Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-009507513-1403USA000980occurcountryUSVersion of Safety Report ID2receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10010775Date Received14/03/2014transmissiondate12/12/2014serious2Date Last Updated23/06/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionDrug ineffectiveOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductOXYTROL FOR WOMENdrugbatchnumb3E09WSdrugauthorizationnumb202211drugdosagetextUNK, UNKNOWNdrugdosageformTRANSDERMAL PATCHdrugadministrationroute062drugindicationURINARY INCONTINENCE

openFDA Info on Medication

Application NumberNDA202211Brand NameOXYTROL FOR WOMENGeneric NameOXYBUTYNINManufacturersAllergan, Inc.product_ndc0023-9637Product TypeHUMAN OTC DRUGRouteTRANSDERMALActive IngredientsOXYBUTYNINRXCUI403799, 404448spl_id15e35837-8b6f-44e6-a5f5-00d32c6a32c0spl_set_id8cdc5b4d-ff8d-4010-97d7-313422a0b868Package NDC0023-9637-04, 0023-9637-08NUIN0000175700, N0000000125Established Pharmacologic ClassCholinergic Muscarinic Antagonist [EPC]Mechanism of ActionCholinergic Muscarinic Antagonists [MoA]UNIIK9P6MC7092

2)

drugcharacterization1medicinalproductOXYTROL FOR WOMENdrugauthorizationnumb202211drugdosageformTRANSDERMAL PATCHdrugindicationURGE INCONTINENCE

openFDA Info on Medication

Application NumberNDA202211Brand NameOXYTROL FOR WOMENGeneric NameOXYBUTYNINManufacturersAllergan, Inc.product_ndc0023-9637Product TypeHUMAN OTC DRUGRouteTRANSDERMALActive IngredientsOXYBUTYNINRXCUI403799, 404448spl_id15e35837-8b6f-44e6-a5f5-00d32c6a32c0spl_set_id8cdc5b4d-ff8d-4010-97d7-313422a0b868Package NDC0023-9637-04, 0023-9637-08NUIN0000175700, N0000000125Established Pharmacologic ClassCholinergic Muscarinic Antagonist [EPC]Mechanism of ActionCholinergic Muscarinic Antagonists [MoA]UNIIK9P6MC7092

3)

drugcharacterization2medicinalproductAMLODIPINEdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, QDdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA211340Brand NameKATERZIAGeneric NameAMLODIPINEManufacturersAzurity Pharmaceuticals, Inc.product_ndc52652-5001Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BENZOATERXCUI2184120, 2184126spl_id33926064-be3f-4380-b051-ac4136524317spl_set_iddf673a4d-acb8-444c-a472-c87ab8cbd366Package NDC52652-5001-1UNIIXD75TQ8A2P

4)

drugcharacterization2medicinalproductESOMEPRAZOLEdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, QDdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberANDA207193, ANDA209202, ANDA212866, ANDA207673Brand Name KIRKLAND SIGNATURE ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE, DG HEALTH ESOMEPRAZOLE ... Generic NameESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUMManufacturers Costco Wholesale Company, Actavis Pharma, Inc., Dolgencorp, LLC, Walgreen Compan ... product_ndc 63981-898, 0591-4187, 55910-250, 0363-1898, 46122-641, 50594-029, 63304-740, 692 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM DIHYDRATE, ESOMEPRAZOLE MAGNESIUMRXCUI606726, 433733spl_id 495105e5-3361-48c3-bdac-14828718eeff, 6fe03f24-f64b-4c07-9564-52f3b7381d4d, 8f97 ... spl_set_id 4a87d5d5-c98b-4dc5-81be-50183342b047, 5b583358-f25d-4bd4-add2-89e4f56f5d41, 8f97 ... Package NDC 63981-898-03, 0591-4187-14, 0591-4187-42, 0591-4187-96, 55910-250-01, 55910-250- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIN3PA6559FT, 36H71644EQ, R6DXU4WAY9

5)

drugcharacterization2medicinalproductHYDROXYZINEdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext25 MG, QDdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberANDA040808Brand NameHYDROXYZINE HYDROCHLORIDEGeneric NameHYDROXYZINEManufacturersAmneal Pharmaceuticals LLCproduct_ndc65162-575, 65162-671, 65162-577Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROXYZINE HYDROCHLORIDERXCUI995218, 995258, 995281spl_id8dad3af3-9788-466a-992a-6e261a3a7600spl_set_id89901966-724b-4773-98b8-ea663ceabd53Package NDC 65162-575-10, 65162-575-11, 65162-575-50, 65162-671-10, 65162-671-11, 65162-671- ... UNII76755771U3

