Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10530350serious1Date Last Updated05/11/2014receiptdateformat102companynumbUS-DRREDDYS-USA/USA/14/0043735occurcountryUSseriousnessother1duplicate1Date Received21/10/2014transmissiondate28/05/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age57Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionEpistaxisOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.0ReactionSkin exfoliationOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.0ReactionOropharyngeal painOutcomeRecovered/resolved

4)

reactionmeddraversionpt18.0ReactionStressOutcomeRecovered/resolved

5)

reactionmeddraversionpt18.0ReactionChapped lipsOutcomeRecovered/resolved

6)

reactionmeddraversionpt18.0ReactionFungal skin infectionOutcomeRecovered/resolved

7)

reactionmeddraversionpt18.0ReactionDiarrhoeaOutcomeRecovered/resolved

8)

reactionmeddraversionpt18.0ReactionSkin burning sensationOutcomeRecovered/resolved

9)

reactionmeddraversionpt18.0ReactionMenstruation irregularOutcomeRecovered/resolved

10)

reactionmeddraversionpt18.0ReactionMyalgiaOutcomeRecovered/resolved

11)

reactionmeddraversionpt18.0ReactionHeadacheOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductBUMETANIDE.drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameBUMETANIDE

openFDA Info on Medication

Application Number ANDA074225, NDA018225, ANDA209916, ANDA202900, ANDA209724, ANDA079196, ANDA07470 ... Brand NameBUMETANIDE, BUMEXGeneric NameBUMETANIDEManufacturers Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Validus Pharmaceu ... product_ndc 14539-700, 14539-701, 14539-702, 30698-630, 30698-631, 30698-632, 0832-0540, 083 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsBUMETANIDERXCUI197417, 197418, 197419, 205488, 205489, 205490, 282486, 1727569spl_id 138f8bdd-34a5-49c6-832f-0d343aa95c7b, a8cdbcbb-2436-4157-9929-e1138035de53, a2d6 ... spl_set_id a51d798c-5847-49b2-ba94-434131848199, 32dfbea3-eb2b-4070-8605-57ce3e6d5a2f, ff5d ... Package NDC 14539-700-01, 14539-700-05, 14539-700-10, 14539-701-01, 14539-701-05, 14539-701- ... NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII0Y2S3XUQ5H

2)

drugcharacterization1medicinalproductZENATANEdrugbatchnumbUNKNOWNdrugauthorizationnumb202099drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationKERATOSIS FOLLICULARdrugstartdateformat102drugstartdate19/09/2014actiondrug4

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA202099Brand NameZENATANEGeneric NameISOTRETINOINManufacturersDr. Reddy's Laboratories Limitedproduct_ndc55111-113, 55111-135, 55111-136, 55111-137Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 1373333, 1373335, 1373337, 1605088spl_id1f5178c1-0f6f-824d-d0ee-1b973377ccc6spl_set_id27b3cf26-f22e-5b70-1c24-009933b7c6eePackage NDC 55111-135-79, 55111-135-81, 55111-136-79, 55111-136-81, 55111-137-79, 55111-137- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

3)

drugcharacterization2medicinalproductNYSTATIN.drugadministrationroute065drugindicationSKIN DISORDER

activesubstance

activesubstancenameNYSTATIN

openFDA Info on Medication

Application Number ANDA203621, ANDA064142, ANDA211838, ANDA062124, ANDA062838, ANDA065148, ANDA0651 ... Brand NameNYSTATIN, NYAMYC, NYSTOPGeneric NameNYSTATIN, NYSTATIN ORAL SUSPENSION, NYSTATIN OINTMENT, NYSTATIN CREAMManufacturers Pharmaceutical Associates, Inc., VistaPharm, Inc., Torrent Pharmaceuticals Limit ... product_ndc 0121-0810, 0121-4810, 66689-037, 13668-534, 0168-0007, 53489-400, 80432-003, 083 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, TOPICALActive IngredientsNYSTATINRXCUI312055, 884308, 312059, 584414, 646456, 543546, 261178spl_id a9034435-e353-7bf6-e053-2995a90a4867, 91e9fe62-a1e7-46e6-8357-cdc2a93cc62f, bede ... spl_set_id 31e3da10-5a7b-4bc5-8a4f-3e786b64c13a, 41034d7b-33a1-4d6d-b425-9cfefff8d518, 4949 ... Package NDC 0121-0810-02, 0121-0810-16, 0121-4810-05, 0121-4810-40, 0121-4810-00, 0121-4810- ... NUIN0000175498, M0017172Established Pharmacologic ClassPolyene Antifungal [EPC]Chemical StructurePolyenes [CS]UNIIBDF1O1C72E

4)

drugcharacterization1medicinalproductZENATANEdrugbatchnumbUNKNOWNdrugauthorizationnumb202099drugadministrationroute048drugindicationPEMPHIGUSdrugstartdateformat102drugstartdate16/05/2013actiondrug4

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA202099Brand NameZENATANEGeneric NameISOTRETINOINManufacturersDr. Reddy's Laboratories Limitedproduct_ndc55111-113, 55111-135, 55111-136, 55111-137Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 1373333, 1373335, 1373337, 1605088spl_id1f5178c1-0f6f-824d-d0ee-1b973377ccc6spl_set_id27b3cf26-f22e-5b70-1c24-009933b7c6eePackage NDC 55111-135-79, 55111-135-81, 55111-136-79, 55111-136-81, 55111-137-79, 55111-137- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

5)

drugcharacterization1medicinalproductZENATANEdrugbatchnumbUNKNOWNdrugauthorizationnumb202099drugindicationBENIGN FAMILIAL PEMPHIGUSactiondrug4

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA202099Brand NameZENATANEGeneric NameISOTRETINOINManufacturersDr. Reddy's Laboratories Limitedproduct_ndc55111-113, 55111-135, 55111-136, 55111-137Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 1373333, 1373335, 1373337, 1605088spl_id1f5178c1-0f6f-824d-d0ee-1b973377ccc6spl_set_id27b3cf26-f22e-5b70-1c24-009933b7c6eePackage NDC 55111-135-79, 55111-135-81, 55111-136-79, 55111-136-81, 55111-137-79, 55111-137- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

6)

drugcharacterization1medicinalproductZENATANEdrugbatchnumbUNKNOWNdrugauthorizationnumb202099drugindicationPEMPHIGOIDactiondrug4

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA202099Brand NameZENATANEGeneric NameISOTRETINOINManufacturersDr. Reddy's Laboratories Limitedproduct_ndc55111-113, 55111-135, 55111-136, 55111-137Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 1373333, 1373335, 1373337, 1605088spl_id1f5178c1-0f6f-824d-d0ee-1b973377ccc6spl_set_id27b3cf26-f22e-5b70-1c24-009933b7c6eePackage NDC 55111-135-79, 55111-135-81, 55111-136-79, 55111-136-81, 55111-137-79, 55111-137- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

7)

drugcharacterization2medicinalproductDOXYCYCLINE.drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameDOXYCYCLINE

openFDA Info on Medication

Application Number ANDA201678, ANDA204234, ANDA209396, ANDA065053, ANDA062432, ANDA210664, ANDA0652 ... Brand Name DOXYCYCLINE, OKEBO, DOXYCYCLINE HYCLATE, ORACEA, VIBRAMYCIN MONOHYDRATE, DOXY 10 ... Generic NameDOXYCYCLINE, DOXYCYCLINE HYCLATEManufacturers Lupin Pharmaceuticals, Inc., Encore Dermatology Inc., Mayne Pharma Inc., Sun Pha ... product_ndc 68180-657, 69482-450, 68180-650, 68180-651, 68180-652, 51862-040, 51862-041, 518 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsDOXYCYCLINE, DOXYCYCLINE HYCLATERXCUI 1650030, 1649990, 2045900, 700408, 1649401, 1650143, 1649429, 1650142, 1650444, ... spl_id bf2b026c-0185-4fc1-a87e-f3f26c47a20f, 5d199431-f92b-4797-a8f6-070d3cd1b900, 1c7d ... spl_set_id e0e80435-1b6a-4361-8c8a-e432f8f23a1b, 5c9f1141-7eb5-5513-e053-2991aa0ad5b3, bcc6 ... Package NDC 68180-657-01, 69482-450-50, 69482-450-06, 68180-650-01, 68180-651-01, 68180-652- ... NUIN0000175882, N0000007948Established Pharmacologic ClassTetracycline-class Drug [EPC]Chemical StructureTetracyclines [Chemical/Ingredient]UNIIN12000U13O, 19XTS3T51U, 8ZL07I20SB

8)

drugcharacterization2medicinalproductNEXIUMdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameESOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMspl_id3797ceb7-550b-4e9a-8314-8e1e4995360b, ac4ba22b-f431-4ab4-b239-0e220ad804ddspl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43HRXCUI486501, 603536

9)

drugcharacterization2medicinalproductMETOLAZONE.drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameMETOLAZONE

openFDA Info on Medication

Application NumberANDA076698, NDA017386, ANDA076466, ANDA076732, ANDA213251Brand NameMETOLAZONEGeneric NameMETOLAZONEManufacturers Mylan Pharmaceuticals Inc., Lannett Company, Inc., Eon Labs, Inc., Alembic Pharm ... product_ndc 0378-6172, 0378-6173, 0378-6174, 0527-2215, 0527-2216, 0527-2217, 0185-0055, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETOLAZONERXCUI197978, 197979, 311671spl_id 6e3e9170-70e3-4642-9c40-a23e5a18a5f3, b6f3bb5c-c896-44d9-88be-eef3a89b1724, 3d77 ... spl_set_id 6639d111-eb21-4997-b964-f5c61bc088f2, 7276cfbf-294d-464d-b8f4-e33da8a15658, 0b61 ... Package NDC 0378-6172-01, 0378-6173-01, 0378-6174-01, 0527-2215-37, 0527-2216-37, 0527-2217- ... NUIN0000175359, N0000175420Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Established Pharmacologic ClassThiazide-like Diuretic [EPC]UNIITZ7V40X7VX

10)

drugcharacterization2medicinalproductCALCIUM D3drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameCALCIUM\CHOLECALCIFEROL

summary

narrativeincludeclinicalCASE EVENT DATE: 201409

Report Duplicate

duplicatesourceDR REDDYSduplicatenumbUS-DRREDDYS-USA/USA/14/0043735

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use