Dilacor XR Side Effects
Generic Name: Diltiazem
Please note - some side effects for Dilacor XR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Dilacor XR - for the consumer
Dilacor XR 24-Hour Sustained-Release Capsules
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Dilacor XR 24-Hour Sustained-Release Capsules:
Seek medical attention right away if any of these SEVERE side effects occur when using Dilacor XR 24-Hour Sustained-Release Capsules:Constipation; dizziness; facial flushing; headache; weakness.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); hallucinations; irregular heartbeat; swelling of the feet or hands; tender, bleeding, or swollen gums.
For the professional
Dilacor XR
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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