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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978733 | 12497873 | 3 | F | 200105 | 20160627 | 20160625 | 20160712 | EXP | GB-APOTEX-2016AP009322 | APOTEX | 30.00 | YR | F | Y | 0.00000 | 20160712 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978733 | 12497873 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Unknown | U | U | 20031 | TABLET | ||||||||
| 124978733 | 12497873 | 2 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | TABLET | |||||||
| 124978733 | 12497873 | 3 | SS | Paroxetine Oral solution | PAROXETINE | 1 | Unknown | UNK | U | U | 0 | ORAL SOLUTION | |||||||
| 124978733 | 12497873 | 4 | SS | FLUPENTHIXOL | FLUPENTIXOL DECANOATE | 1 | Unknown | 1 MG, QD | U | U | 0 | 1 | MG | QD | |||||
| 124978733 | 12497873 | 5 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | Unknown | LESS THAN 0.25 UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124978733 | 12497873 | 1 | Product used for unknown indication |
| 124978733 | 12497873 | 2 | Product used for unknown indication |
| 124978733 | 12497873 | 3 | Product used for unknown indication |
| 124978733 | 12497873 | 4 | Product used for unknown indication |
| 124978733 | 12497873 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124978733 | 12497873 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124978733 | 12497873 | Abnormal dreams | |
| 124978733 | 12497873 | Anxiety | |
| 124978733 | 12497873 | Confusional state | |
| 124978733 | 12497873 | Drug dependence | |
| 124978733 | 12497873 | Drug withdrawal syndrome | |
| 124978733 | 12497873 | Head titubation | |
| 124978733 | 12497873 | Headache | |
| 124978733 | 12497873 | Migraine | |
| 124978733 | 12497873 | Nightmare | |
| 124978733 | 12497873 | Panic attack | |
| 124978733 | 12497873 | Paraesthesia | |
| 124978733 | 12497873 | Stress | |
| 124978733 | 12497873 | Suicidal ideation | |
| 124978733 | 12497873 | Thinking abnormal | |
| 124978733 | 12497873 | 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 |
|---|---|---|---|---|---|---|
| 124978733 | 12497873 | 1 | 20000907 | 0 | ||
| 124978733 | 12497873 | 2 | 20000907 | 0 | ||
| 124978733 | 12497873 | 3 | 20021126 | 0 | ||
| 124978733 | 12497873 | 4 | 20010912 | 0 | ||
| 124978733 | 12497873 | 5 | 2002 | 0 |