Report

reporttype1Version of Safety Report ID7receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID11938375serious1Date Last Updated06/03/2018receiptdateformat102companynumbUS-ASTRAZENECA-2012BM13225occurcountryUSseriousnessother1duplicate1Date Received22/01/2016transmissiondate08/05/2018primarysourcecountryUS

Primary Source

reportercountryUS

Patient

Onset Age27880Unit of Onset AgedaysWeight110.2SexFemale

Contents

Reaction
- 1)
- 2)
- 3)
- 4)
- 5)
- 6)
- 7)
- 8)
- 9)
- 10)
- 11)
- 12)
- 13)
- 14)
- 15)
- 16)
- 17)
- 18)
- 19)
- 20)
- 21)
- 22)
- 23)
- 24)
- 25)
- 26)
- 27)
- 28)
- 29)
- 30)
- 31)
- 32)
- 33)
- 34)
- 35)
Drug
summary

Reaction

1)

reactionmeddraversionpt21.0ReactionWheezingOutcomeUnknown

2)

reactionmeddraversionpt21.0ReactionDiabetes mellitus inadequate controlOutcomeUnknown

3)

reactionmeddraversionpt21.0ReactionObesityOutcomeUnknown

4)

reactionmeddraversionpt21.0ReactionOedema peripheralOutcomeUnknown

5)

reactionmeddraversionpt21.0ReactionAlopeciaOutcomeUnknown

6)

reactionmeddraversionpt21.0ReactionHypoglycaemiaOutcomeUnknown

7)

reactionmeddraversionpt21.0ReactionDrug dose omissionOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt21.0ReactionCoughOutcomeUnknown

9)

reactionmeddraversionpt21.0ReactionEssential hypertensionOutcomeUnknown

10)

reactionmeddraversionpt21.0ReactionBreath sounds abnormalOutcomeUnknown

11)

reactionmeddraversionpt21.0ReactionPedal pulse decreasedOutcomeUnknown

12)

reactionmeddraversionpt21.0ReactionHeadacheOutcomeUnknown

13)

reactionmeddraversionpt21.0ReactionGait disturbanceOutcomeUnknown

14)

reactionmeddraversionpt21.0ReactionAdrenal insufficiencyOutcomeUnknown

15)

reactionmeddraversionpt21.0ReactionAnxietyOutcomeUnknown

16)

reactionmeddraversionpt21.0ReactionHyperkeratosisOutcomeUnknown

17)

reactionmeddraversionpt21.0ReactionChronic kidney diseaseOutcomeUnknown

18)

reactionmeddraversionpt21.0ReactionDevice malfunctionOutcomeUnknown

19)

reactionmeddraversionpt21.0ReactionFaeces discolouredOutcomeNot recovered/not resolved

20)

reactionmeddraversionpt21.0ReactionVisual impairmentOutcomeUnknown

21)

reactionmeddraversionpt21.0ReactionLocalised infectionOutcomeUnknown

22)

reactionmeddraversionpt21.0ReactionDry skinOutcomeUnknown

23)

reactionmeddraversionpt21.0ReactionNauseaOutcomeNot recovered/not resolved

24)

reactionmeddraversionpt21.0ReactionBreast cancer femaleOutcomeUnknown

25)

reactionmeddraversionpt21.0ReactionCushing^s syndromeOutcomeUnknown

26)

reactionmeddraversionpt21.0ReactionLimb injuryOutcomeUnknown

27)

reactionmeddraversionpt21.0ReactionInsomniaOutcomeUnknown

28)

reactionmeddraversionpt21.0ReactionBlood glucose fluctuationOutcomeUnknown

29)

reactionmeddraversionpt21.0ReactionOnychoclasisOutcomeUnknown

30)

reactionmeddraversionpt21.0ReactionProduct compounding quality issueOutcomeUnknown

31)

reactionmeddraversionpt21.0ReactionPainOutcomeNot recovered/not resolved

32)

reactionmeddraversionpt21.0ReactionSleep disorderOutcomeUnknown

33)

reactionmeddraversionpt21.0ReactionNeuropathy peripheralOutcomeUnknown

34)

reactionmeddraversionpt21.0ReactionFatigueOutcomeNot recovered/not resolved

35)

reactionmeddraversionpt21.0ReactionWeight decreasedOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductLASIXdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

activesubstance

activesubstancenameFUROSEMIDE

openFDA Info on Medication

Application NumberNDA016273Brand NameLASIXGeneric NameFUROSEMIDEManufacturersValidus Pharmaceuticals LLCproduct_ndc30698-060, 30698-067, 30698-066Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFUROSEMIDERXCUI197732, 200801, 200809, 205732, 310429, 313988spl_id95a46760-e587-41a3-9ff3-c8dd8505f694spl_set_id2c9b4d8f-0770-482d-a9e6-9c616a440b1aPackage NDC 30698-067-01, 30698-067-10, 30698-060-01, 30698-060-10, 30698-060-50, 30698-066- ... NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

2)

drugcharacterization2medicinalproductALBUTEROL.drugdosagetextAS REQUIREDdrugadministrationroute055

activesubstance

activesubstancenameALBUTEROL

openFDA Info on Medication

Application Number ANDA210948, ANDA077788, ANDA213657, ANDA211397, ANDA208804, ANDA207046, ANDA0728 ... Brand NameALBUTEROL, ALBUTEROL SULFATEGeneric NameALBUTEROL SULFATE, ALBUTEROLManufacturers Nivagen Pharmaceuticals Inc, VistaPharm, Inc., Aurobindo Pharma Limited, Virtus ... product_ndc 75834-273, 75834-274, 66689-100, 59651-333, 59651-334, 69543-290, 69543-291, 692 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALBUTEROL SULFATERXCUI197316, 197318, 755497spl_id b736135f-6e13-3e29-e053-2a95a90a67f4, 737932ca-a391-48c3-96c5-14de8ae1000e, ff9b ... spl_set_id b735e92d-eb1a-6fc1-e053-2995a90afce2, c7713a63-af2a-40d3-8deb-cbb92d5f1cd3, ff9b ... Package NDC 75834-273-01, 75834-274-01, 66689-100-16, 66689-100-08, 59651-333-01, 59651-333- ... UNII021SEF3731

3)

drugcharacterization1medicinalproductBYDUREONdrugbatchnumb72923,JI0395,FF0126,FB0065drugauthorizationnumb022200drugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugadministrationroute058drugindicationTYPE 2 DIABETES MELLITUSdrugstartdateformat610drugstartdate/07/2012drugenddateformat102drugenddate25/01/2018actiondrug6

activesubstance

activesubstancenameEXENATIDE

openFDA Info on Medication

Application NumberNDA022200Brand NameBYDUREONGeneric NameEXENATIDEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc0310-6530, 0310-6520Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsEXENATIDERXCUI1242963, 1242968, 1544916, 1544918spl_idd6ca1074-e59e-46fb-868f-cfc71ca80175spl_set_id71fe88be-b4e6-4c2d-9cc3-8b1864467776Package NDC0310-6530-04, 0310-6530-01, 0310-6530-85, 0310-6520-04NUIN0000178480, M0160181, N0000020058Established Pharmacologic ClassGLP-1 Receptor Agonist [EPC]Chemical StructureGlucagon-Like Peptide 1 [CS]Mechanism of ActionGlucagon-like Peptide-1 (GLP-1) Agonists [MoA]UNII9P1872D4OL

4)

drugcharacterization1medicinalproductBYDUREONdrugbatchnumb,JI0395,FF0126,FB0065drugauthorizationnumb022200drugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugadministrationroute058drugindicationTYPE 2 DIABETES MELLITUSactiondrug6

activesubstance

activesubstancenameEXENATIDE

openFDA Info on Medication

5)

drugcharacterization1medicinalproductLISINOPRIL.drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048actiondrug5drugadditional3

activesubstance

activesubstancenameLISINOPRIL

openFDA Info on Medication

Application Number ANDA076063, ANDA077321, NDA208401, ANDA078402, ANDA212041, ANDA076180, ANDA07616 ... Brand NameLISINOPRIL, QBRELIS, PRINIVIL, ZESTRILGeneric NameLISINOPRILManufacturers Hikma Pharmaceuticals USA Inc., International Laboratories, LLC, Azurity Pharmac ... product_ndc 0143-9713, 0143-9715, 0143-9714, 54458-872, 54458-877, 54458-874, 54458-873, 526 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISINOPRILRXCUI 311354, 314076, 314077, 197884, 1806884, 1806890, 205326, 311353, 206764, 206765 ... spl_id 533f6e0f-04a0-4ef7-81b8-0a7be07ddd1a, b685bb45-44a6-4afc-bb3e-940bce536bda, 2fdc ... spl_set_id b70933da-55b2-4025-a00e-63ce3e6b7fdf, 6eef83b4-ce4c-462b-bcfa-eefa525e682d, 9f6e ... Package NDC 0143-9715-01, 0143-9715-10, 0143-9715-99, 0143-9714-01, 0143-9714-10, 0143-9714- ... UNIIE7199S1YWR

6)

drugcharacterization2medicinalproductMETFORMINdrugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationTYPE 2 DIABETES MELLITUS

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, a353 ... 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

7)

drugcharacterization2medicinalproductPENICILLIN NOSdrugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb4drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationINFECTION

activesubstance

activesubstancenamePENICILLIN

8)

drugcharacterization2medicinalproductMORPHINEdrugdosageformINJECTIONdrugadministrationroute058drugindicationPAIN

activesubstance

activesubstancenameMORPHINE

openFDA Info on Medication

Brand NameOPIUM TINCTURE DEODORIZEDGeneric NameMORPHINEManufacturersEdenbridge Pharmaceuticals, LLCproduct_ndc42799-217Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMORPHINERXCUI830196spl_id5b376952-010f-adfc-e053-2a91aa0ae464spl_set_ide2a5697a-cc41-4cf1-b3a8-59b0268740d7Package NDC42799-217-01, 42799-217-02NUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]UNII76I7G6D29C

9)

drugcharacterization2medicinalproductSTARLIXdrugdosagetextTAKE 1 PILL THREE TIMES A DAY FOR 1 MONTHdrugdosageformTABLETdrugadministrationroute048

activesubstance

activesubstancenameNATEGLINIDE

openFDA Info on Medication

Application NumberNDA021204Brand NameSTARLIXGeneric NameNATEGLINIDEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0351, 0078-0352Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsNATEGLINIDERXCUI284529, 284530, 311919, 314142spl_id7b6f4dc4-ada4-47b5-bf49-af85910ccfafspl_set_id5cbda9bc-3c0d-4d75-a37a-994844680c8cPackage NDC0078-0351-05, 0078-0352-05NUIN0000175428, N0000175448Established Pharmacologic ClassGlinide [EPC]Mechanism of ActionPotassium Channel Antagonists [MoA]UNII41X3PWK4O2

10)

drugcharacterization2medicinalproductVALIUMdrugstructuredosagenumb5drugstructuredosageunit003drugdosagetext5.0MG AS REQUIREDdrugdosageformTABLETdrugadministrationroute048

activesubstance

activesubstancenameDIAZEPAM

openFDA Info on Medication

Application NumberNDA013263Brand NameVALIUMGeneric NameDIAZEPAMManufacturersRoche Laboratories Inc.product_ndc0140-0004, 0140-0005, 0140-0006Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIAZEPAMspl_idc0054f7c-9c38-4ac8-ae8f-5e6427e1fd14spl_set_id554baee5-b171-4452-a50a-41a0946f956cPackage NDC0140-0004-01, 0140-0005-01, 0140-0005-14, 0140-0006-01, 0140-0006-14NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

11)

drugcharacterization2medicinalproductHYDROCODONEdrugdosagetextAS REQUIRED

activesubstance

activesubstancenameHYDROCODONE

12)

drugcharacterization2medicinalproductGABAPENTIN.drugstructuredosagenumb800drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

activesubstance

activesubstancenameGABAPENTIN

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 6e41ce47-a6cc-4c34-84f1-305747df38c2, 5fc4 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

13)

drugcharacterization2medicinalproductPRILOSECdrugadministrationroute048

activesubstance

activesubstancenameOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022056Brand NamePRILOSECGeneric NameOMEPRAZOLE MAGNESIUMManufacturersCovis Pharmaproduct_ndc70515-610, 70515-625Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE MAGNESIUMRXCUI797058, 797061, 797063, 797065spl_id1bd73b0f-b2c2-4409-94ce-1955c6ab119bspl_set_idb6761f84-53ac-4745-a8c8-1e5427d7e179Package NDC70515-625-01, 70515-610-01UNII426QFE7XLK

14)

drugcharacterization2medicinalproductLASIXdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

activesubstance

activesubstancenameFUROSEMIDE

openFDA Info on Medication

15)

drugcharacterization2medicinalproductHYDROCORTISONE.drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

activesubstance

activesubstancenameHYDROCORTISONE

openFDA Info on Medication

Application Number part348, ANDA088799, ANDA040351, ANDA089682, ANDA080706, NDA213876, ANDA040646, ... Brand Name HARRIS TEETER ANTI-ITCH WITH ALOE, DG HEALTH HYDROCORTISONE, PROCTOSOL-HC, GOOD ... Generic Name HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, ANTI-ITCH, HYDROCORTI ... Manufacturers Harris Teeter, Dolgencorp, LLC, Sun Pharmaceutical Industries, Inc., Amerisource ... product_ndc 72036-407, 55910-646, 10631-407, 24385-276, 67091-280, 69396-069, 61010-4402, 70 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteTOPICAL, ORAL, RECTALActive IngredientsHYDROCORTISONE, HYDROCORTISONE ACETATERXCUI 106258, 103403, 310891, 1540356, 203105, 197785, 1790684, 206352, 1043063, 19870 ... spl_id 2b90d9a3-ebb1-4aee-8a9c-6601618b7738, 27dc9e09-fc4f-4b66-a303-177725f3a513, 297a ... spl_set_id 1755c97e-87a3-43c7-ab61-3e971a7b3135, 27dc9e09-fc4f-4b66-a303-177725f3a513, 5652 ... Package NDC 72036-407-28, 55910-646-25, 10631-407-01, 24385-276-03, 67091-280-28, 69396-069- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIWI4X0X7BPJ, 3X7931PO74

16)

drugcharacterization2medicinalproductADVAIR DISKUSdrugdosagetextAS REQUIREDdrugdosageformINHALATION POWDER

activesubstance

activesubstancenameFLUTICASONE PROPIONATE\SALMETEROL XINAFOATE

openFDA Info on Medication

Application NumberNDA021077Brand NameADVAIR DISKUSGeneric NameFLUTICASONE PROPIONATE AND SALMETEROLManufacturersGlaxoSmithKline LLCproduct_ndc0173-0695, 0173-0696, 0173-0697Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsSALMETEROL XINAFOATE, FLUTICASONE PROPIONATERXCUI 896161, 896165, 896184, 896185, 896186, 896190, 896209, 896212, 896218, 896222, ... spl_idc03442a4-17dc-4c49-ae07-3f8f7f26e0dfspl_set_id4eeb5f6a-593f-4a9e-9692-adefa2caf8fcPackage NDC 0173-0695-00, 0173-0695-04, 0173-0696-00, 0173-0696-04, 0173-0697-00, 0173-0697- ... UNIIO2GMZ0LF5W, 6EW8Q962A5

17)

drugcharacterization2medicinalproductNYSTOPdrugdosagetextAS REQUIRED

activesubstance

activesubstancenameNYSTATIN

openFDA Info on Medication

Application NumberANDA064118Brand NameNYSTOPGeneric NameNYSTATINManufacturersPaddock Laboratories, LLCproduct_ndc0574-2008Product TypeHUMAN PRESCRIPTION DRUGRouteTOPICALActive IngredientsNYSTATINRXCUI261178, 646456spl_id8867a998-e308-4b4f-b1d5-1e93d3125452spl_set_ide1b4622c-0f9f-4c00-b42c-2aa85a5e3d4fPackage NDC0574-2008-15, 0574-2008-30, 0574-2008-02NUIN0000175498, M0017172Established Pharmacologic ClassPolyene Antifungal [EPC]Chemical StructurePolyenes [CS]UNIIBDF1O1C72E

18)

drugcharacterization1medicinalproductOMEPRAZOLE.drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute048actiondrug5drugadditional3

activesubstance

activesubstancenameOMEPRAZOLE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA075757, ANDA206877, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, KIRKLAND SIGNATURE OMEPRAZOLE, OMEPRAZOLE, AC ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Costco Wholesale Company, INNOVUS PHARMACEUTICALS, INC., OHM ... product_ndc 46122-281, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 62175-136, 078 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, 8c9d9c38-9da6-4f99-9f08-26ec4693fa55, ce5c ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 48a44d0c-3502-430b-8b75-188a49d14da2, ce5c ... Package NDC 46122-281-04, 46122-281-74, 63981-915-55, 57483-740-01, 57483-740-42, 51660-029- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

19)

drugcharacterization2medicinalproductPOTASSIUM CHLORIDE.drugstructuredosagenumb10drugstructuredosageunit029drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformPROLONGED-RELEASE TABLETdrugadministrationroute048

activesubstance

activesubstancenamePOTASSIUM CHLORIDE

openFDA Info on Medication

Brand Name KALI MURIATICUM, POTASSIUM CHLORIDE, SORE THROAT 911, KLOR-CON M, POTASSIUM CHLO ... Generic NamePOTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASEManufacturers Hyland's, Camber Pharmaceuticals, Inc., Epic Pharma, LLC, DelCorean, LLC, Actavi ... product_ndc 54973-5224, 31722-133, 31722-134, 31722-135, 42806-094, 35484-204, 62037-559, 62 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, TOPICAL, INTRAVENOUS, PARENTERAL, SUBLINGUALActive IngredientsPOTASSIUM CHLORIDE, POTASSIUM CATIONspl_id 603fa445-ab7d-3929-e053-2a91aa0afb47, 4dca93f2-d9a9-4ecb-89d2-f67b819f82dc, ebba ... spl_set_id 2e8a4762-d28d-4b64-892f-913e04d18d2d, b1e827aa-b2fb-4fa5-984d-ddd94338ff53, 1373 ... Package NDC 54973-5224-1, 54973-5224-2, 31722-133-01, 31722-133-05, 31722-133-10, 31722-134- ... UNII660YQ98I10, 295O53K152Application Number ANDA214422, ANDA210200, ANDA077419, ANDA209922, ANDA209786, NDA018279, ANDA08020 ... RXCUI 403888, 1801294, 1801298, 1867544, 312504, 315183, 312515, 314182, 198116, 31252 ... NUIM0026737, N0000175600, N0000175811, N0000009371, N0000009726, N0000010288Chemical StructurePotassium Compounds [CS]Established Pharmacologic ClassPotassium Salt [EPC], Osmotic Laxative [EPC]Physiologic/Pharmacodynamic Effect Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Elect ... Mechanism of ActionOsmotic Activity [MoA]

20)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

21)

drugcharacterization2medicinalproductTEMAZEPAM.drugstructuredosagenumb15drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute048

activesubstance

activesubstancenameTEMAZEPAM

openFDA Info on Medication

Application Number ANDA203482, ANDA071620, ANDA211542, ANDA071456, ANDA071457, ANDA078581, ANDA0711 ... Brand NameTEMAZEPAM, RESTORILGeneric NameTEMAZEPAMManufacturers Amneal Pharmaceuticals LLC, Actavis Pharma, Inc., Alembic Pharmaceuticals Limite ... product_ndc 65162-556, 65162-583, 65162-584, 65162-557, 0228-2076, 0228-2077, 46708-379, 467 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTEMAZEPAMRXCUI198241, 198242, 198243, 485489, 208463, 208464, 208465, 539384spl_id c21455f5-1c17-442d-b1d1-69d27d290d48, eac383e8-6227-4439-b72d-c1b1794ee031, 2676 ... spl_set_id be68c6e0-17ad-40fe-9bc1-58abe24b53f6, a4370eb4-b00d-4247-af8d-980e59fbbec6, db83 ... Package NDC 65162-583-03, 65162-583-10, 65162-583-50, 65162-583-11, 65162-556-03, 65162-556- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIICHB1QD2QSS

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drugcharacterization2medicinalproductMETHOCARBAMOL.drugadministrationroute048

activesubstance

activesubstancenameMETHOCARBAMOL

openFDA Info on Medication

Application Number ANDA208116, ANDA200958, ANDA207522, ANDA204404, ANDA208507, ANDA211504, ANDA0404 ... Brand NameMETHOCARBAMOL, ROBAXIN, METHOCARB 500-EZSGeneric NameMETHOCARBAMOL INJECTION, METHOCARBAMOL, METHOCARBAMOL TABLETSManufacturers Renaissance Lakewood LLC, Westminster Pharmaceuticals, LLC, Somerset Therapeutic ... product_ndc 49396-0711, 69367-255, 69367-256, 70069-101, 67457-273, 76385-123, 76385-124, 43 ... Product TypeHUMAN PRESCRIPTION DRUGRoutePARENTERAL, ORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsMETHOCARBAMOLRXCUI238175, 197943, 197944, 207014, 207016, 1010654spl_id 7d658860-a6e3-cb2f-e053-2991aa0a9461, ae9df131-66a3-0ec7-e053-2995a90a02e4, f868 ... spl_set_id 4a9d9920-c79a-4396-e054-00144ff8d46c, 2199b810-fb84-4dac-b787-ade2b5f67e92, 68dd ... Package NDC 49396-0711-1, 69367-256-01, 69367-256-05, 69367-255-01, 69367-255-05, 70069-101- ... NUIN0000175730, N0000175737Physiologic/Pharmacodynamic EffectCentrally-mediated Muscle Relaxation [PE]Established Pharmacologic ClassMuscle Relaxant [EPC]UNII125OD7737X

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drugcharacterization2medicinalproductPROCYLCE MULTIVITAMIN WITH MINERALSdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

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drugcharacterization2medicinalproductVESICAREdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

activesubstance

activesubstancenameSOLIFENACIN SUCCINATE

openFDA Info on Medication

Application NumberNDA021518, NDA209529Brand NameVESICARE, VESICARE LSGeneric NameSOLIFENACIN SUCCINATEManufacturersAstellas Pharma US, Inc.product_ndc51248-150, 51248-151, 51248-250Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSOLIFENACIN SUCCINATERXCUI477367, 477372, 539815, 539817, 2375321, 2375325spl_id1d7a7ff5-31d2-4957-90e5-173d2200ddb1, 47710f09-a9ef-4007-8a89-cbb8fadc6b4bspl_set_id9acee910-cdb2-4052-b8b3-c26aff1c8716, e0300384-e980-45d5-8ed4-48a2618671aePackage NDC 51248-150-52, 51248-150-03, 51248-150-01, 51248-151-52, 51248-151-03, 51248-151- ... UNIIKKA5DLD701

summary

narrativeincludeclinicalCASE EVENT DATE: 20120719

Report Duplicate

duplicatesourceASTRAZENECAduplicatenumbUS-ASTRAZENECA-2012BM13225

Receiver

receivertype6receiverorganizationFDA

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sendertype2senderorganizationFDA-Public Use

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activesubstance

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activesubstance

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activesubstance

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activesubstance

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activesubstance

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activesubstance

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activesubstance

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activesubstance

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activesubstance

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activesubstance

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activesubstance

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activesubstance

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activesubstance