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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125036572 | 12503657 | 2 | F | 20160604 | 20160830 | 20160628 | 20160907 | EXP | DE-MYLANLABS-2016M1025910 | MYLAN | 0.00 | Y | 0.00000 | 20160907 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125036572 | 12503657 | 1 | PS | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | DAILY DOSE: 40 MG MILLGRAM(S) EVERY DAYS | Y | U | 90868 | 40 | MG | QD | |||||
| 125036572 | 12503657 | 2 | C | SALBUTAMOL | ALBUTEROL | 1 | Respiratory (inhalation) | UNK | U | 0 | |||||||||
| 125036572 | 12503657 | 3 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | DAILY DOSE: 18 ?G MICROGRAM(S) EVERY DAYS | U | 0 | 18 | UG | QD | ||||||
| 125036572 | 12503657 | 4 | C | BUDIAIR | BUDESONIDE | 1 | Respiratory (inhalation) | DAILY DOSE: 400 ?G MICROGRAM(S) EVERY DAYS | U | 0 | 200 | UG | BID | ||||||
| 125036572 | 12503657 | 5 | C | FORMOTEROL | FORMOTEROL | 1 | Respiratory (inhalation) | DAILY DOSE: 2 DF DOSAGE FORM EVERY DAYS | U | 0 | 1 | DF | BID | ||||||
| 125036572 | 12503657 | 6 | C | TORASEMID | TORSEMIDE | 1 | Oral | DAILY DOSE: 10 MG MILLGRAM(S) EVERY DAYS | U | 0 | 10 | MG | QD | ||||||
| 125036572 | 12503657 | 7 | C | RAMIPRIL. | RAMIPRIL | 1 | Oral | DAILY DOSE: 5 MG MILLGRAM(S) EVERY DAYS | U | 0 | 5 | MG | QD | ||||||
| 125036572 | 12503657 | 8 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Oral | DAILY DOSE: 100 MG MILLGRAM(S) EVERY DAYS | U | 0 | 100 | MG | QD | ||||||
| 125036572 | 12503657 | 9 | C | ASPIRIN. | ASPIRIN | 1 | Oral | DAILY DOSE: 100 MG MILLGRAM(S) EVERY DAYS | U | 0 | 100 | MG | QD | ||||||
| 125036572 | 12503657 | 10 | C | METOPROLOL. | METOPROLOL | 1 | Oral | DAILY DOSE: 142.5 MG MILLGRAM(S) EVERY DAYS | U | 0 | 142.5 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125036572 | 12503657 | 1 | Hyperlipidaemia |
| 125036572 | 12503657 | 2 | Chronic obstructive pulmonary disease |
| 125036572 | 12503657 | 3 | Chronic obstructive pulmonary disease |
| 125036572 | 12503657 | 4 | Chronic obstructive pulmonary disease |
| 125036572 | 12503657 | 5 | Chronic obstructive pulmonary disease |
| 125036572 | 12503657 | 6 | Cardiac failure |
| 125036572 | 12503657 | 7 | Hypertension |
| 125036572 | 12503657 | 8 | Hyperuricaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125036572 | 12503657 | LT |
| 125036572 | 12503657 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125036572 | 12503657 | Acute kidney injury | |
| 125036572 | 12503657 | Rhabdomyolysis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |