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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124295052 | 12429505 | 2 | F | 201602 | 20160523 | 20160602 | 20160812 | PER | US-ASTRAZENECA-2016SE56239 | ASTRAZENECA | 823.00 | MON | F | Y | 59.00000 | KG | 20160812 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124295052 | 12429505 | 1 | PS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5, 2 PUFFS TWICE DAILY | N | U | 21929 | ||||||||
| 124295052 | 12429505 | 2 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5, 2 PUFFS TWICE DAILY | N | U | 21929 | ||||||||
| 124295052 | 12429505 | 3 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5, 2 PUFFS TWICE DAILY | N | U | 21929 | ||||||||
| 124295052 | 12429505 | 4 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5, 2 PUFFS TWICE DAILY | N | U | 21929 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124295052 | 12429505 | 1 | Dyspnoea |
| 124295052 | 12429505 | 2 | Lung disorder |
| 124295052 | 12429505 | 3 | Dyspnoea |
| 124295052 | 12429505 | 4 | Lung disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124295052 | 12429505 | Dry mouth | |
| 124295052 | 12429505 | Intentional product misuse | |
| 124295052 | 12429505 | Lip swelling | |
| 124295052 | 12429505 | Off label use | |
| 124295052 | 12429505 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 124295052 | 12429505 | 1 | 20160224 | 201603 | 0 | |
| 124295052 | 12429505 | 2 | 20160224 | 201603 | 0 | |
| 124295052 | 12429505 | 3 | 201605 | 0 | ||
| 124295052 | 12429505 | 4 | 201605 | 0 |