Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10088273serious1Date Last Updated21/04/2014receiptdateformat102companynumbUS-ROCHE-1379590occurcountryUSduplicate1Date Received21/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age68Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionPleural effusionOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionCardiomyopathyOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionAcute respiratory failureOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionAtelectasisOutcomeRecovered/resolved

5)

reactionmeddraversionpt17.0ReactionUpper respiratory tract infectionOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionDecreased appetiteOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionDehydrationOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductPERJETAdrugauthorizationnumb125409drugadministrationroute065drugindicationMETASTATIC NEOPLASMactiondrug5

openFDA Info on Medication

Application NumberBLA125409Brand NamePERJETAGeneric NamePERTUZUMABManufacturersGenentech, Inc.product_ndc50242-145Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsPERTUZUMABRXCUI1298948, 1298953spl_idf4843815-4f02-4079-9496-024996ea7f26spl_set_id17f85d17-ab71-4f5b-9fe3-0b8c822f69ffPackage NDC50242-145-01NUIN0000175661, N0000020008Established Pharmacologic ClassHER2/neu Receptor Antagonist [EPC]Mechanism of ActionHER2/Neu/cerbB2 Antagonists [MoA]UNIIK16AIQ8CTM

2)

drugcharacterization1medicinalproductHERCEPTINdrugauthorizationnumb103792drugadministrationroute065drugindicationMETASTATIC NEOPLASMactiondrug5

openFDA Info on Medication

Application NumberBLA103792Brand NameHERCEPTINGeneric NameTRASTUZUMABManufacturersGenentech, Inc.product_ndc50242-132, 50242-134Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsTRASTUZUMABRXCUI806573, 806575, 1922509, 1922512spl_id68805c84-fc83-4bc6-9311-2fec065cc3b8spl_set_id492dbdb2-077e-4064-bff3-372d6af0a7a2Package NDC50242-134-68, 50242-132-01, 50242-132-10NUIN0000175661, N0000020008Established Pharmacologic ClassHER2/neu Receptor Antagonist [EPC]Mechanism of ActionHER2/Neu/cerbB2 Antagonists [MoA]UNIIP188ANX8CK

3)

drugcharacterization2medicinalproductDOCETAXELdrugindicationMETASTATIC NEOPLASM

openFDA Info on Medication

Application Number ANDA210327, ANDA207252, NDA201525, ANDA204490, NDA203551, NDA022234, ANDA208859, ... Brand NameDOCETAXEL, TAXOTEREGeneric NameDOCETAXEL, DOCETAXEL ANHYDROUSManufacturers Armas Pharmaceuticals Inc., Jiangsu Hengrui Medicine Co., Ltd., Sandoz Inc., Hik ... product_ndc 72485-216, 57884-3041, 57884-3042, 57884-3043, 66758-950, 0143-9204, 0143-9205, ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsDOCETAXEL, DOCETAXEL ANHYDROUSRXCUI1861411, 1860480, 1860485, 1093280, 1001405, 1860619, 1870937, 1860482, 1860486spl_id 10308491-d534-4e9f-9fcc-8d8a3eda213d, af5b8ee7-1566-1ccd-e053-2a95a90afcca, f821 ... spl_set_id 0dd863ec-f9dc-456c-9df5-4e9210d6cbb0, e488100d-6728-4f44-9282-f63a805b8e13, 875b ... Package NDC 72485-216-08, 57884-3041-1, 57884-3042-1, 57884-3043-1, 66758-950-02, 66758-950- ... UNII15H5577CQD, 699121PHCANUIN0000175085, N0000175592Physiologic/Pharmacodynamic EffectMicrotubule Inhibition [PE]Established Pharmacologic ClassMicrotubule Inhibitor [EPC]

