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Cardene SR (Nicardipine Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE EVENTS

In multiple-dose US and foreign controlled studies, 667 patients received CARDENE SR. 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.

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)
Headache6.27.1
Pedal Edema5.91.4
Vasodilatation4.71.4
Palpitation2.81.4
Nausea1.90.7
Dizziness1.60.7
Asthenia0.90.7
Postural Hypotension0.90
Increased Urinary Frequency0.60
Pain0.60
Rash0.60
Sweating Increased0.60
Vomiting0.60

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

Adverse Event CARDENE SR
(n=322)
Placebo
(n=140)
Headache2.51.4
Palpitation2.20.7
Dizziness1.90.7
Asthenia1.90
Pedal Edema1.20
Nausea1.20
Rash0.90.7
Diarrhea0.90
Tachycardia0.90
Blurred Vision0.60
Chest Pain0.60
Face Edema0.60
Myocardial Infarct0.60
Vasodilatation0.60
Vomiting0.60

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%).

Drug label data at the top of this Page last updated: 2008-04-21

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