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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124979012 | 12497901 | 2 | F | 200307 | 20160715 | 20160625 | 20160727 | EXP | GB-APOTEX-2016AP009449 | APOTEX | 0.00 | F | Y | 0.00000 | 20160727 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124979012 | 12497901 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Unknown | 20 MG, QD | U | U | 20031 | 20 | MG | TABLET | QD | ||||
| 124979012 | 12497901 | 2 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | TABLET | |||||||
| 124979012 | 12497901 | 3 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, QD | U | U | 0 | 20 | MG | TABLET | QD | ||||
| 124979012 | 12497901 | 4 | SS | Paroxetine Oral solution | PAROXETINE | 1 | Unknown | 10MG/5ML | U | U | 0 | ORAL SOLUTION | |||||||
| 124979012 | 12497901 | 5 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | UNK | U | 0 | |||||||||
| 124979012 | 12497901 | 6 | C | LUSTRAL | SERTRALINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 124979012 | 12497901 | 7 | C | DULOXETINE. | DULOXETINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 124979012 | 12497901 | 8 | C | HRT | UNSPECIFIED INGREDIENT | 1 | UNK | U | 0 | ||||||||||
| 124979012 | 12497901 | 9 | C | NICOTINE. | NICOTINE | 1 | UNK | U | 0 | ||||||||||
| 124979012 | 12497901 | 10 | C | TESTOSTERONE. | TESTOSTERONE | 1 | UNK | U | 0 | ||||||||||
| 124979012 | 12497901 | 11 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 124979012 | 12497901 | 12 | C | REBOXETINE | REBOXETINE | 1 | UNK | U | 0 | ||||||||||
| 124979012 | 12497901 | 13 | C | SIMVASTATIN. | SIMVASTATIN | 1 | UNK | U | 0 | ||||||||||
| 124979012 | 12497901 | 14 | C | DOMPERIDONE | DOMPERIDONE | 1 | UNK | U | 0 | ||||||||||
| 124979012 | 12497901 | 15 | C | ESOMEPRAZOLE | ESOMEPRAZOLE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124979012 | 12497901 | 1 | Product used for unknown indication |
| 124979012 | 12497901 | 2 | Product used for unknown indication |
| 124979012 | 12497901 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124979012 | 12497901 | OT |
| 124979012 | 12497901 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124979012 | 12497901 | Abnormal behaviour | |
| 124979012 | 12497901 | Aggression | |
| 124979012 | 12497901 | Anger | |
| 124979012 | 12497901 | Anxiety | |
| 124979012 | 12497901 | Depressed mood | |
| 124979012 | 12497901 | Depression | |
| 124979012 | 12497901 | Dizziness | |
| 124979012 | 12497901 | Fatigue | |
| 124979012 | 12497901 | Feelings of worthlessness | |
| 124979012 | 12497901 | Gastrooesophageal reflux disease | |
| 124979012 | 12497901 | Insomnia | |
| 124979012 | 12497901 | Irritability | |
| 124979012 | 12497901 | Loss of libido | |
| 124979012 | 12497901 | Nervousness | |
| 124979012 | 12497901 | Self-injurious ideation | |
| 124979012 | 12497901 | Suicidal ideation | |
| 124979012 | 12497901 | Tension headache | |
| 124979012 | 12497901 | 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 |
|---|---|---|---|---|---|---|
| 124979012 | 12497901 | 1 | 20000411 | 20041207 | 0 | |
| 124979012 | 12497901 | 2 | 19980526 | 0 | ||
| 124979012 | 12497901 | 3 | 19990208 | 20000411 | 0 | |
| 124979012 | 12497901 | 4 | 20001110 | 0 | ||
| 124979012 | 12497901 | 5 | 20000919 | 0 | ||
| 124979012 | 12497901 | 6 | 20010411 | 0 | ||
| 124979012 | 12497901 | 10 | 20000510 | 200011 | 0 | |
| 124979012 | 12497901 | 12 | 20020524 | 0 | ||
| 124979012 | 12497901 | 13 | 200603 | 0 | ||
| 124979012 | 12497901 | 14 | 200609 | 0 | ||
| 124979012 | 12497901 | 15 | 200609 | 0 |