4)

drugcharacterization2medicinalproductAZITHROMYCINdrugstructuredosagenumb250drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

openFDA Info on Medication

Application Number ANDA211791, ANDA065179, ANDA203294, ANDA065511, ANDA209045, ANDA209044, NDA05069 ... Brand NameAZITHROMYCINGeneric Name AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, AZITHROMYCIN FOR ... Manufacturers Alembic Pharmaceuticals Limited, Fresenius Kabi USA, LLC, AuroMedics Pharma LLC, ... product_ndc 46708-057, 63323-398, 55150-174, 0409-0144, 0527-2370, 0527-2395, 59762-3051, 59 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUS, PARENTERALActive IngredientsAZITHROMYCIN DIHYDRATE, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN ANHYDROUSRXCUI308460, 749783, 1668238, 248656, 749780, 204844, 861416, 141963, 308459spl_id deea1a56-84ed-4ce4-9d11-03271510c0a1, 94a38ec5-e40e-dd25-e053-2995a90a2525, 93f2 ... spl_set_id deea1a56-84ed-4ce4-9d11-03271510c0a1, 62f6f327-3fef-49f0-ae90-078356d002b5, b699 ... Package NDC 46708-057-30, 46708-057-06, 63323-398-12, 63323-398-01, 63323-398-10, 55150-174- ... UNII5FD1131I7S, JTE4MNN1MD, J2KLZ20U1MNUIN0000175935, M0028311Established Pharmacologic ClassMacrolide Antimicrobial [EPC]Chemical StructureMacrolides [CS]

5)

drugcharacterization2medicinalproductSALINE NASAL SPRAYdrugdosagetext1 PUFFdrugadministrationroute045

6)

drugcharacterization2medicinalproductCIPROdrugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb12drugintervaldosagedefinition805drugdosageformTABLETdrugadministrationroute048drugindicationPYREXIA

openFDA Info on Medication

Application NumberNDA020805, NDA019537, NDA020780Brand NameCIPRO HC, CIPROGeneric Name CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE, CIPROFLOXACIN HYDROCHLORIDE, CIP ... ManufacturersAlcon Laboratories, Inc., Bayer HealthCare Pharmaceuticals Inc.product_ndc0065-8531, 50419-754, 50419-758, 50419-777, 50419-773Product TypeHUMAN PRESCRIPTION DRUGRouteAURICULAR (OTIC), ORALActive IngredientsCIPROFLOXACIN HYDROCHLORIDE, HYDROCORTISONERXCUI213320, 309305, 197511, 205769, 205770, 213224, 213226, 309308, 309309, 309310spl_idc2edcef4-e70c-4323-83b7-9e2f0c41aad6, 35b84458-fb24-48b1-9bc0-b8ac0c07e37cspl_set_id70b19501-34b6-4f95-a8dd-dd3e67d22399, 888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0Package NDC0065-8531-10, 50419-758-01, 50419-754-01, 50419-777-01, 50419-773-01NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNII4BA73M5E37, WI4X0X7BPJ

7)

drugcharacterization2medicinalproductDEXAMETHASONEdrugstructuredosagenumb4drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb12drugintervaldosagedefinition805drugdosageformTABLETdrugadministrationroute048

openFDA Info on Medication

Application Number NDA022315, ANDA088237, NDA211379, ANDA201270, ANDA088481, ANDA088254, NDA208912, ... Brand Name OZURDEX, TAPERDEX 12-DAY, HEMADY, DEXABLISS, DEXAMETHASONE, DEXAMETHASONE 1.5 MG ... Generic NameDEXAMETHASONE, DEXAMETHASONE 1.5 MGManufacturers Allergan, Inc., Xspire Pharma, Llc, Acrotech Biopharma LLC, Levins Pharmaceutica ... product_ndc 0023-3348, 42195-149, 42195-490, 72893-015, 71905-400, 48102-045, 48102-046, 481 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVITREAL, ORAL, INTRAOCULAR, OPHTHALMIC, INTRACANALICULARActive IngredientsDEXAMETHASONERXCUI 854177, 854181, 197580, 1943550, 1998481, 2261802, 2286261, 2121587, 197577, 197 ... spl_id 04b2b881-a84c-417c-ba09-8a76cf46faea, dff2b4b8-6dba-4bf3-ac9d-3960db623d1b, 20ec ... spl_set_id 4b204f44-6e8a-4d17-803c-268f0b04679f, c3c59b82-1343-470d-bbc7-e40da3c0a28f, aec6 ... Package NDC 0023-3348-07, 0023-3348-08, 42195-149-12, 42195-490-12, 72893-015-24, 72893-015- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNII7S5I7G3JQL

