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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978663 | 12497866 | 3 | F | 20011201 | 20160712 | 20160625 | 20160722 | EXP | GB-APOTEX-2016AP009312 | APOTEX | 30.00 | YR | M | Y | 0.00000 | 20160722 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978663 | 12497866 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Unknown | UNK | U | U | 20031 | TABLET | |||||||
| 124978663 | 12497866 | 2 | SS | PAROXETINE. | PAROXETINE | 1 | U | U | 20031 | TABLET | |||||||||
| 124978663 | 12497866 | 3 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 20 MG, QD | U | U | 20031 | 20 | MG | TABLET | QD | ||||
| 124978663 | 12497866 | 4 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, U | U | U | 0 | 20 | MG | ||||||
| 124978663 | 12497866 | 5 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | U | U | 0 | ||||||||||
| 124978663 | 12497866 | 6 | C | CIPRAMIL | CITALOPRAM HYDROBROMIDE | 1 | UNK | U | U | 0 | |||||||||
| 124978663 | 12497866 | 7 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 124978663 | 12497866 | 8 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | UNK | U | 0 | ||||||||||
| 124978663 | 12497866 | 9 | C | LUSTRAL | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 124978663 | 12497866 | 10 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124978663 | 12497866 | 1 | Anxiety |
| 124978663 | 12497866 | 2 | Depression |
| 124978663 | 12497866 | 4 | Depression |
| 124978663 | 12497866 | 5 | Anxiety |
| 124978663 | 12497866 | 6 | Product used for unknown indication |
| 124978663 | 12497866 | 7 | Product used for unknown indication |
| 124978663 | 12497866 | 8 | Product used for unknown indication |
| 124978663 | 12497866 | 9 | Product used for unknown indication |
| 124978663 | 12497866 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124978663 | 12497866 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124978663 | 12497866 | Abnormal behaviour | |
| 124978663 | 12497866 | Aggression | |
| 124978663 | 12497866 | Agitation | |
| 124978663 | 12497866 | Anxiety | |
| 124978663 | 12497866 | Arthralgia | |
| 124978663 | 12497866 | Decreased appetite | |
| 124978663 | 12497866 | Depression | |
| 124978663 | 12497866 | Derealisation | |
| 124978663 | 12497866 | Diarrhoea | |
| 124978663 | 12497866 | Disorientation | |
| 124978663 | 12497866 | Dizziness exertional | |
| 124978663 | 12497866 | Dysphoria | |
| 124978663 | 12497866 | Emotional disorder | |
| 124978663 | 12497866 | Feeling drunk | |
| 124978663 | 12497866 | Gingival pain | |
| 124978663 | 12497866 | Headache | |
| 124978663 | 12497866 | Hyperhidrosis | |
| 124978663 | 12497866 | Hypoaesthesia | |
| 124978663 | 12497866 | Influenza like illness | |
| 124978663 | 12497866 | Insomnia | |
| 124978663 | 12497866 | Irritability | |
| 124978663 | 12497866 | Lethargy | |
| 124978663 | 12497866 | Libido decreased | |
| 124978663 | 12497866 | Mania | |
| 124978663 | 12497866 | Nausea | |
| 124978663 | 12497866 | Pain in extremity | |
| 124978663 | 12497866 | Palpitations | |
| 124978663 | 12497866 | Paraesthesia | |
| 124978663 | 12497866 | Paranoia | |
| 124978663 | 12497866 | Rash | |
| 124978663 | 12497866 | Restless legs syndrome | |
| 124978663 | 12497866 | Serotonin syndrome | |
| 124978663 | 12497866 | Suicidal ideation | |
| 124978663 | 12497866 | Tardive dyskinesia | |
| 124978663 | 12497866 | Thirst | |
| 124978663 | 12497866 | Tinnitus | |
| 124978663 | 12497866 | Tremor | |
| 124978663 | 12497866 | Visual impairment | |
| 124978663 | 12497866 | Weight decreased | |
| 124978663 | 12497866 | 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 |
|---|---|---|---|---|---|---|
| 124978663 | 12497866 | 1 | 19991206 | 0 | ||
| 124978663 | 12497866 | 3 | 20000131 | 20011129 | 0 | |
| 124978663 | 12497866 | 4 | 20031103 | 0 | ||
| 124978663 | 12497866 | 6 | 20020221 | 0 | ||
| 124978663 | 12497866 | 7 | 20020314 | 0 | ||
| 124978663 | 12497866 | 8 | 20020909 | 0 | ||
| 124978663 | 12497866 | 9 | 20030804 | 0 | ||
| 124978663 | 12497866 | 10 | 20030905 | 0 |