Adverse Event Report

Report

reporttype1receiptdateformat102companynumbB0986081AVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10109992Date Received24/04/2014seriousnesshospitalization1transmissiondate12/12/2014serious1Date Last Updated24/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age9Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionAnticholinergic syndrome

2)

reactionmeddraversionpt17.0ReactionMental status changes

3)

reactionmeddraversionpt17.0ReactionHallucination

4)

reactionmeddraversionpt17.0ReactionMydriasis

5)

reactionmeddraversionpt17.0ReactionTachycardia

6)

reactionmeddraversionpt17.0ReactionPyrexia

7)

reactionmeddraversionpt17.0ReactionSerotonin syndrome

8)

reactionmeddraversionpt17.0ReactionTreatment failure

9)

reactionmeddraversionpt17.0ReactionVision blurred

10)

reactionmeddraversionpt17.0ReactionClonus

Drug

1)

drugcharacterization1medicinalproductSERTRALINEdrugauthorizationnumb20007drugadministrationroute048drugindicationANXIETYdrugadditional1

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

2)

drugcharacterization1medicinalproductHYOSCYAMINEdrugindicationANXIETYdrugadditional1

openFDA Info on Medication

Brand NameHYOSCYAMINE, HYOSCYAMINE ER, HYOSCYAMINE SLGeneric NameHYOSCYAMINE SULFATEManufacturersPatrin Pharma, Wallace Pharmaceuticals Inc.product_ndc39328-048, 51525-0112, 51525-0115, 51525-0113, 39328-047Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYOSCYAMINE SULFATERXCUI1047881, 1047905, 1046770, 1046982, 1047895spl_id 12f9afe0-1263-4198-a6b4-6ce44479e3b3, ae0d2b1d-1ac2-4521-9de7-08c0d0e30413, a627 ... spl_set_id e09f23ca-e6f8-46c3-b713-97b86e3d5c97, 9fb71fa2-2ce8-429e-8719-58f3b12a6163, 5bbc ... Package NDC39328-048-16, 51525-0112-1, 51525-0115-1, 51525-0113-1, 39328-047-15UNIIF2R8V82B84

3)

drugcharacterization1medicinalproductONDANSETRON HYDROCHLORIDEdrugindicationANXIETYdrugadditional1

openFDA Info on Medication

Application Number ANDA076183, ANDA078539, ANDA078776, ANDA090116, ANDA077729, NDA020103, ANDA07697 ... Brand NameONDANSETRON HYDROCHLORIDE, ONDANSETRON, ZOFRANGeneric NameONDANSETRON HYDROCHLORIDE, ONDANSETRONManufacturers Dr. Reddy's Laboratories Limited, Aurobindo Pharma Limited, NorthStar Rx LLC, La ... product_ndc 55111-153, 55111-154, 55111-156, 65862-187, 65862-188, 65862-189, 16714-671, 052 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsONDANSETRON HYDROCHLORIDERXCUI 198052, 312084, 312086, 312085, 283504, 1740467, 104895, 104896, 692695, 1314133 ... spl_id 7112c99c-2cce-1faa-5d82-45b0fd973bb0, 6e42aef7-5459-4ee3-9e3a-7d6d6d8a9b1c, f821 ... spl_set_id 162f2088-9fb1-47e7-b88c-45104be7e7bb, 57578387-1918-4e56-a564-f14fb22340bf, ac3d ... Package NDC 55111-153-30, 55111-153-01, 55111-153-05, 55111-153-78, 55111-153-13, 55111-154- ... UNIINMH84OZK2B, 4AF302ESOSNUIN0000175817, N0000175818Mechanism of ActionSerotonin 3 Receptor Antagonists [MoA]Established Pharmacologic ClassSerotonin-3 Receptor Antagonist [EPC]

4)

drugcharacterization1medicinalproductMONTELUKAST SODIUMdrugindicationANXIETY

openFDA Info on Medication

Application Number ANDA204093, ANDA204604, ANDA205683, ANDA205695, ANDA090984, ANDA201515, ANDA2104 ... Brand NameMONTELUKAST SODIUM, SINGULAIRGeneric NameMONTELUKAST SODIUM, MONTELUKASTManufacturers Camber Pharmaceuticals, Inc., Amneal Pharmaceuticals LLC, Hangzhou Minsheng Binj ... product_ndc 31722-727, 31722-728, 65162-732, 60723-010, 70436-090, 70436-091, 13668-079, 136 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST, MONTELUKAST SODIUMRXCUI242438, 311759, 200224, 351246, 153892, 153893, 261367, 404406spl_id 533559ec-7167-4b38-aa0e-a4e7b3da19fc, 21e6eac4-35e5-488a-8d38-626e9569b200, a622 ... spl_set_id 23964723-2df8-4d0a-a53d-8538469672f1, ccbbf0d6-efd9-4fdd-9e7b-e3d293062609, 7223 ... Package NDC 31722-727-30, 31722-727-01, 31722-727-10, 31722-727-31, 31722-727-32, 31722-727- ... NUIN0000175777, N0000000083Established Pharmacologic ClassLeukotriene Receptor Antagonist [EPC]Mechanism of ActionLeukotriene Receptor Antagonists [MoA]UNIIMHM278SD3E, U1O3J18SFL

5)

drugcharacterization1medicinalproductNITAZOXANIDEdrugindicationANXIETY

openFDA Info on Medication

Application NumberANDA213820, NDA021497, NDA021498Brand NameNITAZOXANIDE, ALINIA, N/AGeneric NameNITAZOXANIDEManufacturers Rising Pharmaceuticals, Inc., Romark Laboratories, L.C., Lupin Pharmaceuticals, ... product_ndc64980-526, 67546-111, 67546-212, 43386-405Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsNITAZOXANIDERXCUI427163, 359822, 404419, 540617spl_id 5d0d1626-742f-4daa-8095-c1cd628f5637, b7c2e839-364b-483f-e053-2995a90a8ef2, ba84 ... spl_set_id c0dc0656-3c46-43f9-adea-5285c522cef8, 56b1575a-dff4-4c5a-a159-2f858e7a0cb8, ba84 ... Package NDC 64980-526-21, 64980-526-03, 67546-111-12, 67546-111-14, 67546-212-21, 43386-405- ... NUIN0000175485Established Pharmacologic ClassAntiprotozoal [EPC]UNIISOA12P041N

6)

drugcharacterization1medicinalproductOMEPRAZOLEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugadditional1

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA075757, ANDA206877, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, KIRKLAND SIGNATURE OMEPRAZOLE, OMEPRAZOLE, AC ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Costco Wholesale Company, INNOVUS PHARMACEUTICALS, INC., OHM ... product_ndc 46122-281, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 62175-136, 078 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, 8c9d9c38-9da6-4f99-9f08-26ec4693fa55, ce5c ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 48a44d0c-3502-430b-8b75-188a49d14da2, ce5c ... Package NDC 46122-281-04, 46122-281-74, 63981-915-55, 57483-740-01, 57483-740-42, 51660-029- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

7)

drugcharacterization1medicinalproductDIPHENHYDRAMINEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugadditional1

openFDA Info on Medication

Application Numberpart341, ANDA205723, ANDA040466Brand NameNIGHTIME SLEEP AID, DIPHENHYDRAMINEGeneric NameDIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HCLManufacturers Velocity Pharma, AAA Pharmaceutical, Inc., Safetec of America, Inc., Micro Labs ... product_ndc76168-065, 57344-090, 61010-4409, 42571-169, 42571-337, 68196-929, 63323-664Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsDIPHENHYDRAMINE HYDROCHLORIDERXCUI1020477, 1049630, 1049909, 1723740spl_id 6cbc010f-0449-cb45-e053-2a91aa0a1ec6, 94e265d8-7fba-2ee9-e053-2a95a90a4993, 8909 ... spl_set_id 9c44e54f-d8bc-4451-8382-40d2e8e03b42, 76724432-ff3c-404f-ba1f-5af68e3ab8c4, ef6b ... Package NDC 76168-065-37, 57344-090-02, 57344-090-03, 61010-4409-0, 61010-4409-1, 61010-4409 ... UNIITC2D6JAD40

Report Duplicate

duplicatesourceGLAXOSMITHKLINEduplicatenumbB0986081A