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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126092981 | 12609298 | 1 | I | 20021201 | 20160718 | 20160801 | 20160801 | EXP | GB-AUROBINDO-AUR-APL-2016-09606 | AUROBINDO | 29.00 | YR | F | Y | 0.00000 | 20160730 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126092981 | 12609298 | 1 | PS | Paroxetine Tablet | PAROXETINE | 1 | Oral | 5 MG, ONCE A DAY | 15979.792 | MG | U | 78406 | 5 | MG | TABLET | QD | |||
| 126092981 | 12609298 | 2 | SS | Paroxetine Tablet | PAROXETINE | 1 | Oral | 20 MG, UNK | 15979.792 | MG | U | 78406 | 20 | MG | TABLET | ||||
| 126092981 | 12609298 | 3 | SS | Paroxetine Tablet | PAROXETINE | 1 | Unknown | UNK | 15979.792 | MG | U | 78406 | TABLET | ||||||
| 126092981 | 12609298 | 4 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | 8 ML, QD | 22775.666 | ML | U | 0 | 8 | ML | QD | ||||
| 126092981 | 12609298 | 5 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | 7.25 ML, QD | 22775.666 | ML | U | 0 | 7.25 | ML | QD | ||||
| 126092981 | 12609298 | 6 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | 5 ML, QD | 22775.666 | ML | U | 0 | 5 | ML | QD | ||||
| 126092981 | 12609298 | 7 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126092981 | 12609298 | 8 | C | BUSPIRONE | BUSPIRONE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126092981 | 12609298 | 9 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126092981 | 12609298 | 10 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | UNK | U | 0 | |||||||||
| 126092981 | 12609298 | 11 | C | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126092981 | 12609298 | 12 | C | MIRTAZAPINE. | MIRTAZAPINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126092981 | 12609298 | 13 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126092981 | 12609298 | 14 | C | STEMETIL /00013301/ | PROCHLORPERAZINE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126092981 | 12609298 | 1 | Depression |
| 126092981 | 12609298 | 4 | Depression |
| 126092981 | 12609298 | 7 | Depression |
| 126092981 | 12609298 | 8 | Product used for unknown indication |
| 126092981 | 12609298 | 9 | Product used for unknown indication |
| 126092981 | 12609298 | 10 | Product used for unknown indication |
| 126092981 | 12609298 | 11 | Product used for unknown indication |
| 126092981 | 12609298 | 12 | Product used for unknown indication |
| 126092981 | 12609298 | 13 | Product used for unknown indication |
| 126092981 | 12609298 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126092981 | 12609298 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126092981 | 12609298 | Abdominal pain upper | |
| 126092981 | 12609298 | Adverse event | |
| 126092981 | 12609298 | Agitation | |
| 126092981 | 12609298 | Anxiety | |
| 126092981 | 12609298 | Decreased appetite | |
| 126092981 | 12609298 | Disturbance in attention | |
| 126092981 | 12609298 | Drug withdrawal syndrome | |
| 126092981 | 12609298 | Dysarthria | |
| 126092981 | 12609298 | Epigastric discomfort | |
| 126092981 | 12609298 | Fatigue | |
| 126092981 | 12609298 | Feeding disorder | |
| 126092981 | 12609298 | Influenza like illness | |
| 126092981 | 12609298 | Insomnia | |
| 126092981 | 12609298 | Loss of consciousness | |
| 126092981 | 12609298 | Muscle tightness | |
| 126092981 | 12609298 | Nervousness | |
| 126092981 | 12609298 | Night sweats | |
| 126092981 | 12609298 | Panic reaction | |
| 126092981 | 12609298 | Paraesthesia | |
| 126092981 | 12609298 | Sensory disturbance | |
| 126092981 | 12609298 | Social avoidant behaviour | |
| 126092981 | 12609298 | Tearfulness | |
| 126092981 | 12609298 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 126092981 | 12609298 | 1 | 20110901 | 0 | ||
| 126092981 | 12609298 | 2 | 20030509 | 20080111 | 0 | |
| 126092981 | 12609298 | 3 | 20010109 | 20101223 | 0 | |
| 126092981 | 12609298 | 4 | 20100917 | 20101221 | 0 | |
| 126092981 | 12609298 | 5 | 20100823 | 0 | ||
| 126092981 | 12609298 | 6 | 20030613 | 20100802 | 0 | |
| 126092981 | 12609298 | 7 | 20110719 | 20110727 | 0 | |
| 126092981 | 12609298 | 8 | 200508 | 0 | ||
| 126092981 | 12609298 | 9 | 20030613 | 0 | ||
| 126092981 | 12609298 | 10 | 20010102 | 20050722 | 0 | |
| 126092981 | 12609298 | 12 | 20030509 | 0 | ||
| 126092981 | 12609298 | 13 | 19980121 | 20010109 | 0 | |
| 126092981 | 12609298 | 14 | 200507 | 0 |