Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10074703serious1Date Last Updated14/04/2014receiptdateformat102companynumbUS-JNJFOC-20140407949occurcountryUSseriousnessother1duplicate1seriousnesscongenitalanomali1Date Received14/04/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionEar disorderOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionFoetal exposure during pregnancyOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionAggressionOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductTOPAMAXdrugdosageformTABLETSdrugadministrationroute064drugindicationMIGRAINEdrugrecurreadministration2

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_id97a88b90-639a-11ea-a5cc-2737fc2ca371spl_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

2)

drugcharacterization1medicinalproductTOPAMAXdrugdosageformTABLETSdrugadministrationroute064drugindicationHEADACHEdrugrecurreadministration2

openFDA Info on Medication

3)

drugcharacterization1medicinalproductTOPAMAXdrugdosageformTABLETSdrugadministrationroute064drugindicationANXIETYdrugrecurreadministration2

openFDA Info on Medication

4)

drugcharacterization1medicinalproductTOPAMAXdrugauthorizationnumb020505drugdosageformTABLETSdrugadministrationroute064drugindicationDEPRESSIONdrugrecurreadministration2

openFDA Info on Medication

5)

drugcharacterization1medicinalproductMAXALTdrugdosageformTABLETSdrugadministrationroute064drugindicationMIGRAINE

openFDA Info on Medication

Application NumberNDA020864Brand NameMAXALTGeneric NameRIZATRIPTAN BENZOATEManufacturersMerck Sharp & Dohme Corp.product_ndc0006-0267, 0006-0266, 0006-3800, 0006-3801Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRIZATRIPTAN BENZOATERXCUI213321, 213322, 312837, 312839, 312840, 314209, 828536, 828537spl_id26ec70b6-95bf-4efa-a907-cc605943d08fspl_set_idd93286f5-99f7-4dc5-aa9d-ad73ab8490dbPackage NDC 0006-0266-01, 0006-0266-18, 0006-0267-01, 0006-0267-18, 0006-3800-01, 0006-3800- ... UNIIWR978S7QHH

6)

drugcharacterization1medicinalproductZOLOFTdrugdosageformTABLETdrugadministrationroute064drugindicationANXIETY

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

7)

drugcharacterization1medicinalproductZOLOFTdrugdosageformTABLETdrugadministrationroute064drugindicationDEPRESSION

openFDA Info on Medication

8)

drugcharacterization1medicinalproductDOXEPINdrugdosageformCAPSULEdrugadministrationroute064drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA201951Brand NameDOXEPINGeneric NameDOXEPINManufacturersActavis Pharma, Inc.product_ndc0228-3315, 0228-3316Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDOXEPIN HYDROCHLORIDERXCUI966787, 966793spl_idaeefed70-09dc-4efa-809e-b80fe14656a6spl_set_idc42333f8-1add-4f33-9458-6fe4436874a1Package NDC0228-3315-03, 0228-3316-03UNII3U9A0FE9N5

9)

drugcharacterization1medicinalproductMECLIZINEdrugdosageformTABLETdrugadministrationroute064drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Numberpart336, ANDA201451Brand NameMECLIZINE, MECLIZINE HYDROCHLORIDEGeneric NameMECLIZINE HCL 25MG, MECLIZINE HCL 12.5 MG, MECLIZINE, MECLIZINE HCL 12.5MGManufacturers Ulai Health LLC, Pharbest Pharmaceuticals, Inc., SDA Laboratories, Inc., RUGBY L ... product_ndc 73057-387, 16103-386, 66424-386, 66424-387, 0536-1297, 16103-387, 65162-441, 651 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMECLIZINE HYDROCHLORIDERXCUI995632, 995624, 995666, 995686spl_id 3c884e11-5f9b-4a8a-9a2b-179a19b20244, 4e199df3-49f3-42f2-add2-00b99d78cc10, 01ec ... spl_set_id ea2e6834-c11a-40f8-887c-e02419023e7b, 8b3c9283-b618-4d57-9f15-7cf73e8737f5, f258 ... Package NDC 73057-387-11, 73057-387-08, 16103-386-08, 16103-386-11, 66424-386-01, 66424-386- ... UNIIHDP7W44CIO

10)

drugcharacterization1medicinalproductHYDROXYZINE PAMOATEdrugdosageformCAPSULEdrugadministrationroute064drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA201507, ANDA088487, ANDA088496, ANDA088488, ANDA040156, NDA011459, ANDA08618 ... Brand NameHYDROXYZINE PAMOATE, VISTARILGeneric NameHYDROXYZINE PAMOATEManufacturers Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Teva Pharmaceutic ... product_ndc 14539-674, 14539-675, 0555-0302, 0555-0323, 0555-0324, 0115-1803, 0115-1804, 006 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROXYZINE PAMOATERXCUI995253, 995278, 995232, 995255, 995274, 995276, 995280spl_id 238d1dcc-5db1-4e6f-a75f-4cfcaa5b590a, 2248d92d-83ac-433e-9648-d7c94a77c6f7, 1ea3 ... spl_set_id 734d32c8-38d3-430f-a2b3-539e03a3687a, 06068fff-2e79-4721-bcc7-b0938aa20e7a, bc82 ... Package NDC 14539-674-01, 14539-674-05, 14539-675-01, 14539-675-05, 0555-0323-02, 0555-0323- ... UNIIM20215MUFR

11)

drugcharacterization1medicinalproductZITHROMAXdrugdosageformUnspecifieddrugadministrationroute064drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Brand NameZITHROMAXGeneric NameAZITHROMYCIN DIHYDRATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc 0069-9500, 0069-3060, 0069-3070, 0069-3110, 0069-3120, 0069-3130, 0069-3140, 006 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsAZITHROMYCIN DIHYDRATERXCUI 212446, 308460, 105260, 141963, 211307, 226827, 248656, 308459, 749780, 749783, ... spl_id 6ea307ee-5dc2-4ef8-9520-5dffec6a3e55, b829a0c5-0929-457e-843c-b9f349c1d99f, ae41 ... spl_set_id fb3d03d8-c7c1-48c4-b5ac-91ed0398f0d2, db52b91e-79f7-4cc1-9564-f2eee8e31c45, 3b63 ... Package NDC 0069-9500-01, 0069-3060-30, 0069-3060-75, 0069-3060-86, 0069-3070-30, 0069-3070- ... UNII5FD1131I7SApplication NumberNDA050711, NDA050784, NDA050710, NDA050733, NDA050693

12)

drugcharacterization1medicinalproductSULFAMETHOXAZOLE/TRIMETHOPRIMdrugdosageformUnspecifieddrugadministrationroute064drugindicationPRODUCT USED FOR UNKNOWN INDICATION

13)

drugcharacterization1medicinalproductAMITRIPTYLINE HCLdrugdosageformUnspecifieddrugadministrationroute064drugindicationPRODUCT USED FOR UNKNOWN INDICATION

14)

drugcharacterization1medicinalproductPRIMACAREdrugdosageformUnspecifieddrugadministrationroute064drugindicationPRODUCT USED FOR UNKNOWN INDICATION

15)

drugcharacterization1medicinalproductERY-TABdrugdosageformUnspecifieddrugadministrationroute064drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA062298Brand NameERY-TABGeneric NameERYTHROMYCINManufacturersArbor Pharmaceuticals, Inc.product_ndc24338-122, 24338-124, 24338-126Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERYTHROMYCINRXCUI206075, 206078, 206080, 310155, 310157, 315090spl_idf7f33758-f601-4397-baa4-30286a9a3a39spl_set_idfda44eb6-7901-4b80-ba0b-216f6cacf3fdPackage NDC 24338-122-13, 24338-122-03, 24338-124-13, 24338-124-03, 24338-126-13, 24338-126- ... NUIN0000009982, N0000175877, N0000175935, M0028311Physiologic/Pharmacodynamic EffectDecreased Sebaceous Gland Activity [PE]Established Pharmacologic ClassMacrolide [EPC], Macrolide Antimicrobial [EPC]Chemical StructureMacrolides [CS]UNII63937KV33D

