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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121986263 | 12198626 | 3 | F | 20130622 | 20160622 | 20160322 | 20160711 | PER | US-JNJFOC-20150809129 | JANSSEN | 42.14 | YR | A | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121986263 | 12198626 | 1 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | 0.5-1MG PO QHS | Y | U | 20272 | TABLETS | |||||||
| 121986263 | 12198626 | 2 | SS | RISPERDAL CONSTA | RISPERIDONE | 1 | Intramuscular | U | U | 21346 | MICROSPHERES | ||||||||
| 121986263 | 12198626 | 3 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | U | 20272 | UNSPECIFIED | ||||||||
| 121986263 | 12198626 | 4 | SS | INVEGA | PALIPERIDONE | 1 | Oral | U | U | 21999 | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | ||||||||
| 121986263 | 12198626 | 5 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | 0 | TABLETS |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121986263 | 12198626 | 1 | Bipolar disorder |
| 121986263 | 12198626 | 2 | Product used for unknown indication |
| 121986263 | 12198626 | 3 | Product used for unknown indication |
| 121986263 | 12198626 | 4 | Product used for unknown indication |
| 121986263 | 12198626 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121986263 | 12198626 | Abdominal distension | |
| 121986263 | 12198626 | Gynaecomastia | |
| 121986263 | 12198626 | Increased appetite | |
| 121986263 | 12198626 | Sedation | |
| 121986263 | 12198626 | Somnolence | |
| 121986263 | 12198626 | Weight increased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |