Report

Version of Safety Report ID1Safety Report ID10996254primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/08/2015reporttype1serious1seriousnessother1receivedateformat102Date Received08/04/2015receiptdateformat102Date Last Updated08/04/2015fulfillexpeditecriteria1companynumbUS-UCBSA-2015010030duplicate1

Report Duplicate

duplicatesourceUCBduplicatenumbUS-UCBSA-2015010030

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexFemale

Contents

Reaction
- 1)
- 2)
- 3)
- 4)
- 5)
- 6)
Drug

Reaction

1)

reactionmeddraversionpt18.0ReactionDrug hypersensitivityOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.0ReactionAnaphylactic shockOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.0ReactionBurning sensationOutcomeUnknown

4)

reactionmeddraversionpt18.0ReactionOral disorderOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionHaemorrhageOutcomeUnknown

6)

reactionmeddraversionpt18.0ReactionFood allergyOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductNEURONTINdrugdosagetextUNKdrugdosageformCAPSULEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate02/12/2013actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameGABAPENTIN

openFDA Info on Medication

Application NumberNDA020882, NDA020235, NDA021129Brand NameNEURONTINGeneric NameGABAPENTINManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0401, 0071-0803, 0071-0805, 0071-0806, 0071-0513, 0071-2012Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 105028, 105029, 105030, 261280, 261281, 283523, 310430, 310431, 310432, 310433, ... spl_id6db0f340-6839-4488-8653-677baad5820bspl_set_idee9ad9ed-6d9f-4ee1-9d7f-cfad438df388Package NDC 0071-0803-24, 0071-0803-40, 0071-0805-24, 0071-0805-40, 0071-0806-24, 0071-0806- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

2)

drugcharacterization2medicinalproductFIBERCONdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameCALCIUM POLYCARBOPHIL

openFDA Info on Medication

Application Numberpart334Brand NameFIBERCONGeneric NameCALCIUM POLYCARBOPHILManufacturersFoundation Consumer Brandsproduct_ndc80070-500Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCALCIUM POLYCARBOPHILRXCUI210665, 308934spl_idaa5be2e6-ba6c-40db-ae32-31cce50bcb2espl_set_id7992a4bb-5535-4a1d-867d-a99f7e0c1be7Package NDC80070-500-14, 80070-500-90UNII8F049NKY49

3)

drugcharacterization2medicinalproductLEXAPROdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameESCITALOPRAM OXALATE

openFDA Info on Medication

Application NumberNDA021323Brand NameLEXAPROGeneric NameESCITALOPRAMManufacturersAllergan, Inc.product_ndc0456-2005, 0456-2010, 0456-2020, 0456-2101Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESCITALOPRAM OXALATERXCUI349332, 351249, 351250, 351285, 352272, 352273, 404408, 404420spl_idd6a08762-d20a-47c9-b92e-b5dde195489cspl_set_id13bb8267-1cab-43e5-acae-55a4d957630aPackage NDC 0456-2005-01, 0456-2010-01, 0456-2010-11, 0456-2010-63, 0456-2020-01, 0456-2020- ... UNII5U85DBW7LO

4)

drugcharacterization2medicinalproductTRAMADOL HCLdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameTRAMADOL HYDROCHLORIDE

openFDA Info on Medication

5)

drugcharacterization1medicinalproductXYREMdrugstructuredosagenumb2.25drugstructuredosageunit002drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2.25 G, 2X/DAY (BID); 500 MG/ML NIGHTLYdrugdosageformORAL SOLUTIONdrugadministrationroute048drugindicationNARCOLEPSYdrugstartdateformat610drugstartdate/11/2009drugenddateformat602drugenddate//2009actiondrug4

activesubstance

activesubstancenameSODIUM OXYBATE

openFDA Info on Medication

Application NumberNDA021196Brand NameXYREMGeneric NameSODIUM OXYBATEManufacturersJazz Pharmaceuticals, Inc.product_ndc68727-100Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSODIUM OXYBATERXCUI349482, 352257spl_id507868f6-2c1d-488d-8132-38d23218caf3spl_set_id926eb076-a4a8-45e4-91ef-411f0aa4f3caPackage NDC68727-100-01UNII7G33012534

