May 27, 2016
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Corlopam

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Corlopam




Corlopam Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 12/26/2015

Corlopam (fenoldopam mesylate) Injection is a dopamine receptor agonist (vasodilator) used for in-hospital, short-term (up to 48 hours) management of severe high blood pressure (hypertension) when rapid, but quickly reversible, emergency reduction of blood pressure is indicated. Corlopam is available in generic form. Common side effects of Corlopam include headache, flushing (warmth, redness, or tingly feeling, particularly in the face and neck), nausea, low blood pressure (hypotension), fast heartbeat, and low blood potassium.

The drug dose rate of Corlopam is individualized for each patient according to body weight and according to the desired rapidity and extent of pharmacodynamic effect. Corlopam may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Corlopam should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Corlopam (fenoldopam mesylate) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Corlopam FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

Event Placebo
(n = 7)
n (%)
Fenoldopam
(n = 125)
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 - Hypokalaemia

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

Post-Marketing Experience

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 entire FDA prescribing information for Corlopam (Fenoldopam Mesylate)

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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