Adverse Event Report

Report

reporttype1receiptdateformat102companynumb2014VER00335Version of Safety Report ID2receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10733945Date Received21/01/2015transmissiondate21/08/2015serious1Date Last Updated28/04/2015primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age18Unit of Onset AgeyearsWeight84.4SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionCondition aggravated

2)

reactionmeddraversionpt18.0ReactionDepressed mood

3)

reactionmeddraversionpt18.0ReactionLip dry

4)

reactionmeddraversionpt18.0ReactionHidradenitis

5)

reactionmeddraversionpt18.0ReactionOff label use

6)

reactionmeddraversionpt18.0ReactionDry skin

Drug

1)

drugcharacterization2medicinalproductZYRTEC

activesubstance

activesubstancenameCETIRIZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022429Brand NameZYRTECGeneric NameCETIRIZINE HYDROCHLORIDEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-779Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCETIRIZINE HYDROCHLORIDERXCUI1014675, 1020023spl_idd7532844-79d8-4648-ab9b-e5d3d3ad76f9spl_set_id605adf29-734f-451a-8ff3-74be7b5814a6Package NDC50580-779-12, 50580-779-25, 50580-779-40, 50580-779-65UNII64O047KTOA

2)

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

3)

drugcharacterization2medicinalproductORTHO TRI CYCLEN

activesubstance

activesubstancenameETHINYL ESTRADIOL\NORGESTIMATE

openFDA Info on Medication

Application NumberNDA019697Brand NameORTHO TRI CYCLENGeneric NameNORGESTIMATE AND ETHINYL ESTRADIOLManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-191, 50458-197Product TypeHUMAN PRESCRIPTION DRUGRXCUI240128, 406396, 687424, 748797, 749784, 749785, 749860, 749861spl_ida5100f0c-d6a0-4340-91ab-04bb630476cbspl_set_id384e7a40-dcbd-4908-bf5e-65abc9932973Package NDC 50458-191-00, 50458-191-15, 50458-191-20, 50458-191-12, 50458-191-28, 50458-191- ...

4)

drugcharacterization2medicinalproductVITAMIN D3

activesubstance

activesubstancenameCHOLECALCIFEROL

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturersStrides Pharma Science Limitedproduct_ndc64380-737Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36Package NDC64380-737-06, 64380-737-25NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

5)

drugcharacterization2medicinalproductALBUTEROL.

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

6)

drugcharacterization1medicinalproductMYORISANdrugauthorizationnumb076485drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, 2X/DAY, ORALdrugadministrationroute048drugindicationACNEdrugstartdateformat610drugstartdate/10/2014drugenddateformat102drugenddate25/11/2014drugadditional1

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA076485Brand NameMYORISANGeneric NameISOTRETINOINManufacturersVersapharm Incorporatedproduct_ndc61748-301, 61748-302, 61748-303, 61748-304Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 1242611, 1242613, 1242615, 1663728spl_id703dd363-236a-4a17-85e9-feb1b3ae540bspl_set_id51ff6346-9256-4c01-9f52-417d13f2df05Package NDC 61748-301-13, 61748-301-11, 61748-301-01, 61748-302-13, 61748-302-11, 61748-302- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

summary

narrativeincludeclinicalCASE EVENT DATE: 2014

Report Duplicate

duplicatesourceVERSAPHARMduplicatenumb2014VER00335