Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11434549primarysourcecountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious1seriousnessother1receivedateformat102Date Received28/08/2015receiptdateformat102Date Last Updated28/08/2015fulfillexpeditecriteria2

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age55Unit of Onset AgeyearsWeight82.56SexMale

Reaction

1)

reactionmeddraversionpt18.1ReactionProduct substitution issue

2)

reactionmeddraversionpt18.1ReactionBlood pressure increased

Drug

1)

drugcharacterization2medicinalproductCRESTOR

activesubstance

activesubstancenameROSUVASTATIN CALCIUM

openFDA Info on Medication

Application NumberNDA021366Brand NameCRESTORGeneric NameROSUVASTATIN CALCIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0310-7560, 0310-7570, 0310-7580, 0310-7590, 0310-0751, 0310-0755, 0310-0752, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsROSUVASTATIN CALCIUMRXCUI859419, 859421, 859424, 859426, 859747, 859749, 859751, 859753spl_id08039402-2a60-4599-83b5-1c63b85ead70, d9298e4d-e35f-4ba4-9fdf-1a8d0358707fspl_set_id325a5d0e-9a72-4015-9fcd-1655fb504cee, bb0f3b5e-4bc6-41c9-66b9-6257e2513512Package NDC 0310-7560-90, 0310-7570-90, 0310-7580-90, 0310-7590-30, 0310-0755-90, 0310-0751- ... UNII83MVU38M7Q

2)

drugcharacterization2medicinalproductGLUCOSAMINE + CHONDROITIN

3)

drugcharacterization2medicinalproductMULTI-VITAMIN

activesubstance

activesubstancename .ALPHA.-TOCOPHEROL ACETATE, DL-\ASCORBIC ACID\CYANOCOBALAMIN\FLUORIDE ION\FOLIC ...

4)

drugcharacterization2medicinalproductALLOPURINOL.

activesubstance

activesubstancenameALLOPURINOL

openFDA Info on Medication

Application Number NDA020298, ANDA203154, ANDA212363, ANDA071450, ANDA204467, NDA018832, NDA018877, ... Brand NameALOPRIM, ALLOPURINOL, ZYLOPRIMGeneric NameALLOPURINOLManufacturers Mylan Institutional LLC, Accord Healthcare Inc., Gland Pharma Limited, Sun Pharm ... product_ndc 67457-978, 16729-134, 16729-135, 68083-380, 53489-156, 53489-157, 23155-693, 231 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsALLOPURINOL SODIUM, ALLOPURINOLRXCUI252931, 261265, 197319, 197320, 213995, 213998spl_id 2acff21e-7d8f-4b03-b7b7-9400f54f66ac, d10d00c1-a0d9-6fd8-e053-2a95a90a588a, 6a0e ... spl_set_id 018525b1-e37d-4ff2-9dc3-36b3d90ac3e0, 682dd8b8-fc6e-47c5-95b7-82d7ad96b750, 4839 ... Package NDC 67457-978-50, 16729-134-10, 16729-134-01, 16729-134-16, 16729-134-17, 16729-135- ... UNII428673RC2Z, 63CZ7GJN5INUIN0000175698, N0000000206Established Pharmacologic ClassXanthine Oxidase Inhibitor [EPC]Mechanism of ActionXanthine Oxidase Inhibitors [MoA]

5)

drugcharacterization2medicinalproductDAYPRO

activesubstance

activesubstancenameOXAPROZIN

openFDA Info on Medication

Application NumberNDA018841Brand NameDAYPROGeneric NameOXAPROZINManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0025-1381Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXAPROZINRXCUI207243, 312132spl_id1d508849-28b8-4a9c-b850-fa47e2481fd5spl_set_idea1de47e-3101-4414-817c-0a098af8988cPackage NDC0025-1381-31, 0025-1381-34, 0025-1381-51NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIMHJ80W9LRB

6)

drugcharacterization2medicinalproductLUNESTA

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

7)

drugcharacterization2medicinalproductCONCERTA

activesubstance

activesubstancenameMETHYLPHENIDATE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021121Brand NameCONCERTAGeneric NameMETHYLPHENIDATE HYDROCHLORIDEManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-585, 50458-588, 50458-586, 50458-587Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETHYLPHENIDATE HYDROCHLORIDERXCUI1091155, 1091157, 1091170, 1091172, 1091185, 1091187, 1091210, 1091212spl_ide07a69ac-3422-4eac-8a0e-bd720a91d991spl_set_id1a88218c-5b18-4220-8f56-526de1a276cdPackage NDC50458-585-01, 50458-588-01, 50458-586-01, 50458-587-01UNII4B3SC438HI

8)

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

9)

drugcharacterization2medicinalproductHYDROXYZINE

activesubstance

activesubstancenameHYDROXYZINE\HYDROXYZINE HYDROCHLORIDE

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

10)

drugcharacterization2medicinalproductCEREFOLIN NAC

11)

drugcharacterization2medicinalproductKAPVAY

activesubstance

activesubstancenameCLONIDINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022331Brand NameKAPVAYGeneric NameCLONIDINE HYDROCHLORIDEManufacturersConcordia Pharmaceuticals Inc.product_ndc59212-658Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONIDINE HYDROCHLORIDERXCUI1013930, 1013934spl_ide68b8728-0681-41f9-a323-3019636a870fspl_set_idaa7700e2-ae5d-44c4-a609-76de19c705a7Package NDC59212-658-60, 59212-658-13UNIIW76I6XXF06

12)

drugcharacterization2medicinalproductKLONOPIN

activesubstance

activesubstancenameCLONAZEPAM

openFDA Info on Medication

Application NumberNDA017533Brand NameKLONOPINGeneric NameCLONAZEPAMManufacturersH2-Pharma, LLC, Genentech, Inc.product_ndc61269-605, 61269-610, 61269-620, 0004-0058, 0004-0068, 0004-0098Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI197527, 197528, 197529, 206157, 206159, 206160spl_id65d5607d-3926-4b60-97dc-18509af3f271, 0d423291-6115-4522-88db-dcd1096bd432spl_set_idcfa0d79a-843c-4b88-95a1-e9511d649ca1, 542f22e8-dad2-47a8-93b6-30936715d73bPackage NDC 61269-605-10, 61269-610-10, 61269-620-10, 0004-0068-01, 0004-0058-01, 0004-0098- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

13)

drugcharacterization1medicinalproductAMLODIPINEdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCOATED TABLETdrugadministrationroute048drugindicationHYPERTENSIONdrugstartdateformat102drugstartdate16/07/2015drugenddateformat102drugenddate15/08/2015drugadditional1

activesubstance

activesubstancenameAMLODIPINE BESYLATE

openFDA Info on Medication

Application NumberNDA214439, NDA211340Brand NameNORLIQVA, KATERZIAGeneric NameAMLODIPINEManufacturersCMP Pharma, Inc., Azurity Pharmaceuticals, Inc.product_ndc46287-035, 52652-5001Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE, AMLODIPINE BENZOATERXCUI2599173, 2599179, 2184120, 2184126spl_id63a6bb49-fb68-4351-be5f-a6b6e8f6b540, df623dda-e184-4011-8fce-4e729b2e6b2dspl_set_idc1730a51-4383-4c61-a9a1-7e1326bd0abe, df673a4d-acb8-444c-a472-c87ab8cbd366Package NDC46287-035-15, 52652-5001-1NUIN0000000069, N0000175421, N0000175566, M0006414, N0000190114Mechanism of ActionCalcium Channel Antagonists [MoA], Cytochrome P450 3A Inhibitors [MoA]Established Pharmacologic ClassDihydropyridine Calcium Channel Blocker [EPC], Calcium Channel Blocker [EPC]Chemical StructureDihydropyridines [CS]UNII1J444QC288, XD75TQ8A2P

14)

drugcharacterization2medicinalproductCYMBALTA

activesubstance

activesubstancenameDULOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021427Brand NameCYMBALTAGeneric NameDULOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3235, 0002-3240, 0002-3270Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDULOXETINE HYDROCHLORIDERXCUI596926, 596928, 596930, 596932, 596934, 615186spl_id892f05de-dd11-4ae3-9a85-ce9cfcbeaaccspl_set_id2f7d4d67-10c1-4bf4-a7f2-c185fbad64baPackage NDC0002-3235-60, 0002-3240-30, 0002-3240-90, 0002-3270-30, 0002-3270-04UNII9044SC542W

15)

drugcharacterization2medicinalproductFISH OIL CAPSULES

16)

drugcharacterization2medicinalproductPEPCID AC

activesubstance

activesubstancenameFAMOTIDINE

openFDA Info on Medication

Application NumberNDA020325Brand NamePEPCID AC MAXIMUM STRENGTH, PEPCID AC, PEPCID AC ORIGINAL STRENGTHGeneric NameFAMOTIDINEManufacturers Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Lil' Drug ... product_ndc16837-855, 66715-9748, 16837-872Product TypeHUMAN OTC DRUGRouteORALActive IngredientsFAMOTIDINERXCUI104094, 310273, 199047, 212072spl_id db577289-71e4-7c02-e053-2a95a90a90ab, c7a71d06-707c-62f2-e053-2a95a90ad6b1, d5ce ... spl_set_id 2854047f-c5c4-43c3-8ef2-5c0a84a307f2, 14406cd8-468b-403d-9be2-43decd304214, 54f4 ... Package NDC 16837-855-05, 16837-855-25, 16837-855-49, 16837-855-50, 16837-855-52, 16837-855- ... NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]UNII5QZO15J2Z8

17)

drugcharacterization2medicinalproductEXFORGE

activesubstance

activesubstancenameAMLODIPINE BESYLATE\VALSARTAN

openFDA Info on Medication

Application NumberNDA021990Brand NameEXFORGEGeneric NameAMLODIPINE BESYLATE AND VALSARTANManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0488, 0078-0489, 0078-0490, 0078-0491Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BESYLATE, VALSARTANRXCUI722126, 722131, 722134, 722137, 724879, 724887, 724891, 724895spl_idd6c63540-b569-446a-83a2-3e13a7a246cbspl_set_idd0caec89-96ec-411d-a933-63eda74a6da7Package NDC0078-0488-15, 0078-0489-15, 0078-0490-15, 0078-0491-15NUIN0000000070, N0000175561Mechanism of ActionAngiotensin 2 Receptor Antagonists [MoA]Established Pharmacologic ClassAngiotensin 2 Receptor Blocker [EPC]UNII864V2Q084H, 80M03YXJ7I