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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978883 | 12497888 | 3 | F | 19991005 | 20160706 | 20160625 | 20160714 | EXP | GB-APOTEX-2016AP009442 | APOTEX | 29.00 | YR | M | Y | 0.00000 | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978883 | 12497888 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Oral | 20 MG, QD | U | U | 20031 | 20 | MG | TABLET | |||||
| 124978883 | 12497888 | 2 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | UNK | U | U | 20031 | TABLET | |||||||
| 124978883 | 12497888 | 3 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 30 MG, QD | U | U | 20031 | 30 | MG | TABLET | |||||
| 124978883 | 12497888 | 4 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 10 MG, UNK | U | U | 20031 | 10 | MG | TABLET | |||||
| 124978883 | 12497888 | 5 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 27.5 MG, DAILY | U | U | 20031 | 27.5 | MG | TABLET | |||||
| 124978883 | 12497888 | 6 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 25 MG, DAILY | U | U | 20031 | 25 | MG | TABLET | |||||
| 124978883 | 12497888 | 7 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | 30 MG, QD | U | U | 0 | 30 | MG | TABLET | |||||
| 124978883 | 12497888 | 8 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Oral | 5 ML, QD | U | U | 0 | 5 | ML | ORAL SUSPENSION | |||||
| 124978883 | 12497888 | 9 | C | SALBUTAMOL | ALBUTEROL | 1 | Respiratory (inhalation) | UNK | U | U | 0 | ||||||||
| 124978883 | 12497888 | 10 | C | BECLOMETHASONE /00212602/ | BECLOMETHASONE | 1 | Respiratory (inhalation) | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124978883 | 12497888 | 1 | Depression |
| 124978883 | 12497888 | 7 | Depression |
| 124978883 | 12497888 | 8 | Depression |
| 124978883 | 12497888 | 9 | Product used for unknown indication |
| 124978883 | 12497888 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124978883 | 12497888 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124978883 | 12497888 | Aggression | |
| 124978883 | 12497888 | Anger | |
| 124978883 | 12497888 | Anxiety | |
| 124978883 | 12497888 | Chills | |
| 124978883 | 12497888 | Crying | |
| 124978883 | 12497888 | Decreased appetite | |
| 124978883 | 12497888 | Depressed mood | |
| 124978883 | 12497888 | Depression | |
| 124978883 | 12497888 | Disability | |
| 124978883 | 12497888 | Dizziness | |
| 124978883 | 12497888 | Drug withdrawal syndrome | |
| 124978883 | 12497888 | Dyspnoea | |
| 124978883 | 12497888 | Facial spasm | |
| 124978883 | 12497888 | Feeling abnormal | |
| 124978883 | 12497888 | Headache | |
| 124978883 | 12497888 | Hyperhidrosis | |
| 124978883 | 12497888 | Influenza like illness | |
| 124978883 | 12497888 | Insomnia | |
| 124978883 | 12497888 | Intentional self-injury | |
| 124978883 | 12497888 | Irritability | |
| 124978883 | 12497888 | Malaise | |
| 124978883 | 12497888 | Mood swings | |
| 124978883 | 12497888 | Muscular weakness | |
| 124978883 | 12497888 | Nausea | |
| 124978883 | 12497888 | Night sweats | |
| 124978883 | 12497888 | Nightmare | |
| 124978883 | 12497888 | Obsessive-compulsive disorder | |
| 124978883 | 12497888 | Paraesthesia | |
| 124978883 | 12497888 | Paranoia | |
| 124978883 | 12497888 | Poor quality sleep | |
| 124978883 | 12497888 | Sleep disorder | |
| 124978883 | 12497888 | Suicidal ideation | |
| 124978883 | 12497888 | Tension | |
| 124978883 | 12497888 | Treatment noncompliance | |
| 124978883 | 12497888 | 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 |
|---|---|---|---|---|---|---|
| 124978883 | 12497888 | 1 | 19980624 | 20050413 | 0 | |
| 124978883 | 12497888 | 2 | 19990408 | 0 | ||
| 124978883 | 12497888 | 3 | 19990419 | 20160412 | 0 | |
| 124978883 | 12497888 | 7 | 19990527 | 0 | ||
| 124978883 | 12497888 | 8 | 20051104 | 20051205 | 0 |