Nitrosid

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

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 Nitrosid

Property Description
Active ingredient Isosorbide Dinitrate (ISDN)
Form Oral Tablets, Sublingual Tablets
Pharmacological class Organic Nitrate Vasodilator, Antianginal Agent
General Purpose Reduction of cardiac workload and prevention of angina
Origin Synthetic Compound

Identity and Classification: What Type of Agent is Isosorbide Dinitrate?

Nitrosid is the trade name for a medication whose active component is Isosorbide Dinitrate (ISDN), an established, prescription-only drug utilized within cardiovascular therapy. The drug belongs to the Organic Nitrate Vasodilator class, a categorization defined by its specific chemical structure and physiological action. It is clinically recognized for its role as an Antianginal Agent, a classification intended to prevent or relieve episodes of chest discomfort. Unlike certain rapid-acting nitrates, Isosorbide Dinitrate is distinguished by its moderate-to-long acting profile, positioning it for the prophylaxis of symptoms associated with Coronary Artery Disease rather than solely for immediate, acute relief.

Composition and Forms: Is Nitrosid a Single Compound Medication?

Isosorbide Dinitrate is a synthetic compound, chemically defined as a nitrate ester, and is typically formulated as a single-ingredient product, containing only the active substance and necessary excipients. The medication is available in several dosage form(s) for oral use, most commonly as standard oral tablets and sublingual tablets. The drug is used to establish a consistent management strategy against discomfort. This formulation strategy offers distinct patient benefits: standard tablets are intended for continuous, sustained effect over time, whereas the sublingual tablets are designed for faster absorption via the sublingual route, enabling quicker symptomatic management when needed.

General Purpose: What is the Main Therapeutic Benefit?

The primary general purpose of Isosorbide Dinitrate is to reduce the overall workload placed upon the heart, mitigating the strain that results from restricted blood flow. This benefit is achieved through its principal action: the relaxation of vascular smooth muscle (vasodilation). This widespread relaxation helps decrease the pressure and volume of blood returning to the heart (reducing preload), while simultaneously improving the flow of oxygen-rich blood to the cardiac tissue. A typical use scenario involves the sustained administration of the medication to help manage the recurring discomfort experienced by patients with chronic stable angina.

What side effects are possible with Nitrosid?

Possible Side Effects and Safety Information

The safety profile for Nitrosid (Isosorbide Dinitrate) is characterized by effects primarily related to its action as a vasodilator, as officially classified by regulatory bodies. Adverse reactions are grouped by frequency and the body system affected.

Frequency-Classified Adverse Reactions

Classification Examples of Reactions
Very Common Headache
Common Hypotension (low blood pressure), Dizziness, Flushing, Reflex Tachycardia
Uncommon Nausea, Vomiting, Allergic skin reaction, Worsening angina pectoris

System-Organ Classes and Safety Concerns

The most frequently affected systems are the Nervous System (headache, dizziness) and Vascular Disorders (hypotension, flushing). The label documents time-related patterns, noting that the Headache is Very Common initially but is officially stated to diminish gradually with continued use.

Serious Adverse Reactions officially listed include Severe Hypotensive Responses (potentially leading to collapse or syncope), and very rarely, conditions such as Stevens-Johnson Syndrome, Angioedema, Methemoglobinemia, and Hypoxaemia.

Safety-Related Restrictions and Considerations

Isosorbide Dinitrate is strictly contraindicated for use with Phosphodiesterase Type 5 (PDE5) inhibitors (e.g., sildenafil) due to the risk of life-threatening severe hypotension. Regulatory documents also restrict use in conditions where a decrease in blood pressure or heart filling pressures is detrimental, such as Severe Hypotension, Acute Circulatory Failure (shock), or certain heart valve conditions like Severe Aortic or Mitral Valve Stenosis.

Official safety notes caution on its use in Geriatric patients due to the higher frequency of decreased organ function, and the drug's safety and effectiveness have not been established for Pediatric Use.

Overdose and Emergency Response

Overdose and When to Seek Help

A Nitrosid (Isosorbide Dinitrate) overdose can result in severe and potentially fatal outcomes, necessitating immediate professional medical attention. Regulatory information documents that a suspected overdose requires contacting emergency services immediately due to the risk of life-threatening events.

