isosorbide mononitrate
Brand names: Imdur
Isosorbide mononitrate is a medicine that helps prevent chest pain. It relaxes your blood vessels, so your heart doesn't have to work as hard.
Drug Pricing (NADAC)
Generic Price
$0.23/unit
Generic Available
Yes (10 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine is used to prevent angina, a type of chest pain.
Common side effects
Headache, Dizziness
Key warnings
You should not take this medicine if you are allergic to nitrates or nitrites.
How It Works
Isosorbide mononitrate is a nitrate. It works by relaxing the muscles in your blood vessels. This allows more blood and oxygen to flow to your heart while reducing its workload.
How to Take It
Take this medicine once a day in the morning after you wake up. You can take it with or without food. Swallow the tablet whole with a half-glass of water. Do not chew or crush the tablet.
Pregnancy & Breastfeeding
It is not known if this medicine will harm an unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. It is also not known if this medicine passes into breast milk. Talk to your doctor if you are breastfeeding.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
Storage
Store at room temperature between 68° and 77°F.
Side Effects (from patient reports)
Based on 11,667 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 19,947 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2002–2025.
Total Reports
19,947
Death-Related Reports
2,526
Hospitalization Reports
9,610
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DYSPNOEA | 1,503 |
| 2 | DIZZINESS | 1,397 |
| 3 | DIARRHOEA | 1,249 |
| 4 | FATIGUE | 1,243 |
| 5 | NAUSEA | 1,231 |
| 6 | CHEST PAIN | 1,185 |
| 7 | MYOCARDIAL INFARCTION | 1,019 |
| 8 | HEADACHE | 1,000 |
| 9 | VOMITING | 943 |
| 10 | HYPOTENSION | 901 |
| 11 | MALAISE | 899 |
| 12 | ACUTE KIDNEY INJURY | 891 |
| 13 | OFF LABEL USE | 856 |
| 14 | PAIN | 843 |
| 15 | FALL | 821 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
You should not take this medicine if you are allergic to nitrates or nitrites.
Common Questions
Can I use this medicine to treat chest pain that I am currently having?
What should I do if I get a headache from this medicine?
Can I cut or crush the tablet?
How long does it take for this medicine to start working?
Can I drink alcohol while taking this medicine?
What strengths does this medication come in?
What should I tell my doctor before starting this medication?
Can I stop taking this medication suddenly?
Does this medication interact with other medications?
What do the tablets look like?
What are the common side effects of isosorbide mononitrate?
What drug class is isosorbide mononitrate?
Is isosorbide mononitrate safe during pregnancy?
Related Medications in Nitrate Vasodilator
Other drugs grouped near isosorbide mononitrate — same-class peers and common alternatives.
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amiodarone
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atropine
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bumetanide
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carvedilol
Coreg
Carvedilol is a medicine that lowers blood pressure and helps your heart work better.
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What the FDA Data Shows for isosorbide mononitrate
The FDA label for isosorbide mononitrate (sold under brand names such as Imdur) classifies it as a prescription-only medication in the Nitrate Vasodilator class. This medicine is used to prevent angina, a type of chest pain. Official labeling lists 2 commonly reported side effects, including Headache, Dizziness.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 11,667 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $0.23.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: October 23, 2024
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages