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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125024792 | 12502479 | 2 | F | 2000 | 20160629 | 20160627 | 20160707 | EXP | GB-APOTEX-2016AP009479 | APOTEX | 0.00 | Y | 0.00000 | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125024792 | 12502479 | 1 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | 20 MG, QD | U | U | 0 | 20 | MG | TABLET | |||||
| 125024792 | 12502479 | 2 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, QD | U | U | 0 | 20 | MG | TABLET | |||||
| 125024792 | 12502479 | 3 | PS | PAROXETINE. | PAROXETINE | 1 | Unknown | 20 MG, QD | U | U | 20031 | 20 | MG | TABLET | |||||
| 125024792 | 12502479 | 4 | C | St Johns Wort | ST. JOHN'S WORT | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125024792 | 12502479 | 5 | C | METHYLPHENIDATE. | METHYLPHENIDATE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125024792 | 12502479 | 6 | C | DEXAMPHETAMINE | AMPHETAMINE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125024792 | 12502479 | 7 | C | ATOMOXETINE HYDROCHLORIDE. | ATOMOXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125024792 | 12502479 | 8 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Unknown | 10 MG | U | U | 0 | 10 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125024792 | 12502479 | 1 | Depression |
| 125024792 | 12502479 | 2 | Depression |
| 125024792 | 12502479 | 3 | Product used for unknown indication |
| 125024792 | 12502479 | 4 | Premenstrual syndrome |
| 125024792 | 12502479 | 5 | Attention deficit/hyperactivity disorder |
| 125024792 | 12502479 | 6 | Attention deficit/hyperactivity disorder |
| 125024792 | 12502479 | 7 | Attention deficit/hyperactivity disorder |
| 125024792 | 12502479 | 8 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125024792 | 12502479 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125024792 | 12502479 | Affective disorder | |
| 125024792 | 12502479 | Aggression | |
| 125024792 | 12502479 | Agitation | |
| 125024792 | 12502479 | Anger | |
| 125024792 | 12502479 | Depression | |
| 125024792 | 12502479 | Dizziness | |
| 125024792 | 12502479 | Emotional disorder | |
| 125024792 | 12502479 | Memory impairment | |
| 125024792 | 12502479 | Musculoskeletal pain | |
| 125024792 | 12502479 | Nausea | |
| 125024792 | 12502479 | Panic attack | |
| 125024792 | 12502479 | Paraesthesia | |
| 125024792 | 12502479 | Suicidal behaviour | |
| 125024792 | 12502479 | 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 |
|---|---|---|---|---|---|---|
| 125024792 | 12502479 | 1 | 20000202 | 0 | ||
| 125024792 | 12502479 | 2 | 20000519 | 0 | ||
| 125024792 | 12502479 | 3 | 20010315 | 0 | ||
| 125024792 | 12502479 | 4 | 200412 | 0 | ||
| 125024792 | 12502479 | 5 | 20061101 | 200611 | 0 | |
| 125024792 | 12502479 | 6 | 20061129 | 200704 | 0 | |
| 125024792 | 12502479 | 7 | 20070404 | 0 | ||
| 125024792 | 12502479 | 8 | 20080215 | 0 |