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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978642 | 12497864 | 2 | F | 199907 | 20160629 | 20160625 | 20160704 | EXP | GB-APOTEX-2016AP009444 | APOTEX | 0.00 | Y | 0.00000 | 20160704 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978642 | 12497864 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Unknown | UNK | U | U | 20031 | TABLET | |||||||
| 124978642 | 12497864 | 2 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, QD | U | U | 0 | 20 | MG | TABLET | QD | ||||
| 124978642 | 12497864 | 3 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ORAL SUSPENSION | |||||||
| 124978642 | 12497864 | 4 | SS | Paroxetine Oral solution | PAROXETINE | 1 | Unknown | 10 MG/ML, QD | U | U | 0 | 10 | DF | ORAL SOLUTION | QD | ||||
| 124978642 | 12497864 | 5 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 124978642 | 12497864 | 6 | C | Cipramil | CITALOPRAM HYDROBROMIDE | 1 | U | 0 | |||||||||||
| 124978642 | 12497864 | 7 | C | DIAZEPAM. | DIAZEPAM | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124978642 | 12497864 | 1 | Product used for unknown indication |
| 124978642 | 12497864 | 2 | Product used for unknown indication |
| 124978642 | 12497864 | 3 | Product used for unknown indication |
| 124978642 | 12497864 | 4 | Product used for unknown indication |
| 124978642 | 12497864 | 5 | Product used for unknown indication |
| 124978642 | 12497864 | 6 | Product used for unknown indication |
| 124978642 | 12497864 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124978642 | 12497864 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124978642 | 12497864 | Abnormal dreams | |
| 124978642 | 12497864 | Affect lability | |
| 124978642 | 12497864 | Affective disorder | |
| 124978642 | 12497864 | Aggression | |
| 124978642 | 12497864 | Anger | |
| 124978642 | 12497864 | Antisocial personality disorder | |
| 124978642 | 12497864 | Anxiety | |
| 124978642 | 12497864 | Apathy | |
| 124978642 | 12497864 | Arthralgia | |
| 124978642 | 12497864 | Asthenia | |
| 124978642 | 12497864 | Chills | |
| 124978642 | 12497864 | Clumsiness | |
| 124978642 | 12497864 | Cognitive disorder | |
| 124978642 | 12497864 | Confusional state | |
| 124978642 | 12497864 | Contusion | |
| 124978642 | 12497864 | Decreased appetite | |
| 124978642 | 12497864 | Dependence | |
| 124978642 | 12497864 | Depressed level of consciousness | |
| 124978642 | 12497864 | Depression | |
| 124978642 | 12497864 | Disturbance in attention | |
| 124978642 | 12497864 | Dizziness | |
| 124978642 | 12497864 | Dyskinesia | |
| 124978642 | 12497864 | Emotional distress | |
| 124978642 | 12497864 | Epistaxis | |
| 124978642 | 12497864 | Extrapyramidal disorder | |
| 124978642 | 12497864 | Feeling abnormal | |
| 124978642 | 12497864 | Feeling drunk | |
| 124978642 | 12497864 | Feeling of despair | |
| 124978642 | 12497864 | Headache | |
| 124978642 | 12497864 | Hypervigilance | |
| 124978642 | 12497864 | Hypoaesthesia oral | |
| 124978642 | 12497864 | Influenza like illness | |
| 124978642 | 12497864 | Irritability | |
| 124978642 | 12497864 | Lethargy | |
| 124978642 | 12497864 | Malaise | |
| 124978642 | 12497864 | Mental impairment | |
| 124978642 | 12497864 | Muscle spasms | |
| 124978642 | 12497864 | Muscle twitching | |
| 124978642 | 12497864 | Nausea | |
| 124978642 | 12497864 | Nightmare | |
| 124978642 | 12497864 | Pain in extremity | |
| 124978642 | 12497864 | Panic reaction | |
| 124978642 | 12497864 | Paraesthesia | |
| 124978642 | 12497864 | Pyrexia | |
| 124978642 | 12497864 | Regurgitation | |
| 124978642 | 12497864 | Restless legs syndrome | |
| 124978642 | 12497864 | Restlessness | |
| 124978642 | 12497864 | Seizure | |
| 124978642 | 12497864 | Sleep disorder | |
| 124978642 | 12497864 | Suicidal ideation | |
| 124978642 | 12497864 | Thinking abnormal | |
| 124978642 | 12497864 | Tremor | |
| 124978642 | 12497864 | Urinary retention | |
| 124978642 | 12497864 | Vision blurred | |
| 124978642 | 12497864 | Visual impairment | |
| 124978642 | 12497864 | Vomiting | |
| 124978642 | 12497864 | Weight decreased | |
| 124978642 | 12497864 | Weight increased | |
| 124978642 | 12497864 | 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 |
|---|---|---|---|---|---|---|
| 124978642 | 12497864 | 1 | 19971117 | 20060725 | 0 | |
| 124978642 | 12497864 | 2 | 19971117 | 20051029 | 0 | |
| 124978642 | 12497864 | 3 | 200008 | 200305 | 0 | |
| 124978642 | 12497864 | 4 | 20021118 | 20040425 | 0 | |
| 124978642 | 12497864 | 5 | 20021014 | 0 | ||
| 124978642 | 12497864 | 6 | 20030811 | 0 | ||
| 124978642 | 12497864 | 7 | 20030811 | 0 |