Report

Version of Safety Report ID1Safety Report ID10874374primarysourcecountryUStransmissiondateformat102transmissiondate21/07/2015reporttype1serious1seriousnessother1receivedateformat102Date Received23/02/2015receiptdateformat102Date Last Updated23/02/2015fulfillexpeditecriteria2

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age58Unit of Onset AgeyearsWeight47.63SexFemale

Contents

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

Reaction

1)

reactionmeddraversionpt18.0ReactionSkin turgor decreased

2)

reactionmeddraversionpt18.0ReactionUrine output decreased

3)

reactionmeddraversionpt18.0ReactionHyperhidrosis

4)

reactionmeddraversionpt18.0ReactionBlood pressure decreased

5)

reactionmeddraversionpt18.0ReactionHeart rate increased

6)

reactionmeddraversionpt18.0ReactionDehydration

Drug

1)

drugcharacterization1medicinalproductELIQUISdrugbatchnumb4D82300Tdrugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationAORTIC THROMBOSISdrugstartdateformat102drugstartdate18/02/2015drugenddateformat102drugenddate18/02/2015drugrecurreadministration2drugadditional1

activesubstance

activesubstancenameAPIXABAN

openFDA Info on Medication

Application NumberNDA202155Brand NameELIQUIS, ELIQUIS 30-DAY STARTER PACKGeneric NameAPIXABANManufacturersE.R. Squibb & Sons, L.L.C.product_ndc0003-0893, 0003-0894, 0003-3764Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAPIXABANRXCUI1364435, 1364441, 1364445, 1364447, 1992427, 1992428spl_idfeddc8d1-823f-4d4e-a1c0-651d2f525e48spl_set_ide9481622-7cc6-418a-acb6-c5450daae9b0Package NDC 0003-0893-21, 0003-0893-31, 0003-0893-91, 0003-0894-21, 0003-0894-70, 0003-0894- ... NUIN0000175637, N0000175635Established Pharmacologic ClassFactor Xa Inhibitor [EPC]Mechanism of ActionFactor Xa Inhibitors [MoA]UNII3Z9Y7UWC1J

2)

drugcharacterization2medicinalproductSEROQUEL XR

activesubstance

activesubstancenameQUETIAPINE FUMARATE

openFDA Info on Medication

Application NumberNDA022047Brand NameSEROQUEL XRGeneric NameQUETIAPINEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc0310-0280, 0310-0282, 0310-0283, 0310-0284, 0310-0281Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI721791, 721793, 721794, 721795, 721796, 721797, 853201, 853202, 895670, 895671spl_idc3b26ed5-6f3a-4ca5-80a5-b98380040294spl_set_id473a3ac4-67f4-4782-baa9-7f9bdd8761f4Package NDC 0310-0282-39, 0310-0282-94, 0310-0282-60, 0310-0283-39, 0310-0283-55, 0310-0283- ... UNII2S3PL1B6UJ

3)

drugcharacterization2medicinalproductMVI

activesubstance

activesubstancenameVITAMINS

4)

drugcharacterization2medicinalproductL-METHYLFOLATE

5)

drugcharacterization1medicinalproductELIQUISdrugbatchnumb4D82300Tdrugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationRENAL INFARCTdrugstartdateformat102drugstartdate18/02/2015drugenddateformat102drugenddate18/02/2015drugrecurreadministration2drugadditional1

activesubstance

activesubstancenameAPIXABAN

openFDA Info on Medication

6)

drugcharacterization2medicinalproductLOSARTAN

activesubstance

activesubstancenameLOSARTAN

7)

drugcharacterization2medicinalproductACETAMINOPHEN AND CODEINE

activesubstance

activesubstancenameACETAMINOPHEN\CODEINE PHOSPHATE

openFDA Info on Medication

Application NumberANDA040779Brand NameACETAMINOPHEN AND CODEINEGeneric NameACETAMINOPHEN AND CODEINEManufacturersAmneal Pharmaceuticals LLCproduct_ndc65162-033Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsACETAMINOPHEN, CODEINE PHOSPHATERXCUI993781spl_idd4866a63-62d6-4baa-8ec7-d7987b7bbad0spl_set_id8bc4108b-314e-4a52-a37c-631c6b869b04Package NDC65162-033-10, 65162-033-50, 65162-033-11UNII362O9ITL9D, GSL05Y1MN6

8)

drugcharacterization2medicinalproductASA

activesubstance

activesubstancenameASPIRIN

9)

drugcharacterization2medicinalproductACETAMINOPHEN.

activesubstance

activesubstancenameACETAMINOPHEN

openFDA Info on Medication

Application Number part343, ANDA211544, ANDA075077, ANDA076200, NDA019872, ANDA070607, ANDA207035, ... Brand Name ACETAMINOPHEN, TYLENOL ACETAMINOPHEN EXTRA STRENGTH, PAIN RELIEVER EXTRA STRENGT ... Generic Name ACETAMINOPHEN, ACETAMINOPHEN,, ACETAMINOPHEN TABLET EXTENDED RELEASE, ACETAMINOP ... Manufacturers Major Pharmaceuticals, Mechanical Servants, LLC, L.N.K. International, Inc., AME ... product_ndc 0904-6719, 29485-1887, 29485-7025, 29485-7003, 29485-6926, 50844-519, 46122-629, ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, RECTAL, INTRAVENOUSActive Ingredients ACETAMINOPHEN, ASPIRIN, CAFFEINE, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCC ... RXCUI 313782, 198440, 209459, 1148399, 307668, 828555, 198439, 313820, 1243440, 198434 ... spl_id 4612b5f6-4120-4364-a6f8-b43d15d0caf8, d0629d2a-8967-26fa-e053-2995a90a9f90, ab4b ... spl_set_id 5483b704-88c0-4176-a04c-f8b2b85e8c57, 68bb463c-91af-4eca-b2d5-9d134a756a45, 72ba ... Package NDC 0904-6719-50, 0904-6719-60, 0904-6719-80, 29485-7025-2, 29485-1887-4, 29485-7003 ... UNII 362O9ITL9D, R16CO5Y76E, 3G6A5W338E, 9D2RTI9KYH, V9BI9B5YI2, 04JA59TNSJ, TC2D6JAD ... NUI N0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832, N0000 ... Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic Effect Decreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE], Ce ... Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS], Xanthines [CS]Established Pharmacologic Class Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], ...

10)

drugcharacterization2medicinalproductSTRATTERA

activesubstance

activesubstancenameATOMOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021411Brand NameSTRATTERAGeneric NameATOMOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3227, 0002-3238, 0002-3228, 0002-3229, 0002-3239, 0002-3250, 0002-3251Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATOMOXETINE HYDROCHLORIDERXCUI 349591, 349592, 349593, 349594, 349595, 352317, 352318, 352319, 352320, 352321, ... spl_id6963b20c-fce1-414e-90b6-5d0730f93191spl_set_id309de576-c318-404a-bc15-660c2b1876fbPackage NDC 0002-3227-30, 0002-3238-30, 0002-3228-30, 0002-3229-30, 0002-3239-30, 0002-3250- ... UNII57WVB6I2W0

11)

drugcharacterization2medicinalproductVIIBRYD

activesubstance

activesubstancenameVILAZODONE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022567Brand NameVIIBRYDGeneric NameVILAZODONE HYDROCHLORIDEManufacturersAllergan, Inc.product_ndc0456-1100, 0456-1110, 0456-1120, 0456-1140, 0456-1101Product TypeHUMAN PRESCRIPTION DRUGRouteORALRXCUI 1086772, 1086776, 1086778, 1086780, 1086784, 1086786, 1086789, 1086790, 1653469, ... spl_id64357f87-0563-474e-909d-44ab85452cd4spl_set_id4c55ccfb-c4cf-11df-851a-0800200c9a66Package NDC0456-1110-30, 0456-1120-30, 0456-1140-30, 0456-1100-31, 0456-1101-30UNIIU8HTX2GK8JActive IngredientsVILAZODONE HYDROCHLORIDE

12)

drugcharacterization2medicinalproductATORVASTATIN

activesubstance

activesubstancenameATORVASTATIN

openFDA Info on Medication

13)

drugcharacterization2medicinalproductESZOPICLONE.

