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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125024562 | 12502456 | 2 | F | 19990108 | 20160708 | 20160627 | 20160715 | EXP | GB-APOTEX-2016AP009470 | APOTEX | 14.00 | YR | F | Y | 0.00000 | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125024562 | 12502456 | 1 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 20 MG, QD | U | U | 0 | 20 | MG | TABLET | |||||
| 125024562 | 12502456 | 2 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | 10 MG/ML | U | U | 0 | ORAL SOLUTION | |||||||
| 125024562 | 12502456 | 3 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | 10 MG X 15ML | U | U | 0 | ORAL SOLUTION | |||||||
| 125024562 | 12502456 | 4 | PS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Endocervical | UNK | U | U | 20031 | TABLET | |||||||
| 125024562 | 12502456 | 5 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 30 MG, UNK | U | U | 20031 | 30 | MG | TABLET | |||||
| 125024562 | 12502456 | 6 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, UNK | U | U | 20031 | 20 | MG | TABLET | |||||
| 125024562 | 12502456 | 7 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 20031 | TABLET | |||||||
| 125024562 | 12502456 | 8 | C | CIPRAMIL /00582602/ | CITALOPRAM HYDROBROMIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125024562 | 12502456 | 9 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125024562 | 12502456 | 10 | C | TRIMIPRAMINE | TRIMIPRAMINE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125024562 | 12502456 | 11 | C | TRIMIPRAMINE | TRIMIPRAMINE | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125024562 | 12502456 | 1 | Product used for unknown indication |
| 125024562 | 12502456 | 2 | Product used for unknown indication |
| 125024562 | 12502456 | 4 | Depression |
| 125024562 | 12502456 | 8 | Product used for unknown indication |
| 125024562 | 12502456 | 9 | Product used for unknown indication |
| 125024562 | 12502456 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125024562 | 12502456 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125024562 | 12502456 | Aggression | |
| 125024562 | 12502456 | Agitation | |
| 125024562 | 12502456 | Anxiety | |
| 125024562 | 12502456 | Decreased appetite | |
| 125024562 | 12502456 | Depression | |
| 125024562 | 12502456 | Disturbance in attention | |
| 125024562 | 12502456 | Dizziness | |
| 125024562 | 12502456 | Drug withdrawal syndrome | |
| 125024562 | 12502456 | Fatigue | |
| 125024562 | 12502456 | Feeling abnormal | |
| 125024562 | 12502456 | Headache | |
| 125024562 | 12502456 | Hyperhidrosis | |
| 125024562 | 12502456 | Influenza | |
| 125024562 | 12502456 | Insomnia | |
| 125024562 | 12502456 | Lethargy | |
| 125024562 | 12502456 | Memory impairment | |
| 125024562 | 12502456 | Mood swings | |
| 125024562 | 12502456 | Nausea | |
| 125024562 | 12502456 | Obsessive-compulsive disorder | |
| 125024562 | 12502456 | Paraesthesia | |
| 125024562 | 12502456 | Photophobia | |
| 125024562 | 12502456 | Pyrexia | |
| 125024562 | 12502456 | Rash | |
| 125024562 | 12502456 | Scar | |
| 125024562 | 12502456 | Seizure | |
| 125024562 | 12502456 | Somnolence | |
| 125024562 | 12502456 | Suicidal behaviour | |
| 125024562 | 12502456 | Tearfulness | |
| 125024562 | 12502456 | Tremor | |
| 125024562 | 12502456 | Vertigo | |
| 125024562 | 12502456 | 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 |
|---|---|---|---|---|---|---|
| 125024562 | 12502456 | 3 | 20040612 | 0 | ||
| 125024562 | 12502456 | 4 | 19980513 | 0 | ||
| 125024562 | 12502456 | 5 | 19990222 | 0 | ||
| 125024562 | 12502456 | 6 | 20020115 | 0 | ||
| 125024562 | 12502456 | 7 | 20040612 | 20040921 | 0 | |
| 125024562 | 12502456 | 8 | 20041021 | 0 | ||
| 125024562 | 12502456 | 9 | 20041116 | 0 | ||
| 125024562 | 12502456 | 10 | 19981030 | 0 | ||
| 125024562 | 12502456 | 11 | 19981221 | 0 |