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adverse reactions
ADVERSE REACTIONS Serious adverse reactions to diltiazem hydrochloride have been rare in studies with other formulations, as well as with diltiazem hydrochloride extended-release capsules. It should be recognized, however, that patients with impaired ventricular function and cardiac conduction abnormalities have usually been excluded from these studies. Hypertension: The most common adverse events (frequency ≥1%) in placebo-controlled, clinical hypertension studies with diltiazem hydrochloride extended-release. using daily doses up to 540 mg, are listed in the table below with placebo-treated patients included for comparison. MOST COMMON ADVERSE EVENTS IN DOUBLE-BLIND, PLACEBO-CONTROLLED HYPERTENSION TRIALS Diltiazem Hydrochloride Extended-Release Adverse events occurring in 1% or more of patients receiving diltiazem hydrochloride extended-release. Placebo Adverse Events n=303 n=87 (COSTART Term) # pts (%) # pts (%) rhinitis 29 (9.6) 7 (8.0) headache 27 (8.9) 12 (13.8) pharyngitis 17 (5.6) 4 (4.6) constipation 11 (3.6) 2 (2.3) cough increase 9 (3.0) 2 (2.3) flu syndrome 7 (2.3) 1 (1.1) edema, peripheral 7 (2.3) 0 (0.0) myalgia 7 (2.3) 0 (0.0) diarrhea 6 (2.0) 0 (0.0) vomiting 6 (2.0) 0 (0.0) sinusitis 6 (2.0) 1 (1.1) asthenia 5 (1.7) 0 (0.0) pain, back 5 (1.7) 2 (2.3) nausea 5 (1.7) 1 (1.1) dyspepsia 4 (1.3) 0 (0.0) vasodilatation 4 (1.3) 0 (0.0) injury, accident 4 (1.3) 0 (0.0) pain, abdominal 3 (1.0) 0 (0.0) arthrosis 3 (1.0) 0 (0.0) insomnia 3 (1.0) 0 (0.0) dyspnea 3 (1.0) 0 (0.0) rash 3 (1.0) 1 (1.1) tinnitus 3 (1.0) 0 (0.0) Angina: The most common adverse events (frequency ≥1%) in a placebo-controlled, short-term (2 week) clinical angina study with diltiazem hydrochloride extended-release are listed in the table below with placebo-treated patients included for comparison. In this trial, following a placebo phase, patients were randomly assigned to once daily doses of either 120, 240, or 480 mg of diltiazem hydrochloride extended-release. MOST COMMON ADVERSE EVENTS IN A DOUBLE-BLIND, PLACEBO-CONTROLLED SHORT-TERM, ANGINA TRIALS Diltiazem Hydrochloride Extended-Release Adverse events occurring in 1% or more of patients receiving diltiazem hydrochloride extended-release. Placebo Adverse Events n=139 n=50 (COSTART Term) # pts (%) # pts (%) asthenia 5 (3.6) 2 (4.0) headache 4 (2.9) 3 (6.0) pain, back 4 (2.9) 1 (2.0) rhinitis 4 (2.9) 1 (2.0) constipation 3 (2.2) 1 (2.0) nausea 3 (2.2) 0 (0.0) edema, peripheral 3 (2.2) 1 (2.0) dizziness 3 (2.2) 0 (0.0) cough, increased 3 (2.2) 0 (0.0) bradycardia 2 (1.4) 0 (0.0) fibrillation, atrial 2 (1.4) 0 (0.0) arthralgia 2 (1.4) 0 (0.0) dream, abnormal 2 (1.4) 0 (0.0) dyspnea 2 (1.4) 0 (0.0) pharyngitis 2 (1.4) 1 (2.0) Infrequent Adverse Events: The following additional events (COSTART Terms), listed by body system, were reported infrequently (less than 1%) in all subjects, hypertensive (n=425) or angina (n=318) patients who received diltiazem hydrochloride extended-release, or with other formulations of diltiazem. Hypertension: Cardiovascular: First-degree AV block, arrhythmia, postural hypotension, tachycardia, pallor, palpitations, phlebitis, ECG abnormality, ST elevation. Nervous System: Vertigo, hypertonia, paresthesia, dizziness, somnolence. Digestive System: Dry mouth, anorexia, tooth disorder, eructation. Skin and Appendages: Sweating, urticaria, skin hypertrophy (nevus). Respiratory System: Epistaxis, bronchitis, respiratory disorder. Urogenital System: Cystitis, kidney calculus, impotence, dysmenorrhea, vaginitis, prostate disease. Metabolic and Nutritional Disorders: Gout, edema. Musculoskeletal System: Arthralgia, bursitis, bone pain. Hemic and Lymphatic System: Lymphadenopathy. Body as a Whole: Pain, unevaluable reaction, neck pain, neck rigidity, fever, chest pain, malaise. Special Senses: Amblyopia (blurred vision), ear pain. Angina: Cardiovascular: Palpitations, AV block, sinus bradycardia, bigeminal extrasystole, angina pectoris, hypertension, hypotension, myocardial infarct, myocardial ischemia, syncope, vasodilatation, ventricular extrasystole. Nervous System: Abnormal thinking, neuropathy, paresthesia. Digestive System: Diarrhea, dyspepsia, vomiting, colitis, flatulence, GI hemorrhage, stomach ulcers. Skin and Appendages: Contact dermatitis, pruritus, sweating. Respiratory System: Respiratory distress. Urogenital System: Kidney failure, pyelonephritis, urinary tract infection. Metabolic and Nutritional Disorders: Weight increase. Musculoskeletal System: Myalgia. Body as a Whole: Chest pain, accidental injury, infection. Special Senses: Eye hemorrhage, ophthalmitis, otitis media, taste perversion, tinnitus. There have been post-marketing reports of Stevens-Johnson syndrome and toxic epidermal necrolysis associated with the use of diltiazem hydrochloride.