ADVERSE REACTIONS
Adult Patients: Fenoldopam mesylate causes a dose-related fall in blood pressure and increase in heart rate (see PRECAUTIONS; Tachycardia, and Hypotension). In controlled clinical studies of severe hypertension in patients with end-organ damage, 3% (4/137) of patients withdrew because of excessive falls in blood pressure. Increased heart rate could, in theory, lead to ischemic cardiac events or worsened heart failure, although these events have not been observed. The most common events reported as associated with fenoldopam mesylate use are headache, cutaneous dilation (flushing), nausea, and hypotension, each reported in more than 5% of patients.
Adverse reactions in controlled trials in hypertensive adult patients
Adverse events occurring more than once in any dosing group (once if potentially important or plausibly drug-related) in the fixed-dose constant-infusion studies are presented in the following Table by infusion-rate group. There was no clear dose relationship, except possibly for headache, nausea, flushing.
Table 3 ADVERSE EVENTS
FROM FIXED-DOSE INFUSION STUDIES BY DOSAGE GROUP | Fenoldopam Mesylate Dosage (mcg/kg/min) (Adults) |
| Body System | Event |
Placebo
(n=7)
|
0.01
(n=26) |
0.03-0.04
(n=31) |
0.1
(n=28) |
0.3-0.4
(n=29) |
0.6-0.8
(n=11) |
| Body, General | Headache | 1 | 5 | 4 | 7 | 8 | 6 |
| Injection site reaction | 0 | 1 | 3 | 0 | 3 | 2 |
| Cardiovascular | ST-T abnormalitites (primarily T-wave inversion) | 0 | 2 | 4 | 0 | 1 | 0 |
| Flushing | 0 | 0 | 0 | 0 | 1 | 3 |
| Hypotension
| 0 | 0 | 0 | 2 | 0 | 2 |
| Postural hypotension | 0 | 2 | 0 | 0 | 0 | 0 |
| Tachycardia | 0 | 0 | 0 | 0 | 0 | 2 |
| Digestive | Nausea | 0 | 3 | 0 | 3 | 5 | 4 |
| Vomiting | 0 | 2 | 0 | 2 | 1 | 2 |
| Abdominal pain/fullness | 0 | 2 | 0 | 0 | 2 | 1 |
| Constipation | 0 | 0 | 0 | 0 | 0 | 2 |
| Diarrhea | 0 | 0 | 0 | 0 | 2 | 0 |
| Metabolic and Nutritional | Increased creatinine | 0 | 0 | 2 | 0 | 0 | 0 |
| Hypokalemia | 0 | 2 | 2 | 0 | 1 | 0 |
| Nervous | Nervousness/anxiety | 0 | 0 | 1 | 0 | 0 | 2 |
| Insomnia | 0 | 2 | 0 | 0 | 0 | 0 |
| Dizziness | 0 | 1 | 1 | 2 | 2 | 0 |
| Respiratory | Nasal congestion | 0 | 0 | 0 | 0 | 0 | 2 |
| Skin and Appendages | Sweating | 0 | 0 | 0 | 1 | 1 | 2 |
| Urogenital | Urinary tract infection | 0 | 2 | 0 | 1 | 0 | 0 |
| Musculoskeletal | Back pain | 0 | 1 | 0 | 1 | 2 | 2 |
Adverse effects in overall database
The adverse event incidences listed below are based on observations of over 1,000 fenoldopam mesylate treated adult patients and not listed in the Table 3 above.
Events reported with a frequency between 0.5 to 5% in patients treated with IV fenoldopam mesylate
| Cardiovascular: | extrasystoles, palpitations, bradycardia, heart failure, ischemic heart disease, myocardial infarction, angina pectoris |
| Metabolic: | elevated BUN, elevated serum glucose, elevated transaminase, elevated LDH |
| General Body: | non-specific chest pain, pyrexia |
| Hematologic/Lymphatic: | leukocytosis, bleeding |
| Respiratory: | dyspnea, upper respiratory disorder |
| Genitourinary: | oliguria |
| Musculoskeletal: | limb cramp |
Pediatric Patients: Information relating to treatment-emergent adverse events of fenoldopam injection in pediatric patients is approved for Abbott Laboratories’ fenoldopam drug products. However, due to Abbott’s marketing exclusivity rights, this drug product is not labeled for pediatric use.
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