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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127903231 | 12790323 | 1 | I | 20160913 | 20160928 | 20160928 | PER | US-ASTRAZENECA-2016SE98260 | ASTRAZENECA | 0.00 | M | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127903231 | 12790323 | 1 | PS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG 2 PUFFS TWICE PER DAY | U | 21929 | |||||||||
| 127903231 | 12790323 | 2 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG 2 PUFFS TWICE PER DAY | U | 21929 | |||||||||
| 127903231 | 12790323 | 3 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG JUST 2 PUFFS IN THE MORNING | U | 21929 | |||||||||
| 127903231 | 12790323 | 4 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG JUST 2 PUFFS IN THE MORNING | U | 21929 | |||||||||
| 127903231 | 12790323 | 5 | SS | PULMICORT FLEXHALER | BUDESONIDE | 1 | Respiratory (inhalation) | 90 MCG 2 PUFFS TWICE PER DAY | U | U | 0 | INHALATION POWDER | |||||||
| 127903231 | 12790323 | 6 | SS | PULMICORT FLEXHALER | BUDESONIDE | 1 | Respiratory (inhalation) | 90 MCG 2 PUFFS TWICE PER DAY | U | U | 0 | INHALATION POWDER | |||||||
| 127903231 | 12790323 | 7 | SS | PULMICORT FLEXHALER | BUDESONIDE | 1 | Respiratory (inhalation) | 90 MCG ONE PUFF TWICE PER DAY | U | U | 0 | INHALATION POWDER | |||||||
| 127903231 | 12790323 | 8 | SS | PULMICORT FLEXHALER | BUDESONIDE | 1 | Respiratory (inhalation) | 90 MCG ONE PUFF TWICE PER DAY | U | U | 0 | INHALATION POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127903231 | 12790323 | 1 | Dyspnoea |
| 127903231 | 12790323 | 2 | Pneumonitis |
| 127903231 | 12790323 | 3 | Dyspnoea |
| 127903231 | 12790323 | 4 | Pneumonitis |
| 127903231 | 12790323 | 5 | Dyspnoea |
| 127903231 | 12790323 | 6 | Pneumonitis |
| 127903231 | 12790323 | 7 | Dyspnoea |
| 127903231 | 12790323 | 8 | Pneumonitis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127903231 | 12790323 | Dyspnoea | |
| 127903231 | 12790323 | Heart rate increased | |
| 127903231 | 12790323 | Insomnia | |
| 127903231 | 12790323 | Pruritus generalised |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |