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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123382483 | 12338248 | 3 | F | 2015 | 20160818 | 20160505 | 20160823 | EXP | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-27495BP | BOEHRINGER INGELHEIM | 0.00 | M | Y | 109.77000 | KG | 20160823 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123382483 | 12338248 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 300 MG | Y | 22512 | 150 | MG | CAPSULE | BID | |||||
| 123382483 | 12338248 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 150 MG | Y | 22512 | 150 | MG | CAPSULE | QD | |||||
| 123382483 | 12338248 | 3 | C | METOPROLOL. | METOPROLOL | 1 | Oral | 50 MG | 0 | 25 | MG | BID | |||||||
| 123382483 | 12338248 | 4 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | 80 MG | 0 | 40 | MG | BID | |||||||
| 123382483 | 12338248 | 5 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | 0 | ||||||||||||
| 123382483 | 12338248 | 6 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Unknown | 25 MG | 0 | 25 | MG | QD | |||||||
| 123382483 | 12338248 | 7 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Respiratory (inhalation) | 270 MCG | 0 | 90 | UG | TID | |||||||
| 123382483 | 12338248 | 8 | C | ALBUTEROL. | ALBUTEROL | 1 | Unknown | 2 ANZ | 0 | BID | |||||||||
| 123382483 | 12338248 | 9 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 40 MG | 0 | 40 | MG | QD | |||||||
| 123382483 | 12338248 | 10 | C | AMIODARONE | AMIODARONE | 1 | Oral | 600 MG | 0 | 200 | MG | TABLET | TID | ||||||
| 123382483 | 12338248 | 11 | C | COLCHOCINE | 2 | Unknown | 0.6 MG | 0 | .6 | MG | QD | ||||||||
| 123382483 | 12338248 | 12 | C | ATORVASTATIN | ATORVASTATIN | 1 | Oral | 10 MG | 0 | 10 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123382483 | 12338248 | 1 | Atrial fibrillation |
| 123382483 | 12338248 | 3 | Hypertension |
| 123382483 | 12338248 | 4 | Hiatus hernia |
| 123382483 | 12338248 | 5 | Gastrooesophageal reflux disease |
| 123382483 | 12338248 | 6 | Thyroid disorder |
| 123382483 | 12338248 | 7 | Lung disorder |
| 123382483 | 12338248 | 8 | Lung disorder |
| 123382483 | 12338248 | 9 | Fluid imbalance |
| 123382483 | 12338248 | 10 | Atrial fibrillation |
| 123382483 | 12338248 | 11 | Inflammation |
| 123382483 | 12338248 | 12 | Blood cholesterol increased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123382483 | 12338248 | OT |
| 123382483 | 12338248 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123382483 | 12338248 | Angina pectoris | |
| 123382483 | 12338248 | Atrial fibrillation | |
| 123382483 | 12338248 | Fine motor skill dysfunction | |
| 123382483 | 12338248 | Hyperhidrosis | |
| 123382483 | 12338248 | Lung infection | |
| 123382483 | 12338248 | Nasopharyngitis | |
| 123382483 | 12338248 | Oedema peripheral | |
| 123382483 | 12338248 | Pericardial effusion | |
| 123382483 | 12338248 | Pulmonary oedema |
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 |
|---|---|---|---|---|---|---|
| 123382483 | 12338248 | 1 | 201209 | 0 | ||
| 123382483 | 12338248 | 2 | 2013 | 0 |