Adverse Event Report

Report

reporttype1Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10274423serious1Date Last Updated23/07/2014receiptdateformat102authoritynumbGB-MHRA-EYC 00112178companynumbGB-WATSON-2014-14257occurcountryGBseriousnessother1duplicate1Date Received02/07/2014seriousnesshospitalization1transmissiondate20/07/2015primarysourcecountryGBseriousnessdisabling1

Primary Source

reportercountryGBqualification5

Patient

Onset Age36Unit of Onset AgeyearsWeight57SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionFatigueOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.0ReactionPainOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.0ReactionParaesthesiaOutcomeUnknown

4)

reactionmeddraversionpt18.0ReactionEnergy increasedOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionTremorOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt18.0ReactionUrinary tract infectionOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt18.0ReactionVisual impairmentOutcomeUnknown

8)

reactionmeddraversionpt18.0ReactionFallOutcomeUnknown

9)

reactionmeddraversionpt18.0ReactionLoss of consciousnessOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt18.0ReactionDysarthriaOutcomeUnknown

11)

reactionmeddraversionpt18.0ReactionFaecal incontinenceOutcomeUnknown

12)

reactionmeddraversionpt18.0ReactionAstheniaOutcomeUnknown

13)

reactionmeddraversionpt18.0ReactionMemory impairmentOutcomeUnknown

14)

reactionmeddraversionpt18.0ReactionErythemaOutcomeNot recovered/not resolved

15)

reactionmeddraversionpt18.0ReactionContusionOutcomeNot recovered/not resolved

16)

reactionmeddraversionpt18.0ReactionSeizureOutcomeNot recovered/not resolved

17)

reactionmeddraversionpt18.0ReactionHeadacheOutcomeUnknown

18)

reactionmeddraversionpt18.0ReactionJoint stiffnessOutcomeNot recovered/not resolved

19)

reactionmeddraversionpt18.0ReactionWeight decreasedOutcomeNot recovered/not resolved

20)

reactionmeddraversionpt18.0ReactionConfusional stateOutcomeNot recovered/not resolved

21)

reactionmeddraversionpt18.0ReactionDizzinessOutcomeNot recovered/not resolved

22)

reactionmeddraversionpt18.0ReactionFeeling drunkOutcomeUnknown

23)

reactionmeddraversionpt18.0ReactionSleep disorderOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductMIRTAZAPINE (UNKNOWN)drugdosageformUNKdrugindicationANXIETYactiondrug5

activesubstance

activesubstancenameMIRTAZAPINE

2)

drugcharacterization1medicinalproductSERTRALINEdrugbatchnumbUNCONFIRMEDdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, UNKNOWNdrugdosageformUNKdrugadministrationroute048drugindicationANXIETYactiondrug5

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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

3)

drugcharacterization1medicinalproductZYRTECdrugindicationANXIETYactiondrug5

activesubstance

activesubstancenameCETIRIZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022429Brand NameZYRTECGeneric NameCETIRIZINE HYDROCHLORIDEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-779Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCETIRIZINE HYDROCHLORIDERXCUI1014675, 1020023spl_idd7532844-79d8-4648-ab9b-e5d3d3ad76f9spl_set_id605adf29-734f-451a-8ff3-74be7b5814a6Package NDC50580-779-12, 50580-779-25, 50580-779-40, 50580-779-65UNII64O047KTOA

4)

drugcharacterization2medicinalproductBUCCASTEMdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

5)

drugcharacterization2medicinalproductPARACETAMOLdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameACETAMINOPHEN

6)

drugcharacterization1medicinalproductTRAMADOL (UNKNOWN)drugbatchnumbUNCONFIRMEDdrugauthorizationnumb075960drugdosagetextUNKdrugdosageformUNKdrugadministrationroute065drugindicationDEPRESSIONactiondrug5

activesubstance

activesubstancenameTRAMADOL

7)

drugcharacterization2medicinalproductSALBUTAMOLdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameALBUTEROL

8)

drugcharacterization2medicinalproductFOSTAIRdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameBECLOMETHASONE\FORMOTEROL

9)

drugcharacterization1medicinalproductSERTRALINEdrugdosageformUNKdrugindicationDEPRESSIONactiondrug5

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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

