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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113357694 | 11335769 | 4 | F | 20150715 | 20160815 | 20150804 | 20160826 | EXP | US-BAUSCH-BL-2015-018407 | BAUSCH AND LOMB | 63.87 | YR | M | Y | 0.00000 | 20160826 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113357694 | 11335769 | 1 | PS | NITROGLYCERINE | NITROGLYCERIN | 1 | Sublingual | AS NEEDED | 89771 | .4 | MG | TABLET | |||||||
| 113357694 | 11335769 | 2 | SS | RAMIPRIL. | RAMIPRIL | 1 | Oral | Y | 0 | 10 | MG | CAPSULE, HARD | QD | ||||||
| 113357694 | 11335769 | 3 | SS | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | Y | 0 | 25 | MG | TABLET | QD | ||||||
| 113357694 | 11335769 | 4 | C | BABY ASPIRIN | ASPIRIN | 1 | Oral | 4-81 MG TABLETS ONCE | 0 | 324 | MG | TABLET | QD | ||||||
| 113357694 | 11335769 | 5 | C | ALBUTEROL SULFATE. | ALBUTEROL SULFATE | 1 | ONE PUFF AS NEEDED VIA INHALATION | 0 | INHALATION | ||||||||||
| 113357694 | 11335769 | 6 | C | GABAPENTIN. | GABAPENTIN | 1 | Oral | 0 | CAPSULE | BID | |||||||||
| 113357694 | 11335769 | 7 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 0 | TABLET | QD | |||||||||
| 113357694 | 11335769 | 8 | C | ATORVASTATIN | ATORVASTATIN | 1 | Oral | EVERY HS | 0 | 80 | MG | TABLET | QD | ||||||
| 113357694 | 11335769 | 9 | C | CARVEDILOL. | CARVEDILOL | 1 | Oral | 0 | TABLET | BID | |||||||||
| 113357694 | 11335769 | 10 | C | CARVEDILOL. | CARVEDILOL | 1 | Oral | 0 | 12.5 | MG | TABLET | TID | |||||||
| 113357694 | 11335769 | 11 | C | CETIRIZINE HYDROCHLORIDE. | CETIRIZINE HYDROCHLORIDE | 1 | Oral | AS REQUIRED | 0 | 10 | MG | TABLET | QD | ||||||
| 113357694 | 11335769 | 12 | C | FLUTICASONE | FLUTICASONEFLUTICASONE PROPIONATE | 1 | ONE SPRAY IN EACH NOSTRIL AS NEEDED | 0 | |||||||||||
| 113357694 | 11335769 | 13 | C | LORATADINE. | LORATADINE | 1 | Oral | AS NEEDED | 0 | 10 | MG | TABLET | QD | ||||||
| 113357694 | 11335769 | 14 | C | FLOMAX | TAMSULOSIN HYDROCHLORIDE | 1 | Oral | 0 | .4 | MG | CAPSULE | QD | |||||||
| 113357694 | 11335769 | 15 | C | WARFARIN | WARFARIN | 1 | Oral | MONDAY, WEDNESDAY AND FRIDAY | 0 | 10 | MG | TABLET | TIW | ||||||
| 113357694 | 11335769 | 16 | C | WARFARIN | WARFARIN | 1 | Oral | TUESDAY, THURSDAY, SATURDAY AND SUNDAY | 0 | 5 | MG | TABLET | |||||||
| 113357694 | 11335769 | 17 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | AS NEEDED | 0 | 40 | MG | TABLET | QD | ||||||
| 113357694 | 11335769 | 18 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 0 | 40 | MG | TABLET | QD | |||||||
| 113357694 | 11335769 | 19 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 0 | 20 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113357694 | 11335769 | 1 | Product used for unknown indication |
| 113357694 | 11335769 | 2 | Hypertension |
| 113357694 | 11335769 | 3 | Cardiomyopathy |
| 113357694 | 11335769 | 4 | Product used for unknown indication |
| 113357694 | 11335769 | 5 | Chronic obstructive pulmonary disease |
| 113357694 | 11335769 | 6 | Neuropathy peripheral |
| 113357694 | 11335769 | 7 | Cardiovascular event prophylaxis |
| 113357694 | 11335769 | 8 | Dyslipidaemia |
| 113357694 | 11335769 | 9 | Hypertension |
| 113357694 | 11335769 | 11 | Rhinitis allergic |
| 113357694 | 11335769 | 12 | Rhinitis allergic |
| 113357694 | 11335769 | 13 | Rhinitis allergic |
| 113357694 | 11335769 | 14 | Benign prostatic hyperplasia |
| 113357694 | 11335769 | 15 | Atrial fibrillation |
| 113357694 | 11335769 | 17 | Oedema |
| 113357694 | 11335769 | 18 | Weight increased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113357694 | 11335769 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113357694 | 11335769 | Acute kidney injury | |
| 113357694 | 11335769 | Dehydration | |
| 113357694 | 11335769 | Hypotension |
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 |
|---|---|---|---|---|---|---|
| 113357694 | 11335769 | 1 | 20150716 | 20150716 | 0 | |
| 113357694 | 11335769 | 2 | 20120217 | 20150716 | 0 | |
| 113357694 | 11335769 | 3 | 20150603 | 20150716 | 0 | |
| 113357694 | 11335769 | 4 | 20150716 | 20150716 | 0 | |
| 113357694 | 11335769 | 5 | 20150105 | 0 | ||
| 113357694 | 11335769 | 6 | 20130321 | 20150716 | 0 | |
| 113357694 | 11335769 | 7 | 20140128 | 0 | ||
| 113357694 | 11335769 | 8 | 20141020 | 0 | ||
| 113357694 | 11335769 | 9 | 20150710 | 20150727 | 0 | |
| 113357694 | 11335769 | 11 | 20150428 | 20150716 | 0 | |
| 113357694 | 11335769 | 12 | 20150105 | 0 | ||
| 113357694 | 11335769 | 13 | 20150506 | 0 | ||
| 113357694 | 11335769 | 14 | 20150428 | 0 | ||
| 113357694 | 11335769 | 15 | 20150403 | 0 | ||
| 113357694 | 11335769 | 16 | 20150403 | 0 | ||
| 113357694 | 11335769 | 17 | 20120217 | 20150716 | 0 | |
| 113357694 | 11335769 | 18 | 20150719 | 20150727 | 0 | |
| 113357694 | 11335769 | 19 | 20150728 | 0 |