6)

drugcharacterization2medicinalproductLEVOTHYROXINE SODIUMdrugstructuredosagenumb100drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MICROGRAM, QDdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA209713, NDA021924, NDA021292, ANDA212399, NDA202231, NDA021342, ANDA208749, ... Brand Name LEVOTHYROXINE SODIUM, EUTHYROX, TIROSINT, LEVO-T, THYQUIDITY, LEVOXYL, UNITHROID ... Generic NameLEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUSManufacturers Lupin Pharmaceuticals, Inc., Lannett Company, Inc., Provell Pharmaceuticals, LLC ... product_ndc 68180-965, 68180-966, 68180-967, 68180-968, 68180-969, 68180-970, 68180-971, 681 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsLEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUSRXCUI 892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966248, 966249, ... spl_id 9c2dfcdd-dc8c-4b32-9e9c-19087205679f, 8c338424-2ed3-45de-87cd-cef28456c4c1, 0b57 ... spl_set_id 18717e58-89fb-4e2f-93b6-d6ac3e988d37, 686ba2cf-7651-44de-9b4d-eeaaf2a0e364, bc3c ... Package NDC 68180-965-01, 68180-965-02, 68180-965-03, 68180-965-09, 68180-966-01, 68180-966- ... UNII9J765S329G, 054I36CPMN

7)

drugcharacterization2medicinalproductOXYCODONEdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK, QDdrugindicationPAINactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberANDA203638, NDA208090, ANDA211748, ANDA211749Brand NameOXYCODONE HYDROCHLORIDE, XTAMPZA ER, OXYCODONEGeneric NameOXYCODONEManufacturers Amneal Pharmaceuticals LLC, Collegium Pharmaceutical, Inc., Ascend Laboratories, ... product_ndc 65162-047, 65162-048, 65162-049, 65162-050, 65162-051, 24510-110, 24510-115, 245 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDE, OXYCODONERXCUI 1049611, 1049618, 1049621, 1049683, 1049686, 1790527, 1790533, 1791558, 1791560, ... spl_id faecea25-bf41-43c2-99de-89ba81a21162, 424fa63c-5bd6-457d-b65e-c40ddfc48d6c, d906 ... spl_set_id 094b64b3-cd32-4de5-afb6-ea00d9caad74, b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c, 08b2 ... Package NDC 65162-047-03, 65162-047-10, 65162-047-25, 65162-047-50, 65162-048-03, 65162-048- ... UNIIC1ENJ2TE6C, CD35PMG570NUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]

8)

drugcharacterization2medicinalproductPOLYETHYLENEdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK, QDdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

9)

drugcharacterization2medicinalproductSERTRALINE HYDROCHLORIDEdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK, QDdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA077206, NDA020990, NDA019839, ANDA078861, ANDA077864, ANDA077106, ANDA076934 ... Brand NameSERTRALINE HYDROCHLORIDE, SERTRALINE, ZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturers Aurobindo Pharma Limited, Greenstone LLC, Rising Pharmaceuticals, Inc., Hikma Ph ... product_ndc 65862-011, 65862-012, 65862-013, 59762-0067, 59762-4960, 59762-4900, 59762-4910, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941, 861064, 208149, 208161, 212233, 861066spl_id 80aac5d8-bb02-46f5-a8ca-5fc9f934541c, 1ef7897d-60bb-4685-820f-21c78a097642, 96aa ... spl_set_id 39a85db1-9e59-4ab0-9e18-36757f019faa, 1a58062b-e635-431a-908d-2651c6a4a21c, af2c ... Package NDC 65862-011-30, 65862-011-50, 65862-011-60, 65862-011-90, 65862-011-01, 65862-011- ... UNIIUTI8907Y6X

10)

drugcharacterization2medicinalproductTEMAZEPAMdrugstructuredosagenumb15drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext15 MG, QPMdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA203482, ANDA071620, ANDA211542, ANDA071456, ANDA071457, ANDA078581, ANDA0711 ... Brand NameTEMAZEPAM, RESTORILGeneric NameTEMAZEPAMManufacturers Amneal Pharmaceuticals LLC, Actavis Pharma, Inc., Alembic Pharmaceuticals Limite ... product_ndc 65162-556, 65162-583, 65162-584, 65162-557, 0228-2076, 0228-2077, 46708-379, 467 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTEMAZEPAMRXCUI198241, 198242, 198243, 485489, 208463, 208464, 208465, 539384spl_id c21455f5-1c17-442d-b1d1-69d27d290d48, eac383e8-6227-4439-b72d-c1b1794ee031, 2676 ... spl_set_id be68c6e0-17ad-40fe-9bc1-58abe24b53f6, a4370eb4-b00d-4247-af8d-980e59fbbec6, db83 ... Package NDC 65162-583-03, 65162-583-10, 65162-583-50, 65162-583-11, 65162-556-03, 65162-556- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIICHB1QD2QSS

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duplicatesourceMERCKduplicatenumbUS-009507513-1403USA000980