Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10159822serious1Date Last Updated17/07/2014receiptdateformat102companynumb2014SP002404occurcountryUSduplicate1Date Received08/05/2014seriousnesshospitalization1transmissiondate26/03/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age37Unit of Onset AgeyearsWeight58.9SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionNauseaOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.1ReactionVertigo positionalOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.1ReactionVertigoOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.1ReactionVomitingOutcomeRecovering/resolving

5)

reactionmeddraversionpt17.1ReactionSyncopeOutcomeRecovering/resolving

Drug

1)

drugcharacterization2medicinalproductOXYCODONEdrugstructuredosagenumb5drugstructuredosageunit003drugadministrationroute048drugindicationMUSCULOSKELETAL CHEST PAINdrugstartdateformat102drugstartdate08/04/2014

activesubstance

activesubstancenameOXYCODONE

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]

2)

drugcharacterization2medicinalproductONDANSETRON HYDROCHLORIDE.drugstructuredosagenumb8drugstructuredosageunit003drugadministrationroute048drugindicationNAUSEAdrugstartdateformat102drugstartdate02/04/2014

activesubstance

activesubstancenameONDANSETRON HYDROCHLORIDE

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]

3)

drugcharacterization1medicinalproductCISPLATIN.drugauthorizationnumb091062drugstructuredosagenumb130drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb3drugintervaldosagedefinition803drugadministrationroute042drugindicationBREAST CANCERdrugstartdateformat102drugstartdate08/04/2014drugenddateformat102drugenddate21/04/2014actiondrug4

activesubstance

activesubstancenameCISPLATIN

openFDA Info on Medication

Application NumberANDA074656, NDA018057, ANDA075036, ANDA206774, ANDA207323, ANDA074735Brand NameCISPLATINGeneric NameCISPLATINManufacturers Teva Parenteral Medicines, Inc., WG Critical Care, LLC, West-Ward Pharmaceutical ... product_ndc 0703-5747, 0703-5748, 44567-530, 0143-9504, 0143-9505, 44567-509, 44567-510, 445 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsCISPLATINRXCUI309311, 1736854spl_id 54b3415c-c095-4c82-b216-e0e6e6bb8d03, 1dda0f66-289e-4c7b-95f6-9e1a25473a95, 2c56 ... spl_set_id a440f077-46f6-4688-a209-65bce38d1c92, 508496cb-3441-46b3-a4fe-e0d440e6adc6, 76ae ... Package NDC 0703-5747-11, 0703-5748-11, 44567-530-01, 0143-9504-01, 0143-9505-01, 44567-509- ... NUIN0000175413, N0000175073Established Pharmacologic ClassPlatinum-based Drug [EPC]UNIIQ20Q21Q62J

4)

drugcharacterization1medicinalproductPF-05212384drugstructuredosagenumb130drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugindicationBREAST CANCERdrugstartdateformat102drugstartdate01/04/2014drugenddateformat102drugenddate21/04/2014

activesubstance

activesubstancenameGEDATOLISIB

5)

drugcharacterization2medicinalproductCODEINEdrugstructuredosagenumb5drugstructuredosageunit012drugadministrationroute048drugindicationCOUGHdrugstartdateformat102drugstartdate21/03/2014

activesubstance

activesubstancenameCODEINE

6)

drugcharacterization2medicinalproductGRANISETRON HYDROCHLORIDE.drugstructuredosagenumb1drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosageformTRANSDERMAL PATCHdrugindicationNAUSEAdrugstartdateformat102drugstartdate09/04/2014

activesubstance

activesubstancenameGRANISETRON HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA078969, ANDA078566, ANDA078564, ANDA078096, ANDA078090, ANDA077842, ANDA0786 ... Brand NameGRANISETRON HYDROCHLORIDE, GRANISETRONGeneric NameGRANISETRON HYDROCHLORIDEManufacturers Natco Pharma Limited, Wockhardt USA LLC., Fresenius Kabi USA, LLC, West-Ward Pha ... product_ndc 63850-0005, 64679-662, 64679-661, 63323-318, 63323-319, 63323-317, 0054-0143, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsGRANISETRON HYDROCHLORIDERXCUI310599, 543218, 1734399, 240912spl_id 67953305-4eb0-4b00-abae-716ac25c5bf9, cfcc32f8-5f6b-450c-88f4-04c0b5b4c865, fdb5 ... spl_set_id d2be8de3-04fe-4e92-82b4-98d749b89596, cb583779-2746-4363-9cf7-f198247188d1, eada ... Package NDC 63850-0005-1, 63850-0005-2, 64679-662-03, 64679-662-02, 64679-662-01, 64679-661- ... UNII318F6L70J8