Documented Manifestations and Severe Outcomes

Overdose manifestations are primarily linked to profound vasodilation and severe hypotension, leading to symptoms such as a prompt fall in blood pressure, persistent throbbing headache, vertigo, palpitation, and syncope. Severe toxicity may progress to neurological effects, including confusion and seizure. A critical, documented risk is Methemoglobinemia, where nitrate metabolism impairs oxygen delivery, potentially leading to circulatory collapse and cardiac arrest. Other signs include cold and cyanotic skin, nausea, vomiting, and visual disturbances.

Required Emergency Actions

Treatment is entirely symptomatic and supportive within a hospital setting, often requiring admission to an Intensive Care Unit. The regulatory guidance specifies procedures such as continuous monitoring of blood pressure and pulse, elevation of the patient's legs, and plasma volume expansion using intravenous fluids to manage hypotension. For documented Methemoglobinemia, Methylene blue or Vitamin C is the treatment of choice. Specific populations, such as patients with concurrent renal failure or congestive heart failure, require cautious management, where invasive monitoring may be necessary.

Therapeutic Uses of Nitrosid

What Nitrosid Treats: Main Uses and Benefits

Nitrosid (Isosorbide Dinitrate) is a prescription medication primarily focused on providing symptomatic management and support within the cardiovascular domain. This medication is commonly used for managing symptoms associated with Coronary Artery Disease, specifically angina pectoris (chest discomfort), and as an adjunctive therapy for heart failure.

The therapeutic approach involves supporting patients during situations involving certain distressing symptoms that are triggered by heightened physiological activity or that are part of recurrent episodes. The medication is applied in clinical settings where short-term symptomatic assistance is needed and where prophylactic support is considered relevant. This may offer supportive relief when symptoms interfere with routine activities.

“This medication is considered relevant in conditions involving episodic or fluctuating manifestations and helps ease the overall symptom burden.”

Core Therapeutic Focus

Nitrosid is used in areas where additional symptomatic support is needed to address symptom clusters that may become intense or disruptive, such as the pressure of Chronic Stable Angina or the shortness of breath linked to cardiac workload overload. Using this medication may assist with maintaining functional stability and contributes to easing the overall symptom load during periods of heightened symptoms.


Quick Fact: Use in Chronic Recurrent Discomfort

Nitrosid is commonly used to help manage the frequency of anginal attacks and may help patients cope more steadily with symptom fluctuations associated with Coronary Artery Disease.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Nitrosid?

The use of Nitrosid is strictly determined by official regulatory documents, which define specific populations who are eligible for treatment and those for whom use is prohibited or restricted.

Populations for Whom Use is Prohibited (Contraindications)

Nitrosid is contraindicated and must not be used by patients with:

  • Known hypersensitivity or allergy to Nitrosid or any of its inactive ingredients.
  • Concomitant use of Phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil) due to the risk of severe, life-threatening hypotension.
  • Severe anemia or conditions associated with increased intracranial pressure, such as recent cerebral hemorrhage or traumatic brain injury.
  • Acute circulatory failure, shock, or severe, uncontrolled hypotension.

Restricted or Special Consideration Groups

Population/Condition Eligibility Status (Regulatory)
Pediatric Patients (Under 18) Use is not established (Safety and effectiveness not proven).
Severe Hepatic Impairment Use is limited and requires close monitoring and dose adjustment.
Pregnancy Contraindicated during the first trimester. Use in later stages only if the potential benefit outweighs the fetal risk.
Lactation Not recommended; a decision must be made to discontinue nursing or the medication, considering the importance of the drug to the mother.

What should I know about interactions with other medicines?

Nitrosid Interactions with other medicines and products

Official regulatory information classifies certain combinations with Nitrosid (Isosorbide Dinitrate) as absolutely contraindicated due to the risk of critical, life-threatening hypotension.


Formally Contraindicated Combinations

Classification Interacting Agents (Examples)
PDE5 Inhibitors Sildenafil, Tadalafil, Vardenafil, Avanafil
sGC Stimulator Riociguat

Co-administration of Nitrosid with any of these products is prohibited, as documented in regulatory prescribing information, because it causes potentiation of the drug’s vasodilatory effects.


Pharmacodynamic and Pharmacokinetic Interactions

Other medicinal products and substances can lead to an additive hypotensive effect or alter drug exposure. This risk is primarily categorized as a pharmacodynamic interaction (additive effects).

