Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10053467serious1Date Last Updated08/04/2014receiptdateformat102companynumbPHFR2005GB04007occurcountryGBseriousnessother1duplicate1Date Received02/04/2014transmissiondate12/12/2014primarysourcecountryGB

Primary Source

reportercountryGBqualification1

Patient

Onset Age45Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionVentricular extrasystolesOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionExtrasystolesOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionCondition aggravatedOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionDiabetes mellitusOutcomeRecovering/resolving

5)

reactionmeddraversionpt17.0ReactionBlood glucose increasedOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionSinus tachycardiaOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb300drugstructuredosageunit003drugdosagetext300 MG, UNKdrugadministrationroute048drugindicationOBSESSIVE-COMPULSIVE DISORDERdrugstartdateformat102drugstartdate14/11/2005actiondrug1drugrecurreadministration3

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_idac5dfac8-8e46-f80d-4152-41ac7a909ce4spl_set_id90876802-0e3a-44c9-9ff7-1754dfbe736aPackage NDC69809-0126-5, 69809-0127-5, 69809-0130-5, 69809-0135-5NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIJ60AR2IKIC

2)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb100drugstructuredosageunit003drugdosagetext100 MG, UNKdrugadministrationroute048drugindicationOFF LABEL USEdrugstartdateformat102drugstartdate16/11/2005actiondrug1drugrecurreadministration3

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_idac5dfac8-8e46-f80d-4152-41ac7a909ce4spl_set_id90876802-0e3a-44c9-9ff7-1754dfbe736aPackage NDC69809-0126-5, 69809-0127-5, 69809-0130-5, 69809-0135-5NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIJ60AR2IKIC

3)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb200drugstructuredosageunit003drugdosagetext200 MG, UNKdrugadministrationroute048actiondrug1drugrecurreadministration3

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_idac5dfac8-8e46-f80d-4152-41ac7a909ce4spl_set_id90876802-0e3a-44c9-9ff7-1754dfbe736aPackage NDC69809-0126-5, 69809-0127-5, 69809-0130-5, 69809-0135-5NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIJ60AR2IKIC

4)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugdosagetextUNKdrugadministrationroute048drugstartdateformat602drugstartdate//2007drugenddateformat602drugenddate//2009actiondrug1drugrecurreadministration3

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_idac5dfac8-8e46-f80d-4152-41ac7a909ce4spl_set_id90876802-0e3a-44c9-9ff7-1754dfbe736aPackage NDC69809-0126-5, 69809-0127-5, 69809-0130-5, 69809-0135-5NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIJ60AR2IKIC

5)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758actiondrug1drugrecurreadministration3

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_idac5dfac8-8e46-f80d-4152-41ac7a909ce4spl_set_id90876802-0e3a-44c9-9ff7-1754dfbe736aPackage NDC69809-0126-5, 69809-0127-5, 69809-0130-5, 69809-0135-5NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIJ60AR2IKIC

6)

drugcharacterization2medicinalproductMETOPROLOLdrugstructuredosagenumb12.5drugstructuredosageunit003drugdosagetext12.5 MG, UNKdrugadministrationroute048drugindicationCARDIAC DISORDERactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberANDA078950, ANDA091045, ANDA202871Brand NameMETOPROLOL, METOPROLOL TARTRATEGeneric NameMETOPROLOL TARTRATE, METOPROLOLManufacturers Baxter Healthcare Corporation, Fresenius Kabi USA, LLC, Alembic Pharmaceuticals ... product_ndc 36000-033, 63323-660, 62332-112, 62332-113, 62332-114, 46708-290, 46708-291, 467 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsMETOPROLOL TARTRATERXCUI866508, 866511, 866514, 866924spl_id 202a1ff0-38f7-4bf2-ade7-6ede8fa64486, 94a4f468-def9-95b9-e053-2995a90a3428, bd31 ... spl_set_id 09566368-f91d-43a3-b683-30c844fb125a, be1c686e-37a5-4a53-945b-68a6ead35134, 2483 ... Package NDC 36000-033-10, 63323-660-05, 62332-112-30, 62332-112-31, 62332-112-91, 62332-113- ... UNIIW5S57Y3A5L

7)

drugcharacterization2medicinalproductRAMIPRILdrugstructuredosagenumb2.5drugstructuredosageunit003drugdosagetext2.5 MG, UNKdrugadministrationroute048drugindicationCARDIAC DISORDERactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA077626, ANDA078832, NDA019901, ANDA090697, ANDA077900, ANDA091604, ANDA20239 ... Brand NameRAMIPRIL, ALTACEGeneric NameRAMIPRILManufacturers Lupin Pharmaceuticals, Inc., Cadila Healthcare Limited, Pfizer Laboratories Div ... product_ndc 68180-589, 68180-588, 68180-590, 68180-591, 65841-655, 65841-656, 65841-657, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRAMIPRILRXCUI 198188, 198189, 261962, 845488, 104384, 104385, 260333, 845489, 251856, 251857, ... spl_id 4b7f8574-0917-4473-a291-6fe01b23ef30, 5c6923e7-888e-4ea4-a32b-7f0dffe52231, adc2 ... spl_set_id a8cdec12-81d1-4ef4-82c0-d05d93c37a07, 496b346b-ca79-4483-a950-bed9464e6a9d, 0fc3 ... Package NDC 68180-588-01, 68180-588-09, 68180-588-02, 68180-589-01, 68180-589-09, 68180-589- ... NUIN0000175562, N0000000181Established Pharmacologic ClassAngiotensin Converting Enzyme Inhibitor [EPC]Mechanism of ActionAngiotensin-converting Enzyme Inhibitors [MoA]UNIIL35JN3I7SJ

8)

drugcharacterization2medicinalproductASPIRINEdrugdosagetextUNKdrugadministrationroute048drugindicationCARDIAC DISORDERactiondrug5drugrecurreadministration3

9)

drugcharacterization2medicinalproductATORVASTATINdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG/DAYdrugadministrationroute048drugindicationBLOOD CHOLESTEROL INCREASEDactiondrug5drugrecurreadministration3

openFDA Info on Medication

10)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb150drugstructuredosageunit003drugdosagetext150 MG/DAYdrugadministrationroute048drugindicationDEPRESSIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

Report Duplicate

duplicatesourceNOVARTISduplicatenumbPHFR2005GB04007

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use