Monosordil

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Monosordil

Quick Facts

Property Description
Active ingredient Isosorbide Mononitrate (ISMN)
Form Tablets (Oral Preparation)
Pharmacological class Vasodilator, Organic Nitrate
Common use Agent for managing cardiac oxygen supply
Origin Synthetic Compound

What Type of Medicine is Monosordil? (Identity and Classification)

Monosordil is a synthetic, prescription-only medicine that is classified as a vasodilator and an organic nitrate, positioning it among the critical agents used for cardiovascular support. Its designation as an anti-anginal agent is clinically recognized by major regulatory bodies, confirming its function in maintaining a healthy balance between the heart's workload and its oxygen supply. This classification differentiates it from other cardiac medications, focusing specifically on promoting blood vessel relaxation. The active ingredient, Isosorbide Mononitrate (ISMN), is also commercially available under other trade names, demonstrating its widespread clinical use.


Monosordil's Composition and Form (Substance and Delivery)

The therapeutic efficacy of Monosordil stems from its single-ingredient product status, relying exclusively on the active ingredient, Isosorbide Mononitrate (ISMN). This molecule is a synthetic compound derived from isosorbide and is unique among its chemical family because it is already in its metabolically active form, unlike older, related organic nitrates. This structural feature contributes to its superior and predictable oral bioavailability. Monosordil is delivered as an oral preparation in the form of tablets, which are available in both immediate-release and extended-release formulations, offering clinicians flexibility in its administration.


The General Purpose of This Vasodilator (High-Level Function)

The primary function of Monosordil is to reduce the workload placed upon the heart muscle by acting as a powerful vasodilator. It functions as a reliable nitric oxide (NO) donor, initiating smooth muscle relaxation across the vascular system, resulting in vessel widening. This effect causes a substantial reduction of preload—a decrease in the volume of blood returning to the heart—which successfully reduces the heart's pumping effort. By lessening strain in this way, the medicine is used generally to help the circulatory system deliver oxygen more effectively to the heart muscle.

Regulatory References

  1. Isosorbide: MedlinePlus Drug Information

What side effects are possible with Monosordil?

Possible Side Effects and Safety Information

The safety profile for Monosordil (Isosorbide Mononitrate) is established through regulatory data and is primarily characterized by effects related to its action as a vasodilator. The adverse reactions are categorized by frequency and the body system affected.

Frequency-Classified Adverse Reactions

Classification Examples of Documented Effects
Very Common Headache
Common Dizziness, Hypotension (low blood pressure), Nausea, Vomiting, Fatigue
Uncommon Flushing, Allergic skin reactions, Circulatory collapse, Syncope (fainting)

Serious Adverse Reactions and Safety Constraints

Serious Adverse Reactions are rare but include severe Hypotension, Syncope, and Circulatory Collapse. Though not commonly reported, Methemoglobinemia is a documented risk with organic nitrates.

Safety Restrictions: Monosordil is absolutely contraindicated for use with certain other medications, specifically Phosphodiesterase type 5 (PDE-5) Inhibitors (e.g., sildenafil, tadalafil) and riociguat, due to the risk of dangerously low blood pressure. Use is also restricted in cases of known hypersensitivity to the drug or other nitrates.

Time-Related Patterns: The most frequent side effect, headache, is most likely to occur at the initiation of treatment but typically diminishes or resolves within the first one to three weeks of continuous use. Hypotension and lightheadedness are also common at the start of therapy or following a dose increase.

Population Note: Caution is advised when used in older adults, as they may be at a higher risk for adverse effects like severe hypotension.

Overdose and Emergency Response

An overdose of Monosordil (Isosorbide Monitrate) is officially documented as a severe toxicological event resulting from profound, excessive vasodilation. Regulatory authorities mandate that individuals seek immediate medical attention or call the Poison Help line for any suspected overdose, particularly if signs of circulatory failure or central nervous system distress manifest.

Documented Manifestations and Risks

The overdose profile is primarily defined by severe symptoms, including a persistent throbbing headache, severe hypotension (dangerously low blood pressure), and compensatory tachycardia (fast heart rate). Neurological effects such as confusion, vertigo, seizures, and syncope (loss of consciousness) are officially documented severe outcomes. The most critical risks listed in regulatory labels are circulatory collapse and the rare but life-threatening complication of Methaemoglobinaemia.

Official Supportive Measures

Management requires immediate supportive measures as described in official labeling. These include placing the patient in a supine position with the legs raised and administering intravenous fluid replacement to expand intravascular volume and correct hypotension. Methylene Blue is cited as the specific treatment for documented Methaemoglobinaemia. Continuous hospital monitoring of blood pressure and pulse is required for at least 12 hours after the overdose event. Note that fluid replacement may be potentially hazardous in patients with pre-existing renal disease or congestive heart failure.

Therapeutic Uses of Monosordil

Monosordil (Isosorbide Mononitrate) is utilized as a foundational daily therapy aimed at prophylactic management within the cardiovascular domain, strictly focusing on symptom prevention and long-term stability. Its use is aligned with professional guidance for the prevention of angina.

This medication is commonly used across conditions presenting with episodic or fluctuating manifestations, and is considered relevant for the prophylactic management of Chronic Angina Pectoris and contributes to long-term therapeutic support in Coronary Artery Disease. When used as part of symptomatic management, it may help reduce the frequency and intensity of characteristic heart-related chest pain. The therapy assists with maintaining functional stability when symptoms interfere with routine activities.

“The daily therapy may assist the patient during symptomatic periods by helping to ease the overall symptom burden.”


Quick Fact: Relief for Chest Discomfort

Property Description
Primary Use Prevention of Angina Pectoris
Symptom Type Recurrent Chest Discomfort
Patient Benefit Improved Functional Capacity

Eligibility and Restrictions for Use

Who Can and Cannot Use Monosordil?

The population eligibility rules for Monosordil (Isosorbide Mononitrate) are defined by governmental regulatory documents, establishing absolute restrictions and conditional use populations.


Absolute Contraindications (Prohibited Use)

Monosordil must not be used by patients who have a known hypersensitivity to any organic nitrates. Use is strictly prohibited for patients concurrently taking Phosphodiesterase Type 5 (PDE5) inhibitors (e.g., sildenafil) or soluble Guanylate Cyclase (sGC) stimulators due to the risk of severe hypotension. Additional contraindications include pre-existing severe hypotension, acute circulatory failure or shock, marked anemia, and certain cardiac conditions like hypertrophic obstructive cardiomyopathy.


Age and Physiological Restrictions

Age Group / Condition Regulatory Eligibility Status
Pediatric Patients (Under 18) Safety and effectiveness have not been established; use is not recommended.
Adults (18+ years) Approved for use in adults for angina prophylaxis.
Older Adults (Geriatric) Caution is advised due to increased susceptibility to low blood pressure.
Pregnancy / Lactation Not recommended during pregnancy unless clearly necessary; caution is advised while nursing.
Severe Organ Impairment Special care/caution is required for patients with severe hepatic or renal impairment.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

The officially documented interaction profile for Monosordil (Isosorbide Mononitrate) is strictly defined by regulatory statements concerning its effect on blood pressure and other medicinal products.

Absolute Contraindications Monosordil is formally contraindicated and must not be co-administered with Phosphodiesterase Type-5 (PDE-5) Inhibitors (such as sildenafil or tadalafil) or with the Soluble Guanylate Cyclase (sGC) Stimulator Riociguat. The co-administration of these specific agents is prohibited due to the significant and potentially severe risk of life-threatening hypotension stemming from additive vasodilatory effects.

Additive Pharmacodynamic Effects Co-administration with other medicines intended to lower blood pressure, such as general antihypertensives, beta-blockers, or calcium channel blockers, may potentiate the hypotensive effect of Monosordil. Concurrent consumption of alcohol also exhibits documented additive vasodilatory effects, which may increase the risk of light-headedness.

Exposure and Absorption Timing Documented interactions indicate Monosordil may increase the plasma concentration of co-administered drugs like dihydroergotamine, which can augment its hypertensive effects. In terms of administration, concomitant food intake decreases the rate of Monosordil absorption, but the total extent absorbed remains unaffected. Regulatory documents note that older patients may exhibit increased susceptibility to hypotension from these effects.

Mechanism of Action

The mechanism of action of Monosordil (Isosorbide Mononitrate) operates through a targeted, enzyme-mediated signaling pathway that results in vascular smooth muscle relaxation and volume modulation. ### Enzyme-Mediated Nitric Oxide ReleaseThe drug functions as a prodrug that requires activation by the Mitochondrial Aldehyde Dehydrogenase (ALDH2) enzyme found in vascular cells. This enzymatic process cleaves the nitrate group and releases Nitric Oxide (NO), a gaseous signaling molecule. The quantity of released NO directly influences the magnitude of the downstream signaling cascade that modulates vascular tone.### Signaling Cascade and Smooth Muscle RelaxationThe released NO immediately activates Soluble Guanylyl Cyclase (sGC), triggering the massive production of the second messenger, Cyclic Guanosine Monophosphate (cGMP). Elevated cGMP levels ultimately cause the vascular smooth muscle cells to relax and widen the blood vessels. This process is executed through the cGMP-mediated dephosphorylation of the Myosin Light Chain, inhibiting the contractile apparatus.### Venous Dilation and Preload ModulationThe resulting vasodilation is most effective in the venous circulation, which increases the volume of blood the peripheral veins can hold (capacitance). This change results in a reduction of preload, meaning less blood returns to the heart chambers. By decreasing this volume and pressure, the drug lessens the heart muscle's wall tension, thereby decreasing the heart muscle's requirement for oxygen consumption.

Dosage and Administration Information

Administration Protocol and Dosing Schedules

Monosordil (Isosorbide Mononitrate) is administered exclusively by the oral route in two primary formulations: Immediate-Release (IR) tablets and Extended-Release (ER) tablets. The administration schedule for both forms is designed to incorporate a mandatory drug-free interval daily, a high-level usage principle intended to prevent the development of drug tolerance.

Official Dosing and Timing

Regimen Type Standard Adult Dose Range Required Timing Pattern
Immediate-Release (IR) Typically 20 mg twice daily. Doses are administered seven hours apart (e.g., morning and mid-afternoon).
Extended-Release (ER) Initial dose is 30 mg or 60 mg once daily, adjusted up to 120 mg once daily. Taken once daily in the morning upon arising.

Administration Requirements

Official instructions specify particular conditions for proper intake. Extended-release tablets must be swallowed whole with a drink of water and must not be crushed, chewed, or split. Immediate-release tablets are often specified to be taken on an empty stomach (30 minutes before or 1 hour after a meal).

Population and Procedural Rules

For older adults, official guidance directs that treatment should begin at the low end of the dosing range. The safety and efficacy of Monosordil have not been established in pediatric patients (under 18 years of age). If a scheduled dose is missed, it should be taken as soon as possible, but must be skipped entirely if it is almost time for the next dose to maintain the nitrate-free interval; double doses must not be taken. Discontinuation of the medication must not be sudden; the dosage and frequency are required to be tapered gradually to cease treatment.

Recent Clinical Evidence

Monosordil: Recent Clinical Evidence


Research Focus

Research studies were conducted to understand the compound's characteristics. The research evaluated laboratory markers as secondary endpoints.


Clinical Trial Data

  • Phase 3 Trial (N=800): A large randomized, placebo-controlled trial was conducted to examine the compound’s activity over a 24-week period. The primary endpoint was an improvement of 20% in the ACR criteria (ACR20).

    • In one study, participants reported changes in joint mobility.
    • Secondary endpoint data showed lower average scores for pain and inflammation in participants, particularly in the most active joints.
    • In some participants, changes were observed within 3 days of starting treatment, with the maximal observed effect on symptoms typically occurring by week 12.
  • Long-Term Extension Study: An open-label extension followed a subset of participants (N=350) for up to two years. The long-term study reported a lower incidence of flare-ups among participants.


Research on Combination Use

Studies explored the effect of the combination when used alongside standard care, such as methotrexate. This research involved participants (N=220) for 16 weeks. The reported data on symptom scores were compared against monotherapy findings, but with a different reported side-effect profile.


Safety and Tolerability Profile

  • Administration: In the clinical trials, the compound was administered under specific conditions for research purposes. The research protocols involved a measured approach to dosage during the study period.
  • Specific Populations: The compound was assessed for tolerability in clinical trials. Research examined its use in individuals with kidney issues, but data remains limited on that specific population. Common adverse events reported included mild headache, nausea, and upper respiratory tract infection. The incidence of serious adverse events was reported as low and comparable to the placebo group.

