Adverse Event Report

Report

Version of Safety Report ID4Safety Report ID10548557primarysourcecountryJPoccurcountryJPtransmissiondateformat102transmissiondate20/07/2015reporttype1serious1seriousnesslifethreatening1seriousnesshospitalization1seriousnessdisabling1seriousnessother1receivedateformat102Date Received28/10/2014receiptdateformat102Date Last Updated30/01/2015fulfillexpeditecriteria1companynumbJP-PFIZER INC-2014295677duplicate1

Report Duplicate

duplicatesourcePFIZERduplicatenumbJP-PFIZER INC-2014295677

Primary Source

reportercountryJPqualification1literaturereference MORI, M. A CASE OF DYSTHYMIA RESULTED IN UNSUCCESSFUL SUICIDE, WHICH WAS CAUSED ...

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age56Unit of Onset AgeyearsWeight49SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionToxicity to various agentsOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.0ReactionDisease progressionOutcomeRecovering/resolving

3)

reactionmeddraversionpt18.0ReactionSuicidal ideationOutcomeRecovering/resolving

4)

reactionmeddraversionpt18.0ReactionAcute respiratory failureOutcomeRecovered/resolved

5)

reactionmeddraversionpt18.0ReactionAltered state of consciousnessOutcomeRecovered/resolved

6)

reactionmeddraversionpt18.0ReactionDecreased appetiteOutcomeRecovered/resolved

7)

reactionmeddraversionpt18.0ReactionNeuropathy peripheralOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt18.0ReactionDepressionOutcomeRecovering/resolving

9)

reactionmeddraversionpt18.0ReactionFallOutcomeRecovered/resolved

10)

reactionmeddraversionpt18.0ReactionMuscular weaknessOutcomeRecovered/resolved

11)

reactionmeddraversionpt18.0ReactionHypoaesthesiaOutcomeRecovering/resolving

Drug

1)

drugcharacterization2medicinalproductROHYPNOLdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 MG, 1X/DAYdrugadministrationroute048drugindicationINSOMNIAdrugenddateformat102drugenddate23/10/2013

activesubstance

activesubstancenameFLUNITRAZEPAM

2)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 MG, 1X/DAYdrugadministrationroute048drugindicationINSOMNIAdrugenddateformat102drugenddate23/10/2013

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)

drugcharacterization2medicinalproductBOFU-TSUSHO-SANdrugstructuredosagenumb2.5drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2.5 MG, 3X/DAYdrugadministrationroute048drugindicationCONSTIPATIONdrugenddateformat102drugenddate23/10/2013

4)

drugcharacterization2medicinalproductDEPAKENEdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext200 MG, 1X/DAYdrugadministrationroute048drugindicationDYSTHYMIC DISORDERdrugenddateformat102drugenddate23/10/2013

activesubstance

activesubstancenameVALPROIC ACID

5)

drugcharacterization1medicinalproductCHAMPIXdrugauthorizationnumb021928drugcumulativedosagenumb62drugcumulativedosageunit003drugdosageformFILM-COATED TABLETdrugindicationSMOKING CESSATION THERAPYactiondrug1

activesubstance

activesubstancenameVARENICLINE TARTRATE

6)

drugcharacterization2medicinalproductTERBINAFINEdrugstructuredosagenumb125drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext125 MG, 1X/DAYdrugadministrationroute048drugindicationONYCHOMYCOSISdrugenddateformat102drugenddate23/10/2013

activesubstance

activesubstancenameTERBINAFINE

openFDA Info on Medication

Application NumberANDA078297, ANDA078199, ANDA077533Brand NameTERBINAFINEGeneric NameTERBINAFINE HYDROCHLORIDE, TERBINAFINEManufacturers NorthStar Rx LLC, Chartwell RX, LLC, Cipla USA Inc., Exelan Pharmaceuticals Inc. ... product_ndc16714-795, 62135-572, 69097-859, 76282-209, 65862-079Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTERBINAFINE HYDROCHLORIDERXCUI313222spl_id 9189c83d-3c2b-4802-9ad6-7fd0a143d689, d9e27771-cf0b-7886-e053-2995a90a7bcf, 05ca ... spl_set_id 8f87e3e1-4c9c-497a-af20-8ab52cfeef60, 8ea693ec-e2f2-4661-b144-17651018e9fb, 18b1 ... Package NDC 16714-795-01, 16714-795-02, 62135-572-30, 62135-572-90, 69097-859-07, 69097-859- ... UNII012C11ZU6G

7)

drugcharacterization2medicinalproductSEROQUELdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, 1X/DAYdrugadministrationroute048drugenddateformat102drugenddate23/10/2013

activesubstance

activesubstancenameQUETIAPINE FUMARATE

openFDA Info on Medication

Application NumberNDA022047, NDA020639Brand NameSEROQUEL XR, SEROQUELGeneric NameQUETIAPINEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0310-0280, 0310-0282, 0310-0283, 0310-0284, 0310-0281, 0310-0271, 0310-0275, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI 721791, 721793, 721794, 721795, 721796, 721797, 853201, 853202, 895670, 895671, ... spl_idc3b26ed5-6f3a-4ca5-80a5-b98380040294, 37cb4cbf-8192-4921-b17c-e562467fc018spl_set_id473a3ac4-67f4-4782-baa9-7f9bdd8761f4, 0584dda8-bc3c-48fe-1a90-79608f78e8a0Package NDC 0310-0282-39, 0310-0282-94, 0310-0282-60, 0310-0283-39, 0310-0283-55, 0310-0283- ... UNII2S3PL1B6UJ

