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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126419931 | 12641993 | 1 | I | 20160427 | 20160802 | 20160810 | 20160810 | EXP | FR-MYLANLABS-2016M1033015 | MYLAN | 0.00 | Y | 0.00000 | 20160810 | OT | FR | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126419931 | 12641993 | 1 | SS | NEFOPAM MYLAN | NEFOPAM | 1 | 20 MG, TID | U | U | 0 | 20 | MG | TID | ||||||
| 126419931 | 12641993 | 2 | PS | ALPRAZOLAM MYLAN 0,25 MG | ALPRAZOLAM | 1 | Oral | 0.5 DF, TID | U | U | 74215 | .5 | DF | TABLET | TID | ||||
| 126419931 | 12641993 | 3 | SS | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 1 DF, QID | U | U | 0 | 1 | DF | QID | |||||
| 126419931 | 12641993 | 4 | SS | TRAMADOL. | TRAMADOL | 1 | Oral | 50 MG, QD | U | U | 0 | 50 | MG | QD | |||||
| 126419931 | 12641993 | 5 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 1 G, UNK | Y | 0 | 1 | G | |||||||
| 126419931 | 12641993 | 6 | SS | CORTANCYL | PREDNISONE | 1 | Oral | 1 DF, QD | U | U | 0 | 1 | DF | TABLET | QD | ||||
| 126419931 | 12641993 | 7 | SS | HYDROCORTISONE ROUSSEL /00028601/ | HYDROCORTISONE | 1 | Oral | 15 MG, QD | U | U | 0 | 15 | MG | QD | |||||
| 126419931 | 12641993 | 8 | SS | OROCAL D3 | CALCIUM CARBONATECHOLECALCIFEROL | 1 | Oral | 1 DF, BID | U | U | 0 | 1 | DF | CHEWABLE TABLET | BID | ||||
| 126419931 | 12641993 | 9 | SS | ACTONEL | RISEDRONATE SODIUM | 1 | Oral | 1 DF, QW | U | U | 0 | 1 | DF | FILM-COATED TABLET | /wk | ||||
| 126419931 | 12641993 | 10 | SS | DIFFU K | POTASSIUM CHLORIDE | 1 | Oral | 600 MG, QD | U | U | 0 | 600 | MG | QD | |||||
| 126419931 | 12641993 | 11 | SS | ZAMUDOL | TRAMADOL HYDROCHLORIDE | 1 | Oral | 1 DF, BID | U | U | 0 | 1 | DF | BID | |||||
| 126419931 | 12641993 | 12 | SS | ADCIRCA | TADALAFIL | 1 | Oral | 1 DF, BID | 12 | DF | Y | U | 0 | 1 | DF | FILM-COATED TABLET | BID | ||
| 126419931 | 12641993 | 13 | SS | IMOVANE | ZOPICLONE | 1 | Oral | 1 DF, QD | U | U | 0 | 1 | DF | FILM-COATED TABLET | QD | ||||
| 126419931 | 12641993 | 14 | SS | COUMADINE | WARFARIN SODIUM | 1 | Oral | 8 MG, QD | U | U | 0 | 8 | MG | TABLET | QD | ||||
| 126419931 | 12641993 | 15 | SS | INNOHEP | TINZAPARIN SODIUM | 1 | Subcutaneous | 1 DF, QD | U | U | 0 | 1 | DF | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126419931 | 12641993 | 1 | Product used for unknown indication |
| 126419931 | 12641993 | 2 | Product used for unknown indication |
| 126419931 | 12641993 | 3 | Product used for unknown indication |
| 126419931 | 12641993 | 4 | Product used for unknown indication |
| 126419931 | 12641993 | 5 | Product used for unknown indication |
| 126419931 | 12641993 | 6 | Product used for unknown indication |
| 126419931 | 12641993 | 7 | Product used for unknown indication |
| 126419931 | 12641993 | 8 | Product used for unknown indication |
| 126419931 | 12641993 | 9 | Product used for unknown indication |
| 126419931 | 12641993 | 10 | Product used for unknown indication |
| 126419931 | 12641993 | 11 | Product used for unknown indication |
| 126419931 | 12641993 | 12 | Product used for unknown indication |
| 126419931 | 12641993 | 13 | Product used for unknown indication |
| 126419931 | 12641993 | 14 | Product used for unknown indication |
| 126419931 | 12641993 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126419931 | 12641993 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126419931 | 12641993 | Hypotension | |
| 126419931 | 12641993 | Rash macular | |
| 126419931 | 12641993 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 126419931 | 12641993 | 1 | 20160418 | 0 | ||
| 126419931 | 12641993 | 2 | 20160423 | 0 | ||
| 126419931 | 12641993 | 3 | 20160317 | 0 | ||
| 126419931 | 12641993 | 4 | 20160419 | 0 | ||
| 126419931 | 12641993 | 5 | 20160427 | 20160427 | 0 | |
| 126419931 | 12641993 | 6 | 20160317 | 0 | ||
| 126419931 | 12641993 | 7 | 20160317 | 0 | ||
| 126419931 | 12641993 | 8 | 20160316 | 0 | ||
| 126419931 | 12641993 | 9 | 20160316 | 0 | ||
| 126419931 | 12641993 | 10 | 20160317 | 0 | ||
| 126419931 | 12641993 | 11 | 20160425 | 0 | ||
| 126419931 | 12641993 | 12 | 20160422 | 20160427 | 0 | |
| 126419931 | 12641993 | 13 | 20160422 | 0 | ||
| 126419931 | 12641993 | 14 | 20160316 | 0 | ||
| 126419931 | 12641993 | 15 | 20160318 | 0 |