DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Cardene (Nicardipine Hydrochloride) - Side Effects and Adverse Reactions



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.


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:

infection, allergic reaction Body as a Whole:

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

sore throat, abnormal liver chemistries Digestive:

arthralgia Musculoskeletal:

hot flashes, vertigo, hyperkinesia, impotence, depression, confusion, anxiety Nervous:

rhinitis, sinusitis Respiratory:

tinnitus, abnormal vision, blurred vision Special Senses:


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%).


Below is a sample of reports where side effects / adverse reactions may be related to Cardene. The information is not vetted and should not be considered as verified clinical evidence.

Possible Cardene side effects / adverse reactions in 76 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-01

Patient: 76 year old male

Reactions: Aortitis Syphilitic, Aortic Arteriosclerosis, Aortic Bypass, Hypotension, Aortic Dissection, Anastomotic Leak, Post Procedural Haemorrhage

Adverse event resulted in: death

Suspect drug(s):

Other drugs received by patient: Bicalutamide; Nitroglycerin; Penicillin; Furosemide

Possible Cardene side effects / adverse reactions in 55 year old male

Reported by a physician from France on 2012-08-05

Patient: 55 year old male

Reactions: Acute Respiratory Distress Syndrome

Adverse event resulted in: hospitalization

Suspect drug(s):

Other drugs received by patient: Ciprofloxacin; Ceftazidime; Nitric Oxide

See index of all Cardene side effect reports >>

Drug label data at the top of this Page last updated: 2010-11-09

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017