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.