Safety and tolerability of ready-to-use CARDENE® I.V. (nicardipine hydrochloride) in clinical trials
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 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 2 multicenter, double-blind, placebo-controlled trials of CARDENE I.V.1
- Adverse events in the placebo-controlled trials were generally not serious, and most were expected consequences of vasodilation1
- The most common adverse reactions (>3%) are headache, nausea/vomiting, hypotension and tachycardia
- Adverse events occasionally required dosing adjustment. Therapy was discontinued in approximately 12% of patients, mainly due to hypotension, headache, and tachycardia