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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123688142 | 12368814 | 2 | F | 20160922 | 20160513 | 20160927 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-29909BI | BOEHRINGER INGELHEIM | 0.00 | M | Y | 0.00000 | 20160927 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123688142 | 12368814 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 300 MG | 22512 | 150 | MG | CAPSULE | BID | ||||||
| 123688142 | 12368814 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 600 MG | 22512 | 300 | MG | CAPSULE | BID | ||||||
| 123688142 | 12368814 | 3 | C | FINASTERIDE. | FINASTERIDE | 1 | Oral | 5 MG | 0 | 5 | MG | TABLET | QD | ||||||
| 123688142 | 12368814 | 4 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | 100 MCG | 0 | 100 | UG | TABLET | QD | ||||||
| 123688142 | 12368814 | 5 | C | LISINOPRIL. | LISINOPRIL | 1 | Oral | 20 MG | 0 | 20 | MG | TABLET | QD | ||||||
| 123688142 | 12368814 | 6 | C | METOPROLOL TARTRATE. | METOPROLOL TARTRATE | 1 | Oral | 25 MG | 0 | 25 | MG | TABLET | QD | ||||||
| 123688142 | 12368814 | 7 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | 30 MG | 0 | 30 | MG | QD | |||||||
| 123688142 | 12368814 | 8 | C | GABAPENTIN. | GABAPENTIN | 1 | Oral | 300 MG | 0 | 300 | MG | TABLET | QD | ||||||
| 123688142 | 12368814 | 9 | C | GABAPENTIN. | GABAPENTIN | 1 | Oral | 300 MG | 0 | 300 | MG | CAPSULE | QD | ||||||
| 123688142 | 12368814 | 10 | C | CILOSTAZOL. | CILOSTAZOL | 1 | Oral | 200 MG | 0 | 100 | MG | TABLET | BID | ||||||
| 123688142 | 12368814 | 11 | C | CILOSTAZOL. | CILOSTAZOL | 1 | Oral | 400 MG | 0 | 200 | MG | TABLET | BID | ||||||
| 123688142 | 12368814 | 12 | C | DONEPEZIL. | DONEPEZIL | 1 | Oral | 10 MG | 0 | 10 | MG | TABLET | QD | ||||||
| 123688142 | 12368814 | 13 | C | TOVIAZ | FESOTERODINE FUMARATE | 1 | Oral | 8 MG | 0 | 8 | MG | QD | |||||||
| 123688142 | 12368814 | 14 | C | HUMULIN NOS | INSULIN HUMAN | 1 | Subcutaneous | DOSE PER APPLICATION: 70/30 100 UNIT/ML (70-30) CRTG 10 UNITS MORNING, 20 UNITS EVENING | 0 | ||||||||||
| 123688142 | 12368814 | 15 | C | ATORVASTATIN | ATORVASTATIN | 1 | Oral | 40 MG | 0 | 40 | MG | TABLET | QD | ||||||
| 123688142 | 12368814 | 16 | C | MULTIPLE VITAMINS | VITAMINS | 1 | Oral | 0 | |||||||||||
| 123688142 | 12368814 | 17 | C | ALPHA LIPOIC ACID | .ALPHA.-LIPOIC ACID | 1 | Oral | 0 | |||||||||||
| 123688142 | 12368814 | 18 | C | POMEGRANATE FRUIT EXTRACT | 2 | Oral | 500 MG | 0 | 250 | MG | CAPSULE | BID | |||||||
| 123688142 | 12368814 | 19 | C | POMEGRANATE FRUIT EXTRACT | 2 | Oral | 250 MG | 0 | 250 | MG | CAPSULE | QD | |||||||
| 123688142 | 12368814 | 20 | C | VITAMIN C | ASCORBIC ACID | 1 | Oral | 500 MG | 0 | 500 | MG | QD | |||||||
| 123688142 | 12368814 | 21 | C | VITAMIN C | ASCORBIC ACID | 1 | Oral | 500 MG | 0 | 500 | MG | TABLET | QD | ||||||
| 123688142 | 12368814 | 22 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | Oral | DOSE PER APPLICATION: 400 UNIT | 0 | CAPSULE | QD | ||||||||
| 123688142 | 12368814 | 23 | C | OSCAL 500+D | 2 | Unknown | STRENGTH: 500 | 0 | QID | ||||||||||
| 123688142 | 12368814 | 24 | C | OSCAL 500+D | 2 | Unknown | STRENGTH: 500 | 0 | CAPSULE | BID | |||||||||
| 123688142 | 12368814 | 25 | C | TIOTROPIUM BROMIDE | TIOTROPIUM BROMIDE | 1 | Respiratory (inhalation) | 0 | |||||||||||
| 123688142 | 12368814 | 26 | C | PROVENTIL | ALBUTEROL | 1 | Respiratory (inhalation) | 0 | |||||||||||
| 123688142 | 12368814 | 27 | C | PROVENTIL | ALBUTEROL | 1 | Respiratory (inhalation) | DOSE PER APPLICATION: 2.5 MG/3ML (0.083%) ; 3 ML NEBULIZER | 0 | ||||||||||
| 123688142 | 12368814 | 28 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | 100 MCG | 0 | 100 | UG | TABLET | QD | ||||||
| 123688142 | 12368814 | 29 | C | ALPHA BETIC MULTIVITAMIN | 2 | Unknown | 0 | BID | |||||||||||
| 123688142 | 12368814 | 30 | C | ALPHA LIPOIC ACID | .ALPHA.-LIPOIC ACID | 1 | Oral | 50 MG | 0 | 50 | MG | CAPSULE | QD | ||||||
| 123688142 | 12368814 | 31 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | METER DOSE INHALER | 0 | INHALATION POWDER, HARD CAPSULE | QD | ||||||||
| 123688142 | 12368814 | 32 | C | ALBUTEROL SULFATE. | ALBUTEROL SULFATE | 1 | Respiratory (inhalation) | DOSE PER APPLICATION: 2.5 MG/0.5ML NEBULE | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123688142 | 12368814 | 1 | Atrial fibrillation |
| 123688142 | 12368814 | 3 | Product used for unknown indication |
| 123688142 | 12368814 | 4 | Product used for unknown indication |
| 123688142 | 12368814 | 5 | Product used for unknown indication |
| 123688142 | 12368814 | 6 | Product used for unknown indication |
| 123688142 | 12368814 | 7 | Product used for unknown indication |
| 123688142 | 12368814 | 8 | Product used for unknown indication |
| 123688142 | 12368814 | 10 | Product used for unknown indication |
| 123688142 | 12368814 | 12 | Product used for unknown indication |
| 123688142 | 12368814 | 13 | Product used for unknown indication |
| 123688142 | 12368814 | 14 | Product used for unknown indication |
| 123688142 | 12368814 | 15 | Product used for unknown indication |
| 123688142 | 12368814 | 16 | Product used for unknown indication |
| 123688142 | 12368814 | 17 | Product used for unknown indication |
| 123688142 | 12368814 | 18 | Product used for unknown indication |
| 123688142 | 12368814 | 20 | Product used for unknown indication |
| 123688142 | 12368814 | 22 | Product used for unknown indication |
| 123688142 | 12368814 | 23 | Product used for unknown indication |
| 123688142 | 12368814 | 25 | Product used for unknown indication |
| 123688142 | 12368814 | 26 | Product used for unknown indication |
| 123688142 | 12368814 | 28 | Product used for unknown indication |
| 123688142 | 12368814 | 29 | Product used for unknown indication |
| 123688142 | 12368814 | 30 | Product used for unknown indication |
| 123688142 | 12368814 | 31 | Product used for unknown indication |
| 123688142 | 12368814 | 32 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123688142 | 12368814 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123688142 | 12368814 | Anaemia | |
| 123688142 | 12368814 | Lower gastrointestinal 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 |
|---|---|---|---|---|---|---|
| 123688142 | 12368814 | 1 | 20140404 | 0 |