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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125298831 | 12529883 | 1 | I | 200302 | 20160622 | 20160706 | 20160706 | EXP | GB-AUROBINDO-AUR-APL-2016-08344 | AUROBINDO | 24.00 | YR | M | Y | 0.00000 | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125298831 | 12529883 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Unknown | UNK | U | U | 78406 | ||||||||
| 125298831 | 12529883 | 2 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125298831 | 12529883 | 1 | Product used for unknown indication |
| 125298831 | 12529883 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125298831 | 12529883 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125298831 | 12529883 | Agitation | |
| 125298831 | 12529883 | Anxiety | |
| 125298831 | 12529883 | Chest pain | |
| 125298831 | 12529883 | Confusional state | |
| 125298831 | 12529883 | Depressed mood | |
| 125298831 | 12529883 | Depression | |
| 125298831 | 12529883 | Disturbance in attention | |
| 125298831 | 12529883 | Drug withdrawal syndrome | |
| 125298831 | 12529883 | Fatigue | |
| 125298831 | 12529883 | Feeling guilty | |
| 125298831 | 12529883 | Insomnia | |
| 125298831 | 12529883 | Lethargy | |
| 125298831 | 12529883 | Libido decreased | |
| 125298831 | 12529883 | Memory impairment | |
| 125298831 | 12529883 | Mental disorder | |
| 125298831 | 12529883 | Mood swings | |
| 125298831 | 12529883 | Nausea | |
| 125298831 | 12529883 | Obsessive-compulsive disorder | |
| 125298831 | 12529883 | Panic attack | |
| 125298831 | 12529883 | Paraesthesia | |
| 125298831 | 12529883 | Self esteem decreased | |
| 125298831 | 12529883 | Sleep disorder | |
| 125298831 | 12529883 | Stress | |
| 125298831 | 12529883 | Suicidal ideation | |
| 125298831 | 12529883 | 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 |
|---|---|---|---|---|---|---|
| 125298831 | 12529883 | 1 | 20020722 | 0 | ||
| 125298831 | 12529883 | 2 | 2002 | 0 |