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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118170812 | 11817081 | 2 | F | 2009 | 20160615 | 20151210 | 20160711 | PER | US-JNJFOC-20151117832 | JANSSEN | 0.00 | T | M | Y | 0.00000 | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118170812 | 11817081 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | IN VARYING DOSES OF 1 TO 2 MG | U | U | 0 | UNSPECIFIED | |||||||
| 118170812 | 11817081 | 2 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | IN VARYING DOSES OF 1 TO 2 MG | U | U | 20272 | UNSPECIFIED | |||||||
| 118170812 | 11817081 | 3 | SS | INVEGA | PALIPERIDONE | 1 | Oral | U | U | 0 | 6 | MG | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | ||||||
| 118170812 | 11817081 | 4 | SS | INVEGA | PALIPERIDONE | 1 | Oral | U | U | 21999 | 6 | MG | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | ||||||
| 118170812 | 11817081 | 5 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | U | 20272 | TABLETS | ||||||||
| 118170812 | 11817081 | 6 | SS | RISPERIDONE M-TAB | RISPERIDONE | 1 | Oral | U | U | 21444 | TABLETS | ||||||||
| 118170812 | 11817081 | 7 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | 0 | TABLETS |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118170812 | 11817081 | 1 | Oppositional defiant disorder |
| 118170812 | 11817081 | 2 | Attention deficit/hyperactivity disorder |
| 118170812 | 11817081 | 3 | Oppositional defiant disorder |
| 118170812 | 11817081 | 4 | Attention deficit/hyperactivity disorder |
| 118170812 | 11817081 | 5 | Product used for unknown indication |
| 118170812 | 11817081 | 6 | Product used for unknown indication |
| 118170812 | 11817081 | 7 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118170812 | 11817081 | Abnormal weight gain | |
| 118170812 | 11817081 | Gynaecomastia | |
| 118170812 | 11817081 | Off label use | |
| 118170812 | 11817081 | 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 |
|---|---|---|---|---|---|---|
| 118170812 | 11817081 | 1 | 2009 | 2013 | 0 | |
| 118170812 | 11817081 | 2 | 2009 | 2013 | 0 | |
| 118170812 | 11817081 | 3 | 2011 | 2012 | 0 | |
| 118170812 | 11817081 | 4 | 2011 | 2012 | 0 |