6)

drugcharacterization2medicinalproductLOMOTILdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameATROPINE SULFATE\DIPHENOXYLATE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA012462Brand NameLOMOTILGeneric NameDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0025-0061Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDERXCUI1190572, 1190641spl_id3e3a06dd-60e1-4f0b-b8e9-ab7180543762spl_set_idf170584a-1072-4fd7-b1dc-6756703483b9Package NDC0025-0061-31UNII03J5ZE7KA5, W24OD7YW48

7)

drugcharacterization2medicinalproductPROVIGILdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameMODAFINIL

openFDA Info on Medication

Application NumberNDA020717Brand NamePROVIGILGeneric NameMODAFINILManufacturersCephalon, Inc.product_ndc63459-101, 63459-201Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMODAFINILRXCUI205324, 213471, 226426, 260218spl_id22321588-2125-4ed0-b9ff-87a8513bf271spl_set_ide16c26ad-7bc2-d155-3a5d-da83ad6492c8Package NDC63459-101-01, 63459-101-30, 63459-201-01, 63459-201-30NUIN0000175729, N0000175651, N0000175769Physiologic/Pharmacodynamic EffectCentral Nervous System Stimulation [PE], Increased Sympathetic Activity [PE]Established Pharmacologic ClassSympathomimetic-like Agent [EPC]UNIIR3UK8X3U3D

8)

drugcharacterization2medicinalproductMECLIZINEdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate05/09/2014actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameMECLIZINE\MECLIZINE HYDROCHLORIDE

openFDA Info on Medication

Application Numberpart336, ANDA201451Brand NameMECLIZINE, MECLIZINE HYDROCHLORIDEGeneric NameMECLIZINE HCL 12.5 MG, MECLIZINE HCL 25MG, MECLIZINE, MECLIZINE HCL 12.5MGManufacturers RUGBY LABORATORIES, Pharbest Pharmaceuticals, Inc., Amneal Pharmaceuticals LLC, ... product_ndc0536-1297, 16103-387, 65162-441, 65162-442, 65162-444, 73057-386Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMECLIZINE HYDROCHLORIDERXCUI995624, 995632, 995666, 995686spl_id 4f0c6a9a-982d-4efd-be18-ba305c39772d, 887b312d-3c2c-4dcb-86eb-316dfb068bc9, a9e0 ... spl_set_id 8a234ce3-eb6b-49dd-9d78-7fc7bdd49d35, 4bac2765-045c-405e-8006-8c5cfdfa89bc, 666d ... Package NDC 0536-1297-01, 0536-1297-10, 16103-387-08, 16103-387-11, 65162-441-03, 65162-441- ... UNIIHDP7W44CIO

9)

drugcharacterization2medicinalproductCALCIUM MAGNESIUMdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameCALCIUM\MAGNESIUM

10)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

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

11)

drugcharacterization2medicinalproductMETHOCARBAMOL.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameMETHOCARBAMOL

openFDA Info on Medication

Application Number ANDA200958, ANDA207522, ANDA204404, ANDA208507, ANDA040489, ANDA211504, ANDA2126 ... Brand Name METHOCARBAMOL, METHOCARBAMOL TABLETS, USP, 500 MG, METHOCARBAMOL TABLETS, USP, 7 ... Generic NameMETHOCARBAMOL, METHOCARBAMOL TABLETSManufacturers Westminster Pharmaceuticals, LLC, Somerset Therapeutics, LLC, Mylan Institutiona ... product_ndc 69367-255, 69367-256, 70069-101, 67457-273, 76385-123, 76385-124, 70868-901, 435 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsMETHOCARBAMOLRXCUI197943, 197944, 238175, 207014spl_id ae9df131-66a3-0ec7-e053-2995a90a02e4, 77cf2a2b-e3af-4755-8923-5226b81aea5c, b0da ... spl_set_id 2199b810-fb84-4dac-b787-ade2b5f67e92, 68dd9c24-4d41-48be-9f54-fceb787bb443, 14d9 ... Package NDC 69367-256-01, 69367-256-05, 69367-255-01, 69367-255-05, 70069-101-01, 70069-101- ... NUIN0000175730, N0000175737Physiologic/Pharmacodynamic EffectCentrally-mediated Muscle Relaxation [PE]Established Pharmacologic ClassMuscle Relaxant [EPC]UNII125OD7737X

