Orthostatic events (orthostatic hypotension and postural dizziness) were seen in less than 1% of patients.

Other adverse reactions that occurred in placebo-controlled clinical trials with Exforge (greater than 0.2%) are listed below. It cannot be determined whether these events were causally related to Exforge.

Blood and Lymphatic System Disorders : Lymphadenopathy

Cardiac Disorders : Palpitations, tachycardia

Ear and Labyrinth Disorders : Ear pain

Gastrointestinal Disorders : Diarrhea, nausea, constipation, dyspepsia, abdominal pain, abdominal pain upper, gastritis, vomiting, abdominal discomfort, abdominal distention, dry mouth, colitis

General Disorders and Administration Site Conditions : Fatigue, chest pain, asthenia, pitting edema, pyrexia, edema

Immune System Disorders : Seasonal allergies

Infections and Infestations : Nasopharyngitis, sinusitis, bronchitis, pharyngitis, gastroenteritis, pharyngotonsillitis, bronchitis acute, tonsillitis

Injury and Poisoning: Epicondylitis, joint sprain, limb injury

Metabolism and Nutrition Disorders : Gout, non-insulin dependent diabetes mellitus, hypercholesterolemia

Musculoskeletal and Connective Tissue Disorders : Arthralgia, back pain, muscle spasms, pain in extremity, myalgia, osteoarthritis, joint swelling, musculoskeletal chest pain

Nervous System Disorders : Headache, sciatica, parasthesia, cerviocobrachial syndrome, carpal tunnel syndrome, hypoaesthesia, sinus headache, somnolence

Psychiatric Disorders : Insomnia, anxiety, depression

Renal and Urinary Disorders : Hematuria, nephrolithiasis, pollakiuria

Reproductive System and Breast Disorders : Erectile dysfunction

Respiratory, Thoracic and Mediastinal Disorders : Cough, pharyngolaryngeal pain, sinus congestion, dyspnea, epistaxis, productive cough, dysphonia, nasal congestion

Skin and Subcutaneous Tissue Disorders : Pruritus, rash, hyperhidrosis, eczema, erythema

Vascular Disorders : Flushing, hot flush

Isolated cases of the following clinically notable adverse reactions were also observed in clinical trials: exanthema, syncope, visual disturbance, hypersensitivity, tinnitus, and hypotension.

Studies with Amlodipine:

Norvasc has been eva luated for safety in more than 11,000 patients in U.S. and foreign clinical trials. Other adverse events that have been reported less than 1% but greater than 0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain were:

Cardiovascular : arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, postural hypotension, vasculitis

Central and Peripheral Nervous System : neuropathy peripheral, tremor

Gastrointestinal: anorexia, dysphagia, pancreatitis, gingival hyperplasia

General: allergic reaction, hot flushes, malaise, rigors, weight gain, weight loss

Musculoskeletal System : arthrosis, muscle cramps

Psychiatric : sexual dysfunction (male and female), nervousness, abnormal dreams, depersonal