· Brand: Matzim La, Cardizem Cd + 6 more

Diltiazem Side Effects: Common, Serious & FDA Warnings

Creator: MedivaScan
Published: 2026-05-28T04:28:23.034875+00:00

Verified from FDA on May 28, 2026Refreshes every 6 hoursFDA-Sourced

FDA-Approved For

Quick answer

Based on 34,000+ FDA adverse event reports, the most-reported diltiazem reactions include dyspnoea, fatigue, and nausea. FDA reports 9 active Class II recalls of diltiazem, primarily for failed dissolution specifications. The FDA-approved label does not carry a boxed warning.

For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.

Common Side Effects of Diltiazem

The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for diltiazem. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.

Reaction	Reports	% of total
Dyspnoea	3,248	9.5%
Fatigue	2,676	7.9%
Nausea	2,409	7.1%
Pain	2,392	7.0%
Dizziness	2,133	6.3%
Diarrhoea	2,072	6.1%
Headache	1,985	5.8%
Atrial Fibrillation	1,764	5.2%
Asthenia	1,718	5.0%
Pneumonia	1,613	4.7%

Source: FDA FAERS·Updated May 28, 2026·n=34,042+·verify on FDA →·Methodology

Serious Outcomes and FDA Warnings

FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.

Outcome flag	Reports	% of total
Serious reports (any flag)	—	—
Hospitalization	—	—

Diltiazem Recalls

FDA enforcement actions matched to diltiazem via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.

Date	Reason	Class	Quantity	Status
2025-04-16	CGMP Deviations Glenmark Pharmaceuticals Inc., USA	Class II	N/A	Ongoing
2024-12-11	cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. Glenmark Pharmaceuticals Inc., USA	Class II	7296 bottles	Ongoing
2024-12-11	cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. Glenmark Pharmaceuticals Inc., USA	Class II	5232 bottles	Ongoing
2024-12-11	cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. Glenmark Pharmaceuticals Inc., USA	Class II	4704 bottles	Ongoing
2024-12-11	cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. Glenmark Pharmaceuticals Inc., USA	Class II	25584 bottles	Ongoing
2024-12-11	cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. Glenmark Pharmaceuticals Inc., USA	Class II	34848 bottles	Ongoing
2024-12-11	cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. Glenmark Pharmaceuticals Inc., USA	Class II	12,864 bottles	Ongoing
2024-05-01	Failed Dissolution Specifications Glenmark Pharmaceuticals Inc., USA	Class II	3,264 bottles	Ongoing
2024-04-10	Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study. Glenmark Pharmaceuticals Inc., USA	Class II	6,528 bottles	Ongoing

Source: FDA Drug Enforcement Reports·Updated May 28, 2026·Refreshes every 6 hours·verify on FDA →

Show 8 closed recalls (2019 to 2023)

Includes resolved and terminated recalls matched to diltiazem. Most recent first.

Date	Reason	Class	Quantity	Status
2023-02-08	Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory. SUN PHARMACEUTICAL INDUSTRIES INC	Class II	Lot # HAC3120A: 6912 Bottles; Lot # HAC3121A: 6792 Bottles; Lot # HAC4460A: 6816 Bottles; Lot # HAD0365A: 6744 Bottles; Lot # HAD1452A: 6840 Bottles	Terminated
2022-08-10	Failed Dissolution Specifications: below specification limits for dissolution. Teva Pharmaceuticals USA Inc	Class II	8022 bottles	Terminated
2021-11-24	Labelling: Incorrect Exp. Date Teva Pharmaceuticals USA	Class II	32316 bottles	Terminated
2019-10-16	GMP Deviation: lot not intended for commercial distribution. Teva Pharmaceuticals USA	Class III	5,849 bottles	Terminated
2019-02-20	Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points. Valeant Pharmaceuticals North America LLC	Class III	22 bottles	Terminated
2019-02-20	Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points. Valeant Pharmaceuticals North America LLC	Class III	390 bottles	Terminated
2019-02-20	Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points. Valeant Pharmaceuticals North America LLC	Class III	1023 bottles	Terminated
2019-02-20	Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points. Valeant Pharmaceuticals North America LLC	Class III	206 bottles	Terminated

Diltiazem Shortages

FDA-listed shortages of diltiazem products. Strength and dosage-form level detail.

Strength	Reason	Resolved	Status
Diltiazem Hydrochloride, Injection, 100 mg Single Dose ADD-Vantage® Glass Vial (NDC 0409-4350-03)	—	—	Discontinued

Source: FDA Drug Shortages·Updated May 28, 2026

Is Diltiazem Safe?

Diltiazem is FDA-approved and the label does not carry a boxed warning.

As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.

Source: DailyMed (diltiazem label)·Updated May 28, 2026

FDA-Approved Indications

Diltiazem is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.

INDICATIONS AND USAGE 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 (diltiazem label)·Updated May 28, 2026·Section 1 (Indications and Usage)

Frequently Asked Questions

What are the most-reported side effects of diltiazem?

Dyspnoea, fatigue, and nausea are among the most-reported reactions in FDA FAERS data for diltiazem. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.

Is diltiazem the same as Matzim La?

Diltiazem is the generic name; Matzim La is a brand name for the same active ingredient. Other brand names include Cardizem Cd, Cardizem La, Cartia Xt, Tiazac Extended Release, Tiazac, Cardizem, and Tiadylt Er. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.

Has diltiazem been recalled?

Yes. Diltiazem has active and closed recalls on record in the FDA enforcement database. Reasons are dominated by CGMP deviations, failed dissolution specifications, and mislabeling. See the recalls table on this page for current counts, firm names, dates, and lot quantities.

What are diltiazem's current ongoing recalls about?

Active diltiazem recalls are listed in the recalls table above with their class, reason, firm, and affected lots. The dominant reasons across these recalls are CGMP deviations and failed dissolution specifications. For lot numbers, distribution patterns, and the FDA enforcement record for any individual recall, follow the verify-on-FDA link from each row.

What do FDA recall classes mean?

Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.

Is there a current shortage of diltiazem?

No active shortages of diltiazem are listed by the FDA. Historical shortage records appear in the shortages table on this page.

Data Sources & Methodology

How each section of this page is sourced, and how often the data is refreshed.

Source	Endpoint	Refresh
FAERS reactions	openFDA `/drug/event.json` count API. Aggregated per drug per reaction term; we do not store individual reports.	Daily
Recalls	openFDA `/drug/enforcement.json`. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here.	6 hours
Shortages	FDA Drug Shortages list.	Daily
Boxed warnings & label sections	openFDA `/drug/label.json`. Labels are stable; monthly cadence is sufficient.	Monthly
Condition categories	Synonym-mapped from drug_labels.indications. Methodology at /methodology/.	Per-drug

What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.