16)

drugcharacterization1medicinalproductAMOXICILLINdrugdosageformUnspecifieddrugadministrationroute064drugindicationFURUNCLE

openFDA Info on Medication

Application Number ANDA064076, ANDA065255, ANDA065056, ANDA065271, ANDA065256, ANDA064013, ANDA0619 ... Brand NameAMOXICILLINGeneric NameAMOXICILLINManufacturers DAVA Pharmaceuticals Inc, Hikma Pharmaceuticals USA Inc., Teva Pharmaceuticals U ... product_ndc 67253-144, 67253-150, 67253-146, 67253-147, 67253-148, 67253-149, 0143-9285, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMOXICILLINRXCUI239191, 308182, 308189, 308191, 313797, 313850, 308194, 308192, 308177, 598025spl_id 0972267b-1a1b-40da-b95c-2dc7be21720e, 11f42795-cdea-4c98-a921-2c54e40370ba, 56ab ... spl_set_id 5f55a89f-a7ca-497f-a17c-f751431e2cfb, c8591c2a-92ef-4432-b19a-bb46063047ee, 20c8 ... Package NDC 67253-144-10, 67253-144-50, 67253-150-10, 67253-150-50, 67253-146-45, 67253-146- ... UNII804826J2HU

17)

drugcharacterization1medicinalproductSPIRONOLACTONEdrugdosageformUnspecifieddrugadministrationroute064drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA091426, ANDA040750, ANDA203512, ANDA203253, NDA012151, ANDA089424, ANDA20593 ... Brand NameSPIRONOLACTONE, ALDACTONEGeneric NameSPIRONOLACTONEManufacturers Amneal Pharmaceuticals LLC, Oxford Pharmaceuticals, LLC, Accord Healthcare, Inc. ... product_ndc 65162-511, 65162-514, 65162-515, 69584-852, 69584-853, 69584-854, 16729-225, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSPIRONOLACTONERXCUI198222, 198223, 313096, 200817, 200820, 200825spl_id 5c663162-67fb-4890-977c-70db2561d387, db73b6cc-b152-4ec1-8566-f4ead6f9ae6d, 9590 ... spl_set_id fb66327e-8261-46ae-b39a-4fa79d520844, 852684dc-e1c6-4caa-bccb-10ac90bbb3bb, 8a96 ... Package NDC 65162-511-03, 65162-511-06, 65162-511-09, 65162-511-10, 65162-511-11, 65162-511- ... NUIN0000175557, N0000011310Established Pharmacologic ClassAldosterone Antagonist [EPC]Mechanism of ActionAldosterone Antagonists [MoA]UNII27O7W4T232

18)

drugcharacterization1medicinalproductIBUPROFENdrugauthorizationnumb017463drugdosageformUnspecifieddrugadministrationroute064drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration2

openFDA Info on Medication

Application Number ANDA077349, ANDA206568, ANDA074937, ANDA091355, ANDA075139, ANDA078682, ANDA0791 ... Brand Name CAREONE IBUPROFEN, IBUPROFEN, HEALTH MART CHILDRENS IBUPROFEN, IBUPROFEN MINIS, ... Generic Name IBUPROFEN, IBUPROFEN TABLETS, IBUPROFEN 200MG, IBUPROFEN ORAL, IBUPFROFEN, IBUPR ... Manufacturers American Sales Company, Family Dollar (FAMILY WELLNESS), Strategic Sourcing Serv ... product_ndc 41520-495, 55319-745, 62011-0214, 49738-510, 59779-392, 11822-3307, 50804-199, 7 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsIBUPROFEN, IBUPROFEN SODIUMRXCUI 310965, 310964, 197803, 204442, 310963, 731536, 197805, 197806, 197807, 206905, ... spl_id 0647c7c2-b153-4d8c-b72b-f63d43c41853, 720dc13b-5778-44fa-a4d2-e35db0b2d589, 397d ... spl_set_id 03cdff8a-8890-440d-82b5-54ce809f88cc, 135f910d-a5cd-46e9-9436-015170cc7e38, 1d81 ... Package NDC 41520-495-71, 41520-495-78, 55319-745-30, 55319-745-80, 55319-745-16, 62011-0214 ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIWK2XYI10QM, RM1CE97Z4N

