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.

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.

Seek medical attention right away if any of these SEVERE side effects occur when using DynaCirc CR Extended-Release Tablets:

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Top

Dynacirc CR Side Effects - for the Professional

DynaCirc CR

In a controlled clinical trial with DynaCirc CR, 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 patients treated with DynaCirc CR or placebo discontinued from these studies due to adverse reactions.

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

Most Frequently Reported Newly-Occurring Adverse Reactions in Dose-Response Study

	DynaCirc CR				Placebo Group
Adverse Reactions (Excluding Non-Drug Related)	5 mg (N=79)	10mg (N=79)	15mg (N=82)	20 mg (N=78)	(N=83)
Headache	13.9%	12.7%	18.3%	10.3%	15.7%
Edema	8.9%	12.7%	15.9%	35.9%	3.6%
Dizziness	5.1%	6.3%	3.7%	6.4%	2.4%
Constipation	3.8%	1.3%	1.2%	2.6%	0.0%
Fatigue	2.5%	7.6%	3.7%	3.8%	2.4%
Flushing	2.5%	3.8%	1.2%	1.3%	1.2%
Abdominal discomfort	1.3%	5.1%	3.7%	5.1%	1.2%
Rash	1.3%	1.3%	0.0%	2.6%	0.0%

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

	Treatment Group
Adverse Reactions (Excluding Non-Drug Related)	DynaCirc CR (N=422)	Placebo (N=186)
Edema	15.2%	2.2%
Headache	13.0%	12.4%
Dizziness	4.7%	2.7%
Fatigue	4.3%	2.2%
Abdominal discomfort	2.8%	0.5%
Flushing	1.9%	0.5%
Constipation	1.7%	0.0%
Palpitations	1.2%	0.0%
Nausea	1.2%	1.6%
Abdominal distention	1.2%	0.0%

The following adverse experiences were reported in 0.5% to 1.0% or less of patients treated with DynaCirc CR or immediate-release DYNACIRC in hypertensive studies, or were noted in postmarketing experience with immediate-release DYNACIRC. 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 Controlled Release Tablets.

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

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

	DYNACIRC				Placebo	Active Controls*
Adverse Experience	All Doses	2.5 mg twice-daily	5 mg twice-daily†	10 mg twice-daily††	(N=297) %	(N=414) %
Headache	13.7	12.6	10.7	22.0	14.1	9.4
Dizziness	7.3	8.0	5.3	3.4	4.4	8.2
Edema	7.2	3.5	8.7	8.5	3.0	2.9
Palpitations	4.0	1.0	4.7	5.1	1.4	1.5
Fatigue	3.9	2.5	2.0	8.5	0.3	6.3
Flushing	2.6	3.0	2.0	5.1	0.0	1.2
Chest pain	2.4	2.5	2.7	1.7	2.4	2.9
Nausea	1.8	1.0	2.7	5.1	1.7	3.1
Dyspnea	1.8	0.5	2.7	3.4	1.0	2.2
Abdominal discomfort	1.7	0.0	3.3	1.7	1.7	3.9
Tachycardia	1.5	1.0	1.3	3.4	0.3	0.5
Rash	1.5	1.5	2.0	1.7	0.3	0.7
Pollakiuria	1.5	2.0	1.3	3.4	0.0	<1.0
Weakness	1.2	0.0	0.7	0.0	0.0	1.2
Vomiting	1.1	1.0	1.3	0.0	0.3	0.2
Diarrhea	1.1	0.0	2.7	3.4	2.0	1.9

*  Propranolol, prazosin, hydrochlorothiazide, enalapril, and captopril.

†  Initial dose of 2.5 mg twice-daily followed by maintenance dose of 5.0 mg twice-daily.

†† Initial dose of 2.5 mg twice-daily followed by sequential titration to 5.0 mg twice-daily, 7.5 mg twice-daily, and maintenance dose of 10.0 mg twice-daily.

In open-label, long-term studies of up to 2 years in duration with immediate-release DYNACIRC, 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.

Top

Side Effects by Body System - for Healthcare Professionals

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.

Top

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.