FDA-filed SPL labeling · retrieved through openFDA

Isosorbide Dinitrate

Isosorbide dinitrate is a nitrate medication used to prevent angina (chest pain) caused by coronary artery disease.

Brand names IsochronIsordilIsoDitrate
Drug class ⓘ Nitrate Vasodilator
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 21 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveMar 2, 2020
Clinical labels in scope ⓘ21
AvailabilityRx
Earliest approval/marketing year ⓘ1959
FDA-listed product records ⓘ151
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 18, 2026
⭐ Isosorbide Dinitrate at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Isosorbide dinitrate tablets prevent angina caused by coronary artery disease — they are not for stopping an attack that's already started. Your dosing schedule must include a daily nitrate-free break of at least 14 hours to keep the medication working. Never combine it with ED medications like sildenafil or tadalafil, as the combination can cause a dangerously severe drop in blood pressure.
How we write & review this content — our editorial policy →

📖 Isosorbide Dinitrate: Patient Information Guide

A plain-language walkthrough of Isosorbide Dinitrate — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Isosorbide dinitrate is used to prevent chest pain (angina) associated with coronary artery disease.

  • Prevention of angina pectoris due to coronary artery disease — supported for isosorbide dinitrate oral tablets (brands including Isordil, Isosorbide, and Isosorbide Dinitrate)
  • This medication is not used to stop an angina attack already in progress — its onset is too slow for that purpose
⚙️How it works▾

Isosorbide dinitrate relaxes smooth muscle in blood vessel walls, causing veins and arteries to widen. Wider veins mean less blood pools back into the heart, reducing how hard the heart has to work to fill and pump. Relaxed arteries lower the pressure the heart pumps against. It also widens the coronary arteries — the vessels that supply the heart muscle itself — which improves blood flow to the heart.

One important pharmacology note: the body becomes tolerant to nitrates quickly if they're present around the clock. That's why dosing schedules must include a daily nitrate-free window — without it, the medication stops working.

💊How it's taken▾

Isosorbide dinitrate tablets are taken by mouth, typically two or three times a day. Because the body builds tolerance to nitrates rapidly with continuous use, every dosing schedule must include a nitrate-free break of at least 14 hours (usually overnight). Anti-anginal effects begin roughly 1 hour after a dose. Always follow your prescriber's specific schedule and take the lowest effective dose.

  • Doses are taken orally (by mouth)
  • A daily nitrate-free interval of at least 14 hours is required to prevent tolerance
  • Effects of second and later daily doses may be smaller and shorter-lasting than the first dose of the day
  • No specific milligram dose is recommended here — follow your prescriber and label
🤒Side effects — in detail▾

Most side effects from isosorbide dinitrate are related to its blood-vessel-widening action and tend to be dose-dependent.

  • Headache — the most common side effect; can be severe and may happen with each dose, especially at higher doses
  • Lightheadedness or dizziness, sometimes tied to drops in blood pressure
  • Low blood pressure (hypotension) — occasionally severe enough to require stopping the medication
  • Fainting (syncope)
  • Worsening chest pain (crescendo angina) — uncommon but serious
  • Rebound high blood pressure — uncommon

Rarely, isosorbide dinitrate can cause methemoglobinemia — a condition where the blood loses its ability to carry oxygen properly. Seek emergency care if you develop bluish skin, confusion, or sudden shortness of breath.

⚠️Warnings & precautions▾
  • Do not combine with ED drugs or riociguat: Taking isosorbide dinitrate with sildenafil, tadalafil, vardenafil, or riociguat can cause a severe, potentially life-threatening drop in blood pressure.
  • Not established for heart attack or heart failure: The benefits of this tablet in acute heart attack or heart failure have not been proven. If used in those settings, careful medical monitoring is essential due to risks of dangerous low blood pressure and rapid heart rate.
  • Tolerance develops quickly: Without a daily nitrate-free interval of at least 14 hours, this medication can lose effectiveness rapidly.
  • Alcohol: Drinking alcohol while on this medication can increase blood-pressure-lowering effects and raise the risk of dizziness and fainting.
🔀What it interacts with▾

Isosorbide dinitrate interacts with several drugs and substances that affect blood pressure or blood vessel tone.

  • ED drugs (sildenafil, tadalafil, vardenafil): Absolutely contraindicated — combining them can cause a severe, dangerous drop in blood pressure
  • Riociguat: Contraindicated — also causes dangerous low blood pressure when combined
  • Alcohol: Adds to the blood-pressure-lowering effect, increasing the risk of dizziness or fainting
  • Other vasodilators (blood-vessel-widening drugs): Effects on blood pressure can add together, increasing the risk of hypotension

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Do not take if you are allergic to isosorbide dinitrate or any ingredient in the tablet
  • Do not take if you use any phosphodiesterase inhibitor for erectile dysfunction: sildenafil, tadalafil, or vardenafil
  • Do not take if you use riociguat (a soluble guanylate cyclase stimulator used for pulmonary hypertension)
  • Use with caution and close medical supervision if you have had a recent heart attack or have heart failure — safety in these conditions has not been established
  • Tell your doctor about all medications, vitamins, and supplements you take before starting
  • Tell your doctor if you drink alcohol regularly
🚑If you take too much▾

Taking too much isosorbide dinitrate causes a dangerous drop in blood pressure due to excessive widening of blood vessels. Symptoms can include severe throbbing headache, confusion, dizziness, fainting, nausea, vomiting, rapid or irregular heartbeat, difficulty breathing, and in severe cases, seizures or loss of consciousness. If overdose is suspected, emergency medical care is needed immediately — treatment focuses on raising blood volume (for example, by elevating the legs or giving IV fluids), and the choice of treatment may be more complex in people with kidney disease or heart failure.

📡Pharmacodynamics — effects in the body▾

Isosorbide dinitrate relaxes smooth muscle in the walls of veins and arteries, causing them to widen. Vein widening reduces the amount of blood returning to the heart, lowering the pressure the heart has to handle as it fills (called preload reduction). Artery relaxation lowers the pressure the heart pumps against (called afterload reduction). The coronary arteries — which feed the heart — also widen. These combined effects reduce the heart's oxygen demand and improve its blood supply, which is why the drug helps prevent angina.

🔬Pharmacokinetics — how your body processes it▾

After you swallow an isosorbide dinitrate tablet, it is absorbed from the gut but goes through heavy processing in the liver before reaching the bloodstream — only about 25% of the dose typically gets through (called first-pass metabolism), though this varies widely from person to person. Blood levels peak roughly 1 hour after taking a dose, and the drug itself has a short half-life of about 1 hour in the blood. It's broken down mainly into two active byproducts — the 5-mononitrate (which stays active for about 5 hours) and the 2-mononitrate (active for about 2 hours) — which continue providing therapeutic effects after the parent drug is cleared.

📦How to store it▾

Store at 20° to 25°C (68° to 77°F) . Protect from moisture. Dispense in a tight, light-resistant container.

📄 Written from Isosorbide Dinitrate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Isosorbide Dinitrate — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is this medication for — and can I use it when chest pain hits? ▾
Isosorbide dinitrate is a prevention medication. It's taken regularly to stop angina attacks from happening in the first place, not to relieve one that's already started. It works too slowly for that. If you get sudden chest pain, you'll need a fast-acting rescue medication — usually nitroglycerin — that your doctor has prescribed separately. Always keep that on hand.
Why does my doctor have me taking it at specific times and not all day long? ▾
That's a really important question. Your body gets used to nitrate medications very quickly if they're in your system around the clock — this is called tolerance, and once it sets in, the drug basically stops working. To prevent that, your schedule has to include a nitrate-free break of at least 14 hours every day, usually overnight. Your prescriber's dosing times are designed specifically around that window, so try to stick to them as closely as you can.
I keep getting headaches every time I take it. Is that normal? ▾
Yes, headaches are actually the most common side effect — and they can be pretty intense, especially at higher doses. The good news is they often get better as your body adjusts over time. Try not to skip doses because of them. Talk to your doctor if they're really bothering you — they may be able to adjust your dose or suggest something to help manage the headache in the meantime.
I take sildenafil (Viagra) — is it okay to use both? ▾
No — this is a serious combination to avoid. Taking isosorbide dinitrate with sildenafil, tadalafil, or vardenafil (ED medications) can cause a sudden, severe drop in blood pressure that can be life-threatening. This applies to all forms of those drugs, including the ones sometimes used for pulmonary hypertension. Make sure every doctor treating you knows you take isosorbide dinitrate.
What should I watch for that means I need to call the doctor or get help right away? ▾
Get medical help immediately if you faint, feel extremely dizzy or weak, notice your chest pain is getting worse rather than better, or if your skin turns bluish and you feel confused or short of breath — that last one is a rare but serious sign the medication may be affecting your blood's ability to carry oxygen. Sudden severe drops in blood pressure and worsening chest pain also need prompt attention.
Can I have a glass of wine or a beer while taking this? ▾
It's best to be cautious. Alcohol can add to the blood-pressure-lowering effect of isosorbide dinitrate, which increases your risk of dizziness, lightheadedness, or even fainting — especially if you stand up quickly. Talk to your doctor about what's safe for you, but be aware that even moderate alcohol use can amplify these effects.
Is Isosorbide Dinitrate available over the counter? ▾
Isosorbide Dinitrate is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Isosorbide Dinitrate first available? ▾
Isosorbide Dinitrate has been available in the United States since at least 1959, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Isosorbide Dinitrate? ▾
Isosorbide Dinitrate is supplied by 28 manufacturers listed in the FDA NDC Directory, including Zydus Pharmaceuticals (USA) Inc., Northstar Rx LLC, Zydus Lifesciences Limited.

