Cardene Side Effects

Generic Name: nicardipine

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

Not all side effects for Cardene may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to nicardipine: oral capsule, oral capsule extended release

Other dosage forms:

In addition to its needed effects, some unwanted effects may be caused by nicardipine (the active ingredient contained in Cardene). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking nicardipine:

More common
  • Arm, back, or jaw pain
  • chest pain or discomfort
  • chest tightness or heaviness
  • fast or irregular heartbeat
  • nausea
  • palpitations
  • shortness of breath
  • sweating
  • swelling of the legs
Less common
  • Shakiness
  • swelling
Rare
  • Blurred vision
  • cold hands and feet
  • cold sweats
  • confusion
  • cough or hoarseness
  • difficulty swallowing
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • extra heartbeat
  • fever or chills
  • hives
  • increase in frequency of urination
  • itching
  • lower back or side pain
  • painful or difficult urination
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash
  • unusual tiredness or weakness
  • wheezing

If any of the following symptoms of overdose occur while taking nicardipine, get emergency help immediately:

Symptoms of overdose
  • Sleepiness
  • slurred speech

Some of the side effects that can occur with nicardipine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Feeling of warmth
  • headache
  • lack or loss of strength
  • redness of the face, neck, arms and occasionally, upper chest
Less common
  • Acid or sour stomach
  • belching
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • difficulty in moving
  • dry mouth
  • heartburn
  • indigestion
  • joint pain
  • muscle aching or cramping
  • muscle pains or stiffness
  • rash
  • stomach discomfort, upset, or pain
  • swollen joints
Rare
  • Changes in vision
  • constipation
  • continuing ringing or buzzing or other unexplained noise in ears
  • decreased interest in sexual intercourse
  • difficult or labored breathing
  • discouragement
  • fear or nervousness
  • feeling of constant movement of self or surroundings
  • feeling sad or empty
  • hearing loss
  • inability to have or keep an erection
  • increase in body movements
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • loss in sexual ability, desire, drive, or performance
  • nervousness
  • pain or tenderness around eyes and cheekbones
  • runny nose
  • sensation of spinning
  • sneezing
  • sore throat
  • stuffy nose
  • trouble concentrating
  • trouble sleeping

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) 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.[Ref]

Cardiovascular

Rare cases of angina pectoris associated with nicardipine (the active ingredient contained in Cardene) 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.[Ref]

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.[Ref]

Nervous system

The dose of nicardipine (the active ingredient contained in Cardene) 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.[Ref]

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.[Ref]

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) A case of parotitis associated with nicardipine has been reported. Noncompliance due to nausea and vomiting has been reported.[Ref]

Other

Other side effects associated with intravenous nicardipine (the active ingredient contained in Cardene) 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) have included rash (up to 6%) and increased sweating (0.6%).[Ref]

Metabolic

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

Musculoskeletal

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

Respiratory

Respiratory side effects associated with intravenous nicardipine (the active ingredient contained in Cardene) have included respiratory disorder and at least one case of pulmonary edema. Dyspnea, rhinitis, and sinusitis have been reported with oral nicardipine.[Ref]

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.[Ref]

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)

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) [Ref]

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)

Hematologic

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

Hepatic

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

Ocular

Ocular side effects associated with intravenous nicardipine (the active ingredient contained in Cardene) have included conjunctivitis. Abnormal vision and blurred vision have been reported with oral nicardipine.

Endocrine

Endocrinologic side effects have rarely included cases of hyperglycemia. One study has shown that nicardipine (the active ingredient contained in Cardene) can cause deterioration in glucose metabolism in hypertensive patients with noninsulin-dependent diabetes mellitus.[Ref]

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.[Ref]

References

1. Levesque H, Moore N, Wolfe LM, Courtois H "Erythromelalgia induced by nicardipine (inverse Raynaud's phenomenon?)." BMJ 298 (1989): 1252-3

2. Porchet HC, Loew F, Gauthey L, Dayer P "Serum concentration-effect relationship of (+ -)-nicardipine and nifedipine in elderly hypertensive patients." Eur J Clin Pharmacol 43 (1992): 551-3

3. Thomassen AR, Bagger JP, Nielsen TT "Hemodynamic and cardiac metabolic changes during nicardipine-induced myocardial ischemia." Cathet Cardiovasc Diagn 14 (1988): 41-3

