Side effect of isosorbide

Isosorbide Mononitrate

  • a diuretic or “water pill”;

  • blood pressure medications including calcium channel blockers (such as nifedipine, Procardia);

  • nitroglycerin; or

  • riociguat (Adempas);

  • This list is not complete. Other drugs may interact with isosorbide mononitrate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

    Further information

    Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use isosorbide mononitrate only for the indication prescribed.

    Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

    Copyright 1996-2020 Cerner Multum, Inc. Version: 13.01.

    Medical Disclaimer

    More about isosorbide mononitrate

    • Side Effects
    • During Pregnancy
    • Dosage Information
    • Drug Images
    • Drug Interactions
    • Compare Alternatives
    • Pricing & Coupons
    • En Español
    • 52 Reviews
    • Drug class: antianginal agents

    Consumer resources

    • Isosorbide Mononitrate Extended-Release Tablets
    • Isosorbide Mononitrate Tablets
    • Isosorbide mononitrate (Advanced Reading)

    Other brands: Imdur, Ismo, Monoket

    Professional resources

    • Isosorbide Mononitrate (Wolters Kluwer)
    • … +2 more

    Related treatment guides

    • Angina
    • Angina Pectoris Prophylaxis
    • Esophageal Spasm
    • Heart Failure

    Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended. If you use too much isosorbide mononitrate, it might stop working as well in controlling your condition.

    Try to rest or stay seated when you take this medicine (may cause dizziness or fainting).

    Do not crush, chew, or break an extended-release tablet. Swallow it whole.

    Not all brands and forms of isosorbide mononitrate are taken the same number of times per day. You may need to take the medicine only once daily, in the morning after getting out of bed. You may also need a second dose later in the day.

    Follow your doctor’s dosing instructions very carefully. If your doctor changes your brand, strength, or type of isosorbide mononitrate, your dosage needs may change. Ask your pharmacist if you have any questions about the new kind of isosorbide mononitrate you receive at the pharmacy.

    You may have very low blood pressure while taking this medicine. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. Prolonged illness can lead to a serious electrolyte imbalance, making it dangerous for you to use isosorbide mononitrate.

    Use isosorbide mononitrate regularly to prevent an angina attack. Get your prescription refilled before you run out of medicine completely.

    You should not stop using isosorbide mononitrate suddenly or you could have a severe attack of angina. Keep this medicine on hand at all times. Get your prescription refilled before you run out of medicine completely.

    Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

    Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of isosorbide mononitrate can be fatal.

    Overdose symptoms may include a severe throbbing headache, fever, confusion, severe dizziness, fast or pounding heartbeats, vision problems, nausea, vomiting, stomach pain, bloody diarrhea, trouble breathing, sweating, cold or clammy skin, fainting, and seizure (convulsions).

    Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

    Copyright 1996-2020 Cerner Multum, Inc.

    Latest Update: 11/9/2018, Version: 13.01

  • vardenafil (Levitra).
  • If you take medicines that lower blood pressure with isosorbide mononitrate, either to treat high blood pressure or other medicines that can lower blood pressure as a side effect, the combination might make you feel dizzy or faint, particularly when getting up from a lying or sitting position. If this happens to you, you should sit or lie down until the symptoms pass. Tell your doctor if continually feel dizzy while taking any other medicine with isosorbide mononitrate, as your doses may need adjusting. Other medicines that can reduce blood pressure include the following:

    • ACE inhibitors, eg enalapril, captopril
    • alpha-blockers, eg alfuzosin, doxazosin
    • aliskiren
    • alprostadil
    • anaesthetics (if you’re due to have any surgery, make sure the medical staff know that you’re taking isosorbide mononitrate)
    • angiotensin II receptor antagonists, eg losartan
    • certain antipsychotic medicines, eg chlorpromazine
    • baclofen
    • benzodiazepines, eg temazepam
    • beta-blockers, eg atenolol
    • calcium-channel blockers, eg diltiazem, verapamil, nifedipine
    • clonidine
    • diuretics, eg furosemide
    • dopamine agonists, eg apomorphine, bromocriptine
    • hydralazine
    • levodopa
    • MAOI antidepressants, eg phenelzine
    • methyldopa
    • minoxidil
    • moxisylyte
    • moxonidine
    • nicorandil
    • other nitrates, eg glyceryl trinitrate, amyl nitrate (poppers)
    • tricyclic antidepressants, eg amitriptyline
    • tizanidine.

    If you need to take a painkiller while you’re taking isosorbide mononitrate it’s fine to take paracetamol. Don’t take anti-inflammatory painkillers (NSAIDs) such as ibuprofen, diclofenac or naproxen without checking with your pharmacist or doctor first, because this type of painkiller may not be suitable for people with heart disease.

    • What is isosorbide mononitrate used for and what should I know?
    • How do I take isosorbide mononitrate?
    • Who shouldn’t take isosorbide mononitrate?
    • What are the possible side effects of isosorbide mononitrate?

    Last updated: 07.03.2017

    Helen Marshall, BPharm, MRPharmS Helen Marshall, BPharm, MRPharmS A UK registered pharmacist with a background in hospital pharmacy.


    How does this medication work? What will it do for me?

    Isosorbide-5-mononitrate belongs to the family of medications known as anti-anginals. This medication is used to prevent angina attacks associated with coronary artery disease. It is not useful for the quick relief of an attack.

