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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123030722 | 12303072 | 2 | F | 2009 | 20160627 | 20160426 | 20160830 | PER | US-JNJFOC-20151102747 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123030722 | 12303072 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | 0.25 - 0.5 MG | U | 0 | UNSPECIFIED | ||||||||
| 123030722 | 12303072 | 2 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | 0.25 - 0.5 MG | U | 20272 | UNSPECIFIED | ||||||||
| 123030722 | 12303072 | 3 | SS | RISPERDAL M-TAB | RISPERIDONE | 1 | Oral | U | 21444 | TABLETS | |||||||||
| 123030722 | 12303072 | 4 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | 0 | TABLETS |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123030722 | 12303072 | 1 | Oppositional defiant disorder |
| 123030722 | 12303072 | 2 | Attention deficit/hyperactivity disorder |
| 123030722 | 12303072 | 3 | Product used for unknown indication |
| 123030722 | 12303072 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123030722 | 12303072 | Abnormal weight gain | |
| 123030722 | 12303072 | Galactorrhoea | |
| 123030722 | 12303072 | Gynaecomastia | |
| 123030722 | 12303072 | Hyperprolactinaemia | |
| 123030722 | 12303072 | Off label use | |
| 123030722 | 12303072 | 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 |
|---|---|---|---|---|---|---|
| 123030722 | 12303072 | 1 | 2009 | 2012 | 0 | |
| 123030722 | 12303072 | 2 | 2009 | 2012 | 0 |