The Safety Rates Drug Report

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Drug     Injury     Quarter    

Person who experienced the adverse event (patient)

Event ID CASEID CASEVERSION I F COD EVENT DT MFR DT INIT FDA DT FDA DT REPT COD AUTH NUM MFR NUM MFR SNDR LIT REF AGE AGE COD AGE GRP GNDR COD E SUB WT WT COD REPT DT TO MFR OCCP COD REPORTER COUNTRY OCCR COUNTRY
124490043 12449004 3 F 20160512 20160801 20160608 20160811 EXP US-MYLANLABS-2016M1023287 MYLAN 29.31 YR F Y 0.00000 20160811 MD US US

Drug(s) used by person

Event ID CASEID DRUG SEQ ROLE COD DRUGNAME PROD AI VAL VBM ROUTE DOSE VBM CUM DOSE CHR CUM DOSE UNIT DECHAL RECHAL LOT NUM EXP DT NDA NUM DOSE AMT DOSE UNIT DOSE FORM DOSE FREQ
124490043 12449004 1 PS AMNESTEEM ISOTRETINOIN 1 Unknown 20 MG, QD 5500 MG N 75945 20 MG CAPSULE QD

Indications of drugs used

no results found

Outcome of event

Event ID CASEID OUTC COD
124490043 12449004 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
124490043 12449004 Breast tenderness
124490043 12449004 Exposure during pregnancy
124490043 12449004 Vaginal haemorrhage

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

Therapies reported

Event ID CASEID DSG DRUG SEQ START DT END DT DUR DUR COD
124490043 12449004 1 20150812 20160512 0