Fenoldopam Side Effects

Not all side effects for fenoldopam may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to fenoldopam: parenteral injection

Side effects include:

Adults: Headache, flushing, nausea, hypotension, hypokalemia.

Pediatric patients: Hypotension, tachycardia.

For Healthcare Professionals

Applies to fenoldopam: intravenous solution

Cardiovascular

Fenoldopam can cause dose-related increases in heart rate and tachycardia and symptomatic decreases in blood pressure. Caution is recommended when administering this drug to patients with acute cerebral infarction or hemorrhage. In addition, because some elderly people may not tolerate sudden or significant decreases in systemic blood pressure due to decreased intracerebral vascular autoregulation, cautious reduction of blood pressure with fenoldopam is recommended when treating the elderly with emergent hypertension.

Animal data have revealed evidence of arterial lesions that have not been documented in humans. These lesions have been characterized by dose-related medial necrosis and hemorrhage in the renal and splanchnic arteries of rats given fenoldopam intravenously in dosages ranging from 1 to 100 mcg/kg/min for 24 hours (the latter dosage is over 300 times the maximum recommended human infusion rate (on a per kg basis). (Similar lesions have been associated with the use of dopamine.) Animal data are conflictual as dog data have not revealed these lesions. The suspected mechanism involves activation of the D1-like dopaminergic receptors.

Oral administration of fenoldopam to rats was associated with a higher incidence of polyarteritis nodosa compared with controls.

Cardiovascular side effects are the most common and potentially serious side effects. In controlled trials of patients with severe hypertension and end-organ damage, 3% (4/137) patients withdrew from therapy due to excessive hypotension. Reflex tachycardia has rarely been associated with the use of this drug. Tachycardia can be associated with increased cardiac work, oxygen demand, and can increase the risk of myocardial ischemia. This may be especially important in some patients with underlying coronary artery disease. Other cardiovascular events associated with the use of fenoldopam include ST-T wave ECG changes in 6% to 33% (suggestive of ischemia) and flushing in 7% to 11% of patients (probably due to peripheral vasodilation). Less common cardiovascular side effects include extrasystoles, palpitations, bradycardia, heart failure, myocardial infarction, and angina pectoris (less than 1% of patients). Many of these events may reflect underlying disease in the populations studied.

Nervous system

Nervous system side effects have included dose-related headaches in 11% to 36% and dizziness in 10% of patients. Less commonly, anxiety and insomnia have been associated with the use of fenoldopam.

Gastrointestinal

Gastrointestinal side effects have included nausea in 20% of patients and rare complaints of vomiting, abdominal pain/fullness, constipation, or diarrhea.

Metabolic

Rarely, the use of fenoldopam has been associated with metabolic side effects, including decreased serum potassium concentrations to values below 3.0 mEq/L. It is unknown whether this hypokalemia resulted from a pressure natriuresis (with enhanced sodium-potassium exchange) or a direct drug effect. Appropriate monitoring of serum potassium and electrolytes is recommended during fenoldopam infusions.

Other metabolic side effects have included elevated BUN, serum glucose, LDH, and serum transaminase values.

Hematologic

Hematologic side effects have only rarely been associated with the use of fenoldopam. They have included leukocytosis and bleeding.

Respiratory

Reported respiratory problems may have been related to underlying disease, and have included dyspnea, wheezing, and nasal congestion.

Renal

In general, the use of fenoldopam has been shown to preserve or improve renal function in patients with severe hypertension. The only adverse effects have been rare cases of elevated BUN and oliguria. The vasodilating effects of this drug have been observed in renal afferent and efferent arterioles. In humans, limited data have shown increases in renal blood flow in hypertensive and normal subjects treated with intravenous fenoldopam. However, no beneficial clinical effect on renal function has been shown in patients with heart failure or hepatic or severe renal disease. The manufacturer promotes this drug's positive effect on the kidney. In clinical trials, use of fenoldopam has been shown to maintain renal perfusion and increase both enuresis and diuresis in patients with normal kidneys and in those with impaired renal function.

Musculoskeletal

Rare complaints of musculoskeletal cramping and back pain have been associated with the use of fenoldopam.

Ocular

The use of fenoldopam has been associated with increased intraocular pressure (IOP) in healthy volunteers and in patients with hypertension. Dose-related increases of 6.5 mm Hg have been associated with fenoldopam infusions of 0.5 mcg/kg/min in patients with open-angle glaucoma after 3.5 hours. The mechanism is unknown. Caution is recommended when administering this drug to patients with glaucoma or other causes of increased IOP.

Data have shown that the infusions of fenoldopam up to 0.5 mcg/kg/min have been associated with significant increases in IOP without significant changes in macular blood flow, visual field, aqueous outflow facility, and aqueous humor production. The increase in IOP among the patients studied (patients with elevated IOP or primary open-angle glaucoma) during infusions of fenoldopam suggests that dopamine-1 (D1) receptors play a role in the regulation of IOP.

Endocrine

Fenoldopam indirectly produces some endocrinologic changes. It induces systemic and renal vasodilation and natriuresis by direct stimulation of D1-like receptors in the proximal renal tubule, which is (partially) counteracted by a rise of plasma renin activity and subsequently of aldosterone. Increased plasma aldosterone can result in a mild kaliuresis and hypokalemia.

Hepatic

Use of fenoldopam in patients with hepatic failure has been approved by the FDA. However, although this drug has been shown to safely decrease systemic blood pressure in this population, increased portal pressures have been documented in patients with liver cirrhosis and ascites (in some cases without significant desired increases in renal blood flow). Because of the increased portal pressure (theoretically due to increased mesenteric blood flow), some experts have expressed concern that this drug could increase the risk of hemorrhage from esophageal varices.

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