12)

drugcharacterization2medicinalproductSEROQUELdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

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

13)

drugcharacterization2medicinalproductSINGULAIRdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameMONTELUKAST SODIUM

openFDA Info on Medication

Application NumberNDA020830, NDA021409, NDA020829Brand NameSINGULAIRGeneric NameMONTELUKAST SODIUMManufacturersOrganon LLCproduct_ndc78206-170, 78206-171, 78206-173, 78206-172Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST SODIUMRXCUI153892, 153893, 200224, 242438, 261367, 311759, 351246, 404406spl_id679860ff-4c1d-432d-856a-90d4eea82ea0spl_set_id482dcc92-b47f-4ea6-854a-f5ac2aea7842Package NDC78206-171-01, 78206-170-01, 78206-173-01, 78206-172-01, 78206-172-02UNIIU1O3J18SFL

14)

drugcharacterization2medicinalproductVICODINdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate19/11/2013actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameACETAMINOPHEN\HYDROCODONE BITARTRATE

15)

drugcharacterization2medicinalproductFLONASEdrugdosagetextUNKdrugdosageformNASAL SPRAYdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameFLUTICASONE PROPIONATE

openFDA Info on Medication

Application NumberNDA205434, part341Brand NameFLONASE ALLERGY RELIEF, FLONASE HEADACHE AND ALLERGY RELIEFGeneric Name FLUTICASONE PROPIONATE, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE H ... ManufacturersGlaxoSmithKline Consumer Healthcare Holdings (US) LLCproduct_ndc0135-0576, 0135-0578Product TypeHUMAN OTC DRUGRouteNASAL, ORALActive Ingredients FLUTICASONE PROPIONATE, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE H ... RXCUI1797907, 1797933, 1046781spl_id1f0c6c8a-8452-45ae-8ed6-517e855d70b9, 282c103c-3888-4a35-a5b1-d492ed6892c1spl_set_idb6134ba0-b70a-4eac-9a82-cef64b242c1d, 282c103c-3888-4a35-a5b1-d492ed6892c1Package NDC 0135-0576-01, 0135-0576-02, 0135-0576-03, 0135-0576-04, 0135-0576-12, 0135-0576- ... UNIIO2GMZ0LF5W, 362O9ITL9D, V1Q0O9OJ9Z, 04JA59TNSJ

16)

drugcharacterization2medicinalproductKLONOPINdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameCLONAZEPAM

openFDA Info on Medication

Application NumberNDA017533Brand NameKLONOPINGeneric NameCLONAZEPAMManufacturersH2-Pharma, LLC, Genentech, Inc.product_ndc61269-605, 61269-610, 61269-620, 0004-0058, 0004-0068, 0004-0098Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI197527, 197528, 197529, 206157, 206159, 206160spl_id65d5607d-3926-4b60-97dc-18509af3f271, 0d423291-6115-4522-88db-dcd1096bd432spl_set_idcfa0d79a-843c-4b88-95a1-e9511d649ca1, 542f22e8-dad2-47a8-93b6-30936715d73bPackage NDC 61269-605-10, 61269-610-10, 61269-620-10, 0004-0068-01, 0004-0058-01, 0004-0098- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

