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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118128902 | 11812890 | 2 | F | 20151121 | 20151217 | 20151209 | 20160101 | EXP | IT-AUROBINDO-AUR-APL-2015-11078 | AUROBINDO | 48.83 | YR | F | Y | 0.00000 | 20160101 | PH | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118128902 | 11812890 | 1 | PS | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Oral | 100 MG TOTAL | U | 77031 | 100 | MG | |||||||
| 118128902 | 11812890 | 2 | SS | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Oral | 5 DF TOTAL | U | 0 | 5 | DF | GASTRO-RESISTANT CAPSULE, HARD | ||||||
| 118128902 | 11812890 | 3 | SS | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Oral | 5 DF,TOTAL | U | 0 | 5 | DF | GASTRO-RESISTANT CAPSULE, HARD | ||||||
| 118128902 | 11812890 | 4 | SS | RIVOTRIL | CLONAZEPAM | 1 | Oral | 6 DF TOTAL | U | 0 | 6 | DF | TABLET | ||||||
| 118128902 | 11812890 | 5 | SS | DEPAKIN CHRONO | VALPROIC ACID | 1 | Oral | 5 DF TOTAL | U | 0 | 5 | DF | PROLONGED-RELEASE TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118128902 | 11812890 | 1 | Product used for unknown indication |
| 118128902 | 11812890 | 2 | Depression |
| 118128902 | 11812890 | 4 | Product used for unknown indication |
| 118128902 | 11812890 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118128902 | 11812890 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118128902 | 11812890 | Aggression | |
| 118128902 | 11812890 | Agitation | |
| 118128902 | 11812890 | Drug abuse | |
| 118128902 | 11812890 | Intentional self-injury |
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 |
|---|---|---|---|---|---|---|
| 118128902 | 11812890 | 1 | 20151121 | 20151121 | 0 | |
| 118128902 | 11812890 | 2 | 20151121 | 20151121 | 0 | |
| 118128902 | 11812890 | 3 | 20151121 | 20051121 | 0 | |
| 118128902 | 11812890 | 4 | 20151121 | 20151121 | 0 | |
| 118128902 | 11812890 | 5 | 20151121 | 20151121 | 0 |