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application Number ANDA091124, ANDA091166, ANDA091103, ANDA091113, ANDA091024, ANDA208451, ANDA2029 ... Brand NameESZOPICLONE, LUNESTAGeneric NameESZOPICLONEManufacturers Lupin Pharmaceuticals, Inc., Glenmark Pharmaceuticals Inc. USA, Sun Pharmaceutic ... product_ndc 68180-322, 68180-323, 68180-324, 68462-382, 68462-383, 68462-384, 47335-586, 473 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, OROPHARYNGEALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id c15b2322-c078-46c1-8959-9288faaab19e, 8d6002b1-95d9-445c-8ace-e6dccea36852, 95e9 ... spl_set_id 7068c455-691e-4c56-9857-b7b4e13f4784, 584dc66c-063a-4552-a056-74b811e2bc80, 8bb1 ... Package NDC 68180-322-01, 68180-322-11, 68180-322-13, 68180-323-01, 68180-323-02, 68180-323- ... UNIIUZX80K71OE

14)

drugcharacterization2medicinalproductOMEGA 3

activesubstance

activesubstancenameOMEGA-3 FATTY ACIDS

15)

drugcharacterization2medicinalproductIBUPROFEN.

activesubstance

activesubstancenameIBUPROFEN

openFDA Info on Medication

Application Number ANDA077349, ANDA074937, ANDA075139, ANDA078682, ANDA079174, NDA019012, ANDA20231 ... Brand Name CAREONE IBUPROFEN, HEALTH MART CHILDRENS IBUPROFEN, IBUPROFEN, WELBY CHILDRENS I ... Generic Name IBUPROFEN, IBUPROFEN 200MG, IBUPROFEN CAPSULES 200 MG, IBUPROFEN ORAL, IBUPFROFE ... Manufacturers American Sales Company, Strategic Sourcing Services LLC, CVS Pharmacy, Rite Aid ... product_ndc 41520-495, 62011-0214, 59779-392, 11822-3307, 50804-199, 64024-003, 55910-847, 2 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsIBUPROFEN, IBUPROFEN SODIUMRXCUI 310965, 197803, 310964, 201126, 204442, 310963, 731536, 197805, 197806, 197807, ... spl_id 0647c7c2-b153-4d8c-b72b-f63d43c41853, 397d86de-d7a7-4087-a017-f714b1c1dd5a, a2fe ... spl_set_id 03cdff8a-8890-440d-82b5-54ce809f88cc, 1d81eea7-0104-4b3d-842c-c763e290581c, 29b2 ... Package NDC 41520-495-71, 41520-495-78, 62011-0214-1, 59779-392-14, 59779-392-08, 59779-392- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIWK2XYI10QM, RM1CE97Z4N

16)

drugcharacterization2medicinalproductCOLACE

activesubstance

activesubstancenameDOCUSATE SODIUM

openFDA Info on Medication

Application Numberpart334Brand NameCOLACE, COLACE KITGeneric NameDOCUSATE SODIUM, DOCUSATE SODIUM - SENNOSIDESManufacturersAvrio Health L.P.product_ndc67618-101, 67618-110, 67618-372, 67618-111Product TypeHUMAN OTC DRUGRouteORALActive IngredientsDOCUSATE SODIUM, SENNOSIDESRXCUI1115005, 1247756, 998740, 1872920, 1247759, 1247761spl_id eb604ae5-34af-482c-9128-5467c7280d12, 002b8417-b154-4158-ac8b-2773c97b34d7, 08b7 ... spl_set_id 7793fced-e8ee-44e2-b212-dd2a59a5f462, 9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b, c5c6 ... Package NDC 67618-101-10, 67618-101-30, 67618-101-60, 67618-101-01, 67618-101-52, 67618-110- ... UNIIF05Q2T2JA0, 3FYP5M0IJX

