DrugLib.com — Drug Information Portal

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

Nicardipine (Nicardipine Hydrochloride) - Side Effects and Adverse Reactions



Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Two hundred forty-four patients participated in two multicenter, double-blind, placebo controlled trials of nicardipine hydrochloride injection. Adverse experiences were generally not serious and most were expected consequences of vasodilation. Adverse experiences occasionally required dosage adjustment.

Therapy was discontinued in approximately 12% of patients, mainly due to hypotension, headache, and tachycardia.
  The table below shows percentage of patients with adverse events where the rate is >3% more common on nicardipine hydrochloride injection than placebo.
  Adverse Experience
  Nicardipine HCl (n=144)
Placebo (n=100)
  Body as a Whole
Headache, n (%)
21 (15)
2 (2)
Hypotension, n (%)
8 (6)
1 (1)
Tachycardia, n (%)
5 (4)
Nausea/vomiting, n (%)
 7 (5)
1 (1)

Other adverse events have been reported in clinical trials or in the literature in association with the use of intravenously administered nicardipine.
Body as a Whole:   fever, neck pain
Cardiovascular:   angina pectoris, atrioventricular block, ST segment depression, inverted T wave, deep-vein thrombophlebitis
Digestive:   dyspepsia
Hemic and Lymphatic:   thrombocytopenia
Metabolic and Nutritional:   hypophosphatemia, peripheral edema
Nervous:   confusion, hypertonia
Respiratory:   respiratory disorder
Special Senses:   conjunctivitis, ear disorder, tinnitus
Urogenital:   urinary frequency
Sinus node dysfunction and myocardial infarction, which may be due to disease progression, have been seen in patients on chronic therapy with orally administered nicardipine.

Drug label data at the top of this Page last updated: 2011-05-17

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

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