💬 Answers drafted from Isosorbide Dinitrate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

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💊 How Isosorbide Dinitrate comes

Isosorbide Dinitrate is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Isordil
How this form is used
What it may be used for
  • Used to prevent angina pectoris due to coronary artery disease
  • Not intended to relieve an acute (sudden) angina attack — works too slowly for that
Important instructions
  • Take by mouth, typically two or three times daily as directed by your prescriber
  • Every dosing schedule must include a nitrate-free interval of at least 14 hours — usually overnight — to prevent tolerance
  • Take the smallest dose that controls your symptoms; follow your prescriber's instructions exactly
  • Isosorbide and Isosorbide Dinitrate tablets: anti-anginal effect begins about 1 hour after a dose — plan your schedule accordingly
Available strengths 5 strengths
5 mg 10 mg 20 mg 30 mg 40 mg
149 FDA-listed product records ⓘ

📊 Isosorbide Dinitrate across the U.S. market

How Isosorbide Dinitrate appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
28
Manufacturers
3
Brand names
151
FDA-listed product records ⓘ
1959
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Zydus Pharmaceuticals (USA) Inc.10%
Northstar Rx LLC8%
Zydus Lifesciences Limited7%
Advagen Pharma Ltd7%
Hikma Pharmaceuticals USA Inc.6%
Remedyrepack Inc.6%
Other makers57%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Isosorbide Dinitrate is used

A general measure of how commonly Isosorbide Dinitrate is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Isosorbide Dinitrate is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

67,209
Medicaid prescriptions filled (Q1–Q4 2025)
$2.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Isosorbide Dinitrate prescribed? Of the 1,596 medications we measure, Isosorbide Dinitrate ranks #576 by Medicaid prescriptions — more than 64% of them.

Where Isosorbide Dinitrate ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #576 of 1,596
#571 Miconazole Vaginal 67,703 Rx #572 Elvitegravir, Cobicist... 67,455 Rx #573 Fosaprepitant Dimeglum... 67,432 Rx #574 Dorzolamide Ophthalmic 67,286 Rx #575 Glucagon Injection / S... 67,274 Rx #576 Isosorbide Dinitrate 67,209 Rx #577 Perphenazine 66,429 Rx #578 Selenium Sulfide 65,979 Rx #579 Pantoprazole Injection 65,430 Rx #580 Ertapenem Injection 65,406 Rx #581 Bismuth Subsalicylate 65,273 Rx

Utilization by Isosorbide Dinitrate product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 10 mg oral tablet is the most-dispensed Isosorbide Dinitrate product — about 35% of these Medicaid prescriptions.

isosorbide dinitrate 10 MG Oral Tablet Most dispensed

23,482 Medicaid prescriptions (Q1–Q4 2025) 35% of Isosorbide Dinitrate prescriptions shown $676,119 gross reimbursement (before rebates) ≈ $29 per prescription (gross)

Summed across the 11 of 44 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 381056

isosorbide dinitrate 20 MG Oral Tablet

22,485 Medicaid prescriptions (Q1–Q4 2025) 33% of Isosorbide Dinitrate prescriptions shown $716,543 gross reimbursement (before rebates) ≈ $32 per prescription (gross)

Summed across the 10 of 34 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 206842

isosorbide dinitrate 30 MG Oral Tablet

11,380 Medicaid prescriptions (Q1–Q4 2025) 17% of Isosorbide Dinitrate prescriptions shown $359,773 gross reimbursement (before rebates) ≈ $32 per prescription (gross)

Summed across the 7 of 16 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197839

isosorbide dinitrate 5 MG Oral Tablet

7,667 Medicaid prescriptions (Q1–Q4 2025) 11% of Isosorbide Dinitrate prescriptions shown $211,394 gross reimbursement (before rebates) ≈ $28 per prescription (gross)

Summed across the 8 of 23 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 314055

isosorbide dinitrate 40 MG Oral Tablet

2,195 Medicaid prescriptions (Q1–Q4 2025) 3% of Isosorbide Dinitrate prescriptions shown $641,172 gross reimbursement (before rebates) ≈ $292 per prescription (gross)

Summed across the 3 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197840

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Isosorbide Dinitrate, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 39 of 126 listed Isosorbide Dinitrate NDCs with Medicaid activity.

🔍 Compare Isosorbide Dinitrate products

A representative set of FDA-listed product records for Isosorbide Dinitrate — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 151 of 151 products — FDA National Drug Code Directory. See every product, package size and price: browse all 151 Isosorbide Dinitrate NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Isosorbide Dinitrate RxCUI 6058 7 dose forms · 14 strengths
  1. Dose form (SCDF) Chewable Tablet RxCUI 381053 No current FDA listing
  2. Dose form (SCDF) Extended Release Oral Capsule RxCUI 381037 No current FDA listing
    Clinical drug / strength (SCD) 40 MG RxCUI 314040
  3. Dose form (SCDF) Extended Release Oral Tablet RxCUI 381040 No current FDA listing
    Clinical drug / strength (SCD) 20 MG RxCUI 358356 40 MG RxCUI 311194
  4. Dose form (SCDF) Injectable Solution RxCUI 381043 No current FDA listing
    Clinical drug / strength (SCD) 0.5 MG/ML RxCUI 104427 1 MG/ML RxCUI 104429
  5. Dose form (SCDF) Oral Spray RxCUI 381045 No current FDA listing
    Clinical drug / strength (SCD) 1.25 MG/ACTUAT RxCUI 104428
  6. Dose form (SCDF) Oral Tablet RxCUI 378739 In current FDA listings
    Clinical drug / strength (SCD) 5 MG RxCUI 314055 10 MG RxCUI 381056 20 MG RxCUI 206842 30 MG RxCUI 197839 40 MG RxCUI 197840
  7. Dose form (SCDF) Sublingual Tablet RxCUI 381046 No current FDA listing
    Clinical drug / strength (SCD) 2.5 MG RxCUI 197838 5 MG RxCUI 197841 10 MG RxCUI 197837

Look up RxCUI 6058 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Isochron Isordil IsoDitrate

🏭 Manufacturers & labelers

Zydus Pharmaceuticals (USA) Inc. 15 Northstar Rx LLC 12 Zydus Lifesciences Limited 10 Advagen Pharma Ltd 10 Hikma Pharmaceuticals USA Inc. 9 Remedyrepack Inc. 9 AvPAK 9 American Health Packaging 6 Sandoz Inc. 6 Cardinal Health 107, LLC 6 Golden State Medical Supply, Inc. 6 Par Pharmaceutical, Inc. 5 Endo USA, Inc. 5 Par Health USA, LLC 5 BluePoint Laboratories 5 Major Pharmaceuticals 4 McKesson Corporation dba SKY Packaging 4 NCS HealthCare of KY, Inc dba Vangard Labs 3 NCS HealthCare of KY, LLC dba Vangard Labs 3 Golden State Medical Supply 3 Bausch Health US LLC 2 Oceanside Pharmaceuticals 2 Dipharma Francis Srl 2 Proficient Rx LP 2

…and 4 more on the FDA NDC directory.

RxNorm drug class

Isosorbide Dinitrate belongs to the Nitrate Vasodilator class.

Pharmacologic class Nitrate Vasodilator
Drug family (ATC) Organic nitrates, Muscle relaxants

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Mar 2, 2020
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Isosorbide Dinitrate.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Isosorbide Dinitrate after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
21
NDC products indexed
151
Distinct labelers/manufacturers represented
28
Linked representative label ⓘ
Oceanside Pharmaceuticals
Linked label effective
Mar 2, 2020
Composite sections available
18
Linked SPL Set ID
723d9f78-9d77-4575-af27-1aa117e6b8d7
Linked SPL Document ID
723d9f78-9d77-4575-af27-1aa117e6b8d7
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 21 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Oceanside Pharmaceuticals is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.