Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11535966primarysourcecountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious1seriousnessdisabling1receivedateformat102Date Received21/09/2015receiptdateformat102Date Last Updated21/09/2015fulfillexpeditecriteria2

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age32Unit of Onset AgeyearsWeight90.72SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionAlopecia

Drug

1)

drugcharacterization2medicinalproductREMERON

activesubstance

activesubstancenameMIRTAZAPINE

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

2)

drugcharacterization2medicinalproductKLONOPIN

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

3)

drugcharacterization2medicinalproductLITHIUM.

activesubstance

activesubstancenameLITHIUM

openFDA Info on Medication

Application NumberNDA018421Brand NameLITHIUMGeneric NameLITHIUM, LITHIUM BROMATUMManufacturersHikma Pharmaceuticals USA Inc., Marco Pharma International LLC.product_ndc 0054-3527, 0054-8528, 0054-4527, 0054-8526, 0054-2526, 0054-8527, 0054-2527, 005 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsLITHIUM CITRATE, LITHIUM BROMIDERXCUI197889, 197890, 197893, 311355, 756059spl_id5975b89d-ea10-48d7-8de8-5d38dff2c0bd, d2bf5b96-6ae5-93a3-e053-2995a90a7a34spl_set_id7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e, f4a1d451-33ad-4df3-ae68-58cfbfccfa89Package NDC 0054-8528-25, 0054-4527-25, 0054-4527-31, 0054-8526-25, 0054-2526-25, 0054-8527- ... UNII5Z6E9K79YV, 2BMD2GNA4V, 864G646I84

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)

drugcharacterization1medicinalproductMIRTAZAPINE 45 MG APOTXdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 PILLdrugadministrationroute048drugindicationPSYCHOTIC DISORDERdrugadditional2

activesubstance

activesubstancenameMIRTAZAPINE

6)

drugcharacterization2medicinalproductEFFEXOR XR

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

7)

drugcharacterization1medicinalproductMIRTAZAPINE 45 MG APOTXdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 PILLdrugadministrationroute048drugindicationMAJOR DEPRESSIONdrugadditional2

activesubstance

activesubstancenameMIRTAZAPINE

8)

drugcharacterization2medicinalproductINDERAL

activesubstance

activesubstancenamePROPRANOLOL HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA018553Brand NameINDERAL LAGeneric NamePROPRANOLOL HYDROCHLORIDEManufacturersANI Pharmaceuticals, Inc.product_ndc62559-520, 62559-521, 62559-522, 62559-523Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPROPRANOLOL HYDROCHLORIDERXCUI856460, 856462, 856481, 856483, 856535, 856537, 856569, 856571spl_idc5f105d2-6601-4538-b70d-b094694b15f6spl_set_id35d28979-36b1-4630-b85e-a44e0a443734Package NDC62559-520-01, 62559-521-01, 62559-522-01, 62559-523-01UNIIF8A3652H1V

9)

drugcharacterization1medicinalproductMIRTAZAPINE 45 MG APOTXdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 PILLdrugadministrationroute048drugindicationANXIETYdrugadditional2

activesubstance

activesubstancenameMIRTAZAPINE

10)

drugcharacterization2medicinalproductTOPAMAX

activesubstance

activesubstancenameTOPIRAMATE

openFDA Info on Medication

Application NumberNDA020505, NDA020844Brand NameTOPAMAXGeneric NameTOPIRAMATEManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-639, 50458-640, 50458-641, 50458-642, 50458-647, 50458-645Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOPIRAMATERXCUI 151226, 151227, 151228, 151229, 152855, 199888, 199889, 199890, 205315, 205316, ... spl_id095baa56-cc0a-4711-b8e4-49b1401b699espl_set_id21628112-0c47-11df-95b3-498d55d89593Package NDC 50458-639-65, 50458-640-65, 50458-641-65, 50458-642-65, 50458-647-65, 50458-645- ... NUIN0000008486, N0000185506, N0000182140Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Mechanism of ActionCytochrome P450 3A4 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNII0H73WJJ391

11)

drugcharacterization2medicinalproductDEXILANT

activesubstance

activesubstancenameDEXLANSOPRAZOLE

openFDA Info on Medication

Application NumberNDA022287Brand NameDEXILANTGeneric NameDEXLANSOPRAZOLEManufacturersTakeda Pharmaceuticals America, Inc.product_ndc64764-171, 64764-175Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDEXLANSOPRAZOLERXCUI833204, 833213, 902624, 902626spl_ide8db649c-1cef-4838-a2e9-1262b2ba4c34spl_set_id9819f033-3bbe-442e-8e92-45fec77b237dPackage NDC 64764-171-30, 64764-171-90, 64764-171-19, 64764-171-11, 64764-171-01, 64764-171- ... NUIN0000175525, N0000000147Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA]UNIIUYE4T5I70X

summary

narrativeincludeclinicalCASE EVENT DATE: 20150515