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Dynacirc CR (Isradipine) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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.

Most Frequently Reported Newly-Occurring Adverse Reactions in Dose-Response Study
DynaCirc CR® (isradipine) Placebo Group
Adverse Reactions (Excluding Non-Drug Related)

 

5 mg (N=79)

 

10 mg (N=79)

 

15 mg (N=82)

 

20 mg (N=78)

 

(N=83)

Headache13.9%12.7%18.3%10.3%15.7%
Edema8.9%12.7%15.9%35.9%3.6%
Dizziness5.1%6.3%3.7%6.4%2.4%
Constipation3.8%1.3%1.2%2.6%0.0%
Fatigue2.5%7.6%3.7%3.8%2.4%
Flushing2.5%3.8%1.2%1.3%1.2%
Abdominal Discomfort1.3%5.1%3.7%5.1%1.2%
Rash1.3%1.3%0.0%2.6%0.0%

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:

Adverse Reactions (Excluding Non-Drug Related) Treatment Group

DynaCirc CR® (isradipine)

(N=422)

Placebo (N=186)
Edema15.2%2.2%
Headache13.0%12.4%
Dizziness4.7%2.7%
Fatigue4.3%2.2%
Abdominal Discomfort2.8%0.5%
Flushing1.9%0.5%
Constipation1.7%0.0%
Palpitations1.2%0.0%
Nausea1.2%1.6%
Abdominal Distention1.2%0.0%

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.

DynaCirc® (isradipine) Placebo (N=297) % Active Controls 1 (N=414) %
Adverse Experience All Doses 2.5 mg b.i.d. 5 mg b.i.d. 2 10 mg b.i.d. 3
Headache13.712.610.722.014.19.4
Dizziness7.38.05.33.44.48.2
Edema7.23.58.78.53.02.9
Palpitations4.01.04.75.11.41.5
Fatigue3.92.52.08.50.36.3
Flushing2.63.02.05.10.01.2
Chest Pain2.42.52.71.72.42.9
Nausea1.81.02.75.11.73.1
Dyspnea1.80.52.73.41.02.2
Abdominal Discomfort1.70.03.31.71.73.9
Tachycardia1.51.01.33.40.30.5
Rash1.51.52.01.70.30.7
Pollakiuria1.52.01.33.40.0<1.0
Weakness1.20.00.70.00.01.2
Vomiting1.11.01.30.00.30.2
Diarrhea1.10.02.73.42.01.9

1 Propranolol, prazosin, hydrochlorothiazide, enalapril, captopril.
2 Initial dose of 2.5 mg b.i.d. followed by maintenance dose of 5.0 mg b.i.d.
3 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.

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.



REPORTS OF SUSPECTED DYNACIRC CR SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Dynacirc CR. The information is not vetted and should not be considered as verified clinical evidence.

Possible Dynacirc CR side effects / adverse reactions in 72 year old male

Reported by a consumer/non-health professional from United States on 2012-02-28

Patient: 72 year old male

Reactions: Product Quality Issue, Blood Pressure Increased, Blood Pressure Inadequately Controlled, Diabetes Mellitus Inadequate Control

Suspect drug(s):
Dynacirc
    Dosage: 5mg per day
    Administration route: Oral
    Indication: Hypertension

Dynacirc CR
    Dosage: 5mg per day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-01-01
    End date: 2012-02-03

Other drugs received by patient: Norvasc; Flomax; Plavix; Lisinopril; Metformin HCL; Tamsulosin HCL; Metoprolol; Crestor



Possible Dynacirc CR side effects / adverse reactions in 60 year old male

Reported by a consumer/non-health professional from United States on 2012-05-11

Patient: 60 year old male

Reactions: Arthralgia, Blood Pressure Inadequately Controlled, Musculoskeletal Pain, Medication Residue

Suspect drug(s):
Dynacirc CR

Other drugs received by patient: Vitamin TAB



Possible Dynacirc CR side effects / adverse reactions in 88 year old female

Reported by a consumer/non-health professional from United States on 2012-05-11

Patient: 88 year old female

Reactions: Blood Pressure Increased, Product Quality Issue, Medication Residue

Suspect drug(s):
Dynacirc CR

Other drugs received by patient: Coumadin



See index of all Dynacirc CR side effect reports >>

Drug label data at the top of this Page last updated: 2007-05-15

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