Adverse Event Report

Report

reporttype1receiptdateformat102companynumb2014VER00006Version of Safety Report ID2receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10241790Date Received12/06/2014transmissiondate12/12/2014serious1Date Last Updated27/06/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age24Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionAnxiety

2)

reactionmeddraversionpt17.0ReactionMood swings

3)

reactionmeddraversionpt17.0ReactionCrying

4)

reactionmeddraversionpt17.0ReactionAbnormal behaviour

5)

reactionmeddraversionpt17.0ReactionDry skin

6)

reactionmeddraversionpt17.0ReactionLip dry

7)

reactionmeddraversionpt17.0ReactionDepression

8)

reactionmeddraversionpt17.0ReactionAgitation

Drug

1)

drugcharacterization1medicinalproductMYORISANdrugauthorizationnumb076485drugdosagetext40 MG, 2XDAY,ORAL.drugindicationACNE CYSTICdrugstartdateformat102drugstartdate24/02/2014drugenddateformat102drugenddate30/05/2014

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

2)

drugcharacterization2medicinalproductCITALOPRAM

openFDA Info on Medication

Application Number ANDA077048, ANDA077043, ANDA077534, ANDA077042, ANDA077031, ANDA077289, ANDA0770 ... Brand NameCITALOPRAM, CITALOPRAM HYDROBROMIDE, CELEXAGeneric NameCITALOPRAM TABLETS, CITALOPRAM TABLET, CITALOPRAM, CITALOPRAM HYDROBROMIDEManufacturers Cosette Pharmaceuticals, Inc., West-Ward Pharmaceuticals Corp, Cipla USA Inc., M ... product_ndc 0713-4740, 0713-4741, 0713-4742, 0054-0062, 69097-822, 69097-823, 69097-824, 037 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCITALOPRAM HYDROBROMIDERXCUI200371, 283672, 309314, 309313, 213344, 213345, 284591spl_id 8eadc3e4-81a3-4b3b-aa1c-1dc65151f94c, 23d9ce12-cfe2-4026-a3dd-6e177a9affb7, 24f9 ... spl_set_id cf7b6823-108b-ebff-8f41-91f8b8325e3a, 29408d84-7b00-4cee-969c-8095f8083ff5, 0580 ... Package NDC 0713-4740-01, 0713-4740-05, 0713-4741-01, 0713-4741-05, 0713-4742-01, 0713-4742- ... UNIII1E9D14F36

3)

drugcharacterization2medicinalproductLEVOTHYROXIN

4)

drugcharacterization2medicinalproductNUVARING (ETONOGESTREL/ETHINYL ESTRADIOL VAGINAL RING)

Report Duplicate

duplicatesourceVERSAPHARMduplicatenumb2014VER00006