Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-000870Version of Safety Report ID5receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10051619Date Received31/03/2014seriousnesshospitalization1transmissiondate28/05/2015serious1Date Last Updated21/10/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age69Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionInjection site pruritus

2)

reactionmeddraversionpt18.0ReactionTherapy change

3)

reactionmeddraversionpt18.0ReactionStoma site irritation

4)

reactionmeddraversionpt18.0ReactionDecreased appetite

5)

reactionmeddraversionpt18.0ReactionCondition aggravated

6)

reactionmeddraversionpt18.0ReactionWeight decreased

7)

reactionmeddraversionpt18.0ReactionDrug ineffective

8)

reactionmeddraversionpt18.0ReactionPain

9)

reactionmeddraversionpt18.0ReactionDiarrhoea

10)

reactionmeddraversionpt18.0ReactionInjection site erythema

11)

reactionmeddraversionpt18.0ReactionSmall intestinal obstruction

12)

reactionmeddraversionpt18.0ReactionInjection site urticaria

13)

reactionmeddraversionpt18.0ReactionNausea

14)

reactionmeddraversionpt18.0ReactionFlatulence

15)

reactionmeddraversionpt18.0ReactionAbdominal pain

16)

reactionmeddraversionpt18.0ReactionAbdominal distension

17)

reactionmeddraversionpt18.0ReactionDrug effect decreased

18)

reactionmeddraversionpt18.0ReactionInjection site irritation

Drug

1)

drugcharacterization2medicinalproductLEVOTHYROXINE

activesubstance

activesubstancenameLEVOTHYROXINE

openFDA Info on Medication

Brand NameLEVOTHYROXINEGeneric NameLEVOTHYROXINEManufacturersDeseret Biologicals, Inc.product_ndc43742-0955Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLEVOTHYROXINEspl_id7c431149-4f46-4c4f-a5bb-c1b1fb705283spl_set_id1a467f8b-2611-4936-af2b-098e4791d6aePackage NDC43742-0955-1NUIN0000175945, M0021504Established Pharmacologic Classl-Thyroxine [EPC]Chemical StructureThyroxine [CS]UNIIQ51BO43MG4

2)

drugcharacterization2medicinalproductASPIRIN.

activesubstance

activesubstancenameASPIRIN

openFDA Info on Medication

Application Numberpart343Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN 81MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 0363-0587, 70000-0218, 70000-0170, 6 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 198471, 825180, 198464 ... spl_id a1833a99-76cc-47fb-80fb-3a6507a2db3e, acc2acbd-b310-e26a-e053-2a95a90a1874, 1b00 ... spl_set_id 2826d84d-b135-4e20-aeea-271e9f74f431, 356e4ff4-a7f1-4a50-9b86-2555e232b300, 4c30 ... Package NDC 49035-914-32, 47682-456-50, 47682-456-47, 42961-044-01, 42961-044-02, 42961-044- ... NUIN0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]UNIIR16CO5Y76E, H0G9379FGK

3)

drugcharacterization2medicinalproductANTIHYPERTENSIVES

activesubstance

activesubstancenameUNSPECIFIED INGREDIENT

4)

drugcharacterization1medicinalproductGATTEXdrugbatchnumbAV13037AAdrugauthorizationnumb203441drugstructuredosagenumb0.3drugstructuredosageunit012drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute058drugindicationSHORT-BOWEL SYNDROMEdrugstartdateformat102drugstartdate31/10/2013drugenddateformat610drugenddate/11/2013drugrecurreadministration2drugadditional1

activesubstance

activesubstancenameTEDUGLUTIDE\WATER

openFDA Info on Medication

Application NumberNDA203441Brand NameGATTEXGeneric NameTEDUGLUTIDEManufacturersShire-NPS Pharmaceuticals, Inc.product_ndc68875-0101, 68875-0103, 68875-0102Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsTEDUGLUTIDERXCUI1364472, 1364477, 1489307spl_idb9133b47-b1c0-4c72-ad63-1fc7a5744aa8spl_set_id66b69c1e-b25c-44d3-b5ff-1c1de9a516faPackage NDC68875-0101-1, 68875-0101-2, 68875-0103-1, 68875-0102-1NUIN0000190992, N0000190990, N0000175140, N0000175452Established Pharmacologic ClassGLP-2 Analog [EPC]Mechanism of ActionGlucagon-like Peptide-2 (GLP-2) Agonists [MoA]Chemical Structure Glucagon-Like Peptide 2 [Chemical/Ingredient], Analogs/Derivatives [Chemical/Ing ... UNII7M19191IKG

