|
Norvasc (amlodipine) has been evaluated for safety in more than 11,000 patients in clinical trials. In general, treatment with Norvasc was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with Norvasc were of mild or moderate severity. In controlled clinical trials directly comparing Norvasc (N=1730) in doses up to 10 mg to placebo (N=1250), discontinuation of Norvasc due to adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most common side effects are headache and edema. The incidence (%) of side effects which occurred in a dose related manner are as follows:
- Edema: 1.8 (2.5 mg N=275), 3.0 (5.0 mg N=296), 10.8 (10.0 mg N=268)
- Dizziness: 1.1 (2.5 mg N=275), 3.4 (5.0 mg N=296), 3.4 (10.0 mg N=268)
- Flushing: 0.7 (2.5 mg N=275), 1.4 (5.0 mg N=296), 2.6 (10.0 mg N=268)
- Palpitation: 0.7 (2.5 mg N=275), 1.4 (5.0 mg N=296), 4.5 (10.0 mg N=268)
|
