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Dilacor XR

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Dilacor XR

Dilacor XR

Dilacor XR Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

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

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Dilacor XR in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Dilacor XR Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, lightheadedness, weakness, nausea, flushing, constipation, and headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To lower the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, slow/irregular/pounding/fast heartbeat, swelling ankles/feet, shortness of breath, unusual tiredness, unexplained/sudden weight gain, mental/mood changes (such as depression, agitation), unusual dreams.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, severe constipation, dark urine, persistent nausea/vomiting, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Dilacor XR (Diltiazem Hydrochloride Capsule, Extended Release)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Dilacor XR FDA Prescribing Information: Side Effects
(Adverse Reactions)

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) »

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Dilacor XR - User Reviews

Dilacor XR User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Dilacor XR sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Hypertension

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