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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978752 | 12497875 | 2 | F | 20040212 | 20160715 | 20160625 | 20160728 | EXP | GB-APOTEX-2016AP009310 | APOTEX | 30.00 | YR | M | Y | 0.00000 | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978752 | 12497875 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Oral | 20 MG, QD | U | U | 75356 | 20 | MG | TABLET | |||||
| 124978752 | 12497875 | 2 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 10 MG, QD | U | U | 75356 | 10 | MG | TABLET | |||||
| 124978752 | 12497875 | 3 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 20 MG, QD | U | U | 75356 | 20 | MG | TABLET | |||||
| 124978752 | 12497875 | 4 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 30 MG, QD | U | U | 75356 | 30 | MG | TABLET | |||||
| 124978752 | 12497875 | 5 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 10MG/5ML EVERY DAY | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124978752 | 12497875 | 1 | Depression |
| 124978752 | 12497875 | 5 | Depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124978752 | 12497875 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124978752 | 12497875 | Abdominal distension | |
| 124978752 | 12497875 | Aggression | |
| 124978752 | 12497875 | Agitation | |
| 124978752 | 12497875 | Akathisia | |
| 124978752 | 12497875 | Arthralgia | |
| 124978752 | 12497875 | Chest pain | |
| 124978752 | 12497875 | Confusional state | |
| 124978752 | 12497875 | Dizziness | |
| 124978752 | 12497875 | Drug withdrawal syndrome | |
| 124978752 | 12497875 | Dry eye | |
| 124978752 | 12497875 | Influenza like illness | |
| 124978752 | 12497875 | Mood swings | |
| 124978752 | 12497875 | Muscle spasms | |
| 124978752 | 12497875 | Myalgia | |
| 124978752 | 12497875 | Night sweats | |
| 124978752 | 12497875 | Paraesthesia | |
| 124978752 | 12497875 | Rash | |
| 124978752 | 12497875 | Skin lesion | |
| 124978752 | 12497875 | Sleep disorder | |
| 124978752 | 12497875 | Suicidal ideation | |
| 124978752 | 12497875 | Tension | |
| 124978752 | 12497875 | Tinnitus |
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 |
|---|---|---|---|---|---|---|
| 124978752 | 12497875 | 1 | 19971117 | 0 | ||
| 124978752 | 12497875 | 2 | 20041124 | 20051010 | 0 | |
| 124978752 | 12497875 | 3 | 20040126 | 20040608 | 0 | |
| 124978752 | 12497875 | 4 | 19971208 | 20040121 | 0 | |
| 124978752 | 12497875 | 5 | 20040908 | 20051010 | 0 |