7)

drugcharacterization2medicinalproductGUAIFENESIN.drugstructuredosagenumb5drugstructuredosageunit012drugadministrationroute048drugindicationCOUGHdrugstartdateformat102drugstartdate21/03/2014

activesubstance

activesubstancenameGUAIFENESIN

openFDA Info on Medication

Application Number part341, NDA021282, ANDA207342, ANDA091009, ANDA209215, ANDA210453, ANDA213420, ... Brand Name SIMPEX GUAIFENESIN, MUCUS, MUCUS RELIEF, MUCUS RELIEF MAXIMUM STRENGTH, MUCUS RE ... Generic NameGUAIFENESINManufacturers Simpex Pharma Pvt. Ltd, KROGER COMPANY, Strategic Sourcing Services LLC, ARMY AN ... product_ndc 76457-004, 30142-701, 70677-0049, 55301-532, 11822-0532, 10956-002, 41520-731, 6 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDERXCUI 359601, 636522, 310604, 310621, 213160, 197741, 198687, 310625, 891301, 1112205, ... spl_id 7d870204-c1ad-fa24-e053-2a91aa0a2be6, 09d93ec2-f597-4038-8d97-7530bc85faba, dcfe ... spl_set_id 1594f9d6-0c48-42bf-b76b-d621f215179a, 20aa5ec5-d14e-4418-b9b9-d7c5c16de80b, 2200 ... Package NDC 76457-004-00, 30142-701-20, 70677-0049-1, 55301-532-11, 11822-0532-3, 11822-0532 ... UNII495W7451VQ, 9D2RTI9KYH

8)

drugcharacterization2medicinalproductLORAZEPAM.drugstructuredosagenumb1drugstructuredosageunit003drugadministrationroute048drugindicationANXIETYdrugstartdateformat610drugstartdate/03/2013

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 IngredientsLORAZEPAMRXCUI238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 763028, 763029spl_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

9)

drugcharacterization2medicinalproductOXYCODONE HYDROCHLORIDE.drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationMUSCULOSKELETAL CHEST PAINdrugstartdateformat102drugstartdate21/03/2014

activesubstance

activesubstancenameOXYCODONE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA205853, ANDA207418, NDA022272, ANDA203638, ANDA208795, ANDA204021, ANDA20989 ... Brand NameOXYCODONE HYDROCHLORIDE, OXYCONTIN, ROXICODONE, OXAYDOGeneric NameOXYCODONE HYDROCHLORIDE, OXYCODONEManufacturers Rhodes Pharmaceuticals L.P., Camber Pharmaceuticals Inc, Purdue Pharma LP, Amnea ... product_ndc 42858-010, 31722-917, 31722-918, 59011-410, 59011-480, 59011-415, 59011-420, 590 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDERXCUI 1049615, 1049611, 1049618, 1049504, 1049545, 1049565, 1049576, 1049586, 1049595, ... spl_id bab5f88d-95e5-6e41-c800-4e3b85583d10, 69cd1131-3a4e-4e63-9734-1b1e3f4ee5c9, 21ec ... spl_set_id bab5f88d-95e5-6e41-c800-4e3b85583d10, 01db4606-d49c-4b10-a78a-1cf41880a9fb, bfdf ... Package NDC 42858-010-15, 31722-917-01, 31722-917-05, 31722-918-01, 31722-918-05, 59011-480- ... UNIIC1ENJ2TE6C

10)

drugcharacterization2medicinalproductSERTRALINE HYDROCHLORIDE.drugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationDEPRESSIONdrugstartdateformat602drugstartdate//2011

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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

11)

drugcharacterization2medicinalproductLORAZEPAM.drugstructuredosagenumb1drugstructuredosageunit003drugadministrationroute048drugindicationINSOMNIAdrugstartdateformat610drugstartdate/03/2013

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 IngredientsLORAZEPAMRXCUI238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 763028, 763029spl_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

summary

narrativeincludeclinicalCASE EVENT DATE: 20140421

Report Duplicate

duplicatesourceSTRIDESduplicatenumb2014SP002404

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use