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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978623 | 12497862 | 3 | F | 20050704 | 20160722 | 20160625 | 20160726 | EXP | GB-APOTEX-2016AP009446 | APOTEX | 44.00 | YR | M | Y | 0.00000 | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978623 | 12497862 | 1 | SS | PAROXETINE. | PAROXETINE | 1 | 20 MG, UNK | U | U | 0 | 20 | MG | TABLET | ||||||
| 124978623 | 12497862 | 2 | PS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, U | U | U | 20031 | 20 | MG | TABLET | |||||
| 124978623 | 12497862 | 3 | C | VOLTAROL | DICLOFENAC SODIUM | 1 | Unknown | UNK UNK, U | U | 0 | |||||||||
| 124978623 | 12497862 | 4 | C | LIPOSTAT | PRAVASTATIN SODIUM | 1 | Unknown | UNK UNK, U | U | 0 | |||||||||
| 124978623 | 12497862 | 5 | C | DICLOFENAC | DICLOFENAC | 1 | UNK, UNK, U | U | 0 | ||||||||||
| 124978623 | 12497862 | 6 | C | ZIMOVANE | ZOPICLONE | 1 | 3.75 MG, UNK | U | 0 | 3.75 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124978623 | 12497862 | 1 | Product used for unknown indication |
| 124978623 | 12497862 | 2 | Product used for unknown indication |
| 124978623 | 12497862 | 3 | Product used for unknown indication |
| 124978623 | 12497862 | 4 | Product used for unknown indication |
| 124978623 | 12497862 | 5 | Product used for unknown indication |
| 124978623 | 12497862 | 6 | Poor quality sleep |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124978623 | 12497862 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124978623 | 12497862 | Aggression | |
| 124978623 | 12497862 | Dizziness | |
| 124978623 | 12497862 | Drug withdrawal syndrome | |
| 124978623 | 12497862 | Initial insomnia | |
| 124978623 | 12497862 | Intentional overdose | |
| 124978623 | 12497862 | Intentional self-injury | |
| 124978623 | 12497862 | Paranoia | |
| 124978623 | 12497862 | Sleep disorder | |
| 124978623 | 12497862 | Suicidal ideation |
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 |
|---|---|---|---|---|---|---|
| 124978623 | 12497862 | 1 | 20000511 | 20160314 | 0 | |
| 124978623 | 12497862 | 2 | 19961220 | 20000410 | 0 | |
| 124978623 | 12497862 | 6 | 19970916 | 200007 | 0 |