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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126044522 | 12604452 | 2 | F | 2009 | 20160901 | 20160728 | 20160909 | EXP | US-ASTRAZENECA-2016SE79879 | ASTRAZENECA | 55.00 | YR | F | Y | 54.00000 | KG | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126044522 | 12604452 | 1 | PS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5, TWO PUFFS TWICE A DAY | 21929 | ||||||||||
| 126044522 | 12604452 | 2 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5, TWO PUFFS TWICE A DAY | 21929 | ||||||||||
| 126044522 | 12604452 | 3 | SS | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 20.0MG AS REQUIRED | 0 | 20 | MG | ||||||||
| 126044522 | 12604452 | 4 | SS | METOPROLOL TARTRATE. | METOPROLOL TARTRATE | 1 | Oral | 0 | 50 | MG | QD | ||||||||
| 126044522 | 12604452 | 5 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | Respiratory (inhalation) | 90MCG, 2 PUFF EVERY FOUR HOURS | 0 | ||||||||||
| 126044522 | 12604452 | 6 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | Respiratory (inhalation) | 90MCG, 2 PUFF EVERY FOUR HOURS | 0 | ||||||||||
| 126044522 | 12604452 | 7 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | Respiratory (inhalation) | 2 PUFFS AS NEEDED | 0 | ||||||||||
| 126044522 | 12604452 | 8 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | Respiratory (inhalation) | 2 PUFFS AS NEEDED | 0 | ||||||||||
| 126044522 | 12604452 | 9 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Oral | 0 | 10 | MG | QD | ||||||||
| 126044522 | 12604452 | 10 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Oral | 0 | 2000 | IU | QD | ||||||||
| 126044522 | 12604452 | 11 | C | MONTELUKAST | MONTELUKAST SODIUM | 1 | Oral | 0 | 10 | MG | QD | ||||||||
| 126044522 | 12604452 | 12 | C | PRAVASTATIN. | PRAVASTATIN | 1 | Oral | 0 | 20 | MG | QD | ||||||||
| 126044522 | 12604452 | 13 | C | BUSPIRONE | BUSPIRONE HYDROCHLORIDE | 1 | Oral | 0 | 10 | MG | TID | ||||||||
| 126044522 | 12604452 | 14 | C | ALENDRONATE | ALENDRONATE SODIUM | 1 | Oral | 0 | 70 | MG | /wk | ||||||||
| 126044522 | 12604452 | 15 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | Oral | TWICE A DAY | 0 | ||||||||||
| 126044522 | 12604452 | 16 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | Oral | DAILY | 0 | ||||||||||
| 126044522 | 12604452 | 17 | C | VITAMIN C | ASCORBIC ACID | 1 | Oral | TWO TIMES A DAY | 0 | ||||||||||
| 126044522 | 12604452 | 18 | C | BYRIDOSTIGMINE | 2 | Oral | 0 | 60 | MG | TID | |||||||||
| 126044522 | 12604452 | 19 | C | STUDY DRUG DAP | 2 | Oral | 10.0MG UNKNOWN | 0 | 10 | MG | |||||||||
| 126044522 | 12604452 | 20 | C | STUDY DRUG DAP | 2 | Oral | 5.0DF UNKNOWN | 0 | 5 | DF | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126044522 | 12604452 | 1 | Chronic obstructive pulmonary disease |
| 126044522 | 12604452 | 2 | Asthma |
| 126044522 | 12604452 | 3 | Abdominal distension |
| 126044522 | 12604452 | 5 | Wheezing |
| 126044522 | 12604452 | 6 | Dyspnoea |
| 126044522 | 12604452 | 7 | Wheezing |
| 126044522 | 12604452 | 8 | Dyspnoea |
| 126044522 | 12604452 | 9 | Rhinitis allergic |
| 126044522 | 12604452 | 10 | Bone disorder |
| 126044522 | 12604452 | 11 | Multiple allergies |
| 126044522 | 12604452 | 13 | Anxiety |
| 126044522 | 12604452 | 14 | Bone disorder |
| 126044522 | 12604452 | 15 | Asthenia |
| 126044522 | 12604452 | 16 | Asthenia |
| 126044522 | 12604452 | 17 | Immune system disorder |
| 126044522 | 12604452 | 18 | Myasthenic syndrome |
| 126044522 | 12604452 | 19 | Myasthenic syndrome |
| 126044522 | 12604452 | 20 | Myasthenic syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126044522 | 12604452 | OT |
| 126044522 | 12604452 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126044522 | 12604452 | Aneurysm | |
| 126044522 | 12604452 | Asthma | |
| 126044522 | 12604452 | Chronic obstructive pulmonary disease | |
| 126044522 | 12604452 | Circumstance or information capable of leading to medication error | |
| 126044522 | 12604452 | Dermatitis | |
| 126044522 | 12604452 | Device failure | |
| 126044522 | 12604452 | Device malfunction | |
| 126044522 | 12604452 | Drug dose omission | |
| 126044522 | 12604452 | Gastrooesophageal reflux disease | |
| 126044522 | 12604452 | Generalised anxiety disorder | |
| 126044522 | 12604452 | Hyperlipidaemia | |
| 126044522 | 12604452 | Impaired fasting glucose | |
| 126044522 | 12604452 | Intentional device misuse | |
| 126044522 | 12604452 | Lipoma | |
| 126044522 | 12604452 | Myasthenic syndrome | |
| 126044522 | 12604452 | Nephropathy | |
| 126044522 | 12604452 | Off label use | |
| 126044522 | 12604452 | Osteoporosis | |
| 126044522 | 12604452 | Palpitations | |
| 126044522 | 12604452 | Product use issue | |
| 126044522 | 12604452 | Rhinitis allergic | |
| 126044522 | 12604452 | Sleep apnoea syndrome | |
| 126044522 | 12604452 | Stress |
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 |
|---|---|---|---|---|---|---|
| 126044522 | 12604452 | 4 | 201605 | 0 | ||
| 126044522 | 12604452 | 12 | 201605 | 0 | ||
| 126044522 | 12604452 | 18 | 2011 | 0 | ||
| 126044522 | 12604452 | 19 | 2011 | 0 |