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Clinical Trials Experience
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 clinical 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 5. There was no clear dose relationship, except possibly for headache, nausea, flushing.
Table 5: Adverse reactions in fixed-dose studies
occurring in > 5% of subjects on fenoldopam
(n = 7)
(n = 125)
|Headache||1 (14%)||30 (24%)|
|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 — Hypokalaemia
Psychiatric Disorders — Nervousness/Anxiety, insomnia
Nervous System Disorders — Dizziness
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 difficult to reliably estimate their frequency or evaluate a causal relationship to drug exposure. Voluntary reports of adverse reactions temporally associated with Corlopam that have been received since market introduction and that may have no causal relationship with the drug include the following:
Cardiac Disorders — Cardiogenic shock
Vascular Disorders — Hypotension
Gastrointestinal Disorders — Abdominal distension
Investigations — Electrocardiogram ST segment depression, oxygen saturation decreased
Read the Corlopam (fenoldopam mesylate) Side Effects Center for a complete guide to possible side effects
Avoid concomitant use of fenoldopam with beta-blockers. If the drugs are used together, blood pressure should be monitored frequently because hypotension could result from beta-blocker inhibition of the sympathetic reflex response to fenoldopam.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/26/2015
Additional Corlopam Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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