Dynacirc CR Side Effects

Generic Name: isradipine

Please note - some side effects for 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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Dynacirc CR - for the Consumer

DynaCirc CR Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using DynaCirc CR Extended-Release Tablets:

Constipation; dizziness; flushing; headache; heartburn; lightheadedness; sinus infection; stomach upset; tiredness; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; hoarseness; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; chills, fever, or persistent sore throat; confusion; decreased urination; fast or irregular heartbeat; numbness of an arm or leg; numbness or tingling of the skin; shortness of breath; speech problems; sudden severe headache, dizziness, vomiting, or fainting; swelling of the feet or hands; tender, bleeding, or swollen gums.

Dynacirc CR Side Effects - for the Professional

DynaCirc CR

In a controlled clinical trial with DynaCirc CR® (isradipine), dose-related edema occurred at an incidence of approximately 9% at 5 mg; 13% at 10 mg; 16% at 15 mg; and 36% at the highest dose studied (20 mg), was mild to moderate in severity, and was not related to age or gender.

The incidences of elicited or volunteered adverse reactions (excluding non-drug related) in the following tables are based on 6-week multicenter, placebo-controlled, double-blind hypertension studies. Less than 1% of DynaCirc CR® (isradipine) or placebo-treated patients discontinued from these studies due to adverse reactions.

The most common adverse experiences (≥1.0%) reported with DynaCirc CR® (isradipine) in a dose-response study are shown in the following table. There were no discontinuations of patients treated with DynaCirc CR® (isradipine) in this study due to these common side effects.

The table below shows elicited or volunteered adverse experiences for DynaCirc CR® (isradipine) treated patients in two 6-week, placebo-controlled, multicenter studies, at doses from 5-20 mg, and considered by the investigator to be at least possibly drug related. The results for DynaCirc CR® (isradipine) treated patients are presented for all doses pooled together (reported by at least 1.0% of active drug treated patients). The incidence of adverse reactions are listed below:

The following adverse experiences were reported in 0.5%-1.0% or less of DynaCirc CR® (isradipine) or immediate-release DynaCirc® (isradipine) treated patients in hypertensive studies, or were noted in postmarketing experience with immediate-release DynaCirc® (isradipine) Capsules. More serious events are shown in italics. The relationship of these adverse experiences to isradipine administration is uncertain.

Skin: pruritus, urticaria, angioedema

Musculoskeletal: backache/pain, joint pain, neck pain/sore/stiff, legs ache/pain, cramps of legs/feet

Respiratory: dyspnea, nasal congestion, cough

Cardiovascular: epistaxis, tachycardia, chest pain, shortness of breath, hypotension, syncope, atrial or ventricular fibrillation, myocardial infarction, heart failure

Gastrointestinal: diarrhea, vomiting, appetite increased or decreased

Urogenital: pollakiuria, impotence, dysuria, nocturia

Central Nervous: drowsiness, insomnia, lethargy, nervousness, libido decrease/frigidity, impotence, depression, paresthesia (which includes numbness and tingling), transient ischemic attack, stroke

Autonomic: dry mouth, hyperhidrosis, visual disturbance

Miscellaneous: weight gain, throat discomfort, drug fever, leukopenia, elevated liver function tests

No gastrointestinal bleeding has been reported in clinical trials with DynaCirc CR® (isradipine) Controlled Release Tablets.

In a long-term (one-year) DynaCirc CR® (isradipine) open-label, hypertension trial, the adverse events reported were generally the same as those seen in the short-term placebo-controlled studies. About 6% of DynaCirc CR® (isradipine) treated patients discontinued the long-term trial due to adverse reactions.

With immediate-release DynaCirc® (isradipine) Capsules, most of the adverse experiences were transient, mild, and related to vasodilatory effects. The following table shows the most common adverse events reported in U.S. clinical trials for immediate-release DynaCirc® (isradipine) Capsules, volunteered or elicited, and considered by the investigator to be at least possibly drug related.

In open-label, long-term studies of up to two years in duration with immediate-release DynaCirc® (isradipine) Capsules, the adverse experiences reported were generally the same as those reported in the short-term controlled trials. The overall frequencies of these adverse events were slightly higher in the long-term than in the controlled studies, but in the controlled studies most adverse reactions were mild and transient.

Side Effects by Body System

General

Isradipine 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. 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 are rare. Pruritus, urticaria, and angioedema have been reported.

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