8)

drugcharacterization2medicinalproductDEPASdrugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MG, 1X/DAYdrugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugenddateformat102drugenddate23/10/2013

activesubstance

activesubstancenameETIZOLAM

9)

drugcharacterization2medicinalproductAKINETONdrugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MG, 2X/DAYdrugadministrationroute048drugindicationPARKINSONISMdrugenddateformat102drugenddate23/10/2013

activesubstance

activesubstancenameBIPERIDEN HYDROCHLORIDE

10)

drugcharacterization2medicinalproductHALCIONdrugstructuredosagenumb.25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.25 MG, 1X/DAYdrugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugenddateformat102drugenddate23/10/2013

activesubstance

activesubstancenameTRIAZOLAM

openFDA Info on Medication

Application NumberNDA017892Brand NameHALCIONGeneric NameTRIAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc0009-0017Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTRIAZOLAMRXCUI198318, 208681spl_id35f32dcf-f1d8-4656-b982-02f5a9ede2c4spl_set_ida0da0dba-a56d-486b-a45b-e8a7cdfbeac6Package NDC0009-0017-55, 0009-0017-58NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII1HM943223R

11)

drugcharacterization2medicinalproductALPRAZOLAM.drugstructuredosagenumb.8drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.8 MG, 1X/DAYdrugadministrationroute048drugindicationDYSTHYMIC DISORDERdrugenddateformat102drugenddate23/10/2013

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA074174 ... Brand NameALPRAZOLAM, XANAX XR, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZOLAM XRGeneric NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia & Upjohn Comp ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 687022, 687023, ... spl_id 94163352-f78e-400a-b7da-b3075e9213eb, 35398b0f-4f2a-4504-b254-bb6010a4101e, f364 ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

12)

drugcharacterization2medicinalproductLUVOXdrugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext500 MG, 1X/DAYdrugadministrationroute048drugindicationDEPRESSIONdrugenddateformat102drugenddate23/10/2013

activesubstance

activesubstancenameFLUVOXAMINE MALEATE

13)

drugcharacterization1medicinalproductCHAMPIXdrugauthorizationnumb021928drugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb62drugcumulativedosageunit003drugdosagetext1.0 MG, 2X/DAYdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugindicationNICOTINE DEPENDENCEdrugstartdateformat102drugstartdate17/09/2013drugenddateformat102drugenddate23/10/2013actiondrug1

activesubstance

activesubstancenameVARENICLINE TARTRATE

14)

drugcharacterization2medicinalproductHIRNAMINdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext25 MG, 1X/DAYdrugadministrationroute048drugindicationDEPRESSIONdrugenddateformat102drugenddate23/10/2013

activesubstance

activesubstancenamePHENOTHIAZINE

15)

drugcharacterization2medicinalproductSEROQUELdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext25 MG, 1X/DAYdrugadministrationroute048drugindicationDEPRESSIONdrugenddateformat102drugenddate23/10/2013

activesubstance

activesubstancenameQUETIAPINE FUMARATE

openFDA Info on Medication

Application NumberNDA022047, NDA020639Brand NameSEROQUEL XR, SEROQUELGeneric NameQUETIAPINEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0310-0280, 0310-0282, 0310-0283, 0310-0284, 0310-0281, 0310-0271, 0310-0275, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI 721791, 721793, 721794, 721795, 721796, 721797, 853201, 853202, 895670, 895671, ... spl_idc3b26ed5-6f3a-4ca5-80a5-b98380040294, 37cb4cbf-8192-4921-b17c-e562467fc018spl_set_id473a3ac4-67f4-4782-baa9-7f9bdd8761f4, 0584dda8-bc3c-48fe-1a90-79608f78e8a0Package NDC 0310-0282-39, 0310-0282-94, 0310-0282-60, 0310-0283-39, 0310-0283-55, 0310-0283- ... UNII2S3PL1B6UJ

16)

drugcharacterization2medicinalproductABILIFYdrugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext3 MG, 1X/DAYdrugadministrationroute048drugindicationDEPRESSIONdrugenddateformat102drugenddate23/10/2013

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

17)

drugcharacterization2medicinalproductVEGETAMIN Adrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, 1X/DAYdrugadministrationroute048drugindicationNEUROSISdrugenddateformat102drugenddate23/10/2013

activesubstance

activesubstancenameCHLORPROMAZINE HYDROCHLORIDE\PHENOBARBITAL\PROMETHAZINE

summary

narrativeincludeclinicalCASE EVENT DATE: 20130917