10)

drugcharacterization1medicinalproductTRAMADOL (UNKNOWN)drugauthorizationnumb075960drugdosageformUNKdrugindicationANXIETYactiondrug5

activesubstance

activesubstancenameTRAMADOL

11)

drugcharacterization1medicinalproductZYRTECdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNKNOWNdrugadministrationroute048drugindicationDEPRESSIONactiondrug5

activesubstance

activesubstancenameCETIRIZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022429Brand NameZYRTECGeneric NameCETIRIZINE HYDROCHLORIDEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-779Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCETIRIZINE HYDROCHLORIDERXCUI1014675, 1020023spl_idd7532844-79d8-4648-ab9b-e5d3d3ad76f9spl_set_id605adf29-734f-451a-8ff3-74be7b5814a6Package NDC50580-779-12, 50580-779-25, 50580-779-40, 50580-779-65UNII64O047KTOA

12)

drugcharacterization2medicinalproductCLARITHROMYCIN.drugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameCLARITHROMYCIN

openFDA Info on Medication

Application Number ANDA208987, ANDA065154, ANDA065489, ANDA065145, ANDA065283, ANDA065266, ANDA0651 ... Brand NameCLARITHROMYCINGeneric NameCLARITHROMYCINManufacturers Lannett Company, Inc., Mayne Pharma Inc., Rising Health, LLC, Actavis Pharma, In ... product_ndc 0527-1930, 51862-194, 57237-044, 57237-045, 0591-2805, 0781-6022, 0781-6023, 646 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLARITHROMYCINRXCUI359385, 197516, 197517, 240741, 309322spl_id 97aea49b-a3a7-c095-e053-2995a90aea23, a7b86340-70de-4683-96bf-83858f873a3b, 4fe3 ... spl_set_id 71a836d0-d60f-6418-e053-2a95a90aa6ef, 75e56d3d-4c84-48b7-ae08-24f664fc0658, 0c4d ... Package NDC 0527-1930-06, 51862-194-60, 57237-044-60, 57237-045-60, 0591-2805-60, 0781-6022- ... NUIN0000175935, M0028311, N0000182141, N0000190114, N0000185503Established Pharmacologic ClassMacrolide Antimicrobial [EPC]Chemical StructureMacrolides [CS]Mechanism of Action Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Gly ... UNIIH1250JIK0A

13)

drugcharacterization2medicinalproductLORAZEPAM.drugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application Number ANDA076150, NDA018140, ANDA203572, ANDA074282, ANDA072755, ANDA090260, ANDA07502 ... Brand NameLORAZEPAM, ATIVANGeneric NameLORAZEPAMManufacturers International Medication Systems, Limited, West-Ward Pharmaceuticals Corp., Auro ... product_ndc 76329-8261, 0641-6207, 13107-083, 13107-084, 13107-085, 0409-6778, 0054-3532, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsLORAZEPAMRXCUI 238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 763028, 763029 ... spl_id decb713d-bc45-4bf5-8f61-c0e2f23051b0, eb500b8e-b94e-4900-bc8a-8217fc718704, e1fa ... spl_set_id 7dda070d-7809-46c4-8592-eb4e4c509707, b79b38ee-c29d-4099-964f-000031f47f5a, 5b85 ... Package NDC 76329-8261-1, 0641-6207-01, 0641-6207-25, 13107-083-10, 13107-083-01, 13107-083- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

14)

drugcharacterization2medicinalproductPREDNISOLONE.drugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenamePREDNISOLONE

openFDA Info on Medication

Application NumberANDA040401, ANDA080354, ANDA202179, ANDA040775Brand NamePREDNISOLONE, MILLIPRED, PREDNISOLONE SODIUM PHOSPHATEGeneric NamePREDNISOLONEManufacturers Hi-Tech Pharmacal Co., Inc., Aytu Therapeutics, Mylan Pharmaceuticals Inc., Lann ... product_ndc50383-042, 23594-505, 0378-4710, 0378-4715, 0378-4730, 0527-5406Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISOLONE, PREDNISOLONE SODIUM PHOSPHATERXCUI 283077, 198142, 808118, 1005830, 1005831, 1013114, 1235042, 643123, 643125, 6431 ... spl_id c4cdae5e-103f-47b3-90b9-8797c544136e, 53c7d3cf-3691-4150-b720-d592931737db, 13ad ... spl_set_id 6b201232-4a52-487c-b963-a98539469e5d, 863ad743-eec0-46f0-beba-c1556384c636, f658 ... Package NDC 50383-042-48, 50383-042-24, 23594-505-01, 23594-505-50, 23594-505-02, 23594-505- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNII9PHQ9Y1OLM, IV021NXA9J

