(fenoldopam mesylate injection, USP)
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most common reactions associated with fenoldopam use are headache, cutaneous dilation (flushing), nausea, and hypotension, each reported in more than 5% of patients.
Adverse reactions 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 Table 3. There was no clear dose relationship, except possibly for headache, nausea, flushing.
Event | Placebo (n = 7) | Fenoldopam (n = 125) |
n (%) | n (%) | |
Headache | 1 (14%) | 30 (24%) |
Nausea | 0 | 15 (12%) |
Vomiting | 0 | 7 (6%) |
Injection site reaction | 0 | 9 (7%) |
Electrocardiogram T wave inversion | 0 | 7 (6%) |
The following additional adverse reactions were observed more frequently in patients treated with fenoldopam
Incidence 0.5% to 5%
Metabolism and Nutrition Disorders — Hypokalemia
Psychiatric Disorders — Nervousness/Anxiety, insomnia
Nervous System Disorders — Dizziness
Cardiac Disorders — Extrasystoles, palpitations, cardiac failure, ischemic heart disease, myocardial infarction, angina pectoris, tachycardia
Gastrointestinal Disorders — Abdominal pain
Skin and Subcutaneous Tissue Disorders — Hyperhidrosis
Musculoskeletal and Connective Tissue Disorders —Muscle spasms
Renal and Urinary Disorders — Oliguria
General Disorders and Administration Site Conditions —Chest pain, pyrexia
Investigations — Blood urea increased, blood creatinine increased, blood glucose increased, transaminases increased, blood lactate dehydrogenase increased
The following adverse reactions have been identified during post approval use of CORLOPAM. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Voluntary reports of adverse reactions temporally associated with CORLOPAM that have been received since market introduction include the following:
Cardiac Disorders — Cardiogenic shock
Vascular Disorders — Hypotension
Gastrointestinal Disorders — Abdominal distension
Investigations — Electrocardiogram ST segment depression, oxygen saturation decreased
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