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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978472 | 12497847 | 2 | F | 200308 | 20160627 | 20160625 | 20160711 | EXP | GB-APOTEX-2016AP009339 | APOTEX | 49.00 | YR | F | Y | 0.00000 | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978472 | 12497847 | 1 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 20 MG,QD | U | 0 | 20 | MG | TABLET | ||||||
| 124978472 | 12497847 | 2 | PS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, QD | U | U | 20031 | 20 | MG | TABLET | |||||
| 124978472 | 12497847 | 3 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | 20 MG, QD | U | U | 20031 | 20 | MG | TABLET | QD | ||||
| 124978472 | 12497847 | 4 | SS | Paroxetine Oral solution | PAROXETINE | 1 | Oral | 10MG/5ML | U | U | 0 | ORAL SOLUTION | |||||||
| 124978472 | 12497847 | 5 | SS | Paroxetine Oral solution | PAROXETINE | 1 | Oral | 5 MG | U | U | 0 | 5 | MG | ORAL SOLUTION | |||||
| 124978472 | 12497847 | 6 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | U | U | 0 | |||||||||
| 124978472 | 12497847 | 7 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | U | U | 0 | |||||||||
| 124978472 | 12497847 | 8 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978472 | 12497847 | 9 | C | MIRTAZAPINE. | MIRTAZAPINE | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124978472 | 12497847 | 1 | Depression |
| 124978472 | 12497847 | 2 | Product used for unknown indication |
| 124978472 | 12497847 | 4 | Depression |
| 124978472 | 12497847 | 6 | Product used for unknown indication |
| 124978472 | 12497847 | 7 | Product used for unknown indication |
| 124978472 | 12497847 | 8 | Product used for unknown indication |
| 124978472 | 12497847 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124978472 | 12497847 | HO |
| 124978472 | 12497847 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124978472 | 12497847 | Abnormal behaviour | |
| 124978472 | 12497847 | Abnormal dreams | |
| 124978472 | 12497847 | Agitation | |
| 124978472 | 12497847 | Anxiety | |
| 124978472 | 12497847 | Confusional state | |
| 124978472 | 12497847 | Crying | |
| 124978472 | 12497847 | Depression | |
| 124978472 | 12497847 | Diarrhoea | |
| 124978472 | 12497847 | Feeling abnormal | |
| 124978472 | 12497847 | Hyperhidrosis | |
| 124978472 | 12497847 | Hypoaesthesia | |
| 124978472 | 12497847 | Nausea | |
| 124978472 | 12497847 | Panic attack | |
| 124978472 | 12497847 | Paraesthesia | |
| 124978472 | 12497847 | Sensory disturbance | |
| 124978472 | 12497847 | Suicidal ideation | |
| 124978472 | 12497847 | Tremor | |
| 124978472 | 12497847 | 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 |
|---|---|---|---|---|---|---|
| 124978472 | 12497847 | 1 | 20000901 | 0 | ||
| 124978472 | 12497847 | 2 | 20010131 | 20030124 | 0 | |
| 124978472 | 12497847 | 3 | 20030124 | 0 | ||
| 124978472 | 12497847 | 4 | 20020729 | 0 | ||
| 124978472 | 12497847 | 6 | 20021030 | 0 | ||
| 124978472 | 12497847 | 7 | 20020730 | 0 | ||
| 124978472 | 12497847 | 8 | 200301 | 0 | ||
| 124978472 | 12497847 | 9 | 2003 | 0 |