    It acts by opening up the blood vessels that supply the heart, increasing the blood and oxygen supply to the heart. Isosorbide-5-mononitrate may reduce the number, length, and severity of angina attacks. Tolerance to exercise may be increased and the need for fast-acting nitroglycerin (tablets and spray) may be reduced.

    Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

    Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

    What form(s) does this medication come in?

    Each oval, yellow, biconvex, film-coated, extended release tablet, scored on both sides and engraved “A” over “ID” on one side, contains isosorbide-5-mononitrate 60 mg. Nonmedicinal ingredients: tablet core: colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, paraffin, and sodium aluminum silicate; coating: hydroxypropyl methylcellulose, iron oxide yellow, paraffin, polyethylene glycol, and titanium dioxide.

    How should I use this medication?

    The recommended adult dose of isosorbide-5-mononitrate is 1 tablet (60 mg) taken once daily in the morning after getting up. Your doctor may increase the dose to 2 tablets (120 mg) once daily in the morning if necessary. To reduce the risk of headache, your doctor may suggest starting with one-half tablet (30 mg) once daily each morning for the first 2 to 4 days.

    Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

    The tablets should not be chewed or crushed, and should be swallowed together with half a glass of water. If necessary, the tablet may be split in half and the half tablet may be swallowed whole. You may sometimes find whole tablets in the stool. These are only the shell of the tablet, and you can be sure that the medication has been released.

    The tablets are available in a 30-day package that is designed to make it easy to keep track of your medication. 28 tablets are labeled with a day of the week. To start, take a tablet in the first row that matches the day you begin this pack. Then take a tablet on each of the following days to complete the 28 labelled tablets. The 2 extra non-labelled tablets should be taken after all the other tablets are gone.

    It is important to take this medication exactly as prescribed by your doctor. Isosorbide-5-mononitrate should be taken at about the same time every day. If you miss a dose and remember within 6 hours, take your usual dose as soon as possible, then go back to your regular schedule. If it has been more than 6 hours when you remember, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

    Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

    Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

    Who should NOT take this medication?

    Do not take this medication if you:

    • are allergic to isosorbide-5-mononitrate or any ingredients of this medication
    • are allergic to other nitrates or nitrites
    • are in a state of acute circulatory failure associated with extremely low blood pressure (e.g., states of shock or collapse)
    • are taking sildenafil, tadalafil, or vardenafil
    • experience dizziness, blurred vision, or loss of consciousness when rising from a sitting or lying position
    • have increased pressure inside the head
    • have myocardial insufficiency due to obstruction
    • have severe anemia

    What side effects are possible with this medication?

    Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

    The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

    The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

    Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

    • abdominal pain
    • constipation
    • diarrhea
    • dizziness or lightheadedness, especially when rising from a lying or sitting position
    • flushing of face and neck
    • gas
    • headache
    • increased sweating
    • nausea
    • restlessness
    • sensation of spinning
    • trouble sleeping

    Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

    Check with your doctor as soon as possible if any of the following side effects occur:

    • blurred vision
    • chest pain (angina pain)
    • cough
    • heartburn
    • rapid or pounding heartbeat
    • severe or prolonged headache

    Stop taking the medication and seek immediate medical attention if any of the following occur:

    • signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)

    Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

    Are there any other precautions or warnings for this medication?

    Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

    Drowsiness/reduced alertness: This medication may cause faintness or dizziness. Do not drive, operate machinery, or perform other potentially hazardous tasks until you have determined how this medication affects you.

    Heart disease: Isosorbide-5-mononitrate may cause some symptoms of heart disease to become worse. If you have heart problems caused by not enough oxygen being available for the heart or other organs of the body, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

    Low blood pressure: Symptoms of severe lowering of blood pressure, such as weakness or dizziness, particularly when rising suddenly from a sitting or lying position, may occur. People who are prone to low blood pressure (e.g., those taking diuretics) should be cautious when using this medication.

    Tolerance: With continued use, isosorbide-5-mononitrate may stop having beneficial effects because the body gets used to it (i.e., develops a tolerance). Call your doctor if at any time you feel that your angina attacks are getting worse or happening more often.

    Withdrawal: Stopping this medication suddenly may occasionally aggravate chest pain or other symptoms of angina. To avoid possible withdrawal effects, this medication should be gradually reduced and not stopped suddenly. Do not change the way you are taking this medication without speaking to your doctor.

    Pregnancy: Studies demonstrating the safety and effectiveness of using isosorbide-5-mononitrate during pregnancy are not available. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

    Breast-feeding: It is not known if isosorbide-5-mononitrate passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

    Children: The safety and effectiveness of using this medication have not been established for children. Its use by this age group is not recommended.

    Seniors: Seniors may be more likely to experience dizziness or lightheadedness while taking this medication.

    What other drugs could interact with this medication?

    There may be an interaction between isosorbide-5-mononitrate and any of the following:

    If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

    • stop taking one of the medications,
    • change one of the medications to another,
    • change how you are taking one or both of the medications, or
    • leave everything as is.

    An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

    Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

    All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source:


    Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins.

    IMDUR® Tablets contain 30 mg, 60 mg, or 120 mg of isosorbide mononitrate in an extended-release formulation. The inactive ingredients are aluminum silicate, colloidal silicon dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide, magnesium stearate, paraffin wax, polyethylene glycol, titanium dioxide, and trace amounts of ethanol.

    The chemical name for ISMN is 1,4:3,6-dianhydro-, D-glucitol 5-nitrate; the compound has the following structural formula:

    ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +144° (2% in water, 20°C).

    Isosorbide mononitrate is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane.


    Mechanism of Action: The IMDUR product is an oral extended-release formulation of ISMN, the major active metabolite of isosorbide dinitrate; most of the clinical activity of the dinitrate is attributable to the mononitrate.

    The principal pharmacological action of ISMN and all organic nitrates in general is relaxation of vascular smooth muscle, producing dilatation of peripheral arteries and veins, especially the latter. Dilatation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (preload). Arteriolar relaxation reduces systemic vascular resistance, and systolic arterial pressure and mean arterial pressure (afterload). Dilatation of the coronary arteries also occurs. The relative importance of preload reduction, afterload reduction, and coronary dilatation remains undefined.

    Pharmacodynamics: Dosing regimens for most chronically used drugs are designed to provide plasma concentrations that are continuously greater than a minimally effective concentration. This strategy is inappropriate for organic nitrates. Several well-controlled clinical trials have used exercise testing to assess the antianginal efficacy of continuously delivered nitrates. In the large majority of these trials, active agents were indistinguishable from placebo after 24 hours (or less) of continuous therapy. Attempts to overcome tolerance by dose escalation, even to doses far in excess of those used acutely, have consistently failed. Only after nitrates have been absent from the body for several hours has their antianginal efficacy been restored. IMDUR Tablets during long-term use over 42 days dosed at 120 mg once daily continued to improve exercise performance at 4 hours and at 12 hours after dosing, but its effects (although better than placebo) are less than or, at best, equal to the effects of the first dose of 60 mg.

    Pharmacokinetics and Metabolism: After oral administration of ISMN as a solution or immediate-release tablets, maximum plasma concentrations of ISMN are achieved in 30 to 60 minutes, with an absolute bioavailability of approximately 100%. After intravenous administration, ISMN is distributed into total body water in about 9 minutes with a volume of distribution of approximately 0.6 to 0.7 L/kg. Isosorbide mononitrate is approximately 5% bound to human plasma proteins and is distributed into blood cells and saliva. Isosorbide mononitrate is primarily metabolized by the liver, but unlike oral isosorbide dinitrate, it is not subject to first-pass metabolism. Isosorbide mononitrate is cleared by denitration to isosorbide and glucuronidation as the mononitrate, with 96% of the administered dose excreted in the urine within 5 days and only about 1% eliminated in the feces. At least six different compounds have been detected in urine, with about 2% of the dose excreted as the unchanged drug and at least five metabolites. The metabolites are not pharmacologically active. Renal clearance accounts for only about 4% of total body clearance. The mean plasma elimination half-life of ISMN is approximately 5 hours.

    The disposition of ISMN in patients with various degrees of renal insufficiency, liver cirrhosis, or cardiac dysfunction was evaluated and found to be similar to that observed in healthy subjects. The elimination half-life of ISMN was not prolonged, and there was no drug accumulation in patients with chronic renal failure after multiple oral dosing.

    The pharmacokinetics and/or bioavailability of IMDUR Tablets have been studied in both normal volunteers and patients following single- and multiple-dose administration. Data from these studies suggest that the pharmacokinetics of ISMN administered as IMDUR Tablets are similar between normal healthy volunteers and patients with angina pectoris. In single- and multiple-dose studies, the pharmacokinetics of ISMN were dose proportional between 30 mg and 240 mg.

    In a multiple-dose study, the effect of age on the pharmacokinetic profile of IMDUR 60 mg and 120 mg (2 × 60 mg) Tablets was evaluated in subjects >/=45 years. The results of that study indicate that there are no significant differences in any of the pharmacokinetic variables of ISMN between elderly (>/=65 years) and younger individuals (45-64 years) for the IMDUR 60-mg dose. The administration of IMDUR Tablets 120 mg (2 × 60 mg tablets every 24 hours for 7 days) produced a dose-proportional increase in C max and AUC, without changes in T max or the terminal half-life. The older group (65-74 years) showed 30% lower apparent oral clearance (Cl/F) following the higher dose, ie, 120 mg, compared to the younger group (45-64 years); Cl/F was not different between the two groups following the 60-mg regimen. While Cl/F was independent of dose in the younger group, the older group showed slightly lower Cl/F following the 120-mg regimen compared to the 60-mg regimen. Differences between the two age groups, however, were not statistically significant. In the same study, females showed a slight (15%) reduction in clearance when the dose was increased. Females showed higher AUCs and C max compared to males, but these differences were accounted for by differences in body weight between the two groups. When the data were analyzed using age as a variable, the results indicated that there were no significant differences in any of the pharmacokinetic variables of ISMN between older (>/=65 years) and younger individuals (45-64 years). The results of this study, however, should be viewed with caution due to the small numbers of subjects in each age subgroup and consequently the lack of sufficient statistical power.

    The following table summarizes key pharmacokinetic parameters of ISMN after single- and multiple-dose administration of ISMN as an oral solution or IMDUR Tablets:

    Food Effects: The influence of food on the bioavailability of ISMN after single-dose administration of IMDUR Tablets 60 mg was evaluated in three different studies involving either a “light” breakfast or a high-calorie, high-fat breakfast. Results of these studies indicate that concomitant food intake may decrease the rate (increase in T max ) but not the extent (AUC) of absorption of ISMN.


    Controlled trials with IMDUR Tablets have demonstrated antianginal activity following acute and chronic dosing. Administration of IMDUR Tablets once daily, taken early in the morning on arising, provided at least 12 hours of antianginal activity.

