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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123033033 | 12303303 | 3 | F | 20060629 | 20160725 | 20160426 | 20160929 | PER | US-JNJFOC-20160402147 | JANSSEN | 9.10 | YR | C | M | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123033033 | 12303303 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | .5 | MG | TABLETS | ||||||
| 123033033 | 12303303 | 2 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | .5 | MG | TABLETS | ||||||
| 123033033 | 12303303 | 3 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | .5 | MG | TABLETS | ||||||
| 123033033 | 12303303 | 4 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | .5 | MG | TABLETS | ||||||
| 123033033 | 12303303 | 5 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | .5 | MG | TABLETS | ||||||
| 123033033 | 12303303 | 6 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | TABLETS | ||||||||
| 123033033 | 12303303 | 7 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | .5 | MG | TABLETS | ||||||
| 123033033 | 12303303 | 8 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | .5 | MG | TABLETS | ||||||
| 123033033 | 12303303 | 9 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | .5 | MG | TABLETS | ||||||
| 123033033 | 12303303 | 10 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | .5 | MG | TABLETS | ||||||
| 123033033 | 12303303 | 11 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | TABLETS | ||||||||
| 123033033 | 12303303 | 12 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 20272 | .5 | MG | TABLETS | ||||||
| 123033033 | 12303303 | 13 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 123033033 | 12303303 | 14 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | U | 0 | 2 | MG | TABLETS | ||||||
| 123033033 | 12303303 | 15 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | U | 0 | 2 | MG | TABLETS | ||||||
| 123033033 | 12303303 | 16 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 123033033 | 12303303 | 17 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | U | 0 | 2 | MG | TABLETS | ||||||
| 123033033 | 12303303 | 18 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | U | 20272 | 2 | MG | TABLETS | ||||||
| 123033033 | 12303303 | 19 | SS | INVEGA | PALIPERIDONE | 1 | Oral | 6 MG AND 9 MG | U | U | 0 | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | |||||||
| 123033033 | 12303303 | 20 | SS | INVEGA | PALIPERIDONE | 1 | Oral | U | U | 0 | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | ||||||||
| 123033033 | 12303303 | 21 | SS | INVEGA | PALIPERIDONE | 1 | Oral | U | U | 0 | 6 | MG | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | ||||||
| 123033033 | 12303303 | 22 | SS | INVEGA | PALIPERIDONE | 1 | Oral | 6 MG AND 9 MG | U | U | 0 | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | |||||||
| 123033033 | 12303303 | 23 | SS | INVEGA | PALIPERIDONE | 1 | Oral | U | U | 0 | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | ||||||||
| 123033033 | 12303303 | 24 | SS | INVEGA | PALIPERIDONE | 1 | Oral | U | U | 0 | 6 | MG | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | ||||||
| 123033033 | 12303303 | 25 | SS | INVEGA | PALIPERIDONE | 1 | Oral | U | U | 0 | 6 | MG | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | ||||||
| 123033033 | 12303303 | 26 | SS | INVEGA | PALIPERIDONE | 1 | Oral | 6 MG AND 9 MG | U | U | 0 | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | |||||||
| 123033033 | 12303303 | 27 | SS | INVEGA | PALIPERIDONE | 1 | Oral | U | U | 21999 | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | ||||||||
| 123033033 | 12303303 | 28 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | 0 | TABLETS | |||||||||
| 123033033 | 12303303 | 29 | SS | RISPERDAL CONSTA | RISPERIDONE | 1 | Intramuscular | U | U | 0 | MICROSPHERES | ||||||||
| 123033033 | 12303303 | 30 | SS | RISPERDAL CONSTA | RISPERIDONE | 1 | Intramuscular | U | U | 0 | MICROSPHERES | ||||||||
| 123033033 | 12303303 | 31 | SS | RISPERDAL CONSTA | RISPERIDONE | 1 | Intramuscular | U | U | 21346 | MICROSPHERES |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123033033 | 12303303 | 1 | Attention deficit/hyperactivity disorder |
| 123033033 | 12303303 | 2 | Attention deficit/hyperactivity disorder |
| 123033033 | 12303303 | 3 | Attention deficit/hyperactivity disorder |
| 123033033 | 12303303 | 4 | Attention deficit/hyperactivity disorder |
| 123033033 | 12303303 | 5 | Attention deficit/hyperactivity disorder |
| 123033033 | 12303303 | 6 | Attention deficit/hyperactivity disorder |
| 123033033 | 12303303 | 7 | Attention deficit/hyperactivity disorder |
| 123033033 | 12303303 | 8 | Attention deficit/hyperactivity disorder |
| 123033033 | 12303303 | 9 | Attention deficit/hyperactivity disorder |
| 123033033 | 12303303 | 10 | Attention deficit/hyperactivity disorder |
| 123033033 | 12303303 | 11 | Attention deficit/hyperactivity disorder |
| 123033033 | 12303303 | 12 | Attention deficit/hyperactivity disorder |
| 123033033 | 12303303 | 13 | Oppositional defiant disorder |
| 123033033 | 12303303 | 14 | Oppositional defiant disorder |
| 123033033 | 12303303 | 15 | Oppositional defiant disorder |
| 123033033 | 12303303 | 16 | Attention deficit/hyperactivity disorder |
| 123033033 | 12303303 | 17 | Attention deficit/hyperactivity disorder |
| 123033033 | 12303303 | 18 | Attention deficit/hyperactivity disorder |
| 123033033 | 12303303 | 19 | Bipolar disorder |
| 123033033 | 12303303 | 20 | Bipolar disorder |
| 123033033 | 12303303 | 21 | Bipolar disorder |
| 123033033 | 12303303 | 22 | Oppositional defiant disorder |
| 123033033 | 12303303 | 23 | Oppositional defiant disorder |
| 123033033 | 12303303 | 24 | Oppositional defiant disorder |
| 123033033 | 12303303 | 25 | Attention deficit/hyperactivity disorder |
| 123033033 | 12303303 | 26 | Attention deficit/hyperactivity disorder |
| 123033033 | 12303303 | 27 | Attention deficit/hyperactivity disorder |
| 123033033 | 12303303 | 28 | Product used for unknown indication |
| 123033033 | 12303303 | 29 | Depression |
| 123033033 | 12303303 | 30 | Oppositional defiant disorder |
| 123033033 | 12303303 | 31 | Attention deficit/hyperactivity disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123033033 | 12303303 | Emotional disorder | |
| 123033033 | 12303303 | Gynaecomastia | |
| 123033033 | 12303303 | Off label use | |
| 123033033 | 12303303 | Product use issue | |
| 123033033 | 12303303 | 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 |
|---|---|---|---|---|---|---|
| 123033033 | 12303303 | 1 | 20061207 | 0 | ||
| 123033033 | 12303303 | 2 | 20061024 | 0 | ||
| 123033033 | 12303303 | 3 | 20060803 | 0 | ||
| 123033033 | 12303303 | 4 | 20060629 | 0 | ||
| 123033033 | 12303303 | 5 | 20060830 | 0 | ||
| 123033033 | 12303303 | 6 | 2006 | 2012 | 0 | |
| 123033033 | 12303303 | 7 | 20061207 | 0 | ||
| 123033033 | 12303303 | 8 | 20060830 | 0 | ||
| 123033033 | 12303303 | 9 | 20060803 | 0 | ||
| 123033033 | 12303303 | 10 | 20060629 | 0 | ||
| 123033033 | 12303303 | 11 | 2006 | 2012 | 0 | |
| 123033033 | 12303303 | 12 | 20061024 | 0 | ||
| 123033033 | 12303303 | 13 | 20120810 | 20120906 | 0 | |
| 123033033 | 12303303 | 14 | 20121019 | 0 | ||
| 123033033 | 12303303 | 15 | 20120923 | 0 | ||
| 123033033 | 12303303 | 16 | 20120810 | 20120906 | 0 | |
| 123033033 | 12303303 | 17 | 20121019 | 0 | ||
| 123033033 | 12303303 | 18 | 20120923 | 0 | ||
| 123033033 | 12303303 | 19 | 20130906 | 20150625 | 0 | |
| 123033033 | 12303303 | 20 | 2013 | 2015 | 0 | |
| 123033033 | 12303303 | 21 | 20150806 | 20150912 | 0 | |
| 123033033 | 12303303 | 22 | 20130906 | 20150625 | 0 | |
| 123033033 | 12303303 | 23 | 2013 | 2015 | 0 | |
| 123033033 | 12303303 | 24 | 20150806 | 20150912 | 0 | |
| 123033033 | 12303303 | 25 | 20150806 | 20150912 | 0 | |
| 123033033 | 12303303 | 26 | 20130906 | 20150625 | 0 | |
| 123033033 | 12303303 | 27 | 2013 | 2015 | 0 | |
| 123033033 | 12303303 | 29 | 2012 | 2012 | 0 | |
| 123033033 | 12303303 | 30 | 2012 | 2012 | 0 | |
| 123033033 | 12303303 | 31 | 2012 | 2012 | 0 |