CORLOPAM SIDE EFFECTS

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 constantinfusion studies are presented in Table 3. There was no clear dose relationship, except possibly for headache, nausea, flushing.

Table 1: Adverse reactions in fixed-dose studies occurring in > 5% of subjects on fenoldopam

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

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