Dynacirc Side Effects

Generic Name: isradipine

Please note - some side effects for Dynacirc 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 - 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.

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Dynacirc Side Effects - for the Professional

DynaCirc

In multiple dose U.S. studies in hypertension, 1228 patients received DynaCirc® (isradipine) alone or in combination with other agents, principally a thiazide diuretic, 934 of them in controlled comparisons with placebo or active agents. An additional 652 patients (which includes 374 normal volunteers) received DynaCirc® (isradipine) in U.S. studies of conditions other than hypertension, and 1321 patients received DynaCirc® (isradipine) in non-U.S. studies. About 500 patients received DynaCirc® (isradipine) in long-term hypertension studies, 410 of them for at least 6 months. The adverse reaction rates given below are principally based on controlled hypertension studies, but rarer serious events are derived from all exposures to DynaCirc® (isradipine), including foreign marketing experience.

Most adverse reactions were mild and related to the vasodilatory effects of DynaCirc® (dizziness, edema, palpitations, flushing, tachycardia), and many were transient. About 5% of isradipine patients left studies prematurely because of adverse reactions (vs. 3% of placebo patients and 6% of active control patients), principally due to headache, edema, dizziness, palpitations, and gastrointestinal disturbances.

The following table shows the most common adverse reactions, volunteered or elicited, considered by the investigator to be at least possibly drug related. The results for

the DynaCirc® (isradipine) treated patients are presented for all doses pooled together (reported by 1% or greater of patients receiving any dose of isradipine), and also for the two treatment regimens most applicable to the treatment of hypertension with DynaCirc® (isradipine): (1) initial and maintenance dose of 2.5 mg b.i.d., and (2) initial dose of 2.5 mg b.i.d. followed by maintenance dose of 5.0 mg b.i.d.

                      DynaCirc® (isradipine)                 

* Initial dose of 2.5 mg b.i.d. followed by maintenance dose of 5.0 mg b.i.d. † Initial dose of 2.5 mg b.i.d. followed by sequential titration to 5.0 mg b.i.d., 7.5 mg b.i.d., and maintenance dose of 10.0 mg b.i.d. ‡ Propranolol, prazosin, hydrochlorothiazide, enalapril, captopril.
N=	All Doses 934	2.5 mg b.i.d. 199	5 mg b.i.d.* 150	10 mg b.i.d.† 59	Placebo 297	Active Controls 414‡
Adverse Experience	%	%	%	%	%	%
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

Except for headache, which is not clearly drug-related, the more frequent adverse reactions listed show little change, or increase slightly, in frequency over time, as shown in the following table:

Incidence Rates for DynaCirc® (isradipine) (All Doses) by Week (%)

Week N	1 694	2 906	3 649	4 847	5 432	6 494
Adverse Reaction
Headache	6.5	6.1	5.2	5.2	5.8	4.5
Dizziness	1.6	1.9	1.7	2.2	2.3	2.0
Edema	1.2	2.5	3.2	3.2	5.3	5.5
Palpitations	1.2	1.3	1.4	1.9	2.1	1.4
Fatigue	0.4	1.0	1.4	1.2	1.2	1.6
Flushing	1.2	1.3	2.0	1.4	2.1	1.4
Week N	7 153	8 377	9 261	10 362	11 107	12 105
Adverse Reaction
Headache	2.0	2.7	1.9	2.8	2.8	3.8
Dizziness	2.0	1.9	2.3	3.9	4.7	3.8
Edema	5.9	5.0	4.6	4.7	3.8	3.8
Palpitations	1.3	0.8	0.8	1.7	1.9	2.9
Fatigue	2.0	2.7	1.5	1.4	0.9	1.9
Flushing	3.3	1.3	1.1	0.8	0.0	0.0

 Edema, palpitations, fatigue, and flushing appear to be dose-related, especially at the higher doses of 15-20 mg/day.

In open-label, long-term studies of up to two years in duration, the adverse events 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 as in the controlled trials most adverse reactions were mild and transient.

The following adverse experiences were reported in 0.5%-1.0% of the isradipine-treated patients in hypertension studies, or are rare. More serious events from this and other data sources, including postmarketing exposure, are shown in italics. The relationship of these adverse events to isradipine administration is uncertain.

Skin: pruritus, urticaria

Musculoskeletal: cramps of legs/feet

Respiratory: cough

Cardiovascular: shortness of breath, hypotension, atrial fibrillation, ventricular fibrillation, myocardial infarction, heart failure

Gastrointestinal: abdominal discomfort, constipation, diarrhea

Urogenital: nocturia

Nervous System: drowsiness, insomnia, lethargy, nervousness, impotence, decreased libido, depression, syncope, paresthesia (which includes numbness and tingling), transient ischemicattack, stroke

Autonomic: hyperhidrosis, visual disturbance, dry mouth, numbness

Miscellaneous: throat discomfort, leukopenia, elevated liver function tests

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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.

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