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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124979082 | 12497908 | 2 | F | 2002 | 20160623 | 20160625 | 20160705 | EXP | GB-APOTEX-2016AP009465 | APOTEX | 0.00 | Y | 0.00000 | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124979082 | 12497908 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Unknown | UNK | U | U | 20031 | TABLET | |||||||
| 124979082 | 12497908 | 2 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 20 MG, QD | U | U | 20031 | 20 | MG | TABLET | QD | ||||
| 124979082 | 12497908 | 3 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 20 MG, QD | U | U | 20031 | 20 | MG | TABLET | |||||
| 124979082 | 12497908 | 4 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 30 MG, QD | U | U | 20031 | 30 | MG | TABLET | |||||
| 124979082 | 12497908 | 5 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | UNK | U | U | 20031 | TABLET | |||||||
| 124979082 | 12497908 | 6 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | TABLET | |||||||
| 124979082 | 12497908 | 7 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 6 MG, QD | U | U | 0 | 6 | MG | TABLET | QD | ||||
| 124979082 | 12497908 | 8 | SS | Paroxetine Oral solution | PAROXETINE | 1 | Oral | REDUCED DOSES | U | U | 0 | ORAL SOLUTION | |||||||
| 124979082 | 12497908 | 9 | SS | Paroxetine Oral solution | PAROXETINE | 1 | Oral | 5 ML, BID, SPOON | U | U | 0 | 5 | ML | ORAL SOLUTION | BID | ||||
| 124979082 | 12497908 | 10 | C | SUMATRIPTAN. | SUMATRIPTAN | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124979082 | 12497908 | 11 | C | ZOPICLONE | ZOPICLONE | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124979082 | 12497908 | 1 | Depression |
| 124979082 | 12497908 | 6 | Product used for unknown indication |
| 124979082 | 12497908 | 8 | Product used for unknown indication |
| 124979082 | 12497908 | 10 | Product used for unknown indication |
| 124979082 | 12497908 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124979082 | 12497908 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124979082 | 12497908 | Abdominal pain | |
| 124979082 | 12497908 | Aggression | |
| 124979082 | 12497908 | Cerebrovascular accident | |
| 124979082 | 12497908 | Depression | |
| 124979082 | 12497908 | Diabetes mellitus | |
| 124979082 | 12497908 | Diarrhoea | |
| 124979082 | 12497908 | Disturbance in attention | |
| 124979082 | 12497908 | Dizziness | |
| 124979082 | 12497908 | Drug withdrawal syndrome | |
| 124979082 | 12497908 | Dyspnoea | |
| 124979082 | 12497908 | Electric shock | |
| 124979082 | 12497908 | Fatigue | |
| 124979082 | 12497908 | Feeling abnormal | |
| 124979082 | 12497908 | Headache | |
| 124979082 | 12497908 | Hyperhidrosis | |
| 124979082 | 12497908 | Influenza like illness | |
| 124979082 | 12497908 | Insomnia | |
| 124979082 | 12497908 | Lethargy | |
| 124979082 | 12497908 | Memory impairment | |
| 124979082 | 12497908 | Migraine | |
| 124979082 | 12497908 | Mood swings | |
| 124979082 | 12497908 | Musculoskeletal stiffness | |
| 124979082 | 12497908 | Myalgia | |
| 124979082 | 12497908 | Nasal obstruction | |
| 124979082 | 12497908 | Nausea | |
| 124979082 | 12497908 | Nightmare | |
| 124979082 | 12497908 | Somnolence | |
| 124979082 | 12497908 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 124979082 | 12497908 | 1 | 19970213 | 199709 | 0 | |
| 124979082 | 12497908 | 2 | 20021204 | 20041204 | 0 | |
| 124979082 | 12497908 | 3 | 20021204 | 20041204 | 0 | |
| 124979082 | 12497908 | 4 | 20030520 | 0 | ||
| 124979082 | 12497908 | 5 | 20040526 | 20041110 | 0 | |
| 124979082 | 12497908 | 6 | 20021118 | 200501 | 0 | |
| 124979082 | 12497908 | 8 | 20040526 | 20041110 | 0 | |
| 124979082 | 12497908 | 9 | 20041117 | 0 | ||
| 124979082 | 12497908 | 10 | 200111 | 0 |