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Cardene

  • Generic Name: nicardipine hydrochloride sustained release capsules
  • Brand Name: Cardene SR

Cardene SR(Nicardipine Hydrochloride Sustained Release Capsules) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Cardene Side Effects Center

What Is Cardene?

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

What Are Side Effects of Cardene?

Dosage for Cardene

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

What Drugs, Substances, or Supplements Interact with Cardene?

The dose of Cardene SR is individually adjusted according to the blood pressure response beginning with 30 mg two times daily.

Cardene During Pregnancy or Breastfeeding

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.

Additional Information

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.

 

Cardene Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • pounding heartbeats or fluttering in your chest; or
  • severe or ongoing chest pain.

Common side effects may include:

  • headache, dizziness;
  • swelling in your feet;
  • weakness;
  • flushing (warmth, redness, or tingly feeling); or
  • nausea.

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.

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)

© 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.