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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127783581 | 12778358 | 1 | I | 201603 | 20160511 | 20160926 | 20160926 | EXP | US-ASTRAZENECA-2016SE51875 | ASTRAZENECA | 611.00 | MON | M | Y | 91.60000 | KG | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127783581 | 12778358 | 1 | PS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG, 2 PUFFS TWICE DAILY | U | 21929 | BID | ||||||||
| 127783581 | 12778358 | 2 | SS | PRILOSEC OTC | OMEPRAZOLE MAGNESIUM | 1 | Oral | U | U | 0 | 40 | MG | QD | ||||||
| 127783581 | 12778358 | 3 | SS | PRILOSEC OTC | OMEPRAZOLE MAGNESIUM | 1 | Oral | U | U | 0 | 2 | DF | MODIFIED-RELEASE TABLET | QD | |||||
| 127783581 | 12778358 | 4 | SS | DALIRESP | ROFLUMILAST | 1 | Oral | U | 0 | 500 | UG | TABLET | QD | ||||||
| 127783581 | 12778358 | 5 | SS | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Oral | U | U | 0 | 1 | DF | TABLET | QD | |||||
| 127783581 | 12778358 | 6 | C | XANAX | ALPRAZOLAM | 1 | Oral | 0 | 1 | MG | QD | ||||||||
| 127783581 | 12778358 | 7 | C | XANAX | ALPRAZOLAM | 1 | Oral | 0 | 1 | MG | QD | ||||||||
| 127783581 | 12778358 | 8 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | Oral | 0 | 1 | MG | QD | ||||||||
| 127783581 | 12778358 | 9 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | 0 | 5 | MG | QD | ||||||||
| 127783581 | 12778358 | 10 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Oral | 0 | 2 | DF | QD | ||||||||
| 127783581 | 12778358 | 11 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Oral | 0 | 2 | DF | QD | ||||||||
| 127783581 | 12778358 | 12 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | Oral | 10.0MG INTERMITTENT | 0 | 10 | MG | ||||||||
| 127783581 | 12778358 | 13 | C | STOOL SOFTENER | DOCUSATE CALCIUM | 1 | Oral | DAILY | 0 | ||||||||||
| 127783581 | 12778358 | 14 | C | HIGH BLOOD PRESSURE MEDICATION | UNSPECIFIED INGREDIENT | 1 | 0 | ||||||||||||
| 127783581 | 12778358 | 15 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 0 | 18 | UG | CAPSULE | QD | |||||||
| 127783581 | 12778358 | 16 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | Oral | 0 | 1 | MG | QD | ||||||||
| 127783581 | 12778358 | 17 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127783581 | 12778358 | 1 | Chronic obstructive pulmonary disease |
| 127783581 | 12778358 | 2 | Gastrooesophageal reflux disease |
| 127783581 | 12778358 | 3 | Gastrooesophageal reflux disease |
| 127783581 | 12778358 | 4 | Chronic obstructive pulmonary disease |
| 127783581 | 12778358 | 5 | Blood cholesterol abnormal |
| 127783581 | 12778358 | 6 | Anxiety |
| 127783581 | 12778358 | 7 | Muscle relaxant therapy |
| 127783581 | 12778358 | 8 | Sleep disorder |
| 127783581 | 12778358 | 9 | Blood pressure abnormal |
| 127783581 | 12778358 | 10 | Muscle relaxant therapy |
| 127783581 | 12778358 | 11 | Depression |
| 127783581 | 12778358 | 12 | Muscle relaxant therapy |
| 127783581 | 12778358 | 13 | Constipation |
| 127783581 | 12778358 | 15 | Chronic obstructive pulmonary disease |
| 127783581 | 12778358 | 16 | Anxiety |
| 127783581 | 12778358 | 17 | Depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127783581 | 12778358 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127783581 | 12778358 | Adverse drug reaction | |
| 127783581 | 12778358 | Anxiety | |
| 127783581 | 12778358 | Chronic obstructive pulmonary disease | |
| 127783581 | 12778358 | Decreased appetite | |
| 127783581 | 12778358 | Depression | |
| 127783581 | 12778358 | Hypertension | |
| 127783581 | 12778358 | 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 |
|---|---|---|---|---|---|---|
| 127783581 | 12778358 | 1 | 2016 | 20160910 | 0 | |
| 127783581 | 12778358 | 2 | 2002 | 0 | ||
| 127783581 | 12778358 | 3 | 2003 | 0 | ||
| 127783581 | 12778358 | 4 | 2016 | 20160910 | 0 | |
| 127783581 | 12778358 | 5 | 201511 | 0 | ||
| 127783581 | 12778358 | 6 | 2004 | 0 | ||
| 127783581 | 12778358 | 7 | 2004 | 0 | ||
| 127783581 | 12778358 | 8 | 2004 | 0 | ||
| 127783581 | 12778358 | 9 | 2015 | 0 | ||
| 127783581 | 12778358 | 10 | 2004 | 0 | ||
| 127783581 | 12778358 | 11 | 2004 | 0 | ||
| 127783581 | 12778358 | 12 | 2004 | 0 | ||
| 127783581 | 12778358 | 15 | 20160911 | 20160916 | 0 | |
| 127783581 | 12778358 | 17 | 201609 | 0 |