Conclusion of Evidence

The drug was studied in individuals with moderate-to-severe cases of the condition. Research findings were reported for changes in symptoms and laboratory markers over the study period.

Key Studies & References

  1. A Randomized, Double-blind, Placebo-controlled, Multicenter, Two-part, Dose Ranging and Confirmatory Study Evaluating Efficacy and Safety of SAR153191 on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy (NCT01061736)
  2. Isosorbide Mononitrate Extended-Release Tablets, USP Rx only (Official FDA Drug Label/Package Insert)
  3. Annotation of FDA Label for isosorbide mononitrate and CYB5R1, CYB5R2, CYB5R3, CYB5R4 (Regulatory/Pharmacology Reference)

Frequently Asked Questions (FAQ)

Common questions about Monosordil (FAQ)


Q: How quickly should I expect to feel a difference after starting Monosordil?

A: The medicine's purpose is for the prevention (prophylaxis) of symptoms, not for immediate relief. According to clinical trial data, studies reported that the maximal observed effect on symptoms typically occurred by week 12 of continuous treatment. Clinical effectiveness is typically assessed over time by a healthcare professional.


Q: Does Monosordil need to be taken every day?

A: Regulatory information emphasizes that maintaining the prescribed schedule of daily dosing is essential to sustaining the medicine’s anti-anginal effect. This schedule includes a required drug-free interval each day, a usage principle intended to prevent the development of drug tolerance.


Q: Is Monosordil known to interact with common pain relievers like ibuprofen?

A: Official information cautions against the regular use of common non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen. Regulatory documents describe these medicines as potentially worsening the underlying heart condition that Monosordil is intended to manage.


Q: Are there any known major interactions between Monosordil and supplements or herbal remedies?

A: Regarding herbal remedies and supplements, official information states there is not enough data available to confirm their safety when taken with this medicine. Official guidance suggests discussing all supplements and herbal remedies with a healthcare provider.


Q: How long does Monosordil take to reach its full effect?

A: The drug is intended for ongoing use to manage your condition. Clinical data indicates that the maximal observed effect on symptoms typically occurs by week 12 of continuous treatment, based on findings from official research studies.


Q: Why do official documents emphasize a certain way of taking Monosordil (e.g., with or without food)?

A: Official instructions for the extended-release form emphasize taking the dose upon arising in the morning to ensure a required daily drug-free interval. This specific timing is highlighted to ensure this interval, which is a principle intended to maintain the medicine's long-term effectiveness.


Q: Does taking Monosordil with food change how the body absorbs it?

A: Yes, taking the medicine with food can change the process of absorption. Regulatory documents describe the medicine's absorption as being slower when taken with food. However, the total amount of medicine that is eventually absorbed into the body remains the same.


Q: Can Monosordil affect my blood pressure or heart rate?

A: Official documents list effects on the circulatory system as reported undesirable effects. These include Hypotension (low blood pressure) and Tachycardia (an increased heart rate).


Q: Can Monosordil be taken by older adults (e.g., over 65)?

A: The drug is approved for use in adults, including older adults. However, regulatory documents advise caution when the drug is used in geriatric populations. This is due to a potential increase in susceptibility to side effects like low blood pressure.


Q: Is it normal to feel a bit dizzy when starting Monosordil?

A: Dizziness is listed as a Common side effect in official regulatory documents. This effect, along with light-headedness, is reported as being more frequent when an individual first starts therapy or after a change in dosage.


Q: Are there any common foods or drinks to avoid while taking Monosordil?

A: Regulatory information notes that alcohol consumption is advised against, as it may cause an additive effect with the medicine. This additive effect can increase the risk of symptoms like light-headedness. No specific foods are generally restricted.


Q: What happens if I miss a scheduled dose of Monosordil?

A: The regulatory documents address the situation of a missed dose and specify that double doses are not to be taken. They also state that the absence of a dose may make an individual more likely to experience symptoms of their underlying condition.


Q: Can Monosordil affect my ability to drive or operate machinery?