    In a placebo-control parallel study, 30, 60, 120, and 240 mg of IMDUR Tablets were administered once daily for up to 6 weeks. Prior to randomization, all patients completed a 1- to 3-week single-blind placebo phase to demonstrate nitrate responsiveness and total exercise treadmill time reproducibility. Exercise tolerance tests using the Bruce Protocol were conducted prior to and at 4 and 12 hours after the morning dose on days 1, 7, 14, 28, and 42 of the double-blind period. IMDUR Tablets 30 and 60 mg (only doses evaluated acutely) demonstrated a significant increase from baseline in total treadmill time relative to placebo at 4 and 12 hours after the administration of the first dose. At day 42, the 120- and 240-mg dose of IMDUR Tablets demonstrated a significant increase in total treadmill time at 4 and 12 hours post-dosing, but by day 42, the 30- and 60-mg doses no longer were differentiable from placebo. Throughout chronic dosing, rebound was not observed in any IMDUR treatment group.

    Pooled data from two other trials, comparing IMDUR Tablets 60 mg once daily, ISDN 30 mg QID, and placebo QID in patients with chronic stable angina using a randomized, double-blind, three-way crossover design found statistically significant increases in exercise tolerance times for IMDUR Tablets compared to placebo at hours 4, 8, and 12 and to ISDN at hour 4. The increases in exercise tolerance on day 14, although statistically significant compared to placebo, were about half of that seen on day 1 of the trial.


    IMDUR Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.


    IMDUR Tablets are contraindicated in patients who have shown hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.


    Amplification of the vasodilatory effects of IMDUR by sildenafil can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion.

    The benefits of ISMN in patients with acute myocardial infarction or congestive heart failure have not been established. Because the effects of isosorbide mononitrate are difficult to terminate rapidly, this drug is not recommended in these settings.

    If isosorbide mononitrate is used in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.


    General: Severe hypotension, particularly with upright posture, may occur with even small doses of isosorbide mononitrate. This drug should therefore be used with caution in patients who may be volume depleted or who, for whatever reason, are already hypotensive. Hypotension induced by isosorbide mononitrate may be accompanied by paradoxical bradycardia and increased angina pectoris.

    Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.

    In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence. The importance of these observations to the routine, clinical use of oral isosorbide mononitrate is not known.

    Information for Patients: Patients should be told that the antianginal efficacy of IMDUR Tablets can be maintained by carefully following the prescribed schedule of dosing. For most patients, this can be accomplished by taking the dose on arising.

    As with other nitrates, daily headaches sometimes accompany treatment with isosorbide mononitrate. In patients who get these headaches, the headaches are a marker of the activity of the drug. Patients should resist the temptation to avoid headaches by altering the schedule of their treatment with isosorbide mononitrate, since loss of headache may be associated with simultaneous loss of antianginal efficacy. Aspirin or acetaminophen often successfully relieves isosorbide mononitrate-induced headaches with no deleterious effect on isosorbide mononitrate’s antianginal efficacy.

    Treatment with isosorbide mononitrate may be associated with light-headedness on standing, especially just after rising from a recumbent or seated position. This effect may be more frequent in patients who have also consumed alcohol.

    Drug Interactions: The vasodilating effects of isosorbide mononitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.

    Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.

    Drug/Laboratory Test Interactions: Nitrates and nitrites may interfere with the Zlatkis-Zak color reaction, causing falsely low readings in serum cholesterol determinations.

    Carcinogenesis, Mutagenesis, Impairment of Fertility: No evidence of carcinogenicity was observed in rats exposed to isosorbide mononitrate in their diets at doses of up to 900 mg/kg/day for the first 6 months and 500 mg/kg/day for the remaining duration of a study in which males were dosed for up to 121 weeks and females were dosed for up to 137 weeks. No evidence of carcinogenicity was observed in mice exposed to isosorbide mononitrate in their diets for up to 104 weeks at doses of up to 900 mg/kg/day.

    Isosorbide mononitrate did not produce gene mutations (Ames test, mouse lymphoma test) or chromosome aberrations (human lymphocyte and mouse micronucleus tests) at biologically relevant concentrations.

    No effects on fertility were observed in a study in which male and female rats were administered doses of up to 750 mg/kg/day beginning, in males, 9 weeks prior to mating, and in females, 2 weeks prior to mating.

    Pregnancy Teratogenic Effects: Pregnancy Category B In studies designed to detect effects of isosorbide mononitrate on embryo-fetal development, doses of up to 240 or 248 mg/kg/day, administered to pregnant rats and rabbits, were unassociated with evidence of such effects. These animal doses are about 100 times the maximum recommended human dose (120 mg in a 50-kg woman) when comparison is based on body weight; when comparison is based on body surface area, the rat dose is about 17 times the human dose and the rabbit dose is about 38 times the human dose. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, IMDUR Tablets should be used during pregnancy only if clearly needed.

    Nonteratogenic Effects: Neonatal survival and development and incidence of stillbirths were adversely affected when pregnant rats were administered oral doses of 750 (but not 300) mg isosorbide mononitrate/kg/day during late gestation and lactation. This dose (about 312 times the human dose when comparison is based on body weight and 54 times the human dose when comparison is based on body surface area) was associated with decreases in maternal weight gain and motor activity and evidence of impaired lactation.

    Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ISMN is administered to a nursing mother.

    Pediatric Use: The safety and effectiveness of ISMN in pediatric patients have not been established.

    Geriatric Use: Clinical studies of IMDUR Tablets did not include sufficient information on patients age 65 and over to determine if they respond differently from younger patients. Other reported clinical experience for IMDUR has not identified differences in response between elderly and younger patients. Clinical experience for organic nitrates reported in the literature identified a potential for severe hypotension and increased sensitivity to nitrates in the elderly. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

    Elderly patients may have reduced baroreceptor function and may develop severe orthostatic hypotension when vasodilators are used. IMDUR should therefore be used with caution in elderly patients who may be volume depleted, on multiple medications, or who, for whatever reason, are already hypotensive. Hypotension induced by isosorbide mononitrate may be accompanied by paradoxical bradycardia and increased angina pectoris.

    Elderly patients may be more susceptible to hypotension and may be at a greater risk of falling at therapeutic doses of nitroglycerin.

    Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy, particularly in the elderly.


    The table below shows the frequencies of the adverse events that occurred in >5% of the subjects in three placebo-controlled North American studies in which patients in the active treatment arm received 30 mg, 60 mg, 120 mg, or 240 mg of isosorbide mononitrate as IMDUR Tablets once daily. In parentheses, the same table shows the frequencies with which these adverse events were associated with the discontinuation of treatment. Overall, 8% of the patients who received 30 mg, 60 mg, 120 mg, or 240 mg of isosorbide mononitrate in the three placebo-controlled North American studies discontinued treatment because of adverse events. Most of these discontinued because of headache. Dizziness was rarely associated with withdrawal from these studies. Since headache appears to be a dose-related adverse effect and tends to disappear with continued treatment, it is recommended that IMDUR treatment be initiated at low doses for several days before being increased to desired levels.

    In addition, the three North American trials were pooled with 11 controlled trials conducted in Europe. Among the 14 controlled trials, a total of 711 patients were randomized to IMDUR Tablets. When the pooled data were reviewed, headache and dizziness were the only adverse events that were reported by >5% of patients. Other adverse events, each reported by </=5% of exposed patients, and in many cases of uncertain relation to drug treatment, were:

    Autonomic Nervous System Disorders: dry mouth, hot flushes.

    Body as a Whole: asthenia, back pain, chest pain, edema, fatigue, fever, flu-like symptoms, malaise, rigors.

    Cardiovascular Disorders, General: cardiac failure, hypertension, hypotension.

    Central and Peripheral Nervous System Disorders: dizziness, headache, hypoesthesia, migraine, neuritis, paresis, paresthesia, ptosis, tremor, vertigo.

    Gastrointestinal System Disorders: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gastric ulcer, gastritis, glossitis, hemorrhagic gastric ulcer, hemorrhoids, loose stools, melena, nausea, vomiting.

    Hearing and Vestibular Disorders: earache, tinnitus, tympanic membrane perforation.

    Heart Rate and Rhythm Disorders: arrhythmia, arrhythmia atrial, atrial fibrillation, bradycardia, bundle branch block, extrasystole, palpitation, tachycardia, ventricular tachycardia.

    Liver and Biliary System Disorders: SGOT increase, SGPT increase.

    Metabolic and Nutritional Disorders: hyperuricemia, hypokalemia.

    Musculoskeletal System Disorders: arthralgia, frozen shoulder, muscle weakness, musculoskeletal pain, myalgia, myositis, tendon disorder, torticollis.

    Myo-, Endo-, Pericardial, and Valve Disorders: angina pectoris aggravated, heart murmur, heart sound abnormal, myocardial infarction, Q wave abnormality.

    Platelet, Bleeding, and Clotting Disorders: purpura, thrombocytopenia.

    Psychiatric Disorders: anxiety, concentration impaired, confusion, decreased libido, depression, impotence, insomnia, nervousness, paroniria, somnolence.

    Red Blood Cell Disorder: hypochromic anemia.

    Reproductive Disorders, Female: atrophic vaginitis, breast pain.

    Resistance Mechanism Disorders: bacterial infection, moniliasis, viral infection.

    Respiratory System Disorders: bronchitis, bronchospasm, coughing, dyspnea, increased sputum, nasal congestion, pharyngitis, pneumonia, pulmonary infiltration, rales, rhinitis, sinusitis.

    Skin and Appendages Disorders: acne, hair texture abnormal, increased sweating, pruritus, rash, skin nodule.

    Urinary System Disorders: polyuria, renal calculus, urinary tract infection.

    Vascular (Extracardiac) Disorders: flushing, intermittent claudication, leg ulcer, varicose vein.

    Vision Disorders: conjunctivitis, photophobia, vision abnormal.

    In addition, the following spontaneous adverse event has been reported during the marketing of isosorbide mononitrate: syncope.


    Hemodynamic Effects: The ill effects of isosorbide mononitrate overdose are generally the results of isosorbide mononitrate’s capacity to induce vasodilatation, venous pooling, reduced cardiac output, and hypotension. These hemodynamic changes may have protean manifestations, including increased intracranial pressure, with any or all of persistent throbbing headache, confusion, and moderate fever; vertigo; palpitations; visual disturbances; nausea and vomiting (possibly with colic and even bloody diarrhea); syncope (especially in the upright posture); air hunger and dyspnea, later followed by reduced ventilatory effort; diaphoresis, with the skin either flushed or cold and clammy; heart block and bradycardia; paralysis; coma; seizures; and death.

    Laboratory determinations of serum levels of isosorbide mononitrate and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of isosorbide mononitrate overdose.

    There are no data suggesting what dose of isosorbide mononitrate is likely to be life threatening in humans. In rats and mice, there is significant lethality at doses of 2000 mg/kg and 3000 mg/kg, respectively.

    No data are available to suggest physiological maneuvers (eg, maneuvers to change the pH of the urine) that might accelerate elimination of isosorbide mononitrate. In particular, dialysis is known to be ineffective in removing isosorbide mononitrate from the body.

    No specific antagonist to the vasodilator effects of isosorbide mononitrate is known, and no intervention has been subject to controlled study as a therapy of isosorbide mononitrate overdose. Because the hypotension associated with isosorbide mononitrate overdose is the result of venodilatation and arterial hypovolemia, prudent therapy in this situation should be directed toward an increase in central fluid volume. Passive elevation of the patient’s legs may be sufficient, but intravenous infusion of normal saline or similar fluid may also be necessary.

    The use of epinephrine or other arterial vasoconstrictors in this setting is likely to do more harm than good.

    In patients with renal disease or congestive heart failure, therapy resulting in central volume expansion is not without hazard. Treatment of isosorbide mononitrate overdose in these patients may be subtle and difficult, and invasive monitoring may be required.

    Methemoglobinemia: Methemoglobinemia has been reported in patients receiving other organic nitrates, and it probably could also occur as a side effect of isosorbide mononitrate. Certainly, nitrate ions liberated during metabolism of isosorbide mononitrate can oxidize hemoglobin into methemoglobin. Even in patients totally without cytochrome b5 reductase activity, however, and even assuming that the nitrate moiety of isosorbide mononitrate is quantitatively applied to oxidation of hemoglobin, about 2 mg/kg of isosorbide mononitrate should be required before any of these patients manifest clinically significant (>/=10%) methemoglobinemia. In patients with normal reductase function, significant production of methemoglobin should require even larger doses of isosorbide mononitrate. In one study in which 36 patients received 2 to 4 weeks of continuous nitroglycerin therapy at 3.1 to 4.4 mg/hr (equivalent, in total administered dose of nitrate ions, to 7.8-11.1 mg of isosorbide mononitrate per hour), the average methemoglobin level measured was 0.2%; this was comparable to that observed in parallel patients who received placebo.

    Notwithstanding these observations, there are case reports of significant methemoglobinemia in association with moderate overdoses of organic nitrates. None of the affected patients had been thought to be unusually susceptible.

    Methemoglobin levels are available from most clinical laboratories. The diagnosis should be suspected in patients who exhibit signs of impaired oxygen delivery despite adequate cardiac output and adequate arterial pO 2 . Classically, methemoglobinemic blood is described as chocolate brown, without color change on exposure to air.

    When methemoglobinemia is diagnosed, the treatment of choice is methylene blue, 1 to 2 mg/kg intravenously.


    The recommended starting dose of IMDUR Tablets is 30 mg (given as a single 30-mg tablet or as 1 / 2 of a 60-mg tablet) or 60 mg (given as a single tablet) once daily. After several days, the dosage may be increased to 120 mg (given as a single 120-mg tablet or as two 60-mg tablets) once daily. Rarely, 240 mg may be required. The daily dose of IMDUR Tablets should be taken in the morning on arising. IMDUR Extended Release Tablets should not be chewed or crushed and should be swallowed together with a half-glassful of fluid.


    IMDUR Extended Release Tablets

    30 mg: rose-colored tablets, scored on both sides and branded with the tradename (“IMDUR”) on one side and the strength on the other.

    Bottles of 100

    NDC 0085-3306-03

    Unit Dose 100 (10 × 10 blister strips)

    NDC 0085-3306-01

    60 mg: yellow-colored tablets, scored on both sides and branded with the tradename (“IMDUR”) on one side and the strength on the other.

    Bottles of 100

    NDC 0085-4110-03

    Unit Dose 100 (10 × 10 blister strips)

    NDC 0085-4110-01

    120 mg: white-colored tablets, branded with the tradename (“IMDUR”) on one side and the strength on the other.

    Bottles of 100

    NDC 0085-1153-03

    Unit Dose 100 (10 x 10 blister strips)

    NDC 0085-1153-04

    Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)

    Protect unit dose from excessive moisture.

    Manufactured for Key Pharmaceuticals, Inc., Kenilworth, NJ 07033 by Astrazeneca PLC, Sweden.

