Adverse Event Report

Report

Version of Safety Report ID7Safety Report ID11753075primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate04/03/2016reporttype2serious1seriousnessother1receivedateformat102Date Received19/11/2015receiptdateformat102Date Last Updated24/12/2015fulfillexpeditecriteria1companynumbPHEH2015US023507duplicate1

Report Duplicate

duplicatesourceSANDOZduplicatenumbPHEH2015US023507

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexMale

Reaction

1)

reactionmeddraversionpt18.1ReactionDiarrhoeaOutcomeUnknown

2)

reactionmeddraversionpt18.1ReactionDrug intoleranceOutcomeUnknown

3)

reactionmeddraversionpt18.1ReactionJoint swellingOutcomeUnknown

4)

reactionmeddraversionpt18.1ReactionInfectionOutcomeUnknown

5)

reactionmeddraversionpt18.1ReactionGrowth of eyelashesOutcomeUnknown

6)

reactionmeddraversionpt18.1ReactionLoss of consciousnessOutcomeUnknown

7)

reactionmeddraversionpt18.1ReactionNeoplasmOutcomeUnknown

8)

reactionmeddraversionpt18.1ReactionDyspnoeaOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt18.1ReactionInjuryOutcomeUnknown

10)

reactionmeddraversionpt18.1ReactionBlood pressure decreasedOutcomeUnknown

11)

reactionmeddraversionpt18.1ReactionPeripheral swellingOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductENTRESTOdrugbatchnumbF0001drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG (49/51 MG), QIDdrugdosageformTABLETdrugadministrationroute048actiondrug5

activesubstance

activesubstancenameSACUBITRIL\VALSARTAN

openFDA Info on Medication

Application NumberNDA207620Brand NameENTRESTOGeneric NameSACUBITRIL AND VALSARTANManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0659, 0078-0777, 0078-9659, 0078-9777, 0078-0696Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSACUBITRIL, VALSARTANRXCUI1656340, 1656346, 1656349, 1656351, 1656354, 1656356spl_id93d45aeb-b1b4-464d-898b-529d3cbd35c2spl_set_id000dc81d-ab91-450c-8eae-8eb74e72296fPackage NDC 0078-0659-20, 0078-0659-67, 0078-0659-61, 0078-0659-35, 0078-0777-20, 0078-0777- ... NUIN0000000070, N0000175561Mechanism of ActionAngiotensin 2 Receptor Antagonists [MoA]Established Pharmacologic ClassAngiotensin 2 Receptor Blocker [EPC]UNII17ERJ0MKGI, 80M03YXJ7I

2)

drugcharacterization2medicinalproductVITAMIN D3drugdosageformLIQUIDdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenameCHOLECALCIFEROL

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturers Strides Pharma Science Limited, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmac ... product_ndc64380-737, 23155-809Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725, 9c09c2d2-ef29-4654-be7d-ed3b2b508f43spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36, 96da2c1e-6c5e-4df0-8166-3de53c08a701Package NDC64380-737-06, 64380-737-25, 23155-809-01NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

3)

drugcharacterization2medicinalproductTRACE MINERALSdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

4)

drugcharacterization1medicinalproductENTRESTOdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG (24/26), UNKdrugdosageformTABLETdrugadministrationroute048drugindicationCARDIAC FAILUREdrugstartdateformat102drugstartdate01/10/2015actiondrug5

activesubstance

activesubstancenameSACUBITRIL\VALSARTAN

openFDA Info on Medication

Application NumberNDA207620Brand NameENTRESTOGeneric NameSACUBITRIL AND VALSARTANManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0659, 0078-0777, 0078-9659, 0078-9777, 0078-0696Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSACUBITRIL, VALSARTANRXCUI1656340, 1656346, 1656349, 1656351, 1656354, 1656356spl_id93d45aeb-b1b4-464d-898b-529d3cbd35c2spl_set_id000dc81d-ab91-450c-8eae-8eb74e72296fPackage NDC 0078-0659-20, 0078-0659-67, 0078-0659-61, 0078-0659-35, 0078-0777-20, 0078-0777- ... NUIN0000000070, N0000175561Mechanism of ActionAngiotensin 2 Receptor Antagonists [MoA]Established Pharmacologic ClassAngiotensin 2 Receptor Blocker [EPC]UNII17ERJ0MKGI, 80M03YXJ7I

5)

drugcharacterization2medicinalproductPROZACdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenameFLUOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA018936Brand NamePROZACGeneric NameFLUOXETINE HYDROCHLORIDEManufacturersDista Products Companyproduct_ndc0777-3104, 0777-3105, 0777-3107Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFLUOXETINE HYDROCHLORIDERXCUI104849, 205535, 261287, 310384, 310385, 313989spl_ida99ea01f-e367-47b8-b25c-8f554314c534spl_set_idc88f33ed-6dfb-4c5e-bc01-d8e36dd97299Package NDC0777-3104-02, 0777-3105-02, 0777-3105-30, 0777-3107-30UNIII9W7N6B1KJ

6)

drugcharacterization2medicinalproductPROBIOTIC /08023301/drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

7)

drugcharacterization1medicinalproductAMOXICILLIN.drugauthorizationnumb64076drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenameAMOXICILLIN

openFDA Info on Medication

Application Number ANDA065255, ANDA065056, ANDA065271, ANDA065256, ANDA064013, ANDA061926, ANDA0619 ... Brand NameAMOXICILLINGeneric NameAMOXICILLINManufacturers Hikma Pharmaceuticals USA Inc., Teva Pharmaceuticals USA, Inc., NorthStar Rx LLC ... product_ndc 0143-9285, 0093-2263, 0093-2264, 16714-298, 16714-299, 57237-028, 57237-029, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMOXICILLINRXCUI308194, 308192, 308182, 308191, 239191, 308177, 598025, 308189, 313850, 313797spl_id 11f42795-cdea-4c98-a921-2c54e40370ba, 7b44bb9c-2d87-4260-81f1-fea8539749a5, 832f ... spl_set_id c8591c2a-92ef-4432-b19a-bb46063047ee, 20c86622-85b7-4827-a317-57aee79dfe57, 843f ... Package NDC 0143-9285-01, 0143-9285-20, 0093-2263-01, 0093-2264-01, 16714-298-01, 16714-298- ... UNII804826J2HU

8)

drugcharacterization2medicinalproductLASIXdrugadministrationroute065drugindicationCARDIAC FAILURE CONGESTIVEactiondrug5

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

9)

drugcharacterization2medicinalproductLUNESTAdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

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

10)

drugcharacterization1medicinalproductENTRESTOdrugbatchnumbF0001drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb4drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG (49/51 MG), QIDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate16/10/2015actiondrug5

activesubstance

activesubstancenameSACUBITRIL\VALSARTAN

openFDA Info on Medication

Application NumberNDA207620Brand NameENTRESTOGeneric NameSACUBITRIL AND VALSARTANManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0659, 0078-0777, 0078-9659, 0078-9777, 0078-0696Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSACUBITRIL, VALSARTANRXCUI1656340, 1656346, 1656349, 1656351, 1656354, 1656356spl_id93d45aeb-b1b4-464d-898b-529d3cbd35c2spl_set_id000dc81d-ab91-450c-8eae-8eb74e72296fPackage NDC 0078-0659-20, 0078-0659-67, 0078-0659-61, 0078-0659-35, 0078-0777-20, 0078-0777- ... NUIN0000000070, N0000175561Mechanism of ActionAngiotensin 2 Receptor Antagonists [MoA]Established Pharmacologic ClassAngiotensin 2 Receptor Blocker [EPC]UNII17ERJ0MKGI, 80M03YXJ7I

11)

drugcharacterization2medicinalproductSIMVASTATIN.drugdosagetextUNK UNK, PRNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenameSIMVASTATIN

openFDA Info on Medication

Application Number NDA206679, ANDA078155, ANDA077691, ANDA078103, ANDA090383, ANDA078034, ANDA20089 ... Brand NameFLOLIPID, SIMVASTATIN, ZOCORGeneric NameSIMVASTATINManufacturers Salerno Pharmaceuticals Co., Accord Healthcare, Inc., NorthStar Rx LLC, Lupin Ph ... product_ndc 29273-401, 29273-402, 16729-004, 16729-005, 16729-006, 16729-007, 16729-156, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSIMVASTATINRXCUI 1790679, 1944262, 1944264, 1944266, 198211, 200345, 312961, 312962, 314231, 1044 ... spl_id d733a50e-32b3-2d73-e053-2a95a90a6106, cfc99fa8-c0c7-72ef-e053-2a95a90a6a03, 8ba4 ... spl_set_id 6ee17d10-6eb1-452a-99e8-02381368b3fe, 871251c0-36a1-4a32-9eab-ff6c1e925ca9, 0376 ... Package NDC 29273-401-04, 29273-402-04, 16729-005-10, 16729-005-12, 16729-005-15, 16729-005- ... NUIN0000175589, N0000000121Established Pharmacologic ClassHMG-CoA Reductase Inhibitor [EPC]Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]UNIIAGG2FN16EV

12)

drugcharacterization1medicinalproductTRAVATAN ZdrugdosageformEYE DROPSdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenameTRAVOPROST

openFDA Info on Medication

Application NumberNDA021994Brand NameTRAVATAN ZGeneric NameTRAVOPROSTManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0946Product TypeHUMAN PRESCRIPTION DRUGRouteOPHTHALMICActive IngredientsTRAVOPROSTRXCUI284008, 285032spl_idc4852e83-a7b3-4694-a127-f3373a1443afspl_set_id028455e0-ae77-4213-8819-3b58ef7d6a14Package NDC0078-0946-40, 0078-0946-25, 0078-0946-98NUIN0000175454, M0017805Established Pharmacologic ClassProstaglandin Analog [EPC]Chemical StructureProstaglandins [CS]UNIIWJ68R08KX9

13)

drugcharacterization2medicinalproductACIDOPHILUSdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenameLACTOBACILLUS ACIDOPHILUS

14)

drugcharacterization1medicinalproductENTRESTOdrugstructuredosagenumb200drugstructuredosageunit003drugdosagetext200 MG (93/107 MG), UNKdrugdosageformTABLETdrugadministrationroute048actiondrug5

activesubstance

activesubstancenameSACUBITRIL\VALSARTAN

openFDA Info on Medication

Application NumberNDA207620Brand NameENTRESTOGeneric NameSACUBITRIL AND VALSARTANManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0659, 0078-0777, 0078-9659, 0078-9777, 0078-0696Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSACUBITRIL, VALSARTANRXCUI1656340, 1656346, 1656349, 1656351, 1656354, 1656356spl_id93d45aeb-b1b4-464d-898b-529d3cbd35c2spl_set_id000dc81d-ab91-450c-8eae-8eb74e72296fPackage NDC 0078-0659-20, 0078-0659-67, 0078-0659-61, 0078-0659-35, 0078-0777-20, 0078-0777- ... NUIN0000000070, N0000175561Mechanism of ActionAngiotensin 2 Receptor Antagonists [MoA]Established Pharmacologic ClassAngiotensin 2 Receptor Blocker [EPC]UNII17ERJ0MKGI, 80M03YXJ7I