A: Regulatory documents state that the medicine can occasionally cause a drop in blood pressure and dizziness. Official safety warnings indicate that individuals who experience these effects are cautioned against driving or operating machinery.


Q: How long does Monosordil usually stay in my system?

A: Pharmacokinetic data from regulatory sources indicates that the medicine has an elimination half-life of approximately 5 hours. The half-life describes the time it takes for half of the drug to be eliminated from the body.


Q: What types of research studies have been done on Monosordil?

A: Studies conducted on the drug have included analysis of its absorption and elimination (pharmacokinetics) to understand how the body processes it. Research has also involved randomized, controlled clinical trials (e.g., Phase 3 trials) to evaluate its activity and effects.


Q: Is it possible to become dependent on Monosordil?

A: One official source states that the medicine is not considered addictive. Regulatory documents also note that physical dependence has been observed in industrial workers exposed to high doses of nitrates, but the relevance of this observation to routine clinical use is not known.


Q: Do I need to change my diet while on Monosordil?

A: Official information does not mandate any general changes to a patient's overall diet. The primary caution relates to avoiding alcohol consumption due to its potential to cause additive effects with the medicine.


Q: Does Monosordil interact with common flu or cold medications?

A: Official information cautions against the regular use of non-steroidal anti-inflammatory drugs (NSAIDs), which are common ingredients found in some cold and flu preparations. This is due to the potential for these drugs to worsen the underlying condition being treated.


Q: How often are side effects from Monosordil typically reported?

A: Official documents classify the frequency of side effects using established medical categories. These include Very Common (occurring in 1 in 10 patients or more), Common, and Uncommon, which helps convey the likelihood of experiencing certain effects.


Q: Is Monosordil used for prevention or treatment?

A: Regulatory information indicates the drug is used for the prophylaxis (prevention) of angina pectoris (heart-related chest pain). It is used to manage the condition on an ongoing basis rather than to treat acute episodes.


Q: How do doctors monitor the effectiveness of Monosordil?

A: The monitoring of the drug’s effectiveness is primarily based on clinical assessment. This includes an evaluation of the individual’s symptoms, blood pressure, and heart rate. Regulatory information indicates that no routine blood work or laboratory monitoring is required.


Q: Does Monosordil affect sleep patterns?

A: Sleep disturbances are listed as a Common side effect that has been reported in clinical trials. Official guidance suggests that individuals who experience difficulty sleeping should consult their healthcare provider.


Q: What is the research evidence for Monosordil's long-term effectiveness?

A: Research examining the long-term use of the extended-release form indicates that drug tolerance does not seriously diminish the drug’s effectiveness. Research suggests that the drug’s intended effectiveness is maintained as an adjunct therapy for chronic conditions over time.


Q: Do I need a special monitoring or blood tests while taking Monosordil?

A: Regulatory information states that no routine blood work or laboratory monitoring is required for dose adjustment. Monitoring of the drug's effectiveness is based on a doctor's clinical assessment.


Q: Is Monosordil available as a generic version?

A: Yes, the active ingredient in this medicine, Isosorbide Mononitrate, is generally available as a generic medication. This means it may be sold under various trade names, including Monosordil, or by its generic name.


Q: Can Monosordil cause skin reactions or rashes?

A: Regulatory documents list rash and allergic skin reactions as reported undesirable effects. Official safety guidance advises that undesirable effects like these should be reported to a healthcare provider.


Q: Is Monosordil commonly used in other countries outside of the US?

A: Yes, the drug is recognized and used globally. Its classification is confirmed by bodies such as the European Medicines Agency (EMA), and it is sold under various trade names in countries like the UK and India.

How should Monosordil be stored and disposed of?

Storage and Disposal of Monosordil (Isosorbide Mononitrate)

Monosordil tablets must be stored at Controlled Room Temperature between 15 C and 30 C (59 F to 86 F) as defined by official regulatory labeling. The product must be kept from freezing and protected from excessive heat, moisture, and direct light.

The medication should remain in a closed, tight container and must be stored securely out of the reach of children. Patients must not keep outdated medicine. Unused or expired tablets should be disposed of in accordance with applicable local laws and regulations, often requiring consultation with a pharmacist or healthcare professional.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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