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Dilacor XR

Last reviewed on RxList: 11/29/2016
Dilacor XR Side Effects Center

Last reviewed on RxList 1/7/2016

Dilacor XR (diltiazem hydrochloride) is a calcium channel blocker used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. Dilacor XR is available in generic form. Common side effects of Dilacor XR include stuffy nose, skin rash or itching, dizziness, headache, tired feeling, nausea, upset stomach, flushing (warmth, itching, redness, or tingly feeling under your skin), weakness, sore throat, or cough.

Dosages of Dilacor XR are adjusted to each patient's needs. To treat hypertension the starting dose is 180 mg or 240 mg once daily. To treat angina, the starting dose is 120 mg once daily, which may be adjusted up to 480 mg once daily. Dilacor XR may interact with amiodarone, buspirone, carbamazepine, cimetidine, cyclosporine, digoxin, lovastatin, rifampin, quinidine, sedatives, antibiotics, antifungals, beta-blockers, or HIV/AIDS medicines. Tell your doctor all medications and supplements you use. During pregnancy, Dilacor XR should be used only if prescribed. This drug passes into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

Our Dilacor XR (diltiazem hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Dilacor XR Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • a red, blistering skin rash;
  • swelling in your hands or feet;
  • trouble breathing;
  • slow heartbeats;
  • dizziness, fainting, fast or pounding heartbeat;
  • upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • headache;
  • dizziness, weakness, tired feeling;
  • upset stomach, nausea;
  • sore throat, cough, stuffy nose; or
  • flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Dilacor XR (Diltiazem Hydrochloride Capsule, Extended Release)

Dilacor XR Professional Information

SIDE EFFECTS

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.

Read the entire FDA prescribing information for Dilacor XR (Diltiazem Hydrochloride Capsule, Extended Release)

Related Resources for Dilacor XR

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