DynaCirc CR Side Effects

Generic name: isradipine

Note: This document contains side effect information about isradipine. Some of the dosage forms listed on this page may not apply to the brand name DynaCirc CR.

Some side effects of DynaCirc CR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to isradipine: oral capsule, oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking isradipine (the active ingredient contained in DynaCirc CR) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• feeling like you might pass out;

• feeling short of breath, even with mild exertion;

• swelling in your hands and feet;

• fast or pounding heartbeats; or

• chest pain.

Less serious side effects of isradipine may include:

• dizziness;

• warmth, redness, or tingly feeling under your skin;

• headache;

• weakness, tired feeling;

• nausea, vomiting, diarrhea, upset stomach; or

• skin rash or itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to isradipine: oral capsule, oral tablet extended release

General

Isradipine (the active ingredient contained in DynaCirc CR) is generally well-tolerated. Most side effects occurred as commonly as with placebo in placebo-controlled trials, except for flushing, headache, and palpitations.

Cardiovascular

Cardiovascular side effects are among the most common, and are related to the vasodilatory properties of isradipine (the active ingredient contained in DynaCirc CR) Peripheral edema and flushing are reported in 3% to 14% of patients, being more common at higher doses. Dizziness occurs in 3% to 8% of patients.

Palpitations or a greater awareness of heart beats is reported in 1% to 5% of patients. Flushing and palpitations are more likely with dosages greater than 5 mg daily; women have reported flushing more than men. Edema was reported in up to 22% of patients in one study (mean dose was 5.9 mg TID). In large studies, the incidence of edema is less than 3%, and appeared to be more likely in patients greater than 60 years of age.

Isradipine does not appear to adversely affect plasma lipids.

Nervous system

Headache was reported in up to 16% of patients in one study, although the mean dose was 5.9 mg three times daily to treat angina pectoris. Headache is more likely with dosages greater than 5 mg daily. Visual disturbances are reported in less than 2% of patients. Sleep disturbances are reported in 0.1% of patients.

Nervous system side effects are probably related to the vasodilatory effects of isradipine. Headache is reported in 9% to 30% of patients and fatigue is reported in 7% of patients.

Gastrointestinal

Anorexia, nausea, vomiting, and diarrhea are reported in less than 4% of patients.

Gastrointestinal side effects are unusual, and include constipation in less than 2% of patients.

Respiratory

Respiratory system complaints include dyspnea and cough in 2% of patients.

Musculoskeletal

Musculoskeletal pain is reported in 1% of patients.

Dermatologic

Dermatologic complaints of "disturbed skin sensation" are reported in less than 4% of patients.

Hypersensitivity

Hypersensitivity reactions to isradipine (the active ingredient contained in DynaCirc CR) are rare. Pruritus, urticaria, and angioedema have been reported.

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