    Use of Sildenafil (Viagra) in Patients With Cardiovascular Disease

  • 12 Andersson KE, Wagner G. Physiology of penile erection. Physiol Rev.1995; 75:191–236.CrossrefMedlineGoogle Scholar
  • 13 Naylor AM. Endogenous neurotransmitters mediating penile erection. Br J Urol.1998; 81:424–431.CrossrefMedlineGoogle Scholar
  • 14 Rajfer J, Aronson WJ, Bush PA, Dory FJ, Ignarro LJ. Nitric oxide as a mediator of relaxation of the corpus cavernosum in response to nonadrenergic, noncholinergic neurotransmission. N Engl J Med.1992; 326:90–94.CrossrefMedlineGoogle Scholar
  • 15 Beavo JA. Cyclic nucleotide phosphodiesterases: functional implications of multiple isoforms. Physiol Rev.1995; 75:725–748.CrossrefMedlineGoogle Scholar
  • 16 McDonald LJ, Murad F. Nitric oxide and cyclic GMP signaling. Proc Soc Exp Biol Med.1996; 211:1–6.CrossrefMedlineGoogle Scholar
  • 17 Packer M, Carver JR, Rodeheffer RJ, et al. Effect of oral milrinone on mortality in severe chronic heart failure: the PROMISE Study Research Group . N Engl J Med.1991; 325:1468–1475.CrossrefMedlineGoogle Scholar
  • 18 Terrett NK, Bell AS, Brown D, et al. A potent and selective inhibitor of type 5 cGMP phosphodiesterase with utility for the treatment of male erectile dysfunction. Bioorg Med Chem Lett. 1996;1819–1824.Google Scholar
  • 19 Nony P, Boissel JP, Lievre M, et al. Evaluation of the effect of phosphodiesterase inhibitors on mortality in chronic heart failure patients: a meta-analysis. Eur J Clin Pharmacol.1994; 46:191–196.CrossrefMedlineGoogle Scholar
  • 20 Degerman E, Belfrage P, Manganiello VC. Structure, localization, and regulation of cGMP-inhibited phosphodiesterase (PDE3). J Biol Chem.1997; 272:6823–6826.CrossrefMedlineGoogle Scholar
  • 21 Saltiel E, Ward A. Ticlopidine: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in platelet-dependent disease states. Drugs.1987; 34:222–262.CrossrefMedlineGoogle Scholar
  • 22 Schror K. The effect of prostaglandins and thromboxane A2 on coronary vessel tone: mechanisms of action and therapeutic implications. Eur Heart J. 1993;suppl I:34–41.Google Scholar
  • 23 Mery PF, Pavoine C, Belhassen L, Pecker F, Fischmeister R. Nitric oxide regulates cardiac Ca2+ current: involvement of cGMP-inhibited and cGMP-stimulated phosphodiesterases through guanylyl cyclase activation. J Biol Chem.1993; 268:26286–26295.MedlineGoogle Scholar
  • 24 Lugnier C, Komas N. Modulation of vascular cyclic nucleotide phosphodiesterases by cyclic GMP: role in vasodilatation. Eur Heart J. 1993;14(suppl I):141–148.Google Scholar
  • 25 Maurice DH, Haslam RJ. Molecular basis of the synergistic inhibition of platelet function by nitrovasodilators and activators of adenylate cyclase: inhibition of cyclic AMP breakdown by cyclic GMP. Mol Pharmacol.1990; 37:671–681.MedlineGoogle Scholar
  • 26 Bohlen JG, Held JP, Sanderson MO, Patterson RP. Heart rate, rate-pressure product, and oxygen uptake during four sexual activities. Arch Intern Med.1984; 144:1745–1748.CrossrefMedlineGoogle Scholar
  • 27 Drory Y, Shapira I, Fisman EZ, Pines A. Myocardial ischemia during sexual activity in patients with coronary artery disease . Am J Cardiol.1995; 75:835–837.CrossrefMedlineGoogle Scholar
  • 28 Johnston BL, Fletcher GF. Dynamic electrocardiographic recording during sexual activity in recent post-myocardial infarction and revascularization patients. Am Heart J.1979; 98:736–741.CrossrefMedlineGoogle Scholar
  • 29 Jackson G. Sexual intercourse and angina pectoris. Int Rehabil Med.1981; 3:35–37.CrossrefMedlineGoogle Scholar
  • 30 Ueno M. The so-called coition death. Jpn J Leg Med.1963; 17:330–340.Google Scholar
  • 31 Muller JE, Mittleman A, Maclure M, Sherwood JB, Tofler GH. Triggering myocardial infarction by sexual activity: low absolute risk and prevention by regular physical exertion: Determinants of Myocardial Infarction Onset study investigators . JAMA.1996; 275:1405–1409.CrossrefMedlineGoogle Scholar
  • 32 Ryan TJ, Anderson JL, Antman EM, et al. ACC/AHA guidelines for the management of patients with acute myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Acute Myocardial Infarction). J Am Coll Cardiol.1996; 28:1328–1428.CrossrefMedlineGoogle Scholar
  • 33 Braunwald E, Mark DB, Jones RH, et al. Unstable angina: diagnosis and management. Clinical Practice Guideline Number 10. Rockville, Md: Agency for Health Care Policy and Research; 1994. Abstract.Google Scholar
  • Isosorbide mononitrate (Oral)

    Isosorbide mononitrate may cause headaches. These headaches are a sign that the medicine is working. Do not stop using the medicine or change the time you use it in order to avoid the headaches. If you have severe pain, talk with your doctor.

    Dizziness, lightheadedness, or faintness may occur, especially when you get up quickly from a lying or sitting position. Getting up slowly may help.

    Dizziness, lightheadedness, or fainting is also more likely to occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. While you are taking isosorbide mononitrate, be careful to limit the amount of alcohol you drink. Also, use extra care during exercise or hot weather or if you must stand for long periods of time.

    Do not stop using isosorbide mononitrate without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

    Make sure any doctor or dentist who treats you knows that you are using isosorbide mononitrate. You may need to stop using isosorbide mononitrate several days before you have medical tests.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter ) medicines and herbal or vitamin supplements.

