-0836Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVENLAFAXINE HYDROCHLORIDERXCUI313581, 313583, 313585, 729929, 729931, 729932spl_id932efe9b-6185-488f-ac7b-5e12203a7821spl_set_id53c3e7ac-1852-4d70-d2b6-4fca819acf26Package NDC 0008-0837-20, 0008-0837-21, 0008-0837-22, 0008-0837-02, 0008-0837-03, 0008-0833- ... UNII7D7RX5A8MO

2)

drugcharacterization2medicinalproductLUNESTAactiondrug5

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

3)

drugcharacterization2medicinalproductEFFEXOR XRdrugstructuredosagenumb37.5drugstructuredosageunit003drugdosagetext37.5 MG, UNKdrugindicationANXIETYactiondrug1

activesubstance

activesubstancenameVENLAFAXINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020699Brand NameEFFEXOR XRGeneric NameVENLAFAXINE HYDROCHLORIDEManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0008-0833, 0008-0837, 0008-0836Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVENLAFAXINE HYDROCHLORIDERXCUI313581, 313583, 313585, 729929, 729931, 729932spl_id932efe9b-6185-488f-ac7b-5e12203a7821spl_set_id53c3e7ac-1852-4d70-d2b6-4fca819acf26Package NDC 0008-0837-20, 0008-0837-21, 0008-0837-22, 0008-0837-02, 0008-0837-03, 0008-0833- ... UNII7D7RX5A8MO

4)

drugcharacterization2medicinalproductEFFEXOR XRdrugstructuredosagenumb75drugstructuredosageunit003drugdosagetext75 MG, UNKactiondrug1

activesubstance

activesubstancenameVENLAFAXINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020699Brand NameEFFEXOR XRGeneric NameVENLAFAXINE HYDROCHLORIDEManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0008-0833, 0008-0837, 0008-0836Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVENLAFAXINE HYDROCHLORIDERXCUI313581, 313583, 313585, 729929, 729931, 729932spl_id932efe9b-6185-488f-ac7b-5e12203a7821spl_set_id53c3e7ac-1852-4d70-d2b6-4fca819acf26Package NDC 0008-0837-20, 0008-0837-21, 0008-0837-22, 0008-0837-02, 0008-0837-03, 0008-0833- ... UNII7D7RX5A8MO

5)

drugcharacterization2medicinalproductPRISTIQ EXTENDED RELEASEdrugindicationANXIETYactiondrug5

activesubstance

activesubstancenameDESVENLAFAXINE SUCCINATE

6)

drugcharacterization2medicinalproductSSRIactiondrug5

activesubstance

activesubstancenameUNSPECIFIED INGREDIENT

7)

drugcharacterization2medicinalproductZOLOFTdrugindicationANXIETYactiondrug1

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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_idca266f27-bd08-49ba-8d79-a6dba8699bd9spl_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

8)

drugcharacterization2medicinalproductEFFEXOR XRdrugstructuredosagenumb75drugstructuredosageunit003drugdosagetext75 MG, UNKactiondrug1

activesubstance

activesubstancenameVENLAFAXINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020699Brand NameEFFEXOR XRGeneric NameVENLAFAXINE HYDROCHLORIDEManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0008-0833, 0008-0837, 0008-0836Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVENLAFAXINE HYDROCHLORIDERXCUI313581, 313583, 313585, 729929, 729931, 729932spl_id932efe9b-6185-488f-ac7b-5e12203a7821spl_set_id53c3e7ac-1852-4d70-d2b6-4fca819acf26Package NDC 0008-0837-20, 0008-0837-21, 0008-0837-22, 0008-0837-02, 0008-0837-03, 0008-0833- ... UNII7D7RX5A8MO

9)

drugcharacterization1medicinalproductZYPREXAdrugauthorizationnumb28705drugdosageformTABLETactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameOLANZAPINE

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

10)

drugcharacterization2medicinalproductKLONOPINactiondrug5

activesubstance

activesubstancenameCLONAZEPAM

openFDA Info on Medication

Application NumberNDA017533Brand NameKLONOPINGeneric NameCLONAZEPAMManufacturersH2-Pharma, LLC, Genentech, Inc.product_ndc61269-605, 61269-610, 61269-620, 0004-0058, 0004-0068, 0004-0098Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI197527, 197528, 197529, 206157, 206159, 206160spl_id65d5607d-3926-4b60-97dc-18509af3f271, 0d423291-6115-4522-88db-dcd1096bd432spl_set_idcfa0d79a-843c-4b88-95a1-e9511d649ca1, 542f22e8-dad2-47a8-93b6-30936715d73bPackage NDC 61269-605-10, 61269-610-10, 61269-620-10, 0004-0068-01, 0004-0058-01, 0004-0098- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB