Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10080267serious1Date Last Updated15/04/2014receiptdateformat102companynumbPHHY2014GB042545occurcountryGBseriousnessother1duplicate1Date Received15/04/2014transmissiondate12/12/2014primarysourcecountryGB

Primary Source

reportercountryGBqualification3

Patient

Onset Age51Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionSkin atrophyOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionSkin depigmentationOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionErythemaOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionPruritusOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionPainOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.0ReactionCondition aggravatedOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductHYDROCORTISONEdrugbatchnumb014414drugauthorizationnumb080692drugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MG, UNKdrugadministrationroute030drugindicationTENOSYNOVITIS STENOSANSdrugstartdateformat102drugstartdate17/10/2013actiondrug1drugrecurreadministration3

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

2)

drugcharacterization1medicinalproductKENALOGdrugbatchnumb3D75814 EXP 03/2016.drugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKdrugadministrationroute030drugindicationSKIN DEPIGMENTATIONdrugstartdateformat102drugstartdate14/11/2013actiondrug1drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA012104, NDA014901Brand NameKENALOG, PRO-C-DURE 6 KIT, PRO-C-DURE 5 KITGeneric NameTRIAMCINOLONE ACETONIDE, KENALOGManufacturersSun Pharmaceutical Industries, Inc., Oaklock, LLCproduct_ndc10631-093, 69263-821, 69263-820Product TypeHUMAN PRESCRIPTION DRUGRouteTOPICAL, INTRA-ARTICULAR, INTRAMUSCULARActive IngredientsTRIAMCINOLONE ACETONIDERXCUI1085736, 1085738, 1085754, 1085756spl_id eeb0548e-810f-4609-b3f0-fae397161fc8, a0974cb2-15b4-3549-e053-2a95a90a52b3, a097 ... spl_set_id cdf6c80c-ddbd-498f-8897-3c0feebafe31, 1129a728-b619-4cf8-8fc8-13bf1ef8a8fb, 68fc ... Package NDC 10631-093-62, 10631-093-07, 10631-093-35, 10631-093-96, 69263-821-01, 0003-0293- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIF446C597KA

3)

drugcharacterization2medicinalproductSERTRALINEactiondrug5drugrecurreadministration3

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

4)

drugcharacterization2medicinalproductNSAID^Sactiondrug5drugrecurreadministration3

Report Duplicate

duplicatesourceSANDOZduplicatenumbPHHY2014GB042545

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use