17)

drugcharacterization1medicinalproductXYREMdrugdosagetextDOSE ADJUSTMENTSdrugdosageformORAL SOLUTIONdrugadministrationroute048actiondrug4

activesubstance

activesubstancenameSODIUM OXYBATE

openFDA Info on Medication

18)

drugcharacterization1medicinalproductXYREMdrugstructuredosagenumb3drugstructuredosageunit002drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext3 G, 2X/DAY (BID)drugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat610drugstartdate/06/2014actiondrug4

activesubstance

activesubstancenameSODIUM OXYBATE

openFDA Info on Medication

19)

drugcharacterization2medicinalproductABILIFYdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

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

20)

drugcharacterization2medicinalproductIMODIUMdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameLOPERAMIDE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA075232, NDA019487, NDA021140Brand NameIMODIUM A-D, IMODIUM MULTI-SYMPTOM RELIEFGeneric NameLOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE AND DIMETHICONEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-317, 50580-134, 50580-338Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLOPERAMIDE HYDROCHLORIDE, DIMETHICONERXCUI978010, 978013, 1250685, 1250693, 978001, 1426827spl_id cd230883-bf53-7a6c-e053-2a95a90aefee, daf73f04-740b-3bbf-e053-2a95a90ac408, dfe6 ... spl_set_id 01da76d0-1979-4c45-9d39-c72ae4e4ffe2, 76a976d5-8bee-4158-a94d-7fbfc5544fd4, ecb9 ... Package NDC 50580-317-01, 50580-317-03, 50580-317-04, 50580-317-05, 50580-317-06, 50580-134- ... UNII77TI35393C, 92RU3N3Y1ONUIN0000010282Physiologic/Pharmacodynamic EffectSkin Barrier Activity [PE]

21)

drugcharacterization2medicinalproductMEDROLdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameMETHYLPREDNISOLONE

openFDA Info on Medication

Application NumberNDA011153Brand NameMEDROLGeneric NameMETHYLPREDNISOLONEManufacturersPharmacia and Upjohn Company LLCproduct_ndc0009-0020, 0009-0049, 0009-0056, 0009-0022, 0009-0073, 0009-0176Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETHYLPREDNISOLONERXCUI 197969, 197971, 197973, 207136, 207137, 207138, 207141, 259966, 260330, 328161, ... spl_id8f9c2163-1d7f-4e6e-bbe5-d758de474744spl_set_id39d5270b-d957-4821-93d6-501b7b9f02d4Package NDC 0009-0049-02, 0009-0056-02, 0009-0056-04, 0009-0022-01, 0009-0073-01, 0009-0176- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIX4W7ZR7023

22)

drugcharacterization2medicinalproductOXYCODONE HCLdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate02/12/2013actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameOXYCODONE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022272Brand NameOXYCODONE HCLGeneric NameOXYCODONE HCLManufacturersAmneal Pharmaceuticals NY LLC, KVK-Tech, Inc.product_ndc69238-2294, 69238-2296, 69238-2298, 69238-2300, 10702-801, 10702-803, 10702-805Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDERXCUI1860129, 1860137, 1860148, 1860157spl_idc454eaf2-d0a9-4c3f-84e1-86b1b6973172, b48ac468-a5e7-4c8e-e053-2a95a90a5fcfspl_set_id8220e596-f32e-49cf-a11c-0c79209c3633, c5b52ff1-21a6-4d28-9982-55b4ac195facPackage NDC 69238-2294-1, 69238-2296-1, 69238-2298-1, 69238-2300-1, 10702-801-01, 10702-803- ... UNIIC1ENJ2TE6C

23)

drugcharacterization2medicinalproductPREDNISONE.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate19/11/2013actiondrug5drugrecurreadministration3

activesubstance

activesubstancenamePREDNISONE

openFDA Info on Medication

Application Number NDA202020, ANDA215246, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., Novitium Pharma LLC, GeneYork Pharmaceuticals Gr ... product_ndc 75987-020, 75987-021, 75987-022, 70954-056, 71329-106, 0378-0640, 0378-0641, 037 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id 96a17428-b512-4fd9-a64d-50160d22aaaa, 7335a293-992b-490c-ab8a-66a7ca1eea30, 4384 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, 7335a293-992b-490c-ab8a-66a7ca1eea30, be50 ... Package NDC 75987-020-02, 75987-020-01, 75987-020-70, 75987-021-02, 75987-021-01, 75987-021- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIVB0R961HZT