5)

drugcharacterization2medicinalproductMAGNESIUM

activesubstance

activesubstancenameMAGNESIUM

openFDA Info on Medication

Brand NameMAGNESIUM METALLICUMGeneric NameMAGNESIUMManufacturersWashington Homeopathic Productsproduct_ndc71919-432, 68428-981Product TypeHUMAN OTC DRUGRouteORALActive IngredientsMAGNESIUMspl_id7e576a9a-5338-06b5-e053-2a91aa0a87b5, f66824cf-f8b0-4a71-b798-821343c5a77bspl_set_idce81f9c8-da78-43dd-a255-46978ec47d9c, 458aa1da-e975-4e11-a0c0-5ce352046ae1Package NDC 71919-432-07, 71919-432-08, 71919-432-09, 71919-432-10, 68428-981-03, 68428-981- ... UNIII38ZP9992A

6)

drugcharacterization2medicinalproductMAGNESIUM OXIDE.

activesubstance

activesubstancenameMAGNESIUM OXIDE

openFDA Info on Medication

Application Numberpart331Brand NameMAGNESIUM OXIDEGeneric NameMAGNESIUM OXIDEManufacturers Westminster Pharmaceuticals, LLC, PAR Pharmaceuticals, Method Pharmaceuticals, L ... product_ndc69367-298, 0603-0209, 58657-120, 54738-973, 0603-0213, 54738-974Product TypeHUMAN OTC DRUGRouteORALActive IngredientsMAGNESIUM OXIDERXCUI198741, 311430spl_id 5501dfcf-df9c-4b51-9722-b7e78076cd6f, 6dae00c5-fb60-4bb5-b278-d38ff3d1068c, 9e50 ... spl_set_id 52eeac0e-94bb-48c3-81dc-578e96406c01, d3c5b01b-f0d6-4503-ab18-b1a72386e2c6, 0af6 ... Package NDC 69367-298-20, 0603-0209-22, 58657-120-12, 54738-973-12, 0603-0213-21, 54738-974- ... UNII3A3U0GI71G

7)

drugcharacterization2medicinalproductZOLOFT

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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

8)

drugcharacterization2medicinalproductIMODIUM

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 ad65b05d-75aa-4f88-b17b-fa90f8b93683, 8e311966-8e66-4598-a287-ca4417461eb5, f8f9 ... 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]

9)

drugcharacterization2medicinalproductLOMOTIL /00034001/

10)

drugcharacterization2medicinalproductIRON

activesubstance

activesubstancenameIRON

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

11)

drugcharacterization2medicinalproductROSMARINUS OFFICINALIS

12)

drugcharacterization2medicinalproductSKIN HAIR NAILS

13)

drugcharacterization2medicinalproductPROBIOTICS NOS

activesubstance

activesubstancenamePROBIOTICS NOS

14)

drugcharacterization2medicinalproductFISH OIL

activesubstance

activesubstancenameFISH OIL

openFDA Info on Medication

Application NumberNDA210589Brand NameOMEGAVENGeneric NameFISH OILManufacturersFresenius Kabi USA, LLCproduct_ndc63323-205Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsFISH OILRXCUI2053499, 2053504, 2053513, 2053514spl_idc4f460d5-da90-4b9b-aff1-df3176a43d47spl_set_id5d9d0b24-e139-48bf-ab2d-536fb59cf8e0Package NDC63323-205-21, 63323-205-50, 63323-205-31, 63323-205-00UNIIXGF7L72M0F

