Cardene IV Side Effects

Generic name: nicardipine

Note: This document contains side effect information about nicardipine. Some of the dosage forms listed on this page may not apply to the brand name Cardene IV.

Some side effects of Cardene IV may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to nicardipine: oral capsule, oral capsule extended release

If you experience any of the following serious side effects, stop taking nicardipine (the active ingredient contained in Cardene IV) and contact your doctor immediately or seek emergency medical treatment:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• unusually fast or slow heartbeats;

• fainting or severe dizziness;

• abnormal behavior or psychosis;

• chest pain or worsening angina;

• jaundice (yellowing of the skin or eyes); or

• swelling of the legs or ankles.

Other, less serious side effects may be more likely to occur. Continue to take nicardipine and talk to your doctor if you experience

• unusual headache, fatigue, or tiredness;

• dizziness;

• flushing;

• rash;

• insomnia;

• vivid or abnormal dreams;

• increased urination;

• dry mouth;

• nausea or constipation; or

• nervousness or tremor.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to nicardipine: compounding powder, injectable solution, intravenous solution, oral capsule, oral capsule extended release

General

Side effects of nicardipine (the active ingredient contained in Cardene IV) 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 (the active ingredient contained in Cardene IV) 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 (the active ingredient contained in Cardene IV) 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 (the active ingredient contained in Cardene IV) 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 (the active ingredient contained in Cardene IV) 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 (the active ingredient contained in Cardene IV) have included rash (up to 6%) and increased sweating (0.6%).

Metabolic

Metabolic side effects associated with intravenous nicardipine (the active ingredient contained in Cardene IV) have included hypophosphatemia and peripheral edema.

Musculoskeletal

Musculoskeletal side effects associated with oral nicardipine (the active ingredient contained in Cardene IV) have included myalgia (1%) and arthralgia.

Respiratory

Respiratory side effects associated with intravenous nicardipine (the active ingredient contained in Cardene IV) 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 (the active ingredient contained in Cardene IV)

Hypersensitivity

Hypersensitivity side effects have included angioedema, wheezing, and rash in patients with suspected hypersensitivity reactions. Allergic reactions have been reported with oral nicardipine (the active ingredient contained in Cardene IV)

Genitourinary

Genitourinary side effects have included increased urinary frequency. Nocturia (0.4%) and impotence have been reported with oral nicardipine (the active ingredient contained in Cardene IV)

Hematologic

Hematologic side effects associated with intravenous nicardipine (the active ingredient contained in Cardene IV) have included thrombocytopenia.

Hepatic

Hepatic side effects associated with oral nicardipine (the active ingredient contained in Cardene IV) have included abnormal liver chemistries.

Ocular

Ocular side effects associated with intravenous nicardipine (the active ingredient contained in Cardene IV) 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 (the active ingredient contained in Cardene IV) 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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