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CORLOPAM Adverse Reactions (fenoldopam mesylate injection, USP)

6 ADVERSE REACTIONS

6.1 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 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.

Table 3. Adverse reactions in fixed-dose studies occurring in > 5% of subjects on fenoldopam

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

6.2 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 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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