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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125447651 | 12544765 | 1 | I | 200212 | 20160627 | 20160711 | 20160711 | EXP | GB-AUROBINDO-AUR-APL-2016-08567 | AUROBINDO | 49.00 | YR | F | Y | 0.00000 | 20160711 | LW | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125447651 | 12544765 | 1 | PS | Paroxetine Tablet | PAROXETINE | 1 | Unknown | 20 MG, ONCE A DAY | 17040.834 | MG | U | 78406 | 20 | MG | TABLET | QD | |||
| 125447651 | 12544765 | 2 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | 10MG/5ML | U | 0 | |||||||||
| 125447651 | 12544765 | 3 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | 20 MG, ONCE A DAY | 14000 | MG | U | 0 | 20 | MG | QD | |||||
| 125447651 | 12544765 | 4 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | 20 MG, ONCE A DAY | 14000 | MG | U | 0 | 20 | MG | QD | ||||
| 125447651 | 12544765 | 5 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | U | 0 | ||||||||||
| 125447651 | 12544765 | 6 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125447651 | 12544765 | 1 | Depression |
| 125447651 | 12544765 | 2 | Depression |
| 125447651 | 12544765 | 3 | Product used for unknown indication |
| 125447651 | 12544765 | 5 | Product used for unknown indication |
| 125447651 | 12544765 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125447651 | 12544765 | OT |
| 125447651 | 12544765 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125447651 | 12544765 | Abnormal behaviour | |
| 125447651 | 12544765 | Abnormal dreams | |
| 125447651 | 12544765 | Agitation | |
| 125447651 | 12544765 | Anxiety | |
| 125447651 | 12544765 | Confusional state | |
| 125447651 | 12544765 | Crying | |
| 125447651 | 12544765 | Depression | |
| 125447651 | 12544765 | Diarrhoea | |
| 125447651 | 12544765 | Feeling abnormal | |
| 125447651 | 12544765 | Hyperhidrosis | |
| 125447651 | 12544765 | Hypoaesthesia | |
| 125447651 | 12544765 | Nausea | |
| 125447651 | 12544765 | Panic attack | |
| 125447651 | 12544765 | Paraesthesia | |
| 125447651 | 12544765 | Sensory disturbance | |
| 125447651 | 12544765 | Suicidal ideation | |
| 125447651 | 12544765 | Tremor | |
| 125447651 | 12544765 | 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 |
|---|---|---|---|---|---|---|
| 125447651 | 12544765 | 1 | 20000901 | 0 | ||
| 125447651 | 12544765 | 2 | 20020729 | 0 | ||
| 125447651 | 12544765 | 3 | 20010131 | 20030124 | 0 | |
| 125447651 | 12544765 | 4 | 20030124 | 0 | ||
| 125447651 | 12544765 | 5 | 20020730 | 0 | ||
| 125447651 | 12544765 | 6 | 20021030 | 0 |