  • Blood Pressure Lowering Agents: Concomitant use with other vasodilators, beta-blockers, calcium antagonists, or tricyclic antidepressants may result in additive lowering of blood pressure, as stated in the Summary of Product Characteristics (SmPC).
  • Alcohol (Ethanol): Official labels state that alcohol consumption exhibits additive effects with the drug’s vasodilating action, which can enhance the risk of symptomatic hypotension.
  • Exposure-Altering Agents: Nitrosid is documented to increase the blood levels and effects of specific co-administered drugs, such as Dihydroergotamine, which is considered a pharmacokinetic interaction involving altered metabolism.

The overall interaction structure is defined by mandatory restrictions (contraindications) and required vigilance against additive hypotensive risks.

Mechanism of Action

Bioactivation and Intracellular Signaling

The action of Nitrosid (Isosorbide Dinitrate) begins as a prodrug requiring biotransformation by specific enzymes, such as mitochondrial aldehyde dehydrogenase ( mtALDH-2), expressed in the vascular wall. This process releases Nitric Oxide (NO), which then activates the enzyme soluble Guanylate Cyclase (sGC) inside the vascular smooth muscle cells. This activation initiates the NO-cGMP signaling cascade, a core pathway that leads directly to the loss of muscle tone.

Modulation of Vascular Tone and Hemodynamics

The resulting signaling cascade causes the muscle cells in blood vessel walls to relax, leading to widespread vasodilation. This effect is more pronounced in the large veins, resulting in venous pooling that rapidly decreases the volume of blood returning to the heart (reducing preload). Arterial relaxation simultaneously lowers the systemic resistance against the heart (reducing afterload). This dual hemodynamic modulation constitutes the drug's primary physiological effect, resulting in altered pressure dynamics throughout the circulatory system.

Dosage and Administration Information

Nitrosid (Isosorbide Dinitrate) is administered through distinct routes, primarily as immediate-release oral tablets and sublingual tablets. The choice of administration route depends on the required usage pattern: oral tablets are designated for sustained, long-term maintenance, while sublingual tablets are reserved for intermittent use when rapid administration is required.

The oral dosing schedule requires a specific regimen to prevent the development of pharmacological tolerance. The regimen involves an asymmetric dosing schedule that incorporates a daily drug-free interval of approximately 14 hours. For angina prophylaxis, the typical starting dose is 5 mg to 20 mg, with maintenance doses ranging from 10 mg to 40 mg administered two or three times daily. Oral tablets are generally taken with water and may be administered without strict regard to meals.

Sublingual tablets, typically dosed between 2.5 mg and 10 mg, must be placed directly under the tongue and allowed to dissolve fully; they must not be chewed or swallowed. When a dose of the oral tablet is missed, the established procedure is to take it as soon as the omission is recognized, unless the time for the next scheduled dose is near. In that situation, the missed dose should be skipped entirely, and the normal dosing sequence should be resumed without doubling the quantity. While specific numerical dose adjustments for older adults are not uniformly prescribed, the general principle is to use the lowest effective dose.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Nitrosid

Research Evidence for Chronic Stable Angina Prophylaxis

Research has primarily focused on the use of Nitrosid (Isosorbide Dinitrate) in patients with chronic stable angina pectoris. Studies conducted in this area often employed short-term Randomized Controlled Trials (RCTs) where patients were assigned to receive the medication or an inactive substance. These trials examined changes in the frequency of chest discomfort and monitored measurements related to exercise capacity.

Findings describe patterns observed in the studies where some measurements were monitored, particularly during short-term use. However, the data show patterns related to a potential loss of sustained effect over time when the medication is taken continuously without a break. Evidence is limited for the long-term, continuous management of angina symptoms with Nitrosid alone. The finding highlights a pattern noted in the studies, indicating that more research is needed to determine long-term dosing schedules.


Clinical Trials for Adjunctive Heart Failure Therapy

Research for heart failure was primarily conducted using a combination therapy that included Nitrosid along with another vasodilator, hydralazine. These trials included large, multi-year RCTs that monitored outcomes related to all-cause mortality and rates of hospitalization in the studied populations.

The highest-level findings were derived from specific trials that focused on an African American patient cohort with moderate-to-severe heart failure. In these specific studies, research monitored the evolution of long-term outcomes in comparison to the placebo group. The evidence is established for the combination product, and data for the single agent (Nitrosid alone) in this specific indication are limited.

Evidence comparing this medication to current standard-of-care agents remains limited in both heart failure and angina. Study results reflect the specific conditions under which they were conducted and do not determine whether an individual will respond similarly.

Frequently Asked Questions (FAQ)

Common questions about Nitrosid (FAQ)


Q: How quickly should I expect to feel the effects of Nitrosid?

A: Regulatory documents describe two distinct forms of the medication. The oral tablet form is designated for sustained, long-term maintenance and is typically not used for immediate relief. The sublingual tablet form, which is placed under the tongue, is used for rapid administration and is typically administered about 15 minutes before anticipated physical or emotional stress.


Q: How long does the effect of one dose of Nitrosid typically last?

A: The drug is generally classified as moderate-to-long acting. The standard oral tablets are intended for long-term prevention, not acute, immediate relief. Official regulatory data describes some extended-release forms of the medication as providing effects for 8 to 10 hours.


Q: Is it safe to consume alcohol while taking Nitrosid?

A: Official labels indicate that consuming alcohol may enhance the drug’s vasodilating effects—the way it relaxes blood vessels. The combination may lead to an intensification of the blood pressure lowering effect (hypotension), which can enhance the risk of symptomatic hypotension.


Q: Is Nitrosid found in breast milk when a woman is nursing?

A: Regulatory information indicates that it is currently unknown whether the active ingredient, isosorbide dinitrate, is excreted into human breast milk. Regulatory documents reflect that a decision regarding discontinuing nursing or discontinuing the medication is required, considering the importance of the drug to the mother.


Q: Does Nitrosid affect the liver?

A: Regulatory information notes that the use of this medication in patients with severe hepatic impairment (severe liver problems) is limited. The use of the drug in these patients is limited and involves dose adjustment and close monitoring, indicating that liver function is a factor in its use.


Q: How does Nitrosid exit the body after it's been used up?

A: The body metabolizes the drug into several active and inactive compounds. The primary active metabolite, Isosorbide Mononitrate, and other compounds are mainly excreted in the urine after they have been processed by the body.


Q: Can I crush or split the Nitrosid tablet?

A: Official regulatory information describes that the extended-release tablets and capsules should be swallowed whole and are not to be crushed, chewed, or divided. Sublingual tablets, which are designed to dissolve under the tongue, must also not be chewed.


Q: What happens if Nitrosid is taken with food?

A: The oral tablets may be administered without strict regard to meals, meaning they can generally be taken with or without food. Regulatory information notes that if headaches occur, oral doses may sometimes be taken with meals.


Q: Is Nitrosid an antibiotic or an anti-inflammatory drug?

A: The medication is officially classified as an Organic Nitrate Vasodilator and an Antianginal Agent, based on its chemical structure and how it works to relieve chest discomfort. It is not classified as an antibiotic, which fights bacteria, or an anti-inflammatory drug.


Q: What is the difference between Nitrosid and similar-sounding medicines I've seen advertised?

A: Nitrosid's active ingredient is Isosorbide Dinitrate. A similar-sounding medicine may be Isosorbide Mononitrate (ISMN). Regulatory data explains that the dinitrate form (Nitrosid) is metabolized by the body into the mononitrate form, which is responsible for some of its clinical activity.


Q: Is Nitrosid a type of steroid?

A: No. The drug is chemically defined as a nitrate ester and is classified as an Organic Nitrate Vasodilator, belonging to the nitrate family of medicines. It is not classified as a steroid.


Q: Why do official documents refer to Nitrosid by a chemical name sometimes?

A: Official documents use the chemical name, Isosorbide Dinitrate, because it is the non-proprietary name for the active ingredient. Using the chemical name is required for universal identification, regulatory consistency, and clarity across different brands and regions.


Q: Does taking Nitrosid affect blood pressure?

A: Yes. The drug’s main physiological effect is widespread vasodilation—the relaxation of blood vessel walls. This action causes a decrease in pressure and volume of blood returning to the heart, which leads to a reduction in systemic arterial pressure (blood pressure).


Q: Can Nitrosid cause unusual changes in mood or sleep patterns?

A: Common side effects listed for the drug include effects on the nervous system, such as dizziness and feeling sleepy. Official warnings state that patients should not drive or operate machinery if they experience these symptoms, as they may be signs of a drop in blood pressure.


Q: Are the side effects of Nitrosid permanent?

A: Official sources note that some common side effects, such as a headache, are stated to often diminish gradually with continued use. Official sources note that side effects that are severe or that do not go away should be reported to a healthcare professional.


Q: Is it normal to feel a bit nauseous when starting Nitrosid?

A: Nausea is listed as an uncommon side effect in official documents. Regulatory sources list side effects that are severe or persistent as symptoms that should be reported to a healthcare professional.


