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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978784 | 12497878 | 4 | F | 200106 | 20160804 | 20160625 | 20160809 | EXP | GB-APOTEX-2016AP009383 | APOTEX | 0.00 | M | Y | 0.00000 | 20160809 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978784 | 12497878 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Unknown | 20 MG, QD | U | U | 20031 | 20 | MG | TABLET | QD | ||||
| 124978784 | 12497878 | 2 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 30 MG, QD | U | U | 20031 | 30 | MG | TABLET | QD | ||||
| 124978784 | 12497878 | 3 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978784 | 12497878 | 4 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 2 MG, QD | U | U | 0 | 2 | MG | ||||||
| 124978784 | 12497878 | 5 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 40 MG, QD | U | U | 0 | 40 | MG | ||||||
| 124978784 | 12497878 | 6 | C | CLOMIPRAMINE | CLOMIPRAMINE | 1 | UNK | U | 0 | ||||||||||
| 124978784 | 12497878 | 7 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 124978784 | 12497878 | 8 | C | CIPRALEX | ESCITALOPRAM OXALATE | 1 | UNK | U | 0 | ||||||||||
| 124978784 | 12497878 | 9 | C | Cipramil | CITALOPRAM HYDROBROMIDE | 1 | UNK | U | 0 | ||||||||||
| 124978784 | 12497878 | 10 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 124978784 | 12497878 | 11 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124978784 | 12497878 | 1 | Product used for unknown indication |
| 124978784 | 12497878 | 3 | Obsessive-compulsive disorder |
| 124978784 | 12497878 | 6 | Obsessive-compulsive disorder |
| 124978784 | 12497878 | 7 | Product used for unknown indication |
| 124978784 | 12497878 | 8 | Product used for unknown indication |
| 124978784 | 12497878 | 9 | Product used for unknown indication |
| 124978784 | 12497878 | 10 | Product used for unknown indication |
| 124978784 | 12497878 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124978784 | 12497878 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124978784 | 12497878 | Aggression | |
| 124978784 | 12497878 | Agitation | |
| 124978784 | 12497878 | Amnesia | |
| 124978784 | 12497878 | Anger | |
| 124978784 | 12497878 | Anxiety | |
| 124978784 | 12497878 | Confusional state | |
| 124978784 | 12497878 | Depersonalisation/derealisation disorder | |
| 124978784 | 12497878 | Disorientation | |
| 124978784 | 12497878 | Fatigue | |
| 124978784 | 12497878 | Hyperhidrosis | |
| 124978784 | 12497878 | Irritability | |
| 124978784 | 12497878 | Mood swings | |
| 124978784 | 12497878 | Obsessive-compulsive disorder | |
| 124978784 | 12497878 | Palpitations | |
| 124978784 | 12497878 | Panic attack | |
| 124978784 | 12497878 | Paraesthesia | |
| 124978784 | 12497878 | Phobia | |
| 124978784 | 12497878 | Self-injurious ideation | |
| 124978784 | 12497878 | 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 |
|---|---|---|---|---|---|---|
| 124978784 | 12497878 | 1 | 19970210 | 19970630 | 0 | |
| 124978784 | 12497878 | 2 | 20010305 | 0 | ||
| 124978784 | 12497878 | 3 | 19961211 | 200302 | 0 | |
| 124978784 | 12497878 | 5 | 2000 | 0 | ||
| 124978784 | 12497878 | 6 | 20031218 | 0 | ||
| 124978784 | 12497878 | 7 | 20030918 | 0 | ||
| 124978784 | 12497878 | 8 | 20030613 | 0 | ||
| 124978784 | 12497878 | 9 | 20020418 | 0 | ||
| 124978784 | 12497878 | 10 | 20020610 | 0 | ||
| 124978784 | 12497878 | 11 | 2004 | 0 |