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Cardene SR

Last reviewed on RxList: 12/5/2016
Cardene Side Effects Center

Last reviewed on RxList 4/12/2016

Cardene SR (nicardipine hydrochloride sustained release capsules) is a calcium channel blocker used to treat hypertension (high blood pressure) and angina (chest pain). Common side effects of Cardene SR include:

  •  dizziness
  • lightheadedness
  • unusual headache
  • flushing
  • swelling ankles/feet
  • fatigue
  • tiredness
  • rash
  • insomnia
  • vivid or abnormal dreams
  • increased urination
  • dry mouth
  • nausea
  • constipation
  • nervousness, or
  • tremor

The dose of Cardene SR is individually adjusted according to the blood pressure response beginning with 30 mg two times daily. Cardene SR may interact with other heart medications to treat the same or another condition, cimetidine, or cyclosporine. Tell your doctor all medications and supplements you use. During pregnancy, Cardene SR should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Cardene SR (nicardipine hydrochloride sustained release capsules) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Cardene Consumer Information

If you experience any of the following serious side effects, stop taking nicardipine 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. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cardene (Nicardipine Hydrochloride Sustained Release Capsules)

Cardene Professional Information

SIDE EFFECTS

In multiple-dose US and foreign controlled studies, 667 patients received CARDENE SR. In these studies adverse events were elicited by non-directed and in some cases directed questioning; adverse events were generally not serious and about 9% of patients withdrew prematurely from the studies because of them.

Hypertension

The incidence rates of adverse events in hypertensive patients were derived from placebo-controlled clinical trials. Following are the rates of adverse events for CARDENE SR (n=322) and placebo (n=140), respectively, that occurred in 0.6% of patients or more on CARDENE SR. These represent events considered probably drug related by the investigator. Where the frequency of adverse events for CARDENE SR and placebo is similar, causal relationship is uncertain. The only dose-related effect was pedal edema.

Percentage of Patients With Probably Drug Related Adverse Events in Placebo-Controlled Studies

Adverse Event CARDENE SR (n=322) Placebo (n=140)
Headache 6.2 7.1
Pedal Edema 5.9 1.4
Vasodilatation 4.7 1.4
Palpitation 2.8 1.4
Nausea 1.9 0.7
Dizziness 1.6 0.7
Asthenia 0.9 0.7
Postural Hypotension 0.9 0
Increased UrinaryFrequency 0.6 0
Pain 0.6 0
Rash 0.6 0
Sweating Increased 0.6 0
Vomiting 0.6 0

Incidence (%) of Discontinuations Due to Any Adverse Event in Placebo-Controlled Studies

Adverse Event CARDENE SR (n=322) Placebo (n=140)
Headache 2.5 1.4
Palpitation 2.2 0.7
Dizziness 1.9 0.7
Asthenia 1.9 0
Pedal Edema 1.2 0
Nausea 1.2 0
Rash 0.9 0.7
Diarrhea 0.9 0
Tachycardia 0.9 0
Blurred Vision 0.6 0
Chest Pain 0.6 0
Face Edema 0.6 0
Myocardial Infarct 0.6 0
Vasodilatation 0.6 0
Vomiting 0.6 0

Uncontrolled experience in over 300 patients with hypertension treated for up to 27.5 months with CARDENE SR has shown no unexpected adverse events or increase in incidence of adverse events compared to the controlled clinical trials.

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, atypical chest pain, peripheral vascular disorder, ventricular extrasystoles, ventricular tachycardia, angina pectoris

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

Angina

Data are available from only 91 patients with chronic stable angina pectoris who received CARDENE SR 30 to 60 mg administered twice daily in open-label clinical trials. Fifty-eight of these patients were treated for at least 30 days. The four most frequently reported adverse events thought by the investigators to be probably related to the use of CARDENE SR were vasodilatation (5.5%), pedal edema (4.4%), asthenia (4.4%), and dizziness (3.3%).

Read the entire FDA prescribing information for Cardene (Nicardipine Hydrochloride Sustained Release Capsules)

Related Resources for Cardene

Read the Cardene User Reviews »

© Cardene Patient Information is supplied by Cerner Multum, Inc. and Cardene Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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