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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126241722 | 12624172 | 2 | F | 201409 | 20160804 | 20160805 | 20160813 | PER | US-ASTRAZENECA-2016SE71201 | ASTRAZENECA | 53.00 | YR | F | Y | 88.50000 | KG | 20160813 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126241722 | 12624172 | 1 | PS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG, 2 PUFFS TWICE A DAY | 21929 | ||||||||||
| 126241722 | 12624172 | 2 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG, 2 PUFFS TWICE A DAY | 3001181C00 | 21929 | |||||||||
| 126241722 | 12624172 | 3 | SS | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | 20 | MG | BID | ||||||||
| 126241722 | 12624172 | 4 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 2, DAILY | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126241722 | 12624172 | 1 | Chronic obstructive pulmonary disease |
| 126241722 | 12624172 | 2 | Chronic obstructive pulmonary disease |
| 126241722 | 12624172 | 3 | Gastrooesophageal reflux disease |
| 126241722 | 12624172 | 4 | Chronic obstructive pulmonary disease |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126241722 | 12624172 | Eye pruritus | |
| 126241722 | 12624172 | Lacrimation increased | |
| 126241722 | 12624172 | Off label use | |
| 126241722 | 12624172 | Product quality issue | |
| 126241722 | 12624172 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 126241722 | 12624172 | 1 | 201409 | 0 | ||
| 126241722 | 12624172 | 2 | 20160609 | 0 | ||
| 126241722 | 12624172 | 4 | 201409 | 0 |