Diltiazem is a calcium channel blocker sold in the U.S. under 8 brand and generic names, for variant angina pectoris, atrial fibrillation and atrial flutter. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Dilacor XR (application NDA020092). Other diltiazem products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Patients controlled on diltiazem alone or in combination with other medications may be switched to diltiazem hydrochloride extended-release capsules (once-a-day dosage) at the nearest equivalent total daily dose. Higher doses of diltiazem hydrochloride extended-release capsules (once-a-day dosage) may be needed in some patients. Monitor patients closely. Subsequent titration to higher or lower doses may be necessary. There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose. Hypertension: Adjust dosage to individual patient needs. When used as monotherapy, reasonable starting doses are 180 to 240 mg once daily, although some patients may respond to lower doses. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, schedule dosage adjustments accordingly. The usual dosage range studied in clinical trials was 240 to 360 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. Angina : Dosages for the treatment of angina should be adjusted to each patient’s needs, starting with a dose of 120 or 180 mg once daily. Individual patients may respond to higher doses of up to 480 mg…
Serious adverse reactions have been rare in studies carried out to date, but it should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities have usually been excluded from these studies. The following table presents the most common adverse reactions reported in placebo-controlled angina and hypertension trials in patients receiving diltiazem hydrochloride extended-release capsule (once-a-day dosage) up to 360 mg with rates in placebo patients shown for comparison. Diltiazem Hydrochloride Extended-release Capsule (once-a-day dosage) Placebo-Controlled Angina and Hypertension Trials Combined Adverse Reactions Diltiazem Hydrochloride Extended-release Capsule (once-a-day dosage) (n=607) Placebo (n=301) Headache 5.4% 5.0% Dizziness 3.0% 3.0% Bradycardia 3.3% 1.3% AV Block First Degree 3.3% 0.0% Edema 2.6% 1.3% Asthenia 1.8% 1.7% In addition, the following events were reported infrequently (less than 1%) in angina or hypertension trials: Cardiovascular: Congestive heart failure, palpitations, syncope, ventricular extrasystoles. 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, mild elevations of SGOT, SGPT, LDH, and alkaline…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Tablet | — | — | View → | |
| 2 | 70/100 | Prescription | Capsule | Generic | $9 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| par;C830 | 180 mg | green, blue | capsule | — |
| TWi;T181 | 60 mg | pink, white | capsule | — |
| par;C829 | 120 mg | gray, gray | capsule | — |
| par;C831 | 240 mg | green, green | capsule | — |
| par;C832 | 300 mg | green, gray | capsule | — |
| T027;180 | 180 mg |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Glenmark Pharmaceuticals Inc., USA · Nov 1, 2024
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Glenmark Pharmaceuticals Inc., USA · Nov 1, 2024
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Glenmark Pharmaceuticals Inc., USA · Nov 1, 2024
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Glenmark Pharmaceuticals Inc., USA · Nov 1, 2024
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Diltiazem hydrochloride extended-release capsules (once-a-day dosage) are contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker, (3) patients with hypotension (less than 90 mm Hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.
Because of the potential for additive effects, slow titration is warranted in patients receiving diltiazem hydrochloride concomitantly with other agents known to affect cardiac contractility and/or conduction (see WARNINGS ). Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with diltiazem hydrochloride extended-release capsules (once-a-day dosage) (see WARNINGS ). Diltiazem is both a substrate and an inhibitor of the Pg-p and cytochrome P450 3A4 enzyme system which may affect exposure to diltiazem and concomitant drugs metabolized by those pathways. Patients with renal and/or hepatic impairment may be particularly at risk of exposure changes. Anesthetics: The depression of cardiac contractility, conductivity, and automaticity as well as the vascular dilation associated with anesthetics may be potentiated by calcium channel blockers. When used concomitantly, titrate anesthetics and calcium blockers slowly. Benzodiazepines: Studies showed that diltiazem increased the AUC of midazolam and triazolam by 3- to 4- fold and the C max by 2-fold, compared to placebo. The elimination half-life of midazolam and triazolam also increased (1.5- to 2.5-fold) during coadministration with diltiazem. These pharmacokinetic effects seen during diltiazem coadministration can result in…
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| 3 | Not yet rated | Prescription | Tablet | Generic | $9 | View → |
| 4 | Not yet rated | Prescription | Capsule | Generic | $9 | View → |
| 5 | Not yet rated | Prescription | Tablet | Generic | $9 | View → |
| 6 | Not yet rated | Prescription | Capsule | Generic | $9 | View → |
| 7 | Not yet rated | Prescription | Capsule | Generic | $9 | View → |
| 8 | Not yet rated | Prescription | Capsule | Generic | $9 | View → |
| blue, blue |
| capsule |
| — |
| TWi;T182 | 90 mg | pink, white | capsule | — |
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| TWi;T183 | 120 mg | pink | capsule | — |
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| 483 | 90 mg | white | oval | — |
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