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
121982642 12198264 2 F 20070323 20160721 20160322 20160830 PER US-JNJFOC-20160217326 JANSSEN 10.79 YR 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
121982642 12198264 1 SS RISPERDAL RISPERIDONE 1 Oral 0.25 TO 1 MG Y U 0 TABLETS
121982642 12198264 2 SS RISPERDAL RISPERIDONE 1 Oral 1 MG TO 2 MG Y U 0 TABLETS
121982642 12198264 3 SS RISPERDAL RISPERIDONE 1 Oral 1 MG TO 2 MG Y U 0 TABLETS
121982642 12198264 4 SS RISPERDAL RISPERIDONE 1 Oral 1 MG TO 2 MG Y U 0 TABLETS
121982642 12198264 5 SS RISPERDAL RISPERIDONE 1 Oral 1 MG TO 2 MG Y U 0 TABLETS
121982642 12198264 6 PS RISPERDAL RISPERIDONE 1 Oral 0.25 TO 1 MG Y U 20272 TABLETS
121982642 12198264 7 SS RISPERDAL M-TAB RISPERIDONE 1 Oral U U 21444 TABLETS
121982642 12198264 8 SS RISPERIDONE. RISPERIDONE 1 Oral Y U 0 UNSPECIFIED
121982642 12198264 9 SS RISPERIDONE. RISPERIDONE 1 Oral Y U 20272 2 MG UNSPECIFIED
121982642 12198264 10 SS RISPERIDONE. RISPERIDONE 1 Oral U 0 TABLETS

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
121982642 12198264 1 Aggression
121982642 12198264 2 Aggression
121982642 12198264 3 Aggression
121982642 12198264 4 Attention deficit/hyperactivity disorder
121982642 12198264 5 Attention deficit/hyperactivity disorder
121982642 12198264 6 Attention deficit/hyperactivity disorder
121982642 12198264 7 Product used for unknown indication
121982642 12198264 8 Attention deficit/hyperactivity disorder
121982642 12198264 9 Attention deficit/hyperactivity disorder
121982642 12198264 10 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
121982642 12198264 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
121982642 12198264 Emotional distress
121982642 12198264 Gynaecomastia
121982642 12198264 Off label use
121982642 12198264 Product use issue
121982642 12198264 Weight increased

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
121982642 12198264 1 20070323 200709 0
121982642 12198264 2 201206 201306 0
121982642 12198264 3 200804 200905 0
121982642 12198264 4 200804 200905 0
121982642 12198264 5 201206 201306 0
121982642 12198264 6 20070323 200709 0
121982642 12198264 8 200703 200906 0
121982642 12198264 9 20110926 20131111 0