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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125353702 | 12535370 | 2 | F | 199712 | 20160728 | 20160707 | 20160811 | EXP | GB-AUROBINDO-AUR-APL-2016-08552 | AUROBINDO | 0.00 | Y | 0.00000 | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125353702 | 12535370 | 1 | PS | Paroxetine tablets 20 mg | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, QD | 360 | MG | U | U | 78406 | 20 | MG | TABLET | |||
| 125353702 | 12535370 | 2 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | TABLET | ||||||||
| 125353702 | 12535370 | 3 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125353702 | 12535370 | 4 | C | LITHIUM CARBONATE. | LITHIUM CARBONATE | 1 | Unknown | 40 MG, ONCE A DAY | U | 0 | 40 | MG | QD | ||||||
| 125353702 | 12535370 | 5 | C | PROCYCLIDINE | PROCYCLIDINE | 1 | Unknown | 5 MG, 3 TIMES A DAY | U | 0 | 5 | MG | TID | ||||||
| 125353702 | 12535370 | 6 | C | ZOPICLONE | ZOPICLONE | 1 | Unknown | 7.5 MG, UNKNOWN | U | 0 | 7.5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125353702 | 12535370 | 1 | Bipolar disorder |
| 125353702 | 12535370 | 2 | Product used for unknown indication |
| 125353702 | 12535370 | 3 | Product used for unknown indication |
| 125353702 | 12535370 | 4 | Product used for unknown indication |
| 125353702 | 12535370 | 5 | Product used for unknown indication |
| 125353702 | 12535370 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125353702 | 12535370 | OT |
| 125353702 | 12535370 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125353702 | 12535370 | Aggression | |
| 125353702 | 12535370 | Agitation | |
| 125353702 | 12535370 | Anger | |
| 125353702 | 12535370 | Anxiety | |
| 125353702 | 12535370 | Asthenia | |
| 125353702 | 12535370 | Burning sensation | |
| 125353702 | 12535370 | Decreased appetite | |
| 125353702 | 12535370 | Depressed mood | |
| 125353702 | 12535370 | Disturbance in attention | |
| 125353702 | 12535370 | Dizziness | |
| 125353702 | 12535370 | Drug withdrawal syndrome | |
| 125353702 | 12535370 | Dyskinesia | |
| 125353702 | 12535370 | Energy increased | |
| 125353702 | 12535370 | Fatigue | |
| 125353702 | 12535370 | Flushing | |
| 125353702 | 12535370 | Head titubation | |
| 125353702 | 12535370 | Headache | |
| 125353702 | 12535370 | Hypoaesthesia | |
| 125353702 | 12535370 | Insomnia | |
| 125353702 | 12535370 | Irritability | |
| 125353702 | 12535370 | Malaise | |
| 125353702 | 12535370 | Mania | |
| 125353702 | 12535370 | Mood altered | |
| 125353702 | 12535370 | Pain | |
| 125353702 | 12535370 | Panic attack | |
| 125353702 | 12535370 | Paraesthesia | |
| 125353702 | 12535370 | Personality change | |
| 125353702 | 12535370 | Rash | |
| 125353702 | 12535370 | Restlessness | |
| 125353702 | 12535370 | Skin reaction | |
| 125353702 | 12535370 | Suicidal ideation | |
| 125353702 | 12535370 | Suicide attempt | |
| 125353702 | 12535370 | 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 |
|---|---|---|---|---|---|---|
| 125353702 | 12535370 | 1 | 19971113 | 0 | ||
| 125353702 | 12535370 | 2 | 19970916 | 0 | ||
| 125353702 | 12535370 | 3 | 19970916 | 0 |