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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125351651 | 12535165 | 1 | I | 20000812 | 20160623 | 20160707 | 20160707 | EXP | GB-AUROBINDO-AUR-APL-2016-08556 | AUROBINDO | 45.00 | YR | F | Y | 0.00000 | 20160707 | CN | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125351651 | 12535165 | 1 | PS | Paroxetine Tablet | PAROXETINE | 1 | Unknown | UNK | U | U | 78406 | TABLET | |||||||
| 125351651 | 12535165 | 2 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | UNK | U | U | 0 | ORAL SOLUTION | |||||||
| 125351651 | 12535165 | 3 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK UNK, U | U | U | 0 | SUSPENSION FOR INJECTION | |||||||
| 125351651 | 12535165 | 4 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK 20 MG HALF A TABLET QD | U | U | 0 | TABLET | |||||||
| 125351651 | 12535165 | 5 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125351651 | 12535165 | 1 | Depression |
| 125351651 | 12535165 | 2 | Product used for unknown indication |
| 125351651 | 12535165 | 3 | Depression |
| 125351651 | 12535165 | 4 | Product used for unknown indication |
| 125351651 | 12535165 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125351651 | 12535165 | OT |
| 125351651 | 12535165 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125351651 | 12535165 | Abdominal pain | |
| 125351651 | 12535165 | Abdominal pain upper | |
| 125351651 | 12535165 | Abnormal behaviour | |
| 125351651 | 12535165 | Anxiety | |
| 125351651 | 12535165 | Confusional state | |
| 125351651 | 12535165 | Crying | |
| 125351651 | 12535165 | Depression | |
| 125351651 | 12535165 | Disturbance in attention | |
| 125351651 | 12535165 | Dizziness | |
| 125351651 | 12535165 | Fatigue | |
| 125351651 | 12535165 | Feeling cold | |
| 125351651 | 12535165 | Genital pain | |
| 125351651 | 12535165 | Hyperhidrosis | |
| 125351651 | 12535165 | Insomnia | |
| 125351651 | 12535165 | Intentional self-injury | |
| 125351651 | 12535165 | Malaise | |
| 125351651 | 12535165 | Nausea | |
| 125351651 | 12535165 | Panic attack | |
| 125351651 | 12535165 | Paraesthesia | |
| 125351651 | 12535165 | Psychiatric symptom | |
| 125351651 | 12535165 | Suicidal ideation | |
| 125351651 | 12535165 | Withdrawal syndrome |
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 |
|---|---|---|---|---|---|---|
| 125351651 | 12535165 | 1 | 20010501 | 0 | ||
| 125351651 | 12535165 | 2 | 20070725 | 20100301 | 0 | |
| 125351651 | 12535165 | 3 | 19990706 | 0 | ||
| 125351651 | 12535165 | 4 | 19990713 | 0 | ||
| 125351651 | 12535165 | 5 | 20020129 | 0 |