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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125690252 | 12569025 | 2 | F | 200509 | 20160721 | 20160719 | 20160804 | EXP | GB-AUROBINDO-AUR-APL-2016-08888 | AUROBINDO | 0.00 | Y | 0.00000 | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125690252 | 12569025 | 1 | PS | Paroxetine tablets 20 mg | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, QD | 13840 | MG | U | U | 78406 | 20 | MG | TABLET | QD | ||
| 125690252 | 12569025 | 2 | SS | Paroxetine tablets 20 mg | PAROXETINE HYDROCHLORIDE | 1 | Oral | 30 MG, QD | 13840 | MG | U | U | 78406 | 30 | MG | TABLET | QD | ||
| 125690252 | 12569025 | 3 | SS | Paroxetine tablets 20 mg | PAROXETINE HYDROCHLORIDE | 1 | Oral | 10 MG, DAILY | 13840 | MG | U | U | 78406 | 10 | MG | TABLET | |||
| 125690252 | 12569025 | 4 | SS | Paroxetine tablets 20 mg | PAROXETINE HYDROCHLORIDE | 1 | Oral | 40 MG, QD | 13840 | MG | U | U | 78406 | 40 | MG | TABLET | QD | ||
| 125690252 | 12569025 | 5 | SS | Paroxetine tablets 20 mg | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | 13840 | MG | U | U | 78406 | TABLET | |||||
| 125690252 | 12569025 | 6 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | 20 DF, ONCE A DAY | 1280 | DF | U | U | 0 | 20 | DF | ORAL SOLUTION | QD | ||
| 125690252 | 12569025 | 7 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | 10 DF, ONCE A DAY | 1280 | DF | U | U | 0 | 10 | DF | ORAL SOLUTION | QD | ||
| 125690252 | 12569025 | 8 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, DAILY | U | U | 0 | 20 | MG | TABLET | |||||
| 125690252 | 12569025 | 9 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 30 MG, DAILY | U | U | 0 | 30 | MG | TABLET | |||||
| 125690252 | 12569025 | 10 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Oral | 30 MG, QD | 43660 | MG | U | U | 0 | 30 | MG | ORAL SOLUTION | QD | ||
| 125690252 | 12569025 | 11 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | 5 MG, PRN | U | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125690252 | 12569025 | 1 | Panic attack |
| 125690252 | 12569025 | 2 | Depression |
| 125690252 | 12569025 | 6 | Depression |
| 125690252 | 12569025 | 8 | Depression |
| 125690252 | 12569025 | 10 | Depression |
| 125690252 | 12569025 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125690252 | 12569025 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125690252 | 12569025 | Agitation | |
| 125690252 | 12569025 | Confusional state | |
| 125690252 | 12569025 | Disturbance in attention | |
| 125690252 | 12569025 | Drug withdrawal syndrome | |
| 125690252 | 12569025 | Fatigue | |
| 125690252 | 12569025 | Hyperhidrosis | |
| 125690252 | 12569025 | Lethargy | |
| 125690252 | 12569025 | Memory impairment | |
| 125690252 | 12569025 | Obsessive thoughts | |
| 125690252 | 12569025 | Sleep disorder | |
| 125690252 | 12569025 | Suicidal ideation | |
| 125690252 | 12569025 | Tremor | |
| 125690252 | 12569025 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 125690252 | 12569025 | 1 | 199910 | 20160411 | 0 | |
| 125690252 | 12569025 | 2 | 20070924 | 20130325 | 0 | |
| 125690252 | 12569025 | 3 | 20090616 | 20130325 | 0 | |
| 125690252 | 12569025 | 4 | 20101011 | 20150128 | 0 | |
| 125690252 | 12569025 | 5 | 20010227 | 0 | ||
| 125690252 | 12569025 | 6 | 20050629 | 20051118 | 0 | |
| 125690252 | 12569025 | 7 | 20020620 | 20051103 | 0 | |
| 125690252 | 12569025 | 8 | 19990910 | 20051021 | 0 | |
| 125690252 | 12569025 | 9 | 20080320 | 0 | ||
| 125690252 | 12569025 | 10 | 20080320 | 0 | ||
| 125690252 | 12569025 | 11 | 20080327 | 0 |