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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123034293 | 12303429 | 3 | F | 2004 | 20160728 | 20160426 | 20160830 | PER | US-JNJFOC-20160402735 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123034293 | 12303429 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | Y | U | 0 | TABLETS | ||||||||
| 123034293 | 12303429 | 2 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | Y | U | 0 | TABLETS | ||||||||
| 123034293 | 12303429 | 3 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | Y | U | 0 | TABLETS | ||||||||
| 123034293 | 12303429 | 4 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | Y | U | 0 | TABLETS | ||||||||
| 123034293 | 12303429 | 5 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | Y | U | 0 | TABLETS | ||||||||
| 123034293 | 12303429 | 6 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | Y | U | 20272 | TABLETS | ||||||||
| 123034293 | 12303429 | 7 | SS | RISPERDAL M-TAB | RISPERIDONE | 1 | Oral | U | U | 21444 | .5 | MG | TABLETS | ||||||
| 123034293 | 12303429 | 8 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | Y | U | 0 | 1 | MG | UNSPECIFIED | ||||||
| 123034293 | 12303429 | 9 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | 0.5 MG AND 1 MG TABLET | Y | U | 0 | UNSPECIFIED | |||||||
| 123034293 | 12303429 | 10 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | Y | U | 0 | .5 | MG | UNSPECIFIED | ||||||
| 123034293 | 12303429 | 11 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | Y | U | 0 | 1 | MG | UNSPECIFIED | ||||||
| 123034293 | 12303429 | 12 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | Y | U | 0 | .5 | MG | UNSPECIFIED | ||||||
| 123034293 | 12303429 | 13 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | 0.5 MG AND 1 MG TABLET | Y | U | 0 | UNSPECIFIED | |||||||
| 123034293 | 12303429 | 14 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | Y | U | 0 | .5 | MG | UNSPECIFIED | ||||||
| 123034293 | 12303429 | 15 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | Y | U | 0 | 1 | MG | UNSPECIFIED | ||||||
| 123034293 | 12303429 | 16 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | 0.5 MG AND 1 MG TABLET | Y | U | 20272 | UNSPECIFIED | |||||||
| 123034293 | 12303429 | 17 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | 0 | TABLETS |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123034293 | 12303429 | 1 | Anger |
| 123034293 | 12303429 | 2 | Anger |
| 123034293 | 12303429 | 3 | Suicidal ideation |
| 123034293 | 12303429 | 4 | Suicidal ideation |
| 123034293 | 12303429 | 5 | Affective disorder |
| 123034293 | 12303429 | 6 | Affective disorder |
| 123034293 | 12303429 | 7 | Product used for unknown indication |
| 123034293 | 12303429 | 8 | Anger |
| 123034293 | 12303429 | 9 | Anger |
| 123034293 | 12303429 | 10 | Anger |
| 123034293 | 12303429 | 11 | Suicidal ideation |
| 123034293 | 12303429 | 12 | Suicidal ideation |
| 123034293 | 12303429 | 13 | Suicidal ideation |
| 123034293 | 12303429 | 14 | Affective disorder |
| 123034293 | 12303429 | 15 | Affective disorder |
| 123034293 | 12303429 | 16 | Affective disorder |
| 123034293 | 12303429 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123034293 | 12303429 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123034293 | 12303429 | Emotional disorder | |
| 123034293 | 12303429 | Gynaecomastia | |
| 123034293 | 12303429 | Off label use | |
| 123034293 | 12303429 | Product use issue | |
| 123034293 | 12303429 | 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 |
|---|---|---|---|---|---|---|
| 123034293 | 12303429 | 1 | 2012 | 0 | ||
| 123034293 | 12303429 | 2 | 2004 | 2009 | 0 | |
| 123034293 | 12303429 | 3 | 2012 | 0 | ||
| 123034293 | 12303429 | 4 | 2004 | 2009 | 0 | |
| 123034293 | 12303429 | 5 | 2012 | 0 | ||
| 123034293 | 12303429 | 6 | 2004 | 2009 | 0 | |
| 123034293 | 12303429 | 7 | 20080422 | 20080425 | 0 | |
| 123034293 | 12303429 | 8 | 20090919 | 0 | ||
| 123034293 | 12303429 | 9 | 200906 | 200909 | 0 | |
| 123034293 | 12303429 | 10 | 20080828 | 0 | ||
| 123034293 | 12303429 | 11 | 20090919 | 0 | ||
| 123034293 | 12303429 | 12 | 20080828 | 0 | ||
| 123034293 | 12303429 | 13 | 200906 | 200909 | 0 | |
| 123034293 | 12303429 | 14 | 20080828 | 0 | ||
| 123034293 | 12303429 | 15 | 20090919 | 0 | ||
| 123034293 | 12303429 | 16 | 200906 | 200909 | 0 |