8)

drugcharacterization2medicinalproductKLONOPINdrugauthorizationnumb017533drugstructuredosagenumb.5drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

openFDA Info on Medication

Application NumberNDA017533Brand NameKLONOPINGeneric NameCLONAZEPAMManufacturersGenentech, Inc.product_ndc0004-0058, 0004-0068, 0004-0098Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI197527, 197528, 197529, 206157, 206159, 206160spl_id7a882463-5215-477c-bc1c-2cce0801bf4bspl_set_id542f22e8-dad2-47a8-93b6-30936715d73bPackage NDC0004-0068-01, 0004-0058-01, 0004-0098-01NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

9)

drugcharacterization2medicinalproductLETROZOLEdrugstructuredosagenumb2.5drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute048

openFDA Info on Medication

Application Number ANDA090934, ANDA091191, ANDA211717, ANDA200161, ANDA090289, ANDA202716, ANDA0913 ... Brand NameLETROZOLE, FEMARAGeneric NameLETROZOLE, LETROZOLE TABLETSManufacturers Accord Healthcare, Inc., Dr. Reddy's Laboratories Limited, Aurobindo Pharma Limi ... product_ndc 16729-034, 55111-646, 59651-180, 63850-0025, 0093-7620, 57884-2021, 60505-3255, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLETROZOLERXCUI200064, 153124spl_id 8db7c753-55f2-4fd5-e053-2a95a90a3679, ec1b249b-2d77-55d9-0520-23884a961cf0, fa07 ... spl_set_id c391fe11-fd47-4a35-af6d-c823ab7b8838, 6cfd29d7-f519-7b8c-4814-07b39f367f0d, ff73 ... Package NDC 16729-034-10, 16729-034-15, 16729-034-01, 16729-034-16, 16729-034-17, 16729-034- ... NUIN0000175563, N0000175080Established Pharmacologic ClassAromatase Inhibitor [EPC]Mechanism of ActionAromatase Inhibitors [MoA]UNII7LKK855W8I

10)

drugcharacterization2medicinalproductPROCHLORPERAZINE MALEATEdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb6drugintervaldosagedefinition805drugdosagetextPRNdrugdosageformTABLETdrugadministrationroute048drugindicationNAUSEA

openFDA Info on Medication

Application NumberANDA040185, ANDA040268Brand NamePROCHLORPERAZINE MALEATEGeneric NamePROCHLORPERAZINE MALEATEManufacturersMylan Pharmaceuticals Inc., JUBILANT CADISTA PHARMACEUTICALS INC.product_ndc0378-5105, 0378-5110, 59746-113, 59746-115Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPROCHLORPERAZINE MALEATERXCUI198365, 312635spl_id6cbe61f6-c324-4882-974e-6e9b562d8619, aeb0f87c-6809-496d-8162-72c2e405bde0spl_set_id6b0e958b-fde0-74ea-b196-1e62f90b5bbe, b05bc20e-cd19-ab40-1ad0-84a115d6d69ePackage NDC 0378-5105-01, 0378-5110-01, 59746-113-06, 59746-113-10, 59746-115-06, 59746-115- ... UNIII1T8O1JTL6

11)

drugcharacterization2medicinalproductRANITIDINE HCLdrugstructuredosagenumb300drugstructuredosageunit003drugdosagetextQHSdrugdosageformCAPSULEdrugadministrationroute048drugindicationNAUSEA

12)

drugcharacterization2medicinalproductRANITIDINE HCLdrugindicationPROPHYLAXIS AGAINST GASTROINTESTINAL ULCER

13)

drugcharacterization2medicinalproductZOFRANdrugstructuredosagenumb8drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb8drugintervaldosagedefinition805drugdosageformTABLETdrugadministrationroute048drugindicationNAUSEA

openFDA Info on Medication

Application NumberNDA020103Brand NameZOFRANGeneric NameONDANSETRON HYDROCHLORIDEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0675, 0078-0676Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsONDANSETRON HYDROCHLORIDERXCUI104895, 104896, 198052, 312086spl_id5de8b98b-16d8-4540-8991-ebaace847a66spl_set_id555f81bc-4ce0-4f77-b394-b974838c4440Package NDC0078-0675-15, 0078-0676-15UNIINMH84OZK2B

14)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb50drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute048

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

15)

drugcharacterization2medicinalproductLEVAQUINdrugadministrationroute048

openFDA Info on Medication

16)

drugcharacterization2medicinalproductVEETIDSdrugstructuredosagenumb1500drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048

17)

drugcharacterization2medicinalproductLIPITORdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048

openFDA Info on Medication

Application NumberNDA020702Brand NameLIPITORGeneric NameATORVASTATIN CALCIUMManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0155, 0071-0156, 0071-0157, 0071-0158Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATORVASTATIN CALCIUM TRIHYDRATERXCUI259255, 262095, 617310, 617311, 617312, 617314, 617318, 617320spl_id0ba214c6-250e-42a0-aea8-5e44aba04882spl_set_idc6e131fe-e7df-4876-83f7-9156fc4e8228Package NDC 0071-0155-23, 0071-0155-40, 0071-0155-10, 0071-0155-97, 0071-0156-23, 0071-0156- ... UNII48A5M73Z4Q

18)

drugcharacterization2medicinalproductADVILdrugstructuredosagenumb600drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb8drugintervaldosagedefinition805drugadministrationroute048

openFDA Info on Medication

Application NumberNDA201803, NDA018989, NDA020402Brand NameADVILGeneric NameIBUPROFEN SODIUM, IBUPROFENManufacturers GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, Lil' Drug Store Products, ... product_ndc 0573-0133, 0573-0134, 0573-0150, 0573-0165, 0573-0154, 0573-0151, 0573-0161, 057 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsIBUPROFEN SODIUM, IBUPROFENRXCUI153008, 310965, 310964, 731533spl_id fc3f9fd1-0569-4374-bcc4-bdbdbcb5411b, 943017cf-1b80-44e5-bef9-20f6604dfb43, 4dc1 ... spl_set_id 5be198b8-396e-4b44-8819-e2e3b5d2ad0e, 1a665e64-9f30-be37-4a83-38789f1f1e89, 1f01 ... Package NDC 0573-0133-20, 0573-0133-40, 0573-0133-80, 0573-0133-02, 0573-0133-04, 0573-0133- ... UNIIRM1CE97Z4N, WK2XYI10QMNUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]

19)

drugcharacterization2medicinalproductSYNTHROIDdrugadministrationroute048

openFDA Info on Medication

Application NumberNDA021402Brand NameSYNTHROIDGeneric NameLEVOTHYROXINE SODIUMManufacturersAbbVie Inc.product_ndc 0074-3727, 0074-7149, 0074-4341, 0074-4552, 0074-5182, 0074-6624, 0074-6594, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOTHYROXINE SODIUMRXCUI 892246, 892251, 892255, 966158, 966171, 966185, 966191, 966201, 966205, 966218, ... spl_iddb21fc0c-4a2d-9922-39bd-8128e429bebcspl_set_id1e11ad30-1041-4520-10b0-8f9d30d30fccPackage NDC 0074-7149-90, 0074-7149-19, 0074-4341-13, 0074-4341-90, 0074-4341-19, 0074-4341- ... UNII9J765S329G

20)

drugcharacterization2medicinalproductCEFTRIAXONE SODIUMdrugstructuredosagenumb1drugstructuredosageunit002drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute042

openFDA Info on Medication

Application Number ANDA065204, ANDA065168, ANDA065169, ANDA065328, ANDA209218, ANDA203702, ANDA0900 ... Brand NameCEFTRIAXONE SODIUM, CEFTRIAXONEGeneric NameCEFTRIAXONE SODIUMManufacturers Hospira, Inc, Sagent Pharmaceuticals, Apotex Corp., Sandoz GmbH, Sandoz Inc, Qil ... product_ndc 0409-7333, 0409-7336, 0409-7334, 0409-7332, 0409-7337, 0409-7338, 0409-7335, 250 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, INTRAMUSCULARActive IngredientsCEFTRIAXONE SODIUMRXCUI1665021, 1665046, 309090, 309092, 1665005spl_id 46119628-25cc-4d4c-8500-bbd2fc86961d, c6bec19b-5b2d-4fd6-a63c-f96060dca058, 5b2d ... spl_set_id 9d1f630b-e759-4395-9d01-ddc90e4fea75, 365fc265-8e6c-432f-9fda-911f5f7fb451, 0328 ... Package NDC 0409-7333-31, 0409-7333-49, 0409-7336-49, 0409-7334-10, 0409-7337-11, 0409-7337- ... UNII023Z5BR09K

Report Duplicate

duplicatesourceROCHEduplicatenumbUS-ROCHE-1379590

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use