17)

drugcharacterization2medicinalproductMETFORMIN

activesubstance

activesubstancenameMETFORMIN HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA200690, ANDA209674, ANDA209313Brand NameMETFORMIN HYDROCHLORIDE, METFORMINGeneric NameMETFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MGManufacturers Mylan Pharmaceuticals Inc., Ingenus Pharmaceuticals, LLC, Granules Pharmaceutica ... product_ndc0378-6001, 0378-6002, 50742-633, 50742-634, 70010-491, 70010-492Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETFORMIN HYDROCHLORIDERXCUI1807894, 1807917, 860975, 860981spl_id b1d71739-26c3-43d3-9088-60bef3689e74, d7e2ad60-7a17-4c65-b836-e56644be754d, d164 ... spl_set_id 7e41818c-60e9-4bcf-9586-7bb8d33d5e89, 49a0b5c2-ebaf-4c4c-905f-dfd1962ac647, 6d6e ... Package NDC 0378-6002-91, 0378-6001-91, 50742-633-60, 50742-633-90, 50742-633-10, 50742-634- ... UNII786Z46389E

18)

drugcharacterization2medicinalproductXARELTO

activesubstance

activesubstancenameRIVAROXABAN

openFDA Info on Medication

Application NumberNDA215859, NDA022406Brand NameXARELTOGeneric NameRIVAROXABANManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-575, 50458-577, 50458-580, 50458-578, 50458-579, 50458-584Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRIVAROXABANRXCUI 1114198, 1114202, 1232082, 1232084, 1232086, 1232088, 1549682, 1549683, 2059015, ... spl_idabfa2b94-8108-11eb-814c-12fffb2ca371spl_set_id10db92f9-2300-4a80-836b-673e1ae91610Package NDC 50458-577-60, 50458-577-18, 50458-577-14, 50458-577-01, 50458-577-10, 50458-580- ... NUIN0000175635, N0000175637Mechanism of ActionFactor Xa Inhibitors [MoA]Established Pharmacologic ClassFactor Xa Inhibitor [EPC]UNII9NDF7JZ4M3

19)

drugcharacterization2medicinalproductMETRONIC PARADIGM

20)

drugcharacterization2medicinalproductONDANSETRON

activesubstance

activesubstancenameONDANSETRON

openFDA Info on Medication

Application Number ANDA206846, ANDA079224, ANDA090648, ANDA078776, ANDA077851, ANDA076972, ANDA0769 ... Brand NameONDANSETRON, ZUPLENZ, ONDANSETRON HYDROCHLORIDEGeneric NameONDANSETRON, ONDANSETRON HYDROCHLORIDE, ONDANSETRON TABLETSManufacturers Accord Healthcare, Inc., Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceutical ... product_ndc 16729-298, 23155-547, 23155-549, 16714-671, 71930-017, 71930-018, 45963-538, 459 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsONDANSETRON, ONDANSETRON HYDROCHLORIDERXCUI 283504, 1740467, 312085, 198052, 312086, 998028, 998032, 998033, 998035, 104894, ... spl_id d925044c-64a5-4a04-e053-2a95a90a8950, 49c66e0c-0444-4c88-942f-7d571aeedfd3, 6a07 ... spl_set_id 35e0d160-813f-41d7-a382-d2cab6485d9c, b746d4db-43e6-4219-9e6b-f53e59581305, ac3d ... Package NDC 16729-298-05, 23155-547-31, 23155-547-41, 23155-547-42, 23155-549-31, 16714-671- ... NUIN0000175817, N0000175818Mechanism of ActionSerotonin 3 Receptor Antagonists [MoA]Established Pharmacologic ClassSerotonin-3 Receptor Antagonist [EPC]UNII4AF302ESOS, NMH84OZK2B

