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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978814 | 12497881 | 4 | F | 20021031 | 20160831 | 20160625 | 20160915 | EXP | GB-APOTEX-2016AP009430 | APOTEX | 35.00 | YR | M | Y | 0.00000 | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978814 | 12497881 | 1 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | UNK | 9510 | MG | U | U | 0 | TABLET | |||||
| 124978814 | 12497881 | 2 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 30 MG, QD | 9510 | MG | U | U | 0 | 30 | MG | TABLET | |||
| 124978814 | 12497881 | 3 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 10 MG, BID | 9510 | MG | U | U | 0 | 10 | MG | TABLET | BID | ||
| 124978814 | 12497881 | 4 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 20 MG, BID | 9510 | MG | U | U | 0 | 20 | MG | TABLET | BID | ||
| 124978814 | 12497881 | 5 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | UNK, QD | 9510 | MG | U | U | 0 | TABLET | |||||
| 124978814 | 12497881 | 6 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 4 MG, DAILY | 9510 | MG | U | U | 0 | 4 | MG | TABLET | |||
| 124978814 | 12497881 | 7 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 40 MG, DAILY | 9510 | MG | U | U | 0 | 40 | MG | TABLET | |||
| 124978814 | 12497881 | 8 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 15 MG, DAILY | 9510 | MG | U | U | 0 | 15 | MG | TABLET | |||
| 124978814 | 12497881 | 9 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 10 MG, Q.O.D. | 9510 | MG | U | U | 0 | 10 | MG | TABLET | QOD | ||
| 124978814 | 12497881 | 10 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 20 MG, Q.O.D. | 9510 | MG | U | U | 0 | 20 | MG | TABLET | QOD | ||
| 124978814 | 12497881 | 11 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 5 MG, UNK | 9510 | MG | U | U | 0 | 5 | MG | TABLET | |||
| 124978814 | 12497881 | 12 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 4/5 MG, ALTERNATE DAYS | 9510 | MG | U | U | 0 | TABLET | |||||
| 124978814 | 12497881 | 13 | PS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 20031 | TABLET | |||||||
| 124978814 | 12497881 | 14 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | 4 ML | U | U | 0 | 4 | ML | ORAL SUSPENSION | BID | ||||
| 124978814 | 12497881 | 15 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ORAL SUSPENSION | |||||||
| 124978814 | 12497881 | 16 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 4ML UNK | U | U | 0 | ORAL SUSPENSION | |||||||
| 124978814 | 12497881 | 17 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK, 1D | U | U | 0 | SUSPENSION FOR INJECTION | |||||||
| 124978814 | 12497881 | 18 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 4 ML, BID | U | U | 0 | 4 | ML | ORAL SOLUTION | BID | ||||
| 124978814 | 12497881 | 19 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 2 ML, UNK | U | U | 0 | 2 | ML | ORAL SOLUTION | |||||
| 124978814 | 12497881 | 20 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978814 | 12497881 | 21 | C | REBOXETINE | REBOXETINE | 1 | Unknown | 4 MG, Q.AM | U | U | 0 | 4 | MG | QD | |||||
| 124978814 | 12497881 | 22 | C | REBOXETINE | REBOXETINE | 1 | Unknown | 4 MG, BID | U | U | 0 | 4 | MG | BID | |||||
| 124978814 | 12497881 | 23 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124978814 | 12497881 | 1 | Depression |
| 124978814 | 12497881 | 2 | Anxiety |
| 124978814 | 12497881 | 13 | Depression |
| 124978814 | 12497881 | 14 | Depression |
| 124978814 | 12497881 | 17 | Depression |
| 124978814 | 12497881 | 18 | Depression |
| 124978814 | 12497881 | 20 | Depression |
| 124978814 | 12497881 | 21 | Product used for unknown indication |
| 124978814 | 12497881 | 23 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124978814 | 12497881 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124978814 | 12497881 | Aggression | |
| 124978814 | 12497881 | Agitation | |
| 124978814 | 12497881 | Anxiety | |
| 124978814 | 12497881 | Depressed mood | |
| 124978814 | 12497881 | Depression | |
| 124978814 | 12497881 | Diarrhoea | |
| 124978814 | 12497881 | Disturbance in attention | |
| 124978814 | 12497881 | Dizziness | |
| 124978814 | 12497881 | Drug withdrawal syndrome | |
| 124978814 | 12497881 | Fatigue | |
| 124978814 | 12497881 | Feeling abnormal | |
| 124978814 | 12497881 | Flat affect | |
| 124978814 | 12497881 | Headache | |
| 124978814 | 12497881 | Hypogeusia | |
| 124978814 | 12497881 | Hyposmia | |
| 124978814 | 12497881 | Influenza like illness | |
| 124978814 | 12497881 | Irritability | |
| 124978814 | 12497881 | Lethargy | |
| 124978814 | 12497881 | Loss of libido | |
| 124978814 | 12497881 | Memory impairment | |
| 124978814 | 12497881 | Mood altered | |
| 124978814 | 12497881 | Negativism | |
| 124978814 | 12497881 | Nightmare | |
| 124978814 | 12497881 | Panic attack | |
| 124978814 | 12497881 | Paraesthesia | |
| 124978814 | 12497881 | Restlessness | |
| 124978814 | 12497881 | Sleep disorder | |
| 124978814 | 12497881 | Suicidal ideation | |
| 124978814 | 12497881 | Tearfulness |
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 |
|---|---|---|---|---|---|---|
| 124978814 | 12497881 | 1 | 20011025 | 20151009 | 0 | |
| 124978814 | 12497881 | 2 | 20011218 | 20160426 | 0 | |
| 124978814 | 12497881 | 3 | 20021031 | 20100817 | 0 | |
| 124978814 | 12497881 | 4 | 20120229 | 20130117 | 0 | |
| 124978814 | 12497881 | 13 | 20070118 | 0 | ||
| 124978814 | 12497881 | 18 | 20070116 | 20070202 | 0 | |
| 124978814 | 12497881 | 20 | 20070118 | 0 | ||
| 124978814 | 12497881 | 21 | 200702 | 0 |