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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125446551 | 12544655 | 1 | I | 200105 | 20160627 | 20160711 | 20160711 | EXP | GB-AUROBINDO-AUR-APL-2016-08575 | AUROBINDO | 30.00 | YR | F | Y | 0.00000 | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125446551 | 12544655 | 1 | PS | Paroxetine Tablet | PAROXETINE | 1 | Unknown | UNK | U | U | 78406 | TABLET | |||||||
| 125446551 | 12544655 | 2 | SS | Paroxetine Tablet | PAROXETINE | 1 | Unknown | UNK | U | U | 78406 | TABLET | |||||||
| 125446551 | 12544655 | 3 | SS | FLUPENTIXOL DECANOATE | FLUPENTIXOL DECANOATE | 1 | Unknown | 1 MG, QD | 134 | MG | U | U | 0 | 1 | MG | QD | |||
| 125446551 | 12544655 | 4 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ORAL SOLUTION | |||||||
| 125446551 | 12544655 | 5 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125446551 | 12544655 | 6 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125446551 | 12544655 | 7 | 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 |
|---|---|---|---|
| 125446551 | 12544655 | 1 | Product used for unknown indication |
| 125446551 | 12544655 | 3 | Product used for unknown indication |
| 125446551 | 12544655 | 4 | Product used for unknown indication |
| 125446551 | 12544655 | 5 | Product used for unknown indication |
| 125446551 | 12544655 | 6 | Product used for unknown indication |
| 125446551 | 12544655 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125446551 | 12544655 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125446551 | 12544655 | Abnormal dreams | |
| 125446551 | 12544655 | Anxiety | |
| 125446551 | 12544655 | Confusional state | |
| 125446551 | 12544655 | Drug dependence | |
| 125446551 | 12544655 | Drug withdrawal syndrome | |
| 125446551 | 12544655 | Head titubation | |
| 125446551 | 12544655 | Headache | |
| 125446551 | 12544655 | Migraine | |
| 125446551 | 12544655 | Nightmare | |
| 125446551 | 12544655 | Panic attack | |
| 125446551 | 12544655 | Paraesthesia | |
| 125446551 | 12544655 | Stress | |
| 125446551 | 12544655 | Suicidal ideation | |
| 125446551 | 12544655 | Thinking abnormal |
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 |
|---|---|---|---|---|---|---|
| 125446551 | 12544655 | 1 | 20000907 | 0 | ||
| 125446551 | 12544655 | 2 | 20021126 | 0 | ||
| 125446551 | 12544655 | 3 | 20010912 | 0 | ||
| 125446551 | 12544655 | 4 | 20021126 | 0 | ||
| 125446551 | 12544655 | 5 | 20000907 | 0 | ||
| 125446551 | 12544655 | 6 | 20000907 | 0 | ||
| 125446551 | 12544655 | 7 | 2002 | 0 |