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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115018414 | 11501841 | 4 | F | 201508 | 20160728 | 20150914 | 20160804 | EXP | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2015-BI-49529BP | BOEHRINGER INGELHEIM | 76.25 | YR | F | Y | 88.00000 | KG | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115018414 | 11501841 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 300 MG | 406588,407451 | 22512 | 150 | MG | CAPSULE | BID | |||||
| 115018414 | 11501841 | 2 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Oral | 100 MG | 0 | 100 | MG | TABLET | QD | ||||||
| 115018414 | 11501841 | 3 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 81 MG | 0 | 81 | MG | TABLET | QD | ||||||
| 115018414 | 11501841 | 4 | C | FUROSIMIDE | FUROSEMIDE | 1 | Oral | 40 MG | 0 | 40 | MG | TABLET | QD | ||||||
| 115018414 | 11501841 | 5 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 25 MG | 0 | 25 | MG | TABLET | QD | ||||||
| 115018414 | 11501841 | 6 | C | LISINOPRIL. | LISINOPRIL | 1 | Oral | 5 MG | 0 | 5 | MG | TABLET | QD | ||||||
| 115018414 | 11501841 | 7 | C | METOPROLOL TARTRATE. | METOPROLOL TARTRATE | 1 | Oral | 200 MG | 0 | 100 | MG | TABLET | BID | ||||||
| 115018414 | 11501841 | 8 | C | PAROXETINE. | PAROXETINE | 1 | Oral | 20 MG | 0 | 20 | MG | TABLET | QD | ||||||
| 115018414 | 11501841 | 9 | C | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | Oral | 25 MG | 0 | 12.5 | MG | TABLET | BID | ||||||
| 115018414 | 11501841 | 10 | C | SIMVASTASTIN | 2 | Oral | 40 MG | 0 | 40 | MG | TABLET | QD | |||||||
| 115018414 | 11501841 | 11 | C | IRON | IRON | 1 | Oral | 325 MG | 0 | 325 | MG | TABLET | QD | ||||||
| 115018414 | 11501841 | 12 | C | MAGNESIUM OXIDE. | MAGNESIUM OXIDE | 1 | Oral | 800 MG | 0 | 400 | MG | TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115018414 | 11501841 | 1 | Atrial fibrillation |
| 115018414 | 11501841 | 2 | Gout |
| 115018414 | 11501841 | 3 | Product used for unknown indication |
| 115018414 | 11501841 | 4 | Fluid retention |
| 115018414 | 11501841 | 5 | Hypothyroidism |
| 115018414 | 11501841 | 6 | Hypertension |
| 115018414 | 11501841 | 7 | Atrial fibrillation |
| 115018414 | 11501841 | 8 | Anxiety |
| 115018414 | 11501841 | 9 | Product used for unknown indication |
| 115018414 | 11501841 | 10 | Hypertension |
| 115018414 | 11501841 | 11 | Supplementation therapy |
| 115018414 | 11501841 | 12 | Supplementation therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115018414 | 11501841 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115018414 | 11501841 | Atrial fibrillation | |
| 115018414 | 11501841 | Dental caries | |
| 115018414 | 11501841 | Dizziness | |
| 115018414 | 11501841 | Dyspnoea | |
| 115018414 | 11501841 | Fatigue | |
| 115018414 | 11501841 | Gait disturbance | |
| 115018414 | 11501841 | Gastrointestinal haemorrhage | |
| 115018414 | 11501841 | Hyperhidrosis | |
| 115018414 | 11501841 | Hypotension | |
| 115018414 | 11501841 | Lip injury |
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 |
|---|---|---|---|---|---|---|
| 115018414 | 11501841 | 1 | 2013 | 0 |