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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123558882 | 12355888 | 2 | F | 20150224 | 20160922 | 20160511 | 20160928 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-29382BI | BOEHRINGER INGELHEIM | 70.56 | YR | F | Y | 88.90000 | KG | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123558882 | 12355888 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 300 MG | 22512 | 150 | MG | CAPSULE | BID | ||||||
| 123558882 | 12355888 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 300 MG | 22512 | 150 | MG | CAPSULE | BID | ||||||
| 123558882 | 12355888 | 3 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 300 MG | 22512 | 150 | MG | CAPSULE | BID | ||||||
| 123558882 | 12355888 | 4 | C | ACYCLOVIR. | ACYCLOVIR | 1 | Oral | 400 MG | 0 | 200 | MG | CAPSULE | BID | ||||||
| 123558882 | 12355888 | 5 | C | GLIMEPIRIDE. | GLIMEPIRIDE | 1 | Oral | 2 MG | 0 | 2 | MG | TABLET | QD | ||||||
| 123558882 | 12355888 | 6 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | Oral | 25 MG | 0 | 25 | MG | TABLET | QD | ||||||
| 123558882 | 12355888 | 7 | C | HUMALOG | INSULIN LISPRO | 1 | Subcutaneous | STRENGTH: 100 UNIT/ML | 0 | ORAL SOLUTION | |||||||||
| 123558882 | 12355888 | 8 | C | LACTOBACILLUS RHAMNOSUS | LACTOBACILLUS RHAMNOSUS | 1 | Oral | 2 ANZ | 0 | CAPSULE | BID | ||||||||
| 123558882 | 12355888 | 9 | C | MELOXICAM. | MELOXICAM | 1 | Oral | 15 MG | 0 | 15 | MG | TABLET | QD | ||||||
| 123558882 | 12355888 | 10 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 1000 MG | 0 | 500 | MG | TABLET | BID | ||||||
| 123558882 | 12355888 | 11 | C | METOPROLOL. | METOPROLOL | 1 | Oral | 50 MG | 0 | 25 | MG | TABLET | BID | ||||||
| 123558882 | 12355888 | 12 | C | MULTIVITAMIN | VITAMINS | 1 | Oral | 1 ANZ | 0 | TABLET | QD | ||||||||
| 123558882 | 12355888 | 13 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | DELAYED RELEASE | 0 | 20 | MG | CAPSULE | |||||||
| 123558882 | 12355888 | 14 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | Oral | 0 | 1 | MG | TABLET | ||||||||
| 123558882 | 12355888 | 15 | C | AUGMENTIN | AMOXICILLINCLAVULANATE POTASSIUM | 1 | Oral | DOSE PER APPLICATION: 875 MG-125 MG; DAILY DOSE: 1,750 MG- 250 MG | 0 | TABLET | Q12H | ||||||||
| 123558882 | 12355888 | 16 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 75 MG | 0 | 75 | MG | CAPSULE | QD | ||||||
| 123558882 | 12355888 | 17 | C | MAG-OX | MAGNESIUM OXIDE | 1 | Oral | 400 MG | 0 | 400 | MG | TABLET | QD | ||||||
| 123558882 | 12355888 | 18 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | TABLET | ||||||||
| 123558882 | 12355888 | 19 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Oral | 100 MG | 0 | 100 | MG | TABLET | QD | ||||||
| 123558882 | 12355888 | 20 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | Oral | 20 MG | 0 | 20 | MG | TABLET | QD | ||||||
| 123558882 | 12355888 | 21 | C | LISINOPRIL. | LISINOPRIL | 1 | Oral | 0.5 MG | 0 | .5 | MG | TABLET | QD | ||||||
| 123558882 | 12355888 | 22 | C | NOVOLIN R | INSULIN HUMAN | 1 | Unknown | FORMULATION: SOLUTION INJECTION; DOSE PER APPLICATION: 100 UNIT/ML | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123558882 | 12355888 | 1 | Atrial fibrillation |
| 123558882 | 12355888 | 4 | Antiviral treatment |
| 123558882 | 12355888 | 5 | Diabetes mellitus |
| 123558882 | 12355888 | 6 | Oedema |
| 123558882 | 12355888 | 7 | Hyperglycaemia |
| 123558882 | 12355888 | 8 | Probiotic therapy |
| 123558882 | 12355888 | 9 | Pain |
| 123558882 | 12355888 | 10 | Diabetes mellitus |
| 123558882 | 12355888 | 11 | Hypertension |
| 123558882 | 12355888 | 12 | Supplementation therapy |
| 123558882 | 12355888 | 13 | Gastrooesophageal reflux disease |
| 123558882 | 12355888 | 14 | Anxiety |
| 123558882 | 12355888 | 15 | Product used for unknown indication |
| 123558882 | 12355888 | 16 | Product used for unknown indication |
| 123558882 | 12355888 | 17 | Product used for unknown indication |
| 123558882 | 12355888 | 18 | Product used for unknown indication |
| 123558882 | 12355888 | 20 | Product used for unknown indication |
| 123558882 | 12355888 | 21 | Product used for unknown indication |
| 123558882 | 12355888 | 22 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123558882 | 12355888 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123558882 | 12355888 | Gastrointestinal haemorrhage | |
| 123558882 | 12355888 | Haemorrhagic anaemia |
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 |
|---|---|---|---|---|---|---|
| 123558882 | 12355888 | 1 | 20140801 | 20140911 | 0 | |
| 123558882 | 12355888 | 2 | 20141114 | 20150225 | 0 | |
| 123558882 | 12355888 | 3 | 20151221 | 0 | ||
| 123558882 | 12355888 | 19 | 20140910 | 0 | ||
| 123558882 | 12355888 | 22 | 20131118 | 0 |