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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126131771 | 12613177 | 1 | I | 20020906 | 20160719 | 20160802 | 20160802 | EXP | GB-AUROBINDO-AUR-APL-2016-09657 | AUROBINDO | 0.00 | F | Y | 0.00000 | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126131771 | 12613177 | 1 | PS | Paroxetine Tablet | PAROXETINE | 1 | Unknown | UNK | 3840 | MG | U | 78406 | TABLET | ||||||
| 126131771 | 12613177 | 2 | SS | Paroxetine Tablet | PAROXETINE | 1 | Unknown | 20 MG, QD | 3840 | MG | U | 78406 | 20 | MG | TABLET | QD | |||
| 126131771 | 12613177 | 3 | SS | Paroxetine Tablet | PAROXETINE | 1 | Unknown | 30 MG, QD | 3840 | MG | U | 78406 | 30 | MG | TABLET | QD | |||
| 126131771 | 12613177 | 4 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20MG/10ML | U | 0 | |||||||||
| 126131771 | 12613177 | 5 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126131771 | 12613177 | 1 | Product used for unknown indication |
| 126131771 | 12613177 | 4 | Product used for unknown indication |
| 126131771 | 12613177 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126131771 | 12613177 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126131771 | 12613177 | Abulia | |
| 126131771 | 12613177 | Asthenia | |
| 126131771 | 12613177 | Chest discomfort | |
| 126131771 | 12613177 | Chest pain | |
| 126131771 | 12613177 | Decreased appetite | |
| 126131771 | 12613177 | Depressed mood | |
| 126131771 | 12613177 | Depression | |
| 126131771 | 12613177 | Disturbance in attention | |
| 126131771 | 12613177 | Dyskinesia | |
| 126131771 | 12613177 | Exposure during pregnancy | |
| 126131771 | 12613177 | Feeling abnormal | |
| 126131771 | 12613177 | Feeling of despair | |
| 126131771 | 12613177 | Headache | |
| 126131771 | 12613177 | Incoherent | |
| 126131771 | 12613177 | Initial insomnia | |
| 126131771 | 12613177 | Irritability | |
| 126131771 | 12613177 | Migraine | |
| 126131771 | 12613177 | Nausea | |
| 126131771 | 12613177 | Panic attack | |
| 126131771 | 12613177 | Peripheral swelling | |
| 126131771 | 12613177 | Sensory disturbance | |
| 126131771 | 12613177 | Social avoidant behaviour | |
| 126131771 | 12613177 | Visual impairment | |
| 126131771 | 12613177 | 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 |
|---|---|---|---|---|---|---|
| 126131771 | 12613177 | 1 | 199905 | 0 | ||
| 126131771 | 12613177 | 2 | 2002 | 20151218 | 0 | |
| 126131771 | 12613177 | 3 | 2002 | 20160622 | 0 | |
| 126131771 | 12613177 | 4 | 20080714 | 0 |