"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
Cardene Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
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:
- unusual headache
- swelling ankles/feet
- vivid or abnormal dreams
- increased urination
- dry mouth
- nervousness, or
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Cardene in Detail - Patient Information: Side Effects
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;
- 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)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Cardene Overview - Patient Information: Side Effects
To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, fast/irregular/pounding heartbeat.
Tell your doctor immediately if any of these rare but very serious side effects occur: vision changes.
Although this medication is effective in preventing chest pain (angina), some people who already have severe heart disease may rarely develop worsening chest pain or a heart attack after starting this medication or increasing the dose. Get medical help right away if you experience: worsening chest pain, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating).
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Cardene (Nicardipine Hydrochloride Sustained Release Capsules)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Cardene FDA Prescribing Information: Side Effects
In multiple-dose US and foreign controlled studies, 667 patients received CARDENE SR (nicardipine hydrochloride sustained release capsules) . In these studies adverse events were elicited by nondirected 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.
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 (nicardipine hydrochloride sustained release capsules) (n=322) and placebo (n=140), respectively, that occurred in 0.6% of patients or more on CARDENE SR (nicardipine hydrochloride sustained release capsules) . These represent events considered probably drug related by the investigator. Where the frequency of adverse events for CARDENE SR (nicardipine hydrochloride sustained release capsules) 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
|Increased Urinary Frequency||0.6||0|
Incidence (%) of Discontinuations Due to Any Adverse Event
in Placebo-Controlled Studies
|Adverse Event||CARDENE SR
Uncontrolled experience in over 300 patients with hypertension treated for up to 27.5 months with CARDENE SR (nicardipine hydrochloride sustained release capsules) has shown no unexpected adverse events or increase in incidence of adverse events compared to the controlled clinical trials.
The following rare adverse events have been reported in clinical trials or the literature:
Digestive: sore throat, abnormal liver chemistries
Special Senses: tinnitus, abnormal vision, blurred vision
Data are available from only 91 patients with chronic stable angina pectoris who received CARDENE SR (nicardipine hydrochloride sustained release capsules) 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 (nicardipine hydrochloride sustained release capsules) 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)
Additional Cardene SR Information
Cardene SR - User Reviews
Cardene SR User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get tips on handling your hypertension.