21)

drugcharacterization2medicinalproductCA+D

22)

drugcharacterization2medicinalproductDIPHENHYDRAMINE

activesubstance

activesubstancenameDIPHENHYDRAMINE

openFDA Info on Medication

Application Numberpart341, ANDA205723, ANDA040466Brand NameNIGHTIME SLEEP AID, DIPHENHYDRAMINEGeneric NameDIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HCLManufacturers Velocity Pharma, AAA Pharmaceutical, Inc., Safetec of America, Inc., Micro Labs ... product_ndc76168-065, 57344-090, 61010-4409, 42571-169, 42571-337, 68196-929, 63323-664Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsDIPHENHYDRAMINE HYDROCHLORIDERXCUI1020477, 1049630, 1049909, 1723740spl_id 6cbc010f-0449-cb45-e053-2a91aa0a1ec6, 94e265d8-7fba-2ee9-e053-2a95a90a4993, 8909 ... spl_set_id 9c44e54f-d8bc-4451-8382-40d2e8e03b42, 76724432-ff3c-404f-ba1f-5af68e3ab8c4, ef6b ... Package NDC 76168-065-37, 57344-090-02, 57344-090-03, 61010-4409-0, 61010-4409-1, 61010-4409 ... UNIITC2D6JAD40

23)

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

24)

drugcharacterization2medicinalproductLORSTADINE

25)

drugcharacterization2medicinalproductNOVOLOG INSULIN

26)

drugcharacterization2medicinalproductPROCHLORPERAZINE.

activesubstance

activesubstancenamePROCHLORPERAZINE

openFDA Info on Medication

Application NumberANDA040058, ANDA040246Brand NamePROCHLORPERAZINE, COMPROGeneric NamePROCHLORPERAZINEManufacturersCosette Pharmaceuticals, Inc., Padagis US LLCproduct_ndc0713-0135, 0574-7226Product TypeHUMAN PRESCRIPTION DRUGRouteRECTALActive IngredientsPROCHLORPERAZINERXCUI198159, 284254spl_ide16d8c54-f115-c7f4-e053-2a95a90a1066, 358480f4-2922-4177-9d2e-70bbbb202061spl_set_id9595346e-76e5-e155-341b-ffaaafb885ab, ea381bc5-0957-4c91-826a-0ff680cebaccPackage NDC0713-0135-12, 0713-0135-10, 0574-7226-12NUIN0000175746, M0016525Established Pharmacologic ClassPhenothiazine [EPC]Chemical StructurePhenothiazines [CS]UNIIYHP6YLT61T

27)

drugcharacterization2medicinalproductALBUTEROL.

activesubstance

activesubstancenameALBUTEROL

openFDA Info on Medication

Application Number ANDA210948, ANDA213657, ANDA211397, ANDA208804, ANDA072894, ANDA207046, ANDA2088 ... Brand NameALBUTEROLGeneric NameALBUTEROL SULFATE, ALBUTEROLManufacturers Nivagen Pharmaceuticals Inc, Aurobindo Pharma Limited, Virtus Pharmaceuticals LL ... product_ndc 75834-273, 75834-274, 59651-333, 59651-334, 69543-290, 69543-291, 69238-1344, 69 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALBUTEROL SULFATERXCUI197316, 197318spl_id 5b89a3bb-e3bb-421d-89f7-f180e01a1b4d, d3cb4534-a60a-4476-928c-6eb52ac01cf8, b9cd ... spl_set_id b735e92d-eb1a-6fc1-e053-2995a90afce2, ff9b287b-e4a4-4c12-ad2f-6b7d55b20dc6, 3f81 ... Package NDC 75834-273-01, 75834-274-01, 59651-333-01, 59651-333-05, 59651-334-01, 59651-334- ... UNII021SEF3731

summary

narrativeincludeclinicalCASE EVENT DATE: 20150218

Adverse Event Report

Report

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

4)

5)

activesubstance

openFDA Info on Medication

6)

activesubstance

7)

activesubstance

openFDA Info on Medication

8)

activesubstance

9)

activesubstance

openFDA Info on Medication

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)

20)

activesubstance

openFDA Info on Medication

21)

22)

activesubstance

openFDA Info on Medication

23)

activesubstance

openFDA Info on Medication

24)

25)

26)

activesubstance

openFDA Info on Medication

27)

activesubstance