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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127796101 | 12779610 | 1 | I | 20160820 | 20160912 | 20160926 | 20160926 | EXP | FR-AUROBINDO-AUR-APL-2016-11739 | AUROBINDO | 53.51 | YR | M | Y | 0.00000 | 20160926 | CN | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127796101 | 12779610 | 1 | PS | PAROXETINE ARROW 20 mg film-coated tablets | PAROXETINE | 1 | Oral | 20 MG, DAILY | Y | U | 78406 | 20 | MG | FILM-COATED TABLET | |||||
| 127796101 | 12779610 | 2 | SS | ZYPREXA | OLANZAPINE | 1 | Oral | 10 MG, ONCE A DAY | Y | U | 0 | 10 | MG | FILM-COATED TABLET | QD | ||||
| 127796101 | 12779610 | 3 | C | XENAZINE | TETRABENAZINE | 1 | Unknown | U | 0 | ||||||||||
| 127796101 | 12779610 | 4 | C | IMOVANE | ZOPICLONE | 1 | Unknown | U | 0 | ||||||||||
| 127796101 | 12779610 | 5 | C | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127796101 | 12779610 | 1 | Product used for unknown indication |
| 127796101 | 12779610 | 2 | Product used for unknown indication |
| 127796101 | 12779610 | 3 | Product used for unknown indication |
| 127796101 | 12779610 | 4 | Product used for unknown indication |
| 127796101 | 12779610 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127796101 | 12779610 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127796101 | 12779610 | Diabetes mellitus | |
| 127796101 | 12779610 | Hepatic steatosis | |
| 127796101 | 12779610 | Hypertriglyceridaemia | |
| 127796101 | 12779610 | 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 |
|---|---|---|---|---|---|---|
| 127796101 | 12779610 | 1 | 201510 | 20160820 | 0 | |
| 127796101 | 12779610 | 2 | 201601 | 20160820 | 0 |