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Side Effects & Drug Interactions
ADVERSE REACTIONS
Serious adverse reactions have been rare in studies carried out to date, but it should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities have usually been excluded from these studies. The following table presents the most common adverse reactions reported in placebo-controlled angina and hypertension trials in patients receiving diltiazem hydrochloride extended-release capsule (once-a-day dosing) product up to 360 mg with rates in placebo patients shown for comparison. Text Continues Below
In clinical trials of Diltiazem hydrochloride Extended-release Capsules (Once A Day Dosage), diltiazem hydrochloride tablets and diltiazem hydrochloride extended-release capsules involving over 3200 patients, the most common events (i. e., greater than 1%) were edema (4.6%),
headache (4.6%),
dizziness (3.5%),
asthenia (2.6%),
first-degree AV block (2.4%),
bradycardia (1.7%),
flushing (1.4%),
nausea (1.4%)
rash (1.2%). In addition, the following events were reported infrequently (less than 1%) in angina or hypertension trials: Cardiovascular Angina, arrhythmia, AV block (second-or third-degree), bundle branch block, congestive heart failure, ECG abnormalities, hypotension, palpitations, syncope, tachycardia, ventricular extrasystoles. Nervous System Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia, nervousness, pares-thesia, personality change, somnolence, tinnitus, tremor. Gastrointestinal Anorexia, constipation, diarrhea, dry mouth, dysgeusia, dyspepsia, mild elevations of SGOT, SGPT, LDH, and alkaline phosphatase (see hepatic warnings), thirst, vomiting, weight increase. Dermatological Petechiae, photosensitivity, pruritus, urticaria. Other Amblyopia, CPK increase, dyspnea, epistaxis, eye irritation, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, nocturia, osteoarticular pain, polyuria, sexual difficulties. Page: 1 | 2 | 3 | 4 | Next >>
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