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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125958081 | 12595808 | 1 | I | 2011 | 20160520 | 20160727 | 20160727 | PER | US-ASTRAZENECA-2016SE55826 | ASTRAZENECA | 54.00 | YR | M | Y | 81.60000 | KG | 20160727 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125958081 | 12595808 | 1 | PS | TUDORZA PRESSAIR | ACLIDINIUM BROMIDE | 1 | Respiratory (inhalation) | 400 UG AS REQUIRED ,1TO 2 PUFFS DAILY, AS NEEDED. USUALLY, ONE PUFF A DAY. | U | 202450 | INHALATION POWDER | ||||||||
| 125958081 | 12595808 | 2 | SS | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | U | 0 | 40 | MG | QD | |||||||
| 125958081 | 12595808 | 3 | SS | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | U | 0 | 40 | MG | QD | |||||||
| 125958081 | 12595808 | 4 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | Oral | 0 | 5 | MG | QD | ||||||||
| 125958081 | 12595808 | 5 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 0 | 81 | MG | QD | ||||||||
| 125958081 | 12595808 | 6 | C | QVAR | BECLOMETHASONE DIPROPIONATE | 1 | Respiratory (inhalation) | EVERY DAY | 0 | ||||||||||
| 125958081 | 12595808 | 7 | C | ROSUVASTATIN. | ROSUVASTATIN | 1 | 0 | ||||||||||||
| 125958081 | 12595808 | 8 | C | FERREX | 2 | 0 | |||||||||||||
| 125958081 | 12595808 | 9 | C | ATORVASTATIN | ATORVASTATIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125958081 | 12595808 | 1 | Chronic obstructive pulmonary disease |
| 125958081 | 12595808 | 2 | Gastric ulcer |
| 125958081 | 12595808 | 3 | Gastric ulcer |
| 125958081 | 12595808 | 6 | Chronic obstructive pulmonary disease |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125958081 | 12595808 | Chest discomfort | |
| 125958081 | 12595808 | Dizziness | |
| 125958081 | 12595808 | Dyspnoea | |
| 125958081 | 12595808 | Gastric ulcer | |
| 125958081 | 12595808 | Hepatic enzyme increased | |
| 125958081 | 12595808 | Intentional product misuse | |
| 125958081 | 12595808 | Malaise | |
| 125958081 | 12595808 | Off label use | |
| 125958081 | 12595808 | Product quality issue | |
| 125958081 | 12595808 | Productive cough | |
| 125958081 | 12595808 | Red blood cell count decreased | |
| 125958081 | 12595808 | White blood cell count 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 |
|---|---|---|---|---|---|---|
| 125958081 | 12595808 | 1 | 2011 | 0 | ||
| 125958081 | 12595808 | 2 | 2011 | 0 | ||
| 125958081 | 12595808 | 4 | 2008 | 0 | ||
| 125958081 | 12595808 | 5 | 2008 | 0 | ||
| 125958081 | 12595808 | 6 | 2011 | 0 |