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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126945441 | 12694544 | 1 | I | 20160810 | 20160823 | 20160829 | 20160829 | PER | US-NEPHRON PHARMACEUTICALS CORPORATION-1056830 | NEPHRON | 69.00 | YR | F | Y | 45.46000 | KG | 20160829 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126945441 | 12694544 | 1 | PS | IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE | ALBUTEROL SULFATEIPRATROPIUM BROMIDE | 1 | Respiratory (inhalation) | Y | Y | 528141/NOV 2017, 628011/DEC 2017 | 76749 | 3 | ML | INHALATION VAPOUR, SOLUTION | |||||
| 126945441 | 12694544 | 2 | C | BREO ELLIPTA | FLUTICASONE FUROATEVILANTEROL TRIFENATATE | 1 | 0 | ||||||||||||
| 126945441 | 12694544 | 3 | C | RESTORIL | TEMAZEPAM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126945441 | 12694544 | 1 | Chronic obstructive pulmonary disease |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126945441 | 12694544 | Disorientation | |
| 126945441 | 12694544 | Dizziness | |
| 126945441 | 12694544 | Eye pain | |
| 126945441 | 12694544 | Heart rate increased | |
| 126945441 | 12694544 | Nausea |
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 |
|---|---|---|---|---|---|---|
| 126945441 | 12694544 | 1 | 20160810 | 0 |