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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118017012 | 11801701 | 2 | F | 2010 | 20160804 | 20151204 | 20160929 | PER | US-JNJFOC-20150923150 | JANSSEN | 0.00 | A | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118017012 | 11801701 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | VARYING DOSES OF 1 MG, 2 MG, 3 MG | U | U | 0 | UNSPECIFIED | |||||||
| 118017012 | 11801701 | 2 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 3 | MG | UNSPECIFIED | ||||||
| 118017012 | 11801701 | 3 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 2 | MG | UNSPECIFIED | ||||||
| 118017012 | 11801701 | 4 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 20272 | UNSPECIFIED | ||||||||
| 118017012 | 11801701 | 5 | SS | INVEGA | PALIPERIDONE | 1 | Oral | U | U | 21999 | 6 | MG | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | ||||||
| 118017012 | 11801701 | 6 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | U | 0 | UNSPECIFIED | ||||||||
| 118017012 | 11801701 | 7 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | U | 0 | 3 | MG | UNSPECIFIED | ||||||
| 118017012 | 11801701 | 8 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | VARYING DOSES OF 2 MG, 3 MG, 4 MG | U | U | 20272 | UNSPECIFIED | |||||||
| 118017012 | 11801701 | 9 | SS | RISPERDAL CONSTA | RISPERIDONE | 1 | Intramuscular | VARYING DOSES OF 37.5 MG, 50 MG | U | U | 0 | MICROSPHERES | |||||||
| 118017012 | 11801701 | 10 | SS | RISPERDAL CONSTA | RISPERIDONE | 1 | Intramuscular | U | U | 0 | MICROSPHERES | ||||||||
| 118017012 | 11801701 | 11 | SS | RISPERDAL CONSTA | RISPERIDONE | 1 | Intramuscular | 25 MG, 37.5 MG | U | U | 0 | MICROSPHERES | |||||||
| 118017012 | 11801701 | 12 | SS | RISPERDAL CONSTA | RISPERIDONE | 1 | Intramuscular | U | U | 21346 | 50 | MG | MICROSPHERES | ||||||
| 118017012 | 11801701 | 13 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | U | U | 22264 | 1.5 | ML | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118017012 | 11801701 | 1 | Depression |
| 118017012 | 11801701 | 2 | Depression |
| 118017012 | 11801701 | 3 | Depression |
| 118017012 | 11801701 | 4 | Depression |
| 118017012 | 11801701 | 5 | Depression |
| 118017012 | 11801701 | 6 | Depression |
| 118017012 | 11801701 | 7 | Depression |
| 118017012 | 11801701 | 8 | Depression |
| 118017012 | 11801701 | 9 | Depression |
| 118017012 | 11801701 | 10 | Depression |
| 118017012 | 11801701 | 11 | Depression |
| 118017012 | 11801701 | 12 | Depression |
| 118017012 | 11801701 | 13 | Depression |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118017012 | 11801701 | Abnormal weight gain | |
| 118017012 | 11801701 | Gynaecomastia | |
| 118017012 | 11801701 | Off label use | |
| 118017012 | 11801701 | 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 |
|---|---|---|---|---|---|---|
| 118017012 | 11801701 | 1 | 2010 | 2012 | 0 | |
| 118017012 | 11801701 | 2 | 2011 | 2012 | 0 | |
| 118017012 | 11801701 | 3 | 20110712 | 0 | ||
| 118017012 | 11801701 | 4 | 201410 | 0 | ||
| 118017012 | 11801701 | 5 | 201311 | 20131227 | 0 | |
| 118017012 | 11801701 | 6 | 201410 | 0 | ||
| 118017012 | 11801701 | 7 | 201305 | 201307 | 0 | |
| 118017012 | 11801701 | 8 | 2010 | 2012 | 0 | |
| 118017012 | 11801701 | 9 | 201305 | 201307 | 0 | |
| 118017012 | 11801701 | 10 | 201410 | 0 | ||
| 118017012 | 11801701 | 11 | 2010 | 2012 | 0 | |
| 118017012 | 11801701 | 12 | 20130513 | 0 | ||
| 118017012 | 11801701 | 13 | 201311 | 20131227 | 0 |