Q: What should I do if I think I missed a dose of Nitrosid?

A: The established procedure documented in official sources describes taking the missed dose as soon as the omission is recognized. If the time for the next scheduled dose is near, the missed dose is to be skipped entirely, and the normal dosing sequence is to be resumed without doubling the quantity.


Q: What happens if I stop taking Nitrosid suddenly?

A: Official warnings describe that stopping the medication abruptly without professional supervision is restricted, as sudden withdrawal has been associated with the potential for angina attacks or a worsening of heart discomfort.


Q: Is Nitrosid considered a controlled substance?

A: No. The drug is a prescription-only medication requiring a professional prescription for dispensing. However, it is not classified as a controlled substance under the US Controlled Substances Act (CSA) or similar international drug scheduling laws.


Q: How is Nitrosid classified in terms of safety by the FDA?

A: The drug is officially classified as an Organic Nitrate Vasodilator. The US FDA is currently transitioning from the old letter-based Pregnancy Risk Categories (A, B, C, D, X) to new labeling that requires a summary of risks and supporting data.


Q: What is the pregnancy risk category for Nitrosid?

A: The drug is no longer assigned an old letter-based pregnancy risk category. However, regulatory information advises that the medication is contraindicated during the first trimester, and its use in later stages is only described if the potential benefit is judged to outweigh the fetal risk.


Q: Have there been recent warnings or updates about Nitrosid from regulatory bodies?

A: Regulatory bodies, such as the FDA, conduct regular reviews and issue updates on prescription drugs. Recent regulatory actions have included the approval of generic versions and adherence to ongoing postmarketing reporting requirements and safety protocols for the medication.


Q: Does taking Nitrosid require regular blood tests?

A: Official prescribing information mandates close monitoring of blood pressure and pulse rate during treatment. Routine blood tests are not uniformly prescribed for all patients, but may be required in special circumstances or for specific existing health conditions.


Q: Is it possible to become dependent on Nitrosid?

A: Official documentation describes instances of physical dependence related to high-dose, long-term occupational exposure to organic nitrates, though the relevance of these observations to the drug's routine clinical use is not known.


Q: Are there studies showing Nitrosid helps long-term?

A: Research evidence for the long-term, continuous management of angina symptoms with the drug alone is described as limited in official documents. Studies suggest a potential loss of sustained effect over time when the drug is taken continuously without incorporating a daily drug-free interval.


Q: Can Nitrosid make me feel tired or affect my ability to drive?

A: Official warnings state that the drug may affect a patient's alertness and reactivity. Restrictions on driving or operating machinery are documented if side effects such as dizziness or feeling tired/sleepy occur.


Q: Does the time of day I take Nitrosid matter?

A: Yes. Regulatory information mandates an asymmetric dosing schedule that includes a daily drug-free interval of approximately 14 hours. This specific timing is implemented to help prevent the development of pharmacological tolerance to the drug's effects.


Q: Are there any major diet restrictions while using Nitrosid?

A: Patients are generally described as continuing their normal diet unless otherwise instructed by a healthcare professional. There are no major food restrictions described in the regulatory prescribing documents for this medication.


Q: Does using Nitrosid affect fertility?

A: Official regulatory studies have indicated no evidence that the active ingredient, isosorbide dinitrate, affects fertility in either male or female subjects studied.


Q: If I have a mild reaction, is it safe to keep taking Nitrosid?

A: Official documentation describes that any side effects that are severe or that do not go away should be reported to a healthcare professional for guidance.


Q: Are the research findings for Nitrosid consistent across different studies?

A: Research indicates that the results reflect the specific conditions under which studies were conducted. Official summaries note that evidence comparing the medication to current standard-of-care agents remains limited, and studies have noted a potential loss of sustained effect over time.

How should Nitrosid be stored and disposed of?

Nitrosid (Isosorbide Dinitrate) must be stored and disposed of according to official regulatory requirements to maintain its stability and ensure safety.

Storage Conditions

The product must be kept at Controlled Room Temperature (CRT), defined as 20 C to 25 C (68 F to 77 F). The medication should remain in its original container and the container must be kept tightly closed to protect the contents from moisture.

Crucially, Nitrosid must be stored out of the sight and reach of children.

Disposal Instructions

Unused or expired Nitrosid must be discarded in compliance with local, state, and federal regulations.

Patients are advised to use community drug take-back programs where available. The medication should not be flushed down the toilet or poured into a drain unless specifically instructed by an authorized program.

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

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