FDA label
What is diltiazem used for?
The FDA-approved uses of diltiazem, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for diltiazem hydrochloride (tablet, extended release) lists 2 uses: Hypertension; Angina.
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Diltiazem Hydrochloride, capsule, extended release
Indications and Usage, quoted from the label by Zydus Pharmaceuticals (USA) Inc. (ANDA206534). Cross-references to other label sections are left out.
Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.
Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.
Source: DailyMed label, set id 1e2f2025-0350-40c4-ab42-3b57f3d105a6, version 6, effective May 1, 2025. NDC 68382-595, one of 159 listings for this product.
Diltiazem Hydrochloride, tablet
Indications and Usage, quoted from the label by ScieGen Pharmaceuticals, Inc (ANDA216521). Cross-references to other label sections are left out.
Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm.
Source: DailyMed label, set id 196fc367-330e-4d15-b1d6-084ad3f97ae7, version 3, effective October 15, 2025. NDC 50228-481, one of 23 listings for this product.
Diltiazem Hydrochloride, tablet, extended release
Indications and Usage, quoted from the label by Slate Run Pharmaceuticals, LLC (ANDA216439). Cross-references to other label sections are left out.
Hypertension
Diltiazem Hydrochloride Extended-Release Tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Diltiazem Hydrochloride Extended-Release Tablets may be used alone or in combination with other antihypertensive medications.
Angina
Diltiazem Hydrochloride Extended-Release Tablets are indicated to improve exercise tolerance in patients with chronic stable angina.
Source: DailyMed label, set id f7137458-0db3-7ecd-e053-6394a90a5f95, version 10, effective August 5, 2026. NDC 70436-195, one of 23 listings for this product.
Questions
What is diltiazem used for?
The FDA label for diltiazem hydrochloride (tablet, extended release) lists 2 uses: Hypertension; Angina.
What drug class is diltiazem?
FDA lists diltiazem in the Calcium Channel Blocker established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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