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
106335842 10633584 2 F 2012 20160606 20141205 20160830 PER US-JNJFOC-20141116214 JANSSEN 0.00 C M Y 0.00000 20160830 CN 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
106335842 10633584 1 PS RISPERDAL RISPERIDONE 1 Oral U U 20272 .5 MG UNSPECIFIED
106335842 10633584 2 SS RISPERIDONE. RISPERIDONE 1 Unknown U 0 TABLETS

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
106335842 10633584 1 Attention deficit/hyperactivity disorder
106335842 10633584 2 Product used for unknown indication

Outcome of event

no results found

Reactions reported

Event ID CASEID DRUG REC ACT PT
106335842 10633584 Abnormal weight gain
106335842 10633584 Galactorrhoea
106335842 10633584 Gynaecomastia
106335842 10633584 Hyperprolactinaemia
106335842 10633584 Off label use
106335842 10633584 Product use issue

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
106335842 10633584 1 2012 2014 0