24)

drugcharacterization2medicinalproductDEPAKOTEdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameDIVALPROEX SODIUM

openFDA Info on Medication

Application NumberNDA021168, NDA018723, NDA019680Brand NameDEPAKOTE ER, DEPAKOTE, DEPAKOTE SPRINKLESGeneric NameDIVALPROEX SODIUMManufacturersAbbVie Inc.product_ndc 0074-3826, 0074-7401, 0074-7126, 0074-7402, 0074-6212, 0074-6214, 0074-6215, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIVALPROEX SODIUMRXCUI 1099563, 1099565, 1099569, 1099571, 1099625, 1099626, 1099678, 1099679, 1099870, ... spl_id 94b6d88a-6c23-4f4a-b3bd-3c8b451ffb43, 7a9c5c8b-3192-4305-b360-ca106a4c85e1, fc9c ... spl_set_id 0dc024ce-efc8-4690-7cb5-639c728fccac, 08a65cf4-7749-4ceb-6895-8f4805e2b01f, 4619 ... Package NDC 0074-3826-13, 0074-3826-11, 0074-7401-13, 0074-7126-13, 0074-7126-53, 0074-7126- ... UNII644VL95AO6

25)

drugcharacterization2medicinalproductWELCHOLdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameCOLESEVELAM HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021176, NDA022362Brand NameWELCHOLGeneric NameCOLESEVELAM HYDROCHLORIDEManufacturersCosette Pharmaceuticals, Inc., Daiichi Sankyo Inc.product_ndc 0713-0879, 0713-0880, 65597-701, 65597-903, 65597-902, 65597-209, 65597-210, 655 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCOLESEVELAM HYDROCHLORIDEspl_ide1f81fc3-4f93-3105-e053-2995a90a46c8, 3e806127-4a87-41cc-9b17-a77e20bb2452spl_set_id89cbd0a3-2d1b-41db-8c97-35ec67b7b09f, 4a06d3b2-7229-4398-baba-5d0a72f63821Package NDC 0713-0879-81, 0713-0880-30, 65597-701-18, 65597-903-60, 65597-902-30, 65597-209- ... UNIIP4SG24WI5QRXCUI866900, 866903, 866905, 866907, 866910, 866912, 2123384, 2123387

26)

drugcharacterization2medicinalproductZOFRANdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate02/12/2013actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameONDANSETRON HYDROCHLORIDE

27)

drugcharacterization2medicinalproductPRILOSECdrugdosagetextUNKdrugdosageformCAPSULEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022056Brand NamePRILOSECGeneric NameOMEPRAZOLE MAGNESIUMManufacturersCovis Pharma US, Incproduct_ndc70515-610, 70515-625Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE MAGNESIUMRXCUI797058, 797061, 797063, 797065spl_idba93d1bb-75ca-407c-b2e0-9aa66d8eed84spl_set_idb6761f84-53ac-4745-a8c8-1e5427d7e179Package NDC70515-625-01, 70515-610-01UNII426QFE7XLK

28)

drugcharacterization1medicinalproductDOXYCYCLINE.drugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameDOXYCYCLINE

openFDA Info on Medication

Application Number ANDA201678, ANDA204234, ANDA065053, ANDA210664, ANDA065285, NDA050805, ANDA06545 ... Brand NameDOXYCYCLINE, ORACEA, VIBRAMYCIN MONOHYDRATE, DOXY 100, DOXYCYCLINE HYCLATEGeneric NameDOXYCYCLINE, DOXYCYCLINE HYCLATEManufacturers Lupin Pharmaceuticals, Inc., Sun Pharmaceutical Industries, Inc., Acella Pharmac ... product_ndc 68180-657, 68180-650, 68180-651, 68180-652, 63304-614, 63304-615, 63304-616, 421 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsDOXYCYCLINE, DOXYCYCLINE HYCLATERXCUI 1650030, 700408, 1649401, 1649990, 1650143, 1649429, 1650142, 1650444, 1652673, ... spl_id c09eb87b-5a56-4166-a905-f2bac5fcd4b2, e4e6b036-db43-4695-bbfe-3aea1790b67e, d87f ... spl_set_id e0e80435-1b6a-4361-8c8a-e432f8f23a1b, bcc65910-30d8-4807-ab61-607a56382924, 829d ... Package NDC 68180-657-01, 68180-650-01, 68180-651-01, 68180-652-08, 68180-652-29, 63304-614- ... NUIN0000175882, N0000007948Established Pharmacologic ClassTetracycline-class Drug [EPC]Chemical StructureTetracyclines [Chemical/Ingredient]UNIIN12000U13O, 19XTS3T51U, 8ZL07I20SB

29)

drugcharacterization2medicinalproductBENTYLdrugdosagetextUNKdrugdosageformCAPSULEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameDICYCLOMINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA008370Brand NameBENTYLGeneric NameDICYCLOMINE HYDROCHLORIDEManufacturersAllergan, Inc.product_ndc58914-080Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULARActive IngredientsDICYCLOMINE HYDROCHLORIDERXCUI991065, 991069spl_idae7ad264-b53f-4545-b9aa-19278c523f68spl_set_idc56598d5-9cd1-4cce-b172-ac338775aec7Package NDC58914-080-52UNIICQ903KQA31

30)

drugcharacterization2medicinalproductMELOXICAM.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameMELOXICAM

openFDA Info on Medication

Application Number ANDA077921, ANDA077932, ANDA211398, ANDA077944, ANDA078008, NDA207233, ANDA07791 ... Brand NameMELOXICAM, VIVLODEX, MOBIC, ANJESOGeneric NameMELOXICAMManufacturers Zydus Pharmaceuticals (USA) Inc., Glenmark Pharmaceuticals Inc., USA, Novitium P ... product_ndc 68382-050, 68382-051, 68462-140, 68462-141, 70954-076, 70954-077, 68180-501, 681 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsMELOXICAMRXCUI 152695, 311486, 1722349, 1722357, 1722355, 1722359, 152697, 152698, 2281106, 228 ... spl_id 7886fdfc-ac20-441f-b046-cab54cd59ae0, 1bfddea3-c305-4688-978d-36c882261be7, 1d5b ... spl_set_id 6c015f72-5ce3-4f56-8237-776fc2165b0c, c51f3abe-02bc-4544-a22f-0f2035fb2271, ce9a ... Package NDC 68382-050-16, 68382-050-01, 68382-050-05, 68382-050-40, 68382-050-30, 68382-050- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIVG2QF83CGL

Adverse Event Report

Report

Report Duplicate

Primary Source

Sender

Receiver

Patient

Reaction

1)

2)

3)

4)

5)

6)

Drug

1)

activesubstance

openFDA Info on Medication

2)

activesubstance

openFDA Info on Medication

3)

activesubstance

openFDA Info on Medication

4)

activesubstance

openFDA Info on Medication

5)

activesubstance

openFDA Info on Medication

6)

activesubstance

openFDA Info on Medication

7)

activesubstance

openFDA Info on Medication

8)

activesubstance

openFDA Info on Medication

9)

activesubstance

10)

activesubstance

openFDA Info on Medication

11)

activesubstance

openFDA Info on Medication

12)

activesubstance

openFDA Info on Medication

13)

activesubstance

openFDA Info on Medication

14)

activesubstance

15)

activesubstance

openFDA Info on Medication

16)

activesubstance

openFDA Info on Medication

17)

activesubstance

openFDA Info on Medication

18)

activesubstance

openFDA Info on Medication

19)

activesubstance

openFDA Info on Medication

20)

activesubstance

openFDA Info on Medication

21)

activesubstance

openFDA Info on Medication

22)

activesubstance

openFDA Info on Medication

23)