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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125848802 | 12584880 | 2 | F | 2008 | 20160713 | 20160722 | 20160728 | EXP | JP-SUNOVION-2016SUN001778 | SUNOVION | 60.00 | YR | F | Y | 0.00000 | 20160728 | CN | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125848802 | 12584880 | 1 | PS | OMNARIS | CICLESONIDE | 1 | Nasal | INTERMITTENTLY | 22004 | NASAL SPRAY | |||||||||
| 125848802 | 12584880 | 2 | SS | Codeine | CODEINE | 1 | Unknown | UNK | Y | 0 | |||||||||
| 125848802 | 12584880 | 3 | SS | KEFLEX | CEPHALEXIN | 1 | Unknown | UNK | Y | 0 | |||||||||
| 125848802 | 12584880 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Unknown | UNK | Y | 0 | |||||||||
| 125848802 | 12584880 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | UNK | Y | 0 | |||||||||
| 125848802 | 12584880 | 6 | C | BUDESONIDE. | BUDESONIDE | 1 | UNK | 0 | |||||||||||
| 125848802 | 12584880 | 7 | C | Salofalk | MESALAMINE | 1 | UNK | 0 | |||||||||||
| 125848802 | 12584880 | 8 | C | Warfarin | WARFARIN | 1 | 4 MG, QD | 0 | 4 | MG | QD | ||||||||
| 125848802 | 12584880 | 9 | C | TELMISARTAN. | TELMISARTAN | 1 | 80 MG, QD | 0 | 80 | MG | QD | ||||||||
| 125848802 | 12584880 | 10 | C | ESTRADIOL. | ESTRADIOL | 1 | Transdermal | UNK, 1/WEEK | 0 | ||||||||||
| 125848802 | 12584880 | 11 | C | PROMETRIUM | PROGESTERONE | 1 | 100 MG, QD | 0 | 100 | MG | QD | ||||||||
| 125848802 | 12584880 | 12 | C | FOLIC ACID. | FOLIC ACID | 1 | 5 MG, QD | 0 | 5 | MG | QD | ||||||||
| 125848802 | 12584880 | 13 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | UNK UNK, Q4WEEKS | 0 | INJECTION | ||||||||||
| 125848802 | 12584880 | 14 | C | Proctol | 2 | UNK | 0 | OINTMENT | |||||||||||
| 125848802 | 12584880 | 15 | C | PREDNISONE. | PREDNISONE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125848802 | 12584880 | 1 | Sinusitis |
| 125848802 | 12584880 | 2 | Product used for unknown indication |
| 125848802 | 12584880 | 3 | Product used for unknown indication |
| 125848802 | 12584880 | 4 | Product used for unknown indication |
| 125848802 | 12584880 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125848802 | 12584880 | HO |
| 125848802 | 12584880 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125848802 | 12584880 | Abscess intestinal | |
| 125848802 | 12584880 | Chills | |
| 125848802 | 12584880 | Chronic sinusitis | |
| 125848802 | 12584880 | Crohn's disease | |
| 125848802 | 12584880 | Dyspnoea | |
| 125848802 | 12584880 | Heart rate increased | |
| 125848802 | 12584880 | Hypertensive crisis | |
| 125848802 | 12584880 | Lethargy | |
| 125848802 | 12584880 | Migraine | |
| 125848802 | 12584880 | Multiple sclerosis | |
| 125848802 | 12584880 | Neurological symptom | |
| 125848802 | 12584880 | Off label use | |
| 125848802 | 12584880 | Product use issue | |
| 125848802 | 12584880 | Rash | |
| 125848802 | 12584880 | Subclavian vein thrombosis | |
| 125848802 | 12584880 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125848802 | 12584880 | 1 | 2008 | 0 | ||
| 125848802 | 12584880 | 2 | 2010 | 2010 | 0 | |
| 125848802 | 12584880 | 3 | 2008 | 2008 | 0 | |
| 125848802 | 12584880 | 4 | 2003 | 2013 | 0 | |
| 125848802 | 12584880 | 5 | 2003 | 2013 | 0 | |
| 125848802 | 12584880 | 6 | 201407 | 0 | ||
| 125848802 | 12584880 | 7 | 201407 | 0 | ||
| 125848802 | 12584880 | 15 | 2014 | 0 |