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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123375502 | 12337550 | 2 | F | 20120224 | 20160829 | 20160505 | 20160902 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-27307BI | BOEHRINGER INGELHEIM | 62.99 | YR | M | Y | 123.37000 | KG | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123375502 | 12337550 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Unknown | U | 22512 | ||||||||||
| 123375502 | 12337550 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | U | 22512 | |||||||||||
| 123375502 | 12337550 | 3 | C | COUMADIN | WARFARIN SODIUM | 1 | Unknown | AS DIRECTED BY PCP | 0 | 5 | MG | ||||||||
| 123375502 | 12337550 | 4 | C | COUMADIN | WARFARIN SODIUM | 1 | Unknown | 0 | 2.5 | MG | TABLET | ||||||||
| 123375502 | 12337550 | 5 | C | DIGOXIN. | DIGOXIN | 1 | Oral | 250 MCG | 0 | 250 | UG | TABLET | QD | ||||||
| 123375502 | 12337550 | 6 | C | FINASTERIDE. | FINASTERIDE | 1 | Oral | 5 MG | 0 | 5 | MG | TABLET | QD | ||||||
| 123375502 | 12337550 | 7 | C | FLOMAX | TAMSULOSIN HYDROCHLORIDE | 1 | Oral | 0.4 MG | 0 | .4 | MG | CAPSULE | QD | ||||||
| 123375502 | 12337550 | 8 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 80 MG | 0 | 40 | MG | TABLET | BID | ||||||
| 123375502 | 12337550 | 9 | C | IPRATROPIUM/ALBUTEROL | ALBUTEROLIPRATROPIUM | 1 | Respiratory (inhalation) | 0.5-3MG (2.5MG BASE)/3 ML NEBULIZATION SOLUTION, 3ML 4 TIMES A DAY | 0 | QID | |||||||||
| 123375502 | 12337550 | 10 | C | LISINOPRIL. | LISINOPRIL | 1 | Oral | 10 MG | 0 | 10 | MG | TABLET | QD | ||||||
| 123375502 | 12337550 | 11 | C | METOPROLOL SUCCINATE ER | METOPROLOL SUCCINATE | 1 | Oral | 200 MG | 0 | 100 | MG | BID | |||||||
| 123375502 | 12337550 | 12 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Oral | 5000 U | 0 | 5000 | IU | TABLET | QD | ||||||
| 123375502 | 12337550 | 13 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Oral | 10 MG | 0 | 10 | MG | TABLET | QD | ||||||
| 123375502 | 12337550 | 14 | C | KLOR-CON M20 | POTASSIUM CHLORIDE | 1 | Oral | M20 MEQ TABLET, EXTENDED RELEASE | 0 | QD | |||||||||
| 123375502 | 12337550 | 15 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 25 MG | 0 | 25 | MG | TABLET | QD | ||||||
| 123375502 | 12337550 | 16 | C | PULMICORT RESPULES | BUDESONIDE | 1 | Respiratory (inhalation) | 0.25 MG/2ML | 0 | ORAL SUSPENSION | BID | ||||||||
| 123375502 | 12337550 | 17 | C | COMBIVENT RESPIMAT | ALBUTEROL SULFATEIPRATROPIUM BROMIDE | 1 | Respiratory (inhalation) | 100MCG-20MCG | 0 | NEBULISER LIQUID | |||||||||
| 123375502 | 12337550 | 18 | C | TAMSULOSIN | TAMSULOSIN | 1 | Oral | 0.4 MG | 0 | .4 | MG | CAPSULE | QD | ||||||
| 123375502 | 12337550 | 19 | C | VOLTAREN | DICLOFENAC SODIUM | 1 | Topical | STRENGTH: 1% | 0 | GEL | |||||||||
| 123375502 | 12337550 | 20 | C | LASIX | FUROSEMIDE | 1 | Oral | 40 MG | 0 | 40 | MG | TABLET | QD | ||||||
| 123375502 | 12337550 | 21 | C | LASIX | FUROSEMIDE | 1 | Oral | 20 MG | 0 | 20 | MG | TABLET | QD | ||||||
| 123375502 | 12337550 | 22 | C | VIBRAMYCIN HYCLATE | DOXYCYCLINE HYCLATE | 1 | Oral | 200 MG | 0 | 100 | MG | CAPSULE | BID | ||||||
| 123375502 | 12337550 | 23 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 40 MG | 0 | 40 | MG | TABLET | QD | ||||||
| 123375502 | 12337550 | 24 | C | NITROGLYCERIN. | NITROGLYCERIN | 1 | Sublingual | TAKE AS DIRECTED | 0 | .4 | MG | TABLET | |||||||
| 123375502 | 12337550 | 25 | C | LOPRESSOR | METOPROLOL TARTRATE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123375502 | 12337550 | 1 | Atrial fibrillation |
| 123375502 | 12337550 | 2 | Cerebrovascular accident prophylaxis |
| 123375502 | 12337550 | 3 | Product used for unknown indication |
| 123375502 | 12337550 | 5 | Product used for unknown indication |
| 123375502 | 12337550 | 6 | Product used for unknown indication |
| 123375502 | 12337550 | 7 | Product used for unknown indication |
| 123375502 | 12337550 | 8 | Product used for unknown indication |
| 123375502 | 12337550 | 9 | Product used for unknown indication |
| 123375502 | 12337550 | 10 | Essential hypertension |
| 123375502 | 12337550 | 11 | Product used for unknown indication |
| 123375502 | 12337550 | 12 | Product used for unknown indication |
| 123375502 | 12337550 | 13 | Product used for unknown indication |
| 123375502 | 12337550 | 14 | Product used for unknown indication |
| 123375502 | 12337550 | 15 | Product used for unknown indication |
| 123375502 | 12337550 | 16 | Product used for unknown indication |
| 123375502 | 12337550 | 17 | Product used for unknown indication |
| 123375502 | 12337550 | 18 | Product used for unknown indication |
| 123375502 | 12337550 | 19 | Product used for unknown indication |
| 123375502 | 12337550 | 20 | Oedema |
| 123375502 | 12337550 | 22 | Product used for unknown indication |
| 123375502 | 12337550 | 23 | Product used for unknown indication |
| 123375502 | 12337550 | 24 | Product used for unknown indication |
| 123375502 | 12337550 | 25 | Atrial fibrillation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123375502 | 12337550 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123375502 | 12337550 | Internal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 123375502 | 12337550 | 1 | 20120210 | 0 |