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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125447802 | 12544780 | 2 | F | 2003 | 20160711 | 20160711 | 20160726 | EXP | GB-AUROBINDO-AUR-APL-2016-08587 | AUROBINDO | 0.00 | F | Y | 0.00000 | 20160725 | LW | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125447802 | 12544780 | 1 | PS | Paroxetine tablets 20 mg | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, UNKNOWN | U | 78406 | 20 | MG | TABLET | ||||||
| 125447802 | 12544780 | 2 | SS | Paroxetine tablets 20 mg | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, 1D | U | 78406 | 20 | MG | TABLET | ||||||
| 125447802 | 12544780 | 3 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | ORAL SOLUTION | ||||||||
| 125447802 | 12544780 | 4 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, QD | 38460.832 | MG | U | 0 | 20 | MG | TABLET | QD | |||
| 125447802 | 12544780 | 5 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 3 MG TO 3.5 MG DAILY | 38460.832 | MG | U | 0 | TABLET | ||||||
| 125447802 | 12544780 | 6 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, ONCE A DAY | 38460.832 | MG | U | 0 | 20 | MG | QD | ||||
| 125447802 | 12544780 | 7 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 3 MG TO 3.5 MG DAILY | 38460.832 | MG | U | 0 | |||||||
| 125447802 | 12544780 | 8 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | UNK | U | 0 | |||||||||
| 125447802 | 12544780 | 9 | C | ZOPICLONE | ZOPICLONE | 1 | Unknown | 3.75 MG, UNK | U | 0 | 3.75 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125447802 | 12544780 | 1 | Panic attack |
| 125447802 | 12544780 | 2 | Depression |
| 125447802 | 12544780 | 3 | Product used for unknown indication |
| 125447802 | 12544780 | 4 | Product used for unknown indication |
| 125447802 | 12544780 | 6 | Product used for unknown indication |
| 125447802 | 12544780 | 8 | Product used for unknown indication |
| 125447802 | 12544780 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125447802 | 12544780 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125447802 | 12544780 | Agitation | |
| 125447802 | 12544780 | Anxiety | |
| 125447802 | 12544780 | Confusional state | |
| 125447802 | 12544780 | Depressed mood | |
| 125447802 | 12544780 | Diarrhoea | |
| 125447802 | 12544780 | Disturbance in attention | |
| 125447802 | 12544780 | Dizziness | |
| 125447802 | 12544780 | Fear | |
| 125447802 | 12544780 | Feeling hot | |
| 125447802 | 12544780 | Hyperhidrosis | |
| 125447802 | 12544780 | Loss of consciousness | |
| 125447802 | 12544780 | Memory impairment | |
| 125447802 | 12544780 | Muscle spasms | |
| 125447802 | 12544780 | Nausea | |
| 125447802 | 12544780 | Nightmare | |
| 125447802 | 12544780 | Panic attack | |
| 125447802 | 12544780 | Paraesthesia | |
| 125447802 | 12544780 | Psychiatric symptom | |
| 125447802 | 12544780 | Sleep disorder | |
| 125447802 | 12544780 | Tremor | |
| 125447802 | 12544780 | Vision blurred | |
| 125447802 | 12544780 | Weight increased | |
| 125447802 | 12544780 | 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 |
|---|---|---|---|---|---|---|
| 125447802 | 12544780 | 2 | 19970902 | 0 | ||
| 125447802 | 12544780 | 3 | 20021014 | 20100427 | 0 | |
| 125447802 | 12544780 | 4 | 19970926 | 0 | ||
| 125447802 | 12544780 | 5 | 20040607 | 0 | ||
| 125447802 | 12544780 | 6 | 19970926 | 0 | ||
| 125447802 | 12544780 | 7 | 20040607 | 0 | ||
| 125447802 | 12544780 | 8 | 20030121 | 0 | ||
| 125447802 | 12544780 | 9 | 20021223 | 0 |