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Cardizem LA

Last reviewed on RxList: 10/17/2016
Cardizem LA Side Effects Center

Last reviewed on RxList 10/13/2016

Cardizem LA (diltiazem hydrochloride) is a calcium channel blocker used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. Cardizem LA is available in generic form. Common side effects of Cardizem LA include:

Tell your doctor if you have unlikely but serious side effects of Cardizem LA including:

  • fainting,
  • slow/irregular/pounding/fast heartbeat,
  • swelling ankles or feet,
  • shortness of breath,
  • unusual tiredness,
  • unexplained or sudden weight gain,
  • mental/mood changes (such as depression, agitation), or
  • unusual dreams.

Cardizem LA is an extended-release formulation intended for once-a-day administration. Dose depends on the condition being treated and the patient's response. Adult oral doses range between 120 and 480 mg daily. Cardizem LA may interact with amiodarone, buspirone, carbamazepine, cimetidine, cyclosporine, digoxin, lovastatin, rifampin, quinidine, sedatives, antibiotics, antifungals, beta-blockers, or HIV/AIDS medicine. During pregnancy, Cardizem LA should be used only when prescribed. This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Our Cardizem LA (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.

Cardizem LA 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 Cardizem LA (Diltiazem)

Cardizem LA Professional Information

SIDE EFFECTS

The following adverse reactions are described in greater detail, in other sections:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

For the hypertension studies, the following table presents adverse reactions more common on diltiazem than on placebo (but excluding events with no plausible relationship to treatment), as reported in placebo-controlled hypertension trials in patients receiving a diltiazem hydrochloride extended-release formulation (once-a-day dosing) up to 540 mg.

Adverse Reactions (MedDRA Term) Placebo Diltiazem hydrochloride extended-release
n=120 # pts. (%) 120-360 mg
n=501 # pts. (%)
540 mg
n=123 # pts. (%)
Edema lower limb 4 (3) 24 (5) 10 (8)
Sinus congestion 0 (0) 2 (1) 2 (2)
Rash 0 (0) 3 (1) 2 (2)

In the angina study, the adverse event profile of CARDIZEM LA was consistent with what has been previously described for CARDIZEM LA and other formulations of diltiazem HCl. The most frequent adverse effects experienced by CARDIZEM LA-treated patients were edema lower-limb (6.8%), dizziness (6.4%), fatigue (4.8%), bradycardia (3.6%), first-degree atrioventricular block (3.2%), and cough (2%).

In addition, the following events have been reported infrequently (less than 1%) in angina or hypertension trials:

Cardiovascular: Angina, bundle branch block, palpitations, syncope, tachycardia, ventricular extrasystoles [see WARNINGS AND PRECAUTIONS].

Nervous System: Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia, nervousness, paresthesia, personality change, somnolence, tinnitus, tremor.

Gastrointestinal: Anorexia, constipation, diarrhea, dry mouth, dysgeusia, dyspepsia, thirst, vomiting, weight increase.

Dermatological: Petechiae, photosensitivity, pruritus, urticarial [see WARNINGS AND PRECAUTIONS].

Other: Amblyopia, CPK increase, dyspnea, epistaxis, eye irritation, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, nocturia, osteoarticular pain, polyuria, sexual difficulties.

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of diltiazem. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.

The following post-marketing reactions have been reported infrequently in patients receiving diltiazem: acute generalized exanthematous pustulosis, allergic reactions, alopecia, angioedema (including facial or periorbital edema), erythema multiforme, extrapyramidal symptoms, gingival hyperplasia, hemolytic anemia, increased bleeding time, leukopenia, photosensitivity (including lichenoid keratosis and hyperpigmentation at sun-exposed skin areas), purpura, retinopathy, myopathy, and thrombocytopenia.

In addition, events such as myocardial infarction have been observed which are not readily distinguishable from the natural history of the disease in these patients.

A number of well-documented cases of generalized rash, some characterized as leukocytoclastic vasculitis, have been reported.

Read the entire FDA prescribing information for Cardizem LA (Diltiazem)

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