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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125283521 | 12528352 | 1 | I | 200310 | 20160627 | 20160705 | 20160705 | EXP | PHHY2016GB088559 | SANDOZ | 0.00 | Y | 0.00000 | 20160705 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125283521 | 12528352 | 1 | PS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | UNK | U | 75566 | |||||||||
| 125283521 | 12528352 | 2 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | 40 MG, QD | U | 75566 | 40 | MG | QD | ||||||
| 125283521 | 12528352 | 3 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | 20 MG, BID | U | 75566 | 20 | MG | BID | ||||||
| 125283521 | 12528352 | 4 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | 30 MG, QD | U | 75566 | 30 | MG | QD | ||||||
| 125283521 | 12528352 | 5 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK UKN, QD | U | 0 | QD | ||||||||
| 125283521 | 12528352 | 6 | C | CIPRAMAX//CISAPRIDE | 2 | Unknown | U | 0 | |||||||||||
| 125283521 | 12528352 | 7 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | U | 0 | ||||||||||
| 125283521 | 12528352 | 8 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 125283521 | 12528352 | 9 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125283521 | 12528352 | 1 | Depression |
| 125283521 | 12528352 | 5 | Depression |
| 125283521 | 12528352 | 6 | Product used for unknown indication |
| 125283521 | 12528352 | 7 | Product used for unknown indication |
| 125283521 | 12528352 | 8 | Product used for unknown indication |
| 125283521 | 12528352 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125283521 | 12528352 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125283521 | 12528352 | Agitation | |
| 125283521 | 12528352 | Anxiety | |
| 125283521 | 12528352 | Confusional state | |
| 125283521 | 12528352 | Disturbance in attention | |
| 125283521 | 12528352 | Dizziness | |
| 125283521 | 12528352 | Drug withdrawal syndrome | |
| 125283521 | 12528352 | Fatigue | |
| 125283521 | 12528352 | Hallucination | |
| 125283521 | 12528352 | Hyperhidrosis | |
| 125283521 | 12528352 | Influenza | |
| 125283521 | 12528352 | Insomnia | |
| 125283521 | 12528352 | Intentional self-injury | |
| 125283521 | 12528352 | Lethargy | |
| 125283521 | 12528352 | Memory impairment | |
| 125283521 | 12528352 | Nightmare | |
| 125283521 | 12528352 | Paraesthesia | |
| 125283521 | 12528352 | Persistent depressive disorder | |
| 125283521 | 12528352 | Personality disorder | |
| 125283521 | 12528352 | Suicidal ideation | |
| 125283521 | 12528352 | Suicide attempt | |
| 125283521 | 12528352 | Tremor | |
| 125283521 | 12528352 | Vertigo |
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 |
|---|---|---|---|---|---|---|
| 125283521 | 12528352 | 1 | 2002 | 20031212 | 0 | |
| 125283521 | 12528352 | 2 | 20031024 | 20031106 | 0 | |
| 125283521 | 12528352 | 3 | 20030228 | 20031106 | 0 | |
| 125283521 | 12528352 | 4 | 2002 | 20030801 | 0 | |
| 125283521 | 12528352 | 5 | 20020926 | 200310 | 0 | |
| 125283521 | 12528352 | 6 | 20031021 | 0 | ||
| 125283521 | 12528352 | 7 | 20030901 | 0 | ||
| 125283521 | 12528352 | 8 | 20031121 | 0 | ||
| 125283521 | 12528352 | 9 | 20031219 | 0 |