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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125317833 | 12531783 | 3 | F | 20011114 | 20160720 | 20160706 | 20160801 | EXP | GB-MYLANLABS-2016M1027700 | MYLAN | 0.00 | Y | 0.00000 | 20160801 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125317833 | 12531783 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Oral | 20 MG, QD (20 MG, QD) | 1020.83301 | MG | U | U | 77873 | 20 | MG | QD | |||
| 125317833 | 12531783 | 2 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 30 MG, QD (30 MG, QD) | 1020.83301 | MG | U | U | 77873 | 30 | MG | QD | |||
| 125317833 | 12531783 | 3 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK (UNK) | U | U | 0 | SOLUTION FOR INJECTION | |||||||
| 125317833 | 12531783 | 4 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 30 MG, UNK (30 MG, UNK) | U | U | 0 | 30 | MG | ||||||
| 125317833 | 12531783 | 5 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | UNK | U | 0 | ||||||||||
| 125317833 | 12531783 | 6 | C | DIHYDROCODEINE | DIHYDROCODEINE | 1 | UNK | U | 0 | ||||||||||
| 125317833 | 12531783 | 7 | C | GAMANIL | 2 | UNK | U | 0 | |||||||||||
| 125317833 | 12531783 | 8 | C | LOFEPRAMINE | LOFEPRAMINE | 1 | UNK | U | 0 | ||||||||||
| 125317833 | 12531783 | 9 | C | MOLIPAXIN | TRAZODONE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125317833 | 12531783 | 10 | C | PROCHLORPERAZINE. | PROCHLORPERAZINE | 1 | UNK | U | 0 | ||||||||||
| 125317833 | 12531783 | 11 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125317833 | 12531783 | 1 | Depression |
| 125317833 | 12531783 | 3 | Depression |
| 125317833 | 12531783 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125317833 | 12531783 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125317833 | 12531783 | Abdominal discomfort | |
| 125317833 | 12531783 | Agitation | |
| 125317833 | 12531783 | Anger | |
| 125317833 | 12531783 | Anxiety | |
| 125317833 | 12531783 | Diarrhoea | |
| 125317833 | 12531783 | Dissociative amnesia | |
| 125317833 | 12531783 | Dizziness | |
| 125317833 | 12531783 | Drug withdrawal syndrome | |
| 125317833 | 12531783 | Mood altered | |
| 125317833 | 12531783 | Nausea | |
| 125317833 | 12531783 | Nervousness | |
| 125317833 | 12531783 | Paraesthesia | |
| 125317833 | 12531783 | Poor quality sleep | |
| 125317833 | 12531783 | Sensory loss | |
| 125317833 | 12531783 | Suicidal ideation | |
| 125317833 | 12531783 | Tremor | |
| 125317833 | 12531783 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125317833 | 12531783 | 1 | 20010924 | 20050323 | 0 | |
| 125317833 | 12531783 | 2 | 20020619 | 20050725 | 0 | |
| 125317833 | 12531783 | 4 | 20130509 | 0 | ||
| 125317833 | 12531783 | 5 | 20031008 | 0 | ||
| 125317833 | 12531783 | 7 | 20050506 | 0 | ||
| 125317833 | 12531783 | 9 | 20050323 | 0 |