Nicardipine Side Effects

Brand Names: Cardene, Cardene IV, Cardene SR

Please note - some side effects for Nicardipine 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 Nicardipine - for the Consumer

Nicardipine

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 Nicardipine:

Dizziness; headache; nausea; upset stomach; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Nicardipine:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); calf pain, swelling, or redness; confusion; fainting; fast or irregular heartbeat; fever; increased chest pain; pain, redness, or swelling at the injection site; pounding in the chest; shortness of breath or wheezing; swelling of the feet, ankles, or hands; unusual bruising or bleeding.

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.

Nicardipine Capsules

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 Nicardipine Capsules:

Dizziness; headache; nausea; upset stomach; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Nicardipine Capsules:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); calf pain, swelling, or redness; confusion; fainting; fast or irregular heartbeat; fever; increased chest pain; pounding in the chest; shortness of breath or wheezing; swelling of the feet, ankles, or hands; unusual bruising or bleeding.

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.

Nicardipine Sustained-Release Capsules

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 Nicardipine Sustained-Release Capsules:

Dizziness; headache; nausea; upset stomach; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Nicardipine Sustained-Release Capsules:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); calf pain, swelling, or redness; confusion; fainting; fast or irregular heartbeat; fever; increased chest pain; pounding in the chest; shortness of breath or wheezing; swelling of the feet, ankles, or hands; unusual bruising or bleeding.

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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Nicardipine Side Effects - for the Professional

Nicardipine

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.

Table 2

Percentage of Patients with Adverse Effects in Controlled Studies vs Percentage of Patients in Placebo Studies
Percent of Patients with Adverse Effects in Controlled Studies (Incidence of discontinuations shown in parentheses)
Adverse Experience	Nicardipine (N= 520)		PLACEBO (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.

Table 3

Percent of Patients with Adverse Effects in Controleld Studies
Percent of Patients with Adverse Effects in Controlled Studies (Incidence of discontinuations shown in parentheses)
Adverse Experience	Nicardipine (N = 1390)		PLACEBO (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)

Rare Events

The following rare adverse events have been reported in clinical trials or the literature:

Body as a Whole: infection, allergic reaction

Cardiovascular: hypotension, postural hypotension, atypical chest pain, peripheral vascular disorder, ventricular extrasystoles, ventricular tachycardia

Digestive: sore throat, abnormal liver chemistries

Musculoskeletal: arthralgia

Nervous: hot flashes, vertigo, hyperkinesia, impotence, depression, confusion, anxiety

Respiratory: rhinitis, sinusitis

Special Senses: tinnitus, abnormal vision, blurred vision

Urogenital: increased urinary frequency

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Side Effects by Body System - for Healthcare Professionals

General

Side effects of nicardipine were generally mild and transient. Most were expected consequences of vasodilation. Therapy was discontinued in approximately 9% to 12% of patients, primarily due to hypotension, headache, and tachycardia.

Cardiovascular

Cardiovascular side effects have included hypotension (up to 8%), tachycardia (up to 5%), and angina pectoris. Atrioventricular block, ST segment depression, inverted T wave, deep vein thrombophlebitis, and at least one case of profound sinus bradycardia have been reported with intravenous nicardipine. Increased angina (5.6%), vasodilatation (4.7%), palpitations (up to 4.1%), postural hypotension (up to 0.9%), sustained tachycardia (0.8%), abnormal ECG (0.6%), chest pain, atypical chest pain, peripheral vascular disorder, and ventricular extrasystoles have been reported with oral nicardipine. Sinus node dysfunction, myocardial infarction, atrial fibrillation, exertional hypotension, pericarditis, heart block, cerebral ischemia, and ventricular tachycardia (any of which may be due to disease progression) have been observed in patients on chronic therapy with oral nicardipine. A case of erythromelalgia (paroxysmal burning or throbbing of the skin) associated with nicardipine has been reported.

Rare cases of angina pectoris associated with nicardipine have been reported. These cases may be due to a coronary artery "steal phenomenon" secondary to coronary vasodilation or increased myocardial oxygen demand secondary to increased heart rate.

