ADVERSE REACTIONS
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 |
| Dilacor XR®* | Placebo |
| Adverse Events | n=303 | n=87 |
| (COSTART Term) | # pts (%) | # pts (%) |
| *Adverse events occurring in 1% or more of patients receiving Dilacor XR. |
| 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 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 |
| Dilacor XR®* | Placebo |
| Adverse Events | n=139 | n=50 |
| (COSTART Term) | # pts (%) | # pts (%) |
| *Adverse events occurring in 1% or more of patients receiving Dilacor XR. |
| 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 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.
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