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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125828713 | 12582871 | 3 | F | 200003 | 20160823 | 20160722 | 20160831 | EXP | GB-APOTEX-2016AP009957 | APOTEX | 31.00 | YR | M | Y | 0.00000 | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125828713 | 12582871 | 1 | PS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, QD | U | U | 20031 | 20 | MG | TABLET | |||||
| 125828713 | 12582871 | 2 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 20031 | TABLET | |||||||
| 125828713 | 12582871 | 3 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 20 MG, QD | U | U | 0 | 20 | MG | TABLET | |||||
| 125828713 | 12582871 | 4 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 50 MG, QD | U | U | 0 | 50 | MG | TABLET | |||||
| 125828713 | 12582871 | 5 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 30 MG, UNK | U | U | 0 | 30 | MG | TABLET | |||||
| 125828713 | 12582871 | 6 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 45 MG, UNK | U | U | 0 | 45 | MG | TABLET | |||||
| 125828713 | 12582871 | 7 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 20 MG, UNK | U | U | 0 | 20 | MG | TABLET | |||||
| 125828713 | 12582871 | 8 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 50 MG, DAILY | U | U | 0 | 50 | MG | TABLET | |||||
| 125828713 | 12582871 | 9 | SS | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125828713 | 12582871 | 10 | SS | CO-DYDRAMOL | ACETAMINOPHENDIHYDROCODEINE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125828713 | 12582871 | 11 | C | FLUOXETINE HYDROCHLORIDE. | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, UNK | U | U | 0 | 20 | MG | ||||||
| 125828713 | 12582871 | 12 | C | FLUOXETINE HYDROCHLORIDE. | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | 50 MG, UNK | U | U | 0 | 50 | MG | ||||||
| 125828713 | 12582871 | 13 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125828713 | 12582871 | 1 | Product used for unknown indication |
| 125828713 | 12582871 | 3 | Product used for unknown indication |
| 125828713 | 12582871 | 9 | Product used for unknown indication |
| 125828713 | 12582871 | 10 | Product used for unknown indication |
| 125828713 | 12582871 | 11 | Product used for unknown indication |
| 125828713 | 12582871 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125828713 | 12582871 | OT |
| 125828713 | 12582871 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125828713 | 12582871 | Agitation | |
| 125828713 | 12582871 | Apathy | |
| 125828713 | 12582871 | Asthenia | |
| 125828713 | 12582871 | Decreased appetite | |
| 125828713 | 12582871 | Depressed mood | |
| 125828713 | 12582871 | Depression | |
| 125828713 | 12582871 | Disturbance in attention | |
| 125828713 | 12582871 | Dizziness | |
| 125828713 | 12582871 | Headache | |
| 125828713 | 12582871 | Insomnia | |
| 125828713 | 12582871 | Nausea | |
| 125828713 | 12582871 | Overdose | |
| 125828713 | 12582871 | Paraesthesia | |
| 125828713 | 12582871 | Suicidal ideation | |
| 125828713 | 12582871 | Tearfulness | |
| 125828713 | 12582871 | Tension | |
| 125828713 | 12582871 | Vomiting | |
| 125828713 | 12582871 | Withdrawal syndrome |
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 |
|---|---|---|---|---|---|---|
| 125828713 | 12582871 | 1 | 20000816 | 0 | ||
| 125828713 | 12582871 | 2 | 19991121 | 200306 | 0 | |
| 125828713 | 12582871 | 3 | 20000626 | 0 | ||
| 125828713 | 12582871 | 4 | 20010329 | 0 | ||
| 125828713 | 12582871 | 5 | 20000218 | 0 | ||
| 125828713 | 12582871 | 7 | 20000218 | 0 | ||
| 125828713 | 12582871 | 8 | 200106 | 0 | ||
| 125828713 | 12582871 | 11 | 2003 | 0 | ||
| 125828713 | 12582871 | 13 | 2000 | 0 |