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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118196153 | 11819615 | 3 | F | 2000 | 20160804 | 20151210 | 20160929 | PER | US-JNJFOC-20150713739 | JANSSEN | 0.00 | T | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118196153 | 11819615 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 2 | MG | UNSPECIFIED | ||||||
| 118196153 | 11819615 | 2 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 4 | MG | UNSPECIFIED | ||||||
| 118196153 | 11819615 | 3 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 20272 | UNSPECIFIED | ||||||||
| 118196153 | 11819615 | 4 | SS | INVEGA | PALIPERIDONE | 1 | Oral | U | U | 0 | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | ||||||||
| 118196153 | 11819615 | 5 | SS | INVEGA | PALIPERIDONE | 1 | Oral | U | U | 21999 | 9 | MG | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | ||||||
| 118196153 | 11819615 | 6 | SS | RISPERDAL CONSTA | RISPERIDONE | 1 | Intramuscular | U | U | 0 | 50 | MG | MICROSPHERES | ||||||
| 118196153 | 11819615 | 7 | SS | RISPERDAL CONSTA | RISPERIDONE | 1 | Intramuscular | U | U | 0 | 50 | MG | MICROSPHERES | ||||||
| 118196153 | 11819615 | 8 | SS | RISPERDAL CONSTA | RISPERIDONE | 1 | Intramuscular | U | U | 0 | 50 | MG | MICROSPHERES | ||||||
| 118196153 | 11819615 | 9 | SS | RISPERDAL CONSTA | RISPERIDONE | 1 | Intramuscular | U | U | 21346 | 50 | MG | MICROSPHERES | ||||||
| 118196153 | 11819615 | 10 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | U | U | 22264 | INJECTION | ||||||||
| 118196153 | 11819615 | 11 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | 0 | TABLETS | |||||||||
| 118196153 | 11819615 | 12 | SS | RESPIDON | RISPERIDONE | 1 | Oral | U | 0 | TABLETS | |||||||||
| 118196153 | 11819615 | 13 | SS | RESPIDON | RISPERIDONE | 1 | Unknown | U | 0 | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118196153 | 11819615 | 1 | Attention deficit/hyperactivity disorder |
| 118196153 | 11819615 | 2 | Attention deficit/hyperactivity disorder |
| 118196153 | 11819615 | 3 | Attention deficit/hyperactivity disorder |
| 118196153 | 11819615 | 4 | Attention deficit/hyperactivity disorder |
| 118196153 | 11819615 | 5 | Attention deficit/hyperactivity disorder |
| 118196153 | 11819615 | 6 | Attention deficit/hyperactivity disorder |
| 118196153 | 11819615 | 7 | Attention deficit/hyperactivity disorder |
| 118196153 | 11819615 | 8 | Attention deficit/hyperactivity disorder |
| 118196153 | 11819615 | 9 | Attention deficit/hyperactivity disorder |
| 118196153 | 11819615 | 10 | Product used for unknown indication |
| 118196153 | 11819615 | 11 | Product used for unknown indication |
| 118196153 | 11819615 | 12 | Product used for unknown indication |
| 118196153 | 11819615 | 13 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118196153 | 11819615 | Abnormal weight gain | |
| 118196153 | 11819615 | Gynaecomastia | |
| 118196153 | 11819615 | Off label use | |
| 118196153 | 11819615 | 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 |
|---|---|---|---|---|---|---|
| 118196153 | 11819615 | 1 | 201202 | 201205 | 0 | |
| 118196153 | 11819615 | 2 | 201107 | 201202 | 0 | |
| 118196153 | 11819615 | 3 | 2000 | 0 | ||
| 118196153 | 11819615 | 4 | 20120228 | 2012 | 0 | |
| 118196153 | 11819615 | 5 | 20110823 | 2012 | 0 | |
| 118196153 | 11819615 | 6 | 201206 | 201208 | 0 | |
| 118196153 | 11819615 | 7 | 201201 | 201202 | 0 | |
| 118196153 | 11819615 | 8 | 201210 | 201302 | 0 | |
| 118196153 | 11819615 | 9 | 201109 | 0 |