Nicardipine Hydrochloride (Page 5 of 6)

Hypertension

The incidence rates of adverse effects in hypertensive patients were derived from multicenter, controlled clinical trials. Following are the rates of adverse effects for nicardipine hydrochloride capsules (n= 1390) and placebo (n= 211), respectively, that occurred in 0.4% of patients or more. These represent events considered probably drug-related by the investigator. Where the frequency of adverse effects for nicardipine hydrochloride capsules and placebo is similar, causal relationship is uncertain. The only dose-related effect was pedal edema.

Table 3

Percent of Patients with Adverse Effects in Controlled Studies

(Incidence of discontinuations shown in parentheses)

Adverse Experience

NICARDIPINE HYDROCHLORIDE CAPSULES

(n = 1390)

PLACEBO

(n = 211)

Flushing

9.7

(2.1)

2.8

(0)

Headache

8.2

(2.6)

4.7

(0)

Pedal Edema

8.0

(1.8)

0.9

(0)

Asthenia

4.2

(1.7)

0.5

(0)

Palpitations

4.1

(1.0)

0.0

(0)

Dizziness

4.0

(1.8)

0.0

(0)

Tachycardia

3.4

(1.2)

0.5

(0)

Nausea

2.2

(0.9)

0.9

(0)

Somnolence

1.1

(0.1)

0.0

(0)

Dyspepsia

0.8

(0.3)

0.5

(0)

Insomnia

0.6

(0.1)

0.0

(0)

Malaise

0.6

(0.1)

0.0

(0)

Other Edema

0.6

(0.3)

1.4

(0)

Abnormal Dreams

0.4

(0)

0.0

(0)

Dry Mouth

0.4

(0.1)

0.0

(0)

Nocturia

0.4

(0)

0.0

(0)

Rash

0.4

(0.4)

0.0

(0)

Vomiting

0.4

(0.4)

0.0

(0)

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, postural hypotension, atypical chest pain, peripheral vascular disorder, ventricular extrasystoles, ventricular tachycardia

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

Urogenital: increased urinary frequency

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