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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118188393 | 11818839 | 3 | F | 2009 | 20160617 | 20151210 | 20160830 | PER | US-JNJFOC-20151114926 | JANSSEN | 0.00 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118188393 | 11818839 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | TABLETS | ||||||||
| 118188393 | 11818839 | 2 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 118188393 | 11818839 | 3 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 118188393 | 11818839 | 4 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 118188393 | 11818839 | 5 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 118188393 | 11818839 | 6 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | TABLETS | ||||||||
| 118188393 | 11818839 | 7 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 118188393 | 11818839 | 8 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 118188393 | 11818839 | 9 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 118188393 | 11818839 | 10 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 118188393 | 11818839 | 11 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | TABLETS | ||||||||
| 118188393 | 11818839 | 12 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 118188393 | 11818839 | 13 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | TABLETS | ||||||||
| 118188393 | 11818839 | 14 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 118188393 | 11818839 | 15 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 118188393 | 11818839 | 16 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 20272 | 1 | MG | TABLETS | ||||||
| 118188393 | 11818839 | 17 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | 0 | TABLETS |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118188393 | 11818839 | 1 | Psychotic disorder |
| 118188393 | 11818839 | 2 | Psychotic disorder |
| 118188393 | 11818839 | 3 | Psychotic disorder |
| 118188393 | 11818839 | 4 | Psychotic disorder |
| 118188393 | 11818839 | 5 | Irritability |
| 118188393 | 11818839 | 6 | Irritability |
| 118188393 | 11818839 | 7 | Irritability |
| 118188393 | 11818839 | 8 | Irritability |
| 118188393 | 11818839 | 9 | Mood swings |
| 118188393 | 11818839 | 10 | Mood swings |
| 118188393 | 11818839 | 11 | Mood swings |
| 118188393 | 11818839 | 12 | Mood swings |
| 118188393 | 11818839 | 13 | Depression |
| 118188393 | 11818839 | 14 | Depression |
| 118188393 | 11818839 | 15 | Depression |
| 118188393 | 11818839 | 16 | Depression |
| 118188393 | 11818839 | 17 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118188393 | 11818839 | Gynaecomastia | |
| 118188393 | 11818839 | Off label use | |
| 118188393 | 11818839 | Product use issue | |
| 118188393 | 11818839 | 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 |
|---|---|---|---|---|---|---|
| 118188393 | 11818839 | 1 | 2013 | 0 | ||
| 118188393 | 11818839 | 2 | 2012 | 0 | ||
| 118188393 | 11818839 | 3 | 2011 | 0 | ||
| 118188393 | 11818839 | 4 | 2009 | 0 | ||
| 118188393 | 11818839 | 5 | 2009 | 0 | ||
| 118188393 | 11818839 | 6 | 2013 | 0 | ||
| 118188393 | 11818839 | 7 | 2011 | 0 | ||
| 118188393 | 11818839 | 8 | 2012 | 0 | ||
| 118188393 | 11818839 | 9 | 2012 | 0 | ||
| 118188393 | 11818839 | 10 | 2011 | 0 | ||
| 118188393 | 11818839 | 11 | 2013 | 0 | ||
| 118188393 | 11818839 | 12 | 2009 | 0 | ||
| 118188393 | 11818839 | 13 | 2013 | 0 | ||
| 118188393 | 11818839 | 14 | 2012 | 0 | ||
| 118188393 | 11818839 | 15 | 2011 | 0 | ||
| 118188393 | 11818839 | 16 | 2009 | 0 |