15)

drugcharacterization2medicinalproductVENLAFAXINEdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameVENLAFAXINE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA211323, ANDA079098, ANDA206250, ANDA078627, ANDA078932, ANDA090555, ANDA0776 ... Brand NameVENLAFAXINE, VENLAFAXINE HYDROCHLORIDEGeneric NameVENLAFAXINE, VENLAFAXINE HYDROCHLORIDEManufacturers Cadila Pharmaceuticals Limited, Amneal Pharmaceuticals LLC, Sun Pharmaceutical I ... product_ndc 71209-087, 71209-088, 71209-089, 65162-300, 65162-302, 65162-306, 65162-307, 651 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVENLAFAXINE HYDROCHLORIDERXCUI808744, 808748, 808753, 313580, 313582, 313584, 313586, 314277, 808751spl_id f0cda912-3f9e-4f18-a55e-a5cc80bd2e7a, 11f387e7-a398-4a1f-90d8-7454e9bd499d, a3b2 ... spl_set_id 516e7566-35c2-4a25-88d8-54d9dbc8f6be, 62c02cdb-ea65-41ff-a531-4d9ea498f705, 2ed6 ... Package NDC 71209-087-01, 71209-087-04, 71209-087-11, 71209-088-01, 71209-088-04, 71209-088- ... UNII7D7RX5A8MO

16)

drugcharacterization1medicinalproductMIRTAZAPINE (UNKNOWN)drugbatchnumbUNCONFIRMEDdrugstructuredosagenumb30drugstructuredosageunit003drugdosagetext30 MG, UNKNOWNdrugdosageformUNKdrugadministrationroute048drugindicationDEPRESSIONactiondrug5

activesubstance

activesubstancenameMIRTAZAPINE

17)

drugcharacterization2medicinalproductACICLOVIRdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameACYCLOVIR

18)

drugcharacterization2medicinalproductCLOZAPINE.drugdosagetextUNKdrugadministrationroute065drugindicationINSOMNIAactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

Application Number ANDA203807, ANDA206433, ANDA075713, NDA019758, ANDA203039, ANDA090308, NDA203479 ... Brand NameCLOZAPINE, VERSACLOZ, CLOZARIL, FAZACLOGeneric NameCLOZAPINEManufacturers Mayne Pharma, Aurobindo Pharma Limited, Sun Pharmaceutical Industries, Inc., San ... product_ndc 51862-900, 51862-901, 51862-902, 51862-903, 65862-844, 65862-845, 65862-846, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLOZAPINERXCUI 197535, 197536, 309374, 429212, 996921, 1006801, 476177, 476179, 721773, 1369825 ... spl_id 1c8cbfec-b968-45f6-982e-3b1ae865ffb5, bfffe563-bd1f-44ce-bb33-b064dc1186c3, 6236 ... spl_set_id 9f10ba5d-40f7-42bf-bda8-d262abeb0059, 5021d643-32d2-4167-b5d8-90870e68a787, 53bd ... Package NDC 51862-900-01, 51862-900-05, 51862-901-01, 51862-901-05, 51862-902-01, 51862-902- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIJ60AR2IKIC

19)

drugcharacterization2medicinalproductLACTULOSE.drugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameLACTULOSE

openFDA Info on Medication

Application Number ANDA074076, ANDA074623, ANDA074712, ANDA090503, ANDA203762, ANDA075993, ANDA2095 ... Brand NameLACTULOSE, KRISTALOSE, CONSTULOSE, ENULOSE, GENERLACGeneric NameLACTULOSEManufacturers Hi-Tech Pharmacal Co., Inc., Pharmaceutical Associates, Inc,, Cumberland Pharmac ... product_ndc 50383-779, 0121-0577, 0121-4577, 0121-1154, 66220-719, 66220-729, 45963-439, 136 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, RECTALActive IngredientsLACTULOSERXCUI391937, 1251190, 1251192, 1251194, 1251196, 544452, 755470, 544455spl_id 841d4b42-5176-4d3d-ac1c-4d10c535fbb3, 9c9999b9-8d1e-67f7-e053-2995a90aac96, 22d5 ... spl_set_id 19455240-16b6-4e25-a5c9-a6c965e5ec19, 0f19e4ed-c90a-4330-a7fa-bf911aa98f09, 535d ... Package NDC 50383-779-15, 50383-779-17, 50383-779-30, 50383-779-31, 50383-779-33, 50383-779- ... NUIN0000175811, N0000010288, N0000175833, N0000009871Established Pharmacologic ClassOsmotic Laxative [EPC]Mechanism of ActionOsmotic Activity [MoA], Acidifying Activity [MoA]Physiologic/Pharmacodynamic EffectStimulation Large Intestine Fluid/Electrolyte Secretion [PE]UNII9U7D5QH5AE

Report Duplicate

duplicatesourceACTAVISduplicatenumbGB-WATSON-2014-14257

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use