Table 3.
Adverse drug reactions reported in the FAERS database (submitted to FDA)
| Drug (SOC) | No. ADRs No. (%) of reports in FAERS database | ADR signals stratified by number of reports |
||||||
|---|---|---|---|---|---|---|---|---|
| <3 reports | 3–5 reports | 6–10 reports | 11–30 reports | 31–50 reports | 51–100 reports | >100 reports | ||
| Bisacodyl (Cardiac disorders) | 39 ADRs in 354 of 14 645 reports (2.44%) | Atrial hypertrophy, cardioactive drug level above therapeutic, cardiorenal syndrome, cardiopulmonary failure, cardiac pacemaker replacement, cardiolipin antibody positive, cardiac pacemaker insertion, cardiac flutter, cardiac output decreased, cardiac failure chronic, cardiac myxoma, conduction disorder (n = 12) | Atrial tachycardia, ventricular hypertrophy, ventricular hypokinesia, cardiac asthma, cardiac failure acute, cardioactive drug level increased, cardiac valve disease, ventricular dysfunction, cardiac tamponade, dyspnea paroxysmal nocturnal (n = 10) | Ventricular fibrillation, cardiomyopathy, cardiogenic shock, ventricular extrasystole, dyspnea exertional, cardiac murmur, cardiovascular disorder (n = 7) | Cardiac arrest, cardiac failure, cardiomegaly, arrhythmia, atrial flutter, cardiac disorder, ventricular tachycardia (n = 7) | Atrial fibrillation, cardiorespiratory arrest (n = 2) | Cardiac failure congestive (n = 1) | |
| Prazosin (Metabolism and nutrition disorders) | 6 ADRs in 110 reports (1.45%) | Hypernatremia, hypophosphatemia (n = 2) | Weight decreased, dehydration, decreased appetite (n = 4) | Hyperkalemia (n = 1) | ||||
| Phenylephrine (Psychiatric disorders) | 14 ADRs in 398 reports (4.29%) | Confusion postoperative, mental disorder due to a general medical condition, consciousness fluctuating (n = 3) | Disorientation, mental impairment (n = 2) | Somnolence, mental disorder, delirium (n = 3) | Fear of death, confusional state, mental status changes, psychiatric symptom (n = 4) | Depression (n = 1) | Emotional distress (n = 1) | |
| Sucralfate (Renal and urinary disorders) | 65 ADRs in 705 reports (1.99%) | Urine output increased, nephritis, urinary tract infection pseudomonal, bladder spasm, bladder cancer, ureteric obstruction, renal cancer metastatic, renal artery arteriosclerosis, renal tubular acidosis, urethral stenosis, urine color abnormal, urine chloride decreased, urine bilirubin increased, urine calcium decreased, urinary bladder hemorrhage, urinary bladder rupture, urinary tract infection fungal, glomerulonephritis, glomerulonephritis proliferative, bladder pain, bladder neoplasm, bladder dilatation, bladder diverticulum, bladder obstruction, bladder irritation, urge incontinence, renal tubular disorder, renal stone removal, renal necrosis, renal pain, renal hematoma, renal cortical necrosis, renal atrophy, renal arteriosclerosis, renal ischemia (n = 35) | Proteinuria, bladder disorder, renal function test abnormal, renal mass, renal artery stenosis, renal cancer, urine analysis abnormal, urinary tract obstruction, bladder prolapse, renal hemorrhage, renal transplant (n = 11) | Chromaturia, azotemia, tubulointerstitial nephritis, oliguria, renal cell carcinoma, urinary hesitation, urinary tract disorder (n = 7) | Renal disorder, renal impairment, urinary retention, renal cyst, urinary incontinence, renal tubular necrosis, urine output decreased, renal injury (n = 8) | Renal failure chronic (n = 1) | Renal failure, renal failure acute, urinary tract infection (n = 3) | |