Nervous system

The dose of nicardipine SR for a 74-year-old man with angina pectoris was increased over a 2-week period from 30 mg BID to 60 mg BID. One week later the patient suffered two episodes of severe generalized tonic and clonic muscular contractions. There was no loss of bladder control or loss of consciousness. The symptoms were controlled by IV diazepam. Diltiazem was substituted and his symptoms never recurred. The patient refused rechallenge. The authors of this case report speculated whether some calcium channel blockers adversely affect calcium-mediated neurotransmission.

Nervous system side effects have included headache (up to 21%) and tinnitus. Hypertonia and ear disorder have been reported with intravenous nicardipine. Dizziness (up to 6.9%), somnolence (up to 1.4%), paresthesia (1%), syncope (0.8%), insomnia (0.6%), tremor (0.6%), vertigo, and hyperkinesia have been reported with oral nicardipine. A single case of severe dyskinesia has been associated with nicardipine SR.

Gastrointestinal

Gastrointestinal side effects have included nausea/vomiting (up to 7%) and dyspepsia (up to 1.5%). Dry mouth (up to 1.4%), constipation (0.6%), and sore throat have been reported with oral nicardipine. A case of parotitis associated with nicardipine has been reported. Noncompliance due to nausea and vomiting has been reported.

Other

Other side effects associated with intravenous nicardipine have included fever and neck pain. Pedal edema (up to 8%), asthenia (up to 5.8%), flushing (up to 9.7%), other edema (up to 1%), malaise (0.6%), pain (0.6%), infection, hot flashes, and face edema have been reported with oral nicardipine.

Dermatologic

Dermatologic side effects associated with oral nicardipine have included rash (up to 6%) and increased sweating (0.6%).

Metabolic

Metabolic side effects associated with intravenous nicardipine have included hypophosphatemia and peripheral edema.

Musculoskeletal

Musculoskeletal side effects associated with oral nicardipine have included myalgia (1%) and arthralgia.

Respiratory

Respiratory side effects associated with intravenous nicardipine have included respiratory disorder and at least one case of pulmonary edema. Dyspnea, rhinitis, and sinusitis have been reported with oral nicardipine.

At least one case of pulmonary edema during tocolytic therapy with nicardipine has been reported. The patient developed pulmonary edema 3 days after starting intravenous nicardipine (2 mg/hr). Symptoms included dyspnea, orthopnea, cough, and tachycardia which rapidly responded to diuretic and oxygen therapy.

Psychiatric

Psychiatric side effects have included confusion. Nervousness (0.6%), abnormal dreams (0.4%), depression, and anxiety have been reported with oral nicardipine.

Hypersensitivity

Hypersensitivity side effects have included angioedema, wheezing, and rash in patients with suspected hypersensitivity reactions. Allergic reactions have been reported with oral nicardipine.

Genitourinary

Genitourinary side effects have included increased urinary frequency. Nocturia (0.4%) and impotence have been reported with oral nicardipine.

Hematologic

Hematologic side effects associated with intravenous nicardipine have included thrombocytopenia.

Hepatic

Hepatic side effects associated with oral nicardipine have included abnormal liver chemistries.

Ocular

Ocular side effects associated with intravenous nicardipine have included conjunctivitis. Abnormal vision and blurred vision have been reported with oral nicardipine.

Endocrine

A small study (9 patients) has shown that the use of nicardipine to control blood pressure in hypertensive patients with noninsulin-dependent diabetes mellitus is associated with progressively and significantly elevated hemoglobin A1C concentrations.

Rare cases of hyperglycemia associated with nicardipine are reported. This is thought to be due to inhibition of pancreatic beta islet cellular insulin production and secretion. The Japanese have used some calcium channel blockers to reverse the frequency and severity of hypoglycemic symptoms in patients with insulinoma.

Endocrinologic side effects have rarely included cases of hyperglycemia. One study has shown that nicardipine can cause deterioration in glucose metabolism in hypertensive patients with noninsulin-dependent diabetes mellitus.

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