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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
123031032 | 12303103 | 2 | F | 2011 | 20160623 | 20160426 | 20160830 | PER | US-JNJFOC-20151102749 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
123031032 | 12303103 | 1 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | 0.25 AND 0.5 MG | U | U | UNKNOWN | 20272 | UNSPECIFIED | ||||||
123031032 | 12303103 | 2 | SS | RISPERIDONE M-TAB | RISPERIDONE | 1 | Oral | U | U | 21444 | TABLETS | ||||||||
123031032 | 12303103 | 3 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | U | 20588 | SOLUTION | ||||||||
123031032 | 12303103 | 4 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | U | 0 | TABLETS |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
123031032 | 12303103 | 1 | Anxiety |
123031032 | 12303103 | 2 | Product used for unknown indication |
123031032 | 12303103 | 3 | Product used for unknown indication |
123031032 | 12303103 | 4 | Product used for unknown indication |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
123031032 | 12303103 | Drug ineffective | |
123031032 | 12303103 | Galactorrhoea | |
123031032 | 12303103 | Gynaecomastia | |
123031032 | 12303103 | Hyperprolactinaemia | |
123031032 | 12303103 | Increased appetite | |
123031032 | 12303103 | Obesity | |
123031032 | 12303103 | Off label use | |
123031032 | 12303103 | 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 |
---|---|---|---|---|---|---|
123031032 | 12303103 | 1 | 201111 | 201301 | 0 |