Nicardipine Hydrochloride (Page 4 of 5)

ADVERSE REACTIONS

In multiple-dose U.S. and foreign controlled short-term (up to three months) studies 1,910 patients received nicardipine alone or in combination with other drugs. In these studies adverse events were reported spontaneously; adverse experiences were generally not serious but occasionally required dosage adjustment and about 10% of patients left the studies prematurely because of them. Peak responses were not observed to be associated with adverse effects during clinical trials, but physicians should be aware that adverse effects associated with decreases in blood pressure (tachycardia, hypotension, etc.) could occur around the time of the peak effect. Most adverse effects were expected consequences of the vasodilator effects of nicardipine.

Angina

The incidence rates of adverse effects in anginal patients were derived from multicenter, controlled clinical trials. Following are the rates of adverse effects for nicardipine (N=520) and placebo (N=310), respectively, that occurred in 0.4% of patients or more. These represent events considered probably drug-related by the investigator (except for certain cardiovascular events which were recorded in a different category). Where the frequency of adverse effects for nicardipine and placebo is similar, causal relationship is uncertain. The only dose-related effects were pedal edema and increased angina.

Percent of Patients with Adverse Effects in Controlled Studies
(Incidence of discontinuations shown in parentheses)
Adverse Experience Nicardipine PLACEBO
(N= 520) (N= 310)
Pedal Edema 7.1 (0) 0.3 (0)
Dizziness 6.9 (1.2) 0.6 (0)
Headache 6.4 (0.6) 2.6 (0)
Asthenia 5.8 (0.4) 2.6 (0)
Flushing 5.6 (0.4) 1.0 (0)
Increased Angina 5.6 (3.5) 4.2 (1.9)
Palpitations 3.3 (0.4) 0.0 (0)
Nausea 1.9 (0) 0.3 (0)
Dyspepsia 1.5 (0.6) 0.6 (0.3)
Dry Mouth 1.4 (0) 0.3 (0)
Somnolence 1.4 (0) 1.0 (0)
Rash 1.2 (0.2) 0.3 (0)
Tachycardia 1.2 (0.2) 0.6 (0)
Myalgia 1.0 (0) 0.0 (0)
Other edema 1.0 (0) 0.0 (0)
Paresthesia 1.0 (0.2) 0.3 (0)
Sustained Tachycardia 0.8 (0.6) 0.0 (0)
Syncope 0.8 (0.2) 0.0 (0)
Constipation 0.6 (0.2) 0.6 (0)
Dyspnea 0.6 (0) 0.0 (0)
Abnormal ECG 0.6 (0.6) 0.0 (0)
Malaise 0.6 (0) 0.0 (0)
Nervousness 0.6 (0) 0.3 (0)
Tremor 0.6 (0) 0.0 (0)

In addition, adverse events were observed which are not readily distinguishable from the natural history of the atherosclerotic vascular disease in these patients. Adverse events in this category each occurred in <0.4% of patients receiving nicardipine and included myocardial infarction, atrial fibrillation, exertional hypotension, pericarditis, heart block, cerebral ischemia and ventricular tachycardia. It is possible that some of these events were drug-related.

Hypertension

The incidence rates of adverse effects in hypertensive patients were derived from multicenter, controlled clinical trials. Following are the rates of adverse effects for nicardipine (N= 1390) and placebo (N= 211), respectively, that occurred in 0.4% of patients or more. These represent events considered probably drug-related by the investigator. Where the frequency of adverse effects for nicardipine and placebo is similar, causal relationship is uncertain. The only dose-related effect was pedal edema.

Percent of Patients with Adverse Effects in Controlled Studies
(Incidence of discontinuations shown in parentheses)
Adverse Experience Nicardipine PLACEBO
(N = 1390) (N = 211)
Flushing 9.7 (2.1) 2.8 (0)
Headache 8.2 (2.6) 4.7 (0)
Pedal Edema 8.0 (1.8) 0.9 (0)
Asthenia 4.2 (1.7) 0.5 (0)
Palpitations 4.1 (1.0) 0.0 (0)
Dizziness 4.0 (1.8) 0.0 (0)
Tachycardia 3.4 (1.2) 0.5 (0)
Nausea 2.2 (0.9) 0.9 (0)
Somnolence 1.1 (0.1) 0.0 (0)
Dyspepsia 0.8 (0.3) 0.5 (0)
Insomnia 0.6 (0.1) 0.0 (0)
Malaise 0.6 (0.1) 0.0 (0)
Other edema 0.6 (0.3) 1.4 (0)
Abnormal dreams 0.4 (0) 0.0 (0)
Dry mouth 0.4 (0.1) 0.0 (0)
Nocturia 0.4 (0) 0.0 (0)
Rash 0.4 (0.4) 0.0 (0)
Vomiting 0.4 (0.4) 0.0 (0)

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