4. Dubois C, Blanchard D "Efficacy and safety of nicardipine in 29,104 patients with hypertension." Clin Ther 11 (1989): 452-60

5. "Efficacy and safety of intravenous nicardipine in the control of postoperative hypertension. IV Nicardipine Study Group." Chest 99 (1991): 393-8

6. Taylor SH, Frais MA, Lee P, Verma SP, Jackson N, Reynolds G, Silke B "A study of the long-term efficacy and tolerability of oral nicardipine in hypertensive patients." Br J Clin Pharmacol 20 (1985): s139-42

7. Saruta T "Effects of nicardipine on blood pressure and renal function in elderly hypertensive patients with renal dysfunction." Am Heart J 117 (1989): 243-9

8. Habib GB, Dunbar LM, Rodrigues R, Neale AC, Friday KJ "Evaluation of the efficacy and safety of oral nicardipine in treatment of urgent hypertension: a multicenter, randomized, double-blind, parallel, placebo-controlled clinical trial." Am Heart J 129 (1995): 917-23

9. Scheidt S, LeWinter MM, Hermanovich J, Venkataraman K, Freedman D "Efficacy and safety of nicardipine for chronic, stable angina pectoris: a multicenter randomized trial." Am J Cardiol 58 (1986): 715-21

10. Lee, SM, Williams R, Warnock D, et al "The effects of nicardipine in hypertensive subjects with impaired renal function." Br J Clin Pharmacol 22 (1986): s297-306

11. Kubota K, Pearce GL, Inman WHW "Vasodilation-related adverse events in diltiazem and dihydropyridine calcium antagonists studied by prescription-event monitoring." Eur J Clin Pharmacol 48 (1995): 1-7

12. Brown ST III, Freedman D, DeVault GA, et al "Safety efficacy and pharmacokinetics of nicardipine in elderly hypertensive patients." Br J Clin Pharmacol 22 (1986): s289-95

13. Arima H, Sobue K, Tanaka S, Morishima T, Ando H, Katsuya H "Profound sinus bradycardia after intravenous nicardipine." Anesth Analg 95 (2002): 53-5

14. "Product Information. Cardene (nicardipine)." Syntex Laboratories Inc, Palo Alto, CA.

15. Sorkin E, Clissold S "Nicardipine: A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy, in the treatment of angina pectoris, hypertension, and relate." Drugs 33 (1987): 296-345

16. Bowles MJ, Khurmi NS, O'Hara MJ, Raftery EB "Randomized double-blind placebo-controlled comparison of nicardipine and nifedipine in patients with chronic stable angina pectoris." Chest 89 (1986): 260-5

17. DeWood MA, Wolbach RA "Randomized double-blind comparison of side effects of nicardipine and nifedipine in angina pectoris. The Nicardipine Investigators Group." Am Heart J 119 (1990): 468-78

18. Lambert CR, Hill JA, Feldman RL, Pepine CJ "Myocardial ischemia during intravenous nicardipine administration." Am J Cardiol 55 (1985): 844-5

19. Fujii Y, Toyooka H, Amaha K "Nicardipine enhances diaphragmatic fatigue." Can J Anaesth 41 (1994): 435-9

20. Das G "Severe generalized hyperkinesia to nicardipine SR therapy." Int J Clin Pharmacol Ther 32 (1994): 612-3

21. Bal L, Thierry S, Brocas E, Adam M, Van De Louw A, Tenaillon A "Pulmonary edema induced by calcium-channel blockade for tocolysis." Anesth Analg 99 (2004): 910-1

22. Bosch X, Sobrino J, Lopez-Soto A, Urbano-Marquez A "Parotitis due to nicardipine." Br Med J 304 (1992): 882

23. Weir MR, Wright JT, Jr Ferdinand KC, Cook CA, Champion D, Wong S, Jenkins PA, Kong BW "Comparison of the efficacy and metabolic effects of nicardipine and hydrochlorothiazide in hypertensive black men and women." J Hum Hypertens 7 (1993): 141-7

24. Ahmad S "Nicardipine-induced hyperglycemia ." Am Fam Physician 45 (1992): 449,

25. Sasaki H, Naka K, Kishi Y, Ohoshi T, Hagihara T, Matsuo H, Sowa R, Matsumoto G, Sanke T, Nanjo K "Nicardipine may impair glucose metabolism in hypertensive diabetic patients." Diabetes Res Clin Pract 26 (1994): 67-75

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