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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118188163 | 11818816 | 3 | F | 2011 | 20160628 | 20151210 | 20160830 | PER | US-JNJFOC-20151114037 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118188163 | 11818816 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | UNSPECIFIED | ||||||
| 118188163 | 11818816 | 2 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 20272 | 1 | MG | UNSPECIFIED | ||||||
| 118188163 | 11818816 | 3 | SS | RISPERIDONE. | RISPERIDONE | 1 | U | 0 | TABLETS | ||||||||||
| 118188163 | 11818816 | 4 | SS | RISPERDAL M-TAB | RISPERIDONE | 1 | Oral | U | U | 21444 | TABLETS | ||||||||
| 118188163 | 11818816 | 5 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | 20272 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118188163 | 11818816 | 1 | Autism |
| 118188163 | 11818816 | 2 | Autism |
| 118188163 | 11818816 | 3 | Product used for unknown indication |
| 118188163 | 11818816 | 4 | Product used for unknown indication |
| 118188163 | 11818816 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118188163 | 11818816 | Aggression | |
| 118188163 | 11818816 | Disturbance in social behaviour | |
| 118188163 | 11818816 | Gynaecomastia | |
| 118188163 | 11818816 | Irritability | |
| 118188163 | 11818816 | 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 |
|---|---|---|---|---|---|---|
| 118188163 | 11818816 | 1 | 201301 | 201306 | 0 | |
| 118188163 | 11818816 | 2 | 2009 | 2012 | 0 |