19)

drugcharacterization1medicinalproductPHENAZOPYRIDINEdrugdosageformUnspecifieddrugadministrationroute064drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Brand NamePYRIDIUM, PHENAZOPYRIDINE HYDROCHLORIDEGeneric NamePHENAZOPYRIDINEManufacturersAmneal Pharmaceuticals LLC, ECI Pharmaceuticals, LLC, Skya Health, LLCproduct_ndc 60846-501, 60846-502, 51293-810, 51293-811, 65162-681, 65162-682, 73086-101, 730 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPHENAZOPYRIDINE HYDROCHLORIDERXCUI1094104, 1094107, 1094109, 1094122spl_id 46b5ceb6-b7bc-47c2-b8c7-0749922ec7d1, 1c1118af-aafb-40a7-9967-13751b416918, abd6 ... spl_set_id 165d01d4-a9f7-2293-e054-00144ff8d46c, c2049b62-04d7-44a4-968c-a1e7fccb0125, b424 ... Package NDC 60846-501-01, 60846-502-01, 51293-810-01, 51293-811-01, 65162-681-10, 65162-682- ... UNII0EWG668W17

20)

drugcharacterization1medicinalproductZYRTECdrugauthorizationnumb019835drugdosageformTABLETdrugadministrationroute064drugrecurreadministration2

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

21)

drugcharacterization1medicinalproductZYRTECdrugauthorizationnumb019835drugdosageformTABLETdrugadministrationroute064drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration2

openFDA Info on Medication

22)

drugcharacterization2medicinalproductFERROUS SULFATEdrugdosageformTABLETdrugadministrationroute064drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Brand NameFERROUS SULFATE, FERRUM SULPHURICUMGeneric NameFERROUS SULFATE, IRON SUPPLEMENT THERAPYManufacturers Richmond Pharmaceuticals, Inc., Boiron, Healthlife of USA, Washington Homeopathi ... product_ndc54738-963, 0220-2111, 69517-133, 68428-941, 71919-293Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFERROUS SULFATERXCUI310325spl_id 9a63ba0a-0ded-744b-e053-2a95a90a9344, 8723d1f8-ed45-3373-e053-2991aa0a81d7, 655e ... spl_set_id 58dd4f30-980b-44bc-9f8e-8d4626854b91, 7a4087d8-d054-bbdc-e053-2991aa0ae8cf, 3810 ... Package NDC 54738-963-01, 54738-963-03, 0220-2111-41, 69517-133-30, 68428-941-03, 68428-941- ... UNII39R4TAN1VT

23)

drugcharacterization2medicinalproductIRONdrugdosageformUnspecifieddrugadministrationroute064drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Brand NameFERRUM METALLICUM, BILIOUSNESS DIARRHEAGeneric NameIRONManufacturersWashington Homeopathic Products, Boiron, Natural Health Supply, Seroyal USAproduct_ndc 71919-289, 0220-2055, 0220-2085, 0220-2051, 0220-2050, 0220-2047, 64117-791, 022 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsIRONspl_id 7e4e7e58-41be-89a2-e053-2a91aa0a790b, 8591b12c-51c9-9839-e053-2a91aa0aa937, 8737 ... spl_set_id bbca0ba2-37e5-4667-80ff-365490b25624, 8591b12c-51c8-9839-e053-2a91aa0aa937, 8737 ... Package NDC 71919-289-07, 71919-289-08, 71919-289-09, 71919-289-10, 0220-2055-41, 0220-2085- ... UNIIE1UOL152H7

24)

drugcharacterization2medicinalproductPRENATAL VITAMINSdrugdosageformUnspecifieddrugadministrationroute064drugindicationPRODUCT USED FOR UNKNOWN INDICATION

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duplicatesourceMCNEILduplicatenumbUS-JNJFOC-20140407949

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