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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109487314 | 10948731 | 4 | F | 20120502 | 20160630 | 20150324 | 20160708 | EXP | US-ASTRAZENECA-2012SE29145 | ASTRAZENECA | 22181.00 | DY | F | Y | 0.00000 | 20160709 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109487314 | 10948731 | 1 | PS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG 120 INHALATIONS, 2 PUFFS BID | U | U | 21929 | ||||||||
| 109487314 | 10948731 | 2 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG 120 INHALATIONS, 2 PUFFS BID | U | U | 21929 | ||||||||
| 109487314 | 10948731 | 3 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 1 PUFF, FREQUENCY UNKNOWN | U | U | 21929 | ||||||||
| 109487314 | 10948731 | 4 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 1 PUFF, FREQUENCY UNKNOWN | U | U | 21929 | ||||||||
| 109487314 | 10948731 | 5 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 2 PUFFS BID | U | U | 21929 | ||||||||
| 109487314 | 10948731 | 6 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 2 PUFFS BID | U | U | 21929 | ||||||||
| 109487314 | 10948731 | 7 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG 120 INHALATIONS, 2 PUFFS BID | U | U | 21929 | ||||||||
| 109487314 | 10948731 | 8 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG 120 INHALATIONS, 2 PUFFS BID | U | U | 21929 | ||||||||
| 109487314 | 10948731 | 9 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | U | U | 21929 | |||||||||
| 109487314 | 10948731 | 10 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | U | U | 21929 | |||||||||
| 109487314 | 10948731 | 11 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5MCG, 2 PUFFS TWICE DAILY | U | U | 21929 | ||||||||
| 109487314 | 10948731 | 12 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5MCG, 2 PUFFS TWICE DAILY | U | U | 21929 | ||||||||
| 109487314 | 10948731 | 13 | C | COMBIVENT | ALBUTEROL SULFATEIPRATROPIUM BROMIDE | 1 | 0 | ||||||||||||
| 109487314 | 10948731 | 14 | C | COMBIVENT | ALBUTEROL SULFATEIPRATROPIUM BROMIDE | 1 | 0 | ||||||||||||
| 109487314 | 10948731 | 15 | C | FLOVENT | FLUTICASONE PROPIONATE | 1 | 1 INHALATION AT NIGHT BEFORE BED | 0 | |||||||||||
| 109487314 | 10948731 | 16 | C | FLOVENT | FLUTICASONE PROPIONATE | 1 | 2 PUFFS TWICE DAILY | 0 | |||||||||||
| 109487314 | 10948731 | 17 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | 0 | ||||||||||||
| 109487314 | 10948731 | 18 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | 0 | ||||||||||||
| 109487314 | 10948731 | 19 | C | HERBAL NOS | HERBALS | 1 | 0 | ||||||||||||
| 109487314 | 10948731 | 20 | C | DOXYCYCLINE. | DOXYCYCLINE | 1 | Oral | 0 | 100 | MG | BID | ||||||||
| 109487314 | 10948731 | 21 | C | PREDNISONE. | PREDNISONE | 1 | 0 | ||||||||||||
| 109487314 | 10948731 | 22 | C | DULERA | FORMOTEROL FUMARATE DIHYDRATEMOMETASONE FUROATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109487314 | 10948731 | 1 | Asthma |
| 109487314 | 10948731 | 2 | Chronic obstructive pulmonary disease |
| 109487314 | 10948731 | 3 | Asthma |
| 109487314 | 10948731 | 4 | Chronic obstructive pulmonary disease |
| 109487314 | 10948731 | 5 | Asthma |
| 109487314 | 10948731 | 6 | Chronic obstructive pulmonary disease |
| 109487314 | 10948731 | 7 | Asthma |
| 109487314 | 10948731 | 8 | Chronic obstructive pulmonary disease |
| 109487314 | 10948731 | 9 | Asthma |
| 109487314 | 10948731 | 10 | Chronic obstructive pulmonary disease |
| 109487314 | 10948731 | 11 | Asthma |
| 109487314 | 10948731 | 12 | Chronic obstructive pulmonary disease |
| 109487314 | 10948731 | 13 | Asthma |
| 109487314 | 10948731 | 14 | Chronic obstructive pulmonary disease |
| 109487314 | 10948731 | 15 | Asthma |
| 109487314 | 10948731 | 16 | Asthma |
| 109487314 | 10948731 | 17 | Asthma |
| 109487314 | 10948731 | 18 | Chronic obstructive pulmonary disease |
| 109487314 | 10948731 | 20 | Pneumonia |
| 109487314 | 10948731 | 21 | Pneumonia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109487314 | 10948731 | OT |
| 109487314 | 10948731 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109487314 | 10948731 | Cataract | |
| 109487314 | 10948731 | Cough | |
| 109487314 | 10948731 | Drug dose omission | |
| 109487314 | 10948731 | Drug ineffective | |
| 109487314 | 10948731 | Dyspnoea | |
| 109487314 | 10948731 | Eye disorder | |
| 109487314 | 10948731 | Feeling abnormal | |
| 109487314 | 10948731 | Hot flush | |
| 109487314 | 10948731 | Intentional product misuse | |
| 109487314 | 10948731 | Lung disorder | |
| 109487314 | 10948731 | Malaise | |
| 109487314 | 10948731 | Osteoporosis | |
| 109487314 | 10948731 | Pneumonia | |
| 109487314 | 10948731 | Product quality issue | |
| 109487314 | 10948731 | Pulmonary congestion | |
| 109487314 | 10948731 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 109487314 | 10948731 | 1 | 2010 | 0 | ||
| 109487314 | 10948731 | 2 | 2010 | 0 | ||
| 109487314 | 10948731 | 3 | 20120502 | 0 | ||
| 109487314 | 10948731 | 4 | 20120502 | 0 | ||
| 109487314 | 10948731 | 5 | 20120502 | 0 | ||
| 109487314 | 10948731 | 6 | 20120502 | 0 | ||
| 109487314 | 10948731 | 7 | 20120502 | 0 | ||
| 109487314 | 10948731 | 8 | 20120502 | 0 | ||
| 109487314 | 10948731 | 9 | 20150202 | 0 | ||
| 109487314 | 10948731 | 10 | 20150202 | 0 | ||
| 109487314 | 10948731 | 11 | 20160621 | 0 | ||
| 109487314 | 10948731 | 12 | 20160621 | 0 |