15)

drugcharacterization2medicinalproductHYOSCYAMINE

activesubstance

activesubstancenameHYOSCYAMINE

openFDA Info on Medication

Brand NameHYOSCYAMINE, HYOSCYAMINE ER, HYOSCYAMINE SLGeneric NameHYOSCYAMINE SULFATEManufacturersPatrin Pharma, Wallace Pharmaceuticals Inc.product_ndc39328-048, 51525-0112, 51525-0115, 51525-0113, 39328-047Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYOSCYAMINE SULFATERXCUI1047881, 1047905, 1046770, 1046982, 1047895spl_id 12f9afe0-1263-4198-a6b4-6ce44479e3b3, ae0d2b1d-1ac2-4521-9de7-08c0d0e30413, a627 ... spl_set_id e09f23ca-e6f8-46c3-b713-97b86e3d5c97, 9fb71fa2-2ce8-429e-8719-58f3b12a6163, 5bbc ... Package NDC39328-048-16, 51525-0112-1, 51525-0115-1, 51525-0113-1, 39328-047-15UNIIF2R8V82B84

16)

drugcharacterization2medicinalproductVITAMIN D3

activesubstance

activesubstancenameCHOLECALCIFEROL

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturersStrides Pharma Science Limitedproduct_ndc64380-737Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36Package NDC64380-737-06, 64380-737-25NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

17)

drugcharacterization2medicinalproductMULTIVITAMIN /00097801/

activesubstance

activesubstancenameVITAMINS

18)

drugcharacterization2medicinalproductCALCIUM

activesubstance

activesubstancenameCALCIUM

openFDA Info on Medication

Brand Name P D ALL, ONLYCAL, RESTO L, P D M, RESTORATION TREATMENT, TALL G U, C P RE, D T B ... Generic NameCALCIUMManufacturerscoexleaders co.,ltd.product_ndc 81445-0002, 81445-0005, 81445-0006, 81445-0003, 81445-0001, 81445-0008, 81445-00 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCALCIUMspl_id b9e7d910-8df8-ca9a-e053-2995a90a0d05, b9eb3dea-4f3e-1d23-e053-2995a90a4eb2, b9eb ... spl_set_id b9e7d869-d218-d60c-e053-2995a90af542, b9eb3cc9-e340-c77d-e053-2995a90a1628, b9eb ... Package NDC 81445-0002-1, 81445-0005-1, 81445-0006-1, 81445-0003-1, 81445-0001-1, 81445-0008 ... NUIM0003153, N0000175901, N0000175597, N0000020074Chemical StructureCalcium [CS]Established Pharmacologic ClassCalcium [EPC], Phosphate Binder [EPC]Mechanism of ActionPhosphate Chelating Activity [MoA]UNIISY7Q814VUP

19)

drugcharacterization2medicinalproductSYNTHROID

activesubstance

activesubstancenameLEVOTHYROXINE SODIUM

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)

drugcharacterization2medicinalproductSOLUTIONS FOR PARENTERAL NUTRITION

activesubstance

activesubstancenameAMINO ACIDS\DEXTROSE\ELECTROLYTES NOS

21)

drugcharacterization2medicinalproductBIOTIN

activesubstance

activesubstancenameBIOTIN

openFDA Info on Medication

Brand NameHAIRJOY EYEBROW SIGNATURE, HAIRJOY EYELASH SIGNATUREGeneric NameBIOTINManufacturersHAIRJOYproduct_ndc69384-090, 69384-080Product TypeHUMAN OTC DRUGRouteTOPICALActive IngredientsBIOTINspl_ide3180639-1e79-4ccd-be0d-119f17386386, 6159acee-5315-4e8f-b37b-88b4244c3cf8spl_set_ideb0813ab-dea6-4b13-b517-8e1ad1861c5d, ca42d0a4-b9f8-48b9-bd4c-8c669e31e772Package NDC69384-090-01, 69384-090-02, 69384-080-01, 69384-080-02UNII6SO6U10H04

summary

narrativeincludeclinicalCASE EVENT DATE: 201311

Report Duplicate

duplicatesourceNPSduplicatenumbUS-000870