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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127056591 | 12705659 | 1 | I | 201606 | 20160824 | 20160901 | 20160901 | PER | US-ASTRAZENECA-2016SE91428 | ASTRAZENECA | 883.00 | MON | M | Y | 66.70000 | KG | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127056591 | 12705659 | 1 | PS | PULMICORT TURBUHALER | BUDESONIDE | 1 | Respiratory (inhalation) | TWICE A DAY | 21949 | NEBULISER SUSPENSION | |||||||||
| 127056591 | 12705659 | 2 | SS | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 43840 | MG | U | U | 0 | 20 | MG | BID | ||||
| 127056591 | 12705659 | 3 | SS | DALIRESP | ROFLUMILAST | 1 | Oral | N | U | 0 | 500 | UG | TABLET | QD | |||||
| 127056591 | 12705659 | 4 | SS | DALIRESP | ROFLUMILAST | 1 | Oral | N | U | 0 | 500 | UG | TABLET | QD | |||||
| 127056591 | 12705659 | 5 | SS | DALIRESP | ROFLUMILAST | 1 | Oral | N | U | 0 | 500 | UG | TABLET | QD | |||||
| 127056591 | 12705659 | 6 | SS | DALIRESP | ROFLUMILAST | 1 | Oral | N | U | 0 | 250 | UG | TABLET | QD | |||||
| 127056591 | 12705659 | 7 | C | ALBUTEROL. | ALBUTEROL | 1 | Respiratory (inhalation) | 0 | |||||||||||
| 127056591 | 12705659 | 8 | C | BROBANA | 2 | Respiratory (inhalation) | 0 | ||||||||||||
| 127056591 | 12705659 | 9 | C | BEANO | ASPERGILLUS NIGER .ALPHA.-GALACTOSIDASE | 1 | Oral | 0 | |||||||||||
| 127056591 | 12705659 | 10 | C | FLOMAX | TAMSULOSIN HYDROCHLORIDE | 1 | 0.4MG UNKNOWN | 0 | .4 | MG | |||||||||
| 127056591 | 12705659 | 11 | C | LASIX | FUROSEMIDE | 1 | Oral | 0 | 40 | MG | QD | ||||||||
| 127056591 | 12705659 | 12 | C | PRILOCAINE | PRILOCAINE | 1 | Topical | 0 | CREAM | ||||||||||
| 127056591 | 12705659 | 13 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | Oral | 0 | |||||||||||
| 127056591 | 12705659 | 14 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | Respiratory (inhalation) | 0 | |||||||||||
| 127056591 | 12705659 | 15 | C | PROBIOTIC | PROBIOTICS NOS | 1 | Oral | 0 | |||||||||||
| 127056591 | 12705659 | 16 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | 0 | |||||||||||
| 127056591 | 12705659 | 17 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | 0 | .5 | MG | QD | |||||||||
| 127056591 | 12705659 | 18 | C | ZOCOR | SIMVASTATIN | 1 | 0 | 40 | MG | QD | |||||||||
| 127056591 | 12705659 | 19 | C | CITRUCEL OTC | 2 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127056591 | 12705659 | 2 | Gastrointestinal disorder |
| 127056591 | 12705659 | 3 | Chronic obstructive pulmonary disease |
| 127056591 | 12705659 | 4 | Chronic obstructive pulmonary disease |
| 127056591 | 12705659 | 5 | Chronic obstructive pulmonary disease |
| 127056591 | 12705659 | 6 | Chronic obstructive pulmonary disease |
| 127056591 | 12705659 | 7 | Chronic obstructive pulmonary disease |
| 127056591 | 12705659 | 9 | Gastrointestinal disorder |
| 127056591 | 12705659 | 10 | Urine analysis abnormal |
| 127056591 | 12705659 | 11 | Fluid retention |
| 127056591 | 12705659 | 12 | Pruritus |
| 127056591 | 12705659 | 13 | Gastrointestinal disorder |
| 127056591 | 12705659 | 15 | Constipation |
| 127056591 | 12705659 | 17 | Anxiety |
| 127056591 | 12705659 | 18 | Blood cholesterol abnormal |
| 127056591 | 12705659 | 19 | Diarrhoea |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127056591 | 12705659 | Abdominal discomfort | |
| 127056591 | 12705659 | Abdominal pain upper | |
| 127056591 | 12705659 | Diarrhoea | |
| 127056591 | 12705659 | Insomnia | |
| 127056591 | 12705659 | Intentional product misuse | |
| 127056591 | 12705659 | Middle insomnia | |
| 127056591 | 12705659 | Peripheral swelling | |
| 127056591 | 12705659 | Pruritus | |
| 127056591 | 12705659 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 127056591 | 12705659 | 1 | 2010 | 0 | ||
| 127056591 | 12705659 | 2 | 2013 | 0 | ||
| 127056591 | 12705659 | 3 | 201606 | 0 | ||
| 127056591 | 12705659 | 4 | 201608 | 0 | ||
| 127056591 | 12705659 | 5 | 201608 | 201608 | 0 | |
| 127056591 | 12705659 | 6 | 20160824 | 0 | ||
| 127056591 | 12705659 | 8 | 2008 | 0 | ||
| 127056591 | 12705659 | 13 | 2013 | 0 | ||
| 127056591 | 12705659 | 18 | 2013 | 0 | ||
| 127056591 | 12705659 | 19 | 20160824 | 0 |