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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125784501 | 12578450 | 1 | I | 20160531 | 20160711 | 20160721 | 20160721 | EXP | FR-AFSSAPS-CF20160298 | FR-APOTEX-2016AP009837 | APOTEX | 41.00 | YR | F | Y | 0.00000 | 20160721 | CN | GB | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125784501 | 12578450 | 1 | PS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | 20 MG, BID | U | 20031 | 20 | MG | TABLET | BID | |||||
| 125784501 | 12578450 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | UNK | Y | U | 0 | ||||||||
| 125784501 | 12578450 | 3 | SS | TILDIEM | DILTIAZEM HYDROCHLORIDE | 1 | Oral | 60 MG, QID | U | 0 | 60 | MG | QID | ||||||
| 125784501 | 12578450 | 4 | SS | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | Oral | 1 DF, TID | 0 | 1 | DF | TID | |||||||
| 125784501 | 12578450 | 5 | SS | ESOMEPRAZOLE | ESOMEPRAZOLE | 1 | Oral | UNK | U | 0 | |||||||||
| 125784501 | 12578450 | 6 | C | LAROXYL | AMITRIPTYLINE | 1 | Oral | UNK | 0 | ||||||||||
| 125784501 | 12578450 | 7 | C | FOLIC ACID. | FOLIC ACID | 1 | 5 MG, TID | 0 | 5 | MG | TID | ||||||||
| 125784501 | 12578450 | 8 | C | NICORETTE | NICOTINE | 1 | 0 | ||||||||||||
| 125784501 | 12578450 | 9 | C | NICOPATCH | NICOTINE | 1 | Transdermal | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125784501 | 12578450 | 1 | Product used for unknown indication |
| 125784501 | 12578450 | 2 | Product used for unknown indication |
| 125784501 | 12578450 | 3 | Product used for unknown indication |
| 125784501 | 12578450 | 4 | Product used for unknown indication |
| 125784501 | 12578450 | 5 | Product used for unknown indication |
| 125784501 | 12578450 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125784501 | 12578450 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125784501 | 12578450 | Dyspnoea | |
| 125784501 | 12578450 | Incorrect dose administered | |
| 125784501 | 12578450 | Oedema peripheral | |
| 125784501 | 12578450 | Sinus tachycardia |
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 |
|---|---|---|---|---|---|---|
| 125784501 | 12578450 | 2 | 20160531 | 20160617 | 0 |