Skip to main content

Serious adverse reactions to diltiazem hydrochloride have been rare in studies with other formulations, as well as with Dilacor XR®. 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 Dilacor XR 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

Adverse Events (COSTART Term) Dilacor XR®*
n=303
# pts (%)
Placebo
n=87
# 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)
*Adverse events occurring in 1% or more of patients receiving Dilacor XR.

Angina

The most common adverse events (frequency ≥ 1%) in a placebo-controlled, short-term (2 week) clinical angina study with Dilacor XR 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 Dilacor XR.

MOST COMMON ADVERSE EVENTS IN A DOUBLE-BLIND, PLACEBO-CONTROLLED SHORT-TERM, ANGINA TRIALS

Adverse Events (COSTART Term) Dilacor XR®*
n=139
# pts (%)
Placebo
n=50
# 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)
*Adverse events occurring in 1% or more of patients receiving Dilacor XR.

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 Dilacor XR, 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.