    Isosorbide mononitrate side effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    Less common

    • Abnormal heart sound
    • absence of or decrease in body movement
    • arm, back, or jaw pain
    • black, tarry stools
    • bladder pain
    • bleeding after defecation
    • bleeding gums
    • blood in the urine or stools
    • blurred vision
    • body aches or pain
    • burning while urinating
    • burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
    • chest pain or discomfort
    • chest tightness or heaviness
    • chills
    • cold sweats
    • colds
    • confusion
    • convulsions
    • cough or hoarseness
    • decreased urine
    • diarrhea
    • difficult or labored breathing
    • difficult, burning, or painful urination
    • dilated neck veins
    • dizziness
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • dry mouth
    • ear congestion
    • extra heartbeats
    • fainting
    • fast, slow, irregular, pounding, or racing heartbeat or pulse
    • fever or chills
    • flu-like symptoms
    • frequent urge to urinate
    • frequent urination
    • general feeling of discomfort or illness
    • headache
    • headache, severe and throbbing
    • heart murmur
    • increased need to urinate
    • increased sweating
    • increased thirst
    • increased volume of pale, dilute urine
    • irregular breathing
    • itching, pain, redness, or swelling on the leg
    • joint pain, stiffness, or swelling
    • lightheadedness
    • loss of appetite
    • loss of voice
    • lower back, side, or stomach pain
    • muscle aches and pains
    • muscle cramps
    • nasal congestion
    • nausea or vomiting
    • nervousness
    • numbness or tingling in the hands, feet, or lips
    • pain or discomfort in the arms, jaw, back, or neck
    • pain, tension, and weakness upon walking that subsides during periods of rest
    • partial or slight paralysis
    • passing urine more often
    • pinpoint red or purple spots on the skin
    • pounding in the ears
    • runny nose
    • shakiness in the legs, arms, hands, or feet
    • shivering
    • sneezing
    • sore on the leg
    • sore throat
    • sudden decrease in the amount of urine
    • sweating
    • swelling
    • swelling of the face, fingers, feet, or lower legs
    • tightness in the chest
    • trembling or shaking of the hands or feet
    • trouble sleeping
    • troubled breathing
    • uncomfortable swelling around the anus
    • unusual bleeding or bruising
    • unusual tiredness or weakness
    • vomiting of blood or material that looks like coffee grounds
    • weakness
    • weight gain


    • Bluish-colored lips, fingernails, or palms
    • dark urine
    • pale skin
    • rapid heart rate

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

    • Blurred or loss of vision
    • bulging soft spot on the head of an infant
    • change in consciousness
    • change in the ability to see colors, especially blue or yellow
    • cold, clammy skin
    • disturbed color perception
    • double vision
    • feeling of constant movement of self or surroundings
    • halos around lights
    • headache, severe and throbbing
    • loss of consciousness
    • night blindness
    • overbright appearance of lights
    • paralysis
    • sensation of spinning
    • tunnel vision

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    Less common

    • Acid or sour stomach
    • anxiety
    • back pain
    • belching
    • blemishes on the skin
    • bloated
    • breast pain
    • burning feeling in the chest or stomach
    • burning, dry, or itching eyes
    • change in color vision
    • changes in vision
    • cold sweats
    • congestion
    • constipation
    • continuing ringing or buzzing or other unexplained noise in the ears
    • cough producing mucus
    • decreased interest in sexual intercourse
    • difficulty seeing at night
    • difficulty with moving
    • discharge, excessive tearing
    • double vision
    • drooping upper eyelids
    • dull ache or feeling of pressure or heaviness in the legs
    • earache
    • excess air or gas in the stomach or intestines
    • feeling of constant movement of self or surroundings
    • feeling of warmth
    • feeling unusually cold
    • frequent urge to defecate
    • frozen shoulder
    • full feeling
    • hearing loss
    • heartburn
    • hyperventilation
    • inability to have or keep an erection
    • increased appetite
    • increased sensitivity of the eyes to sunlight
    • increased sputum
    • indigestion
    • irritability
    • itching skin near damaged veins
    • lack or loss of strength
    • loss in sexual ability, desire, drive, or performance
    • muscle or bone pain
    • muscle stiffness or weakness
    • nightmares
    • noisy breathing
    • pain or tenderness around the eyes and cheekbones
    • passing gas
    • pimples
    • poor concentration
    • rash
    • redness of the face, neck, arms, and occasionally, upper chest
    • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
    • redness, swelling, or soreness of the tongue
    • restlessness
    • seeing double
    • sensation of spinning
    • sleepiness or unusual drowsiness
    • small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope
    • small lumps under the skin
    • sore mouth or tongue
    • stiff neck
    • stomach bloating, burning, cramping, or pain
    • stomach discomfort or upset
    • straining while passing stool
    • stuffy nose
    • sudden sweating
    • swollen feet and ankles
    • tender, swollen glands in the neck
    • tenderness in the stomach area
    • terrifying dreams causing sleep disturbances
    • tooth disorder
    • trouble swallowing
    • uncontrolled twisting movements of the neck
    • voice changes
    • weight loss
    • white patches in the mouth, tongue, or throat

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

    Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

    Copyright 2019 Truven Health Analytics, Inc. All Rights Reserved.

    Medical Disclaimer

    Isosorbide mononitrate


    Are you a new drug developer? Contact us to learn more about our customized products and solutions. Stay in the know! As part of our commitment to providing the most up-to-date drug information, we will be releasing #DrugBankUpdates with our newly added curated drug pages. #DrugBankUpdates Name Isosorbide mononitrate Accession Number DB01020 (APRD00528) Type Small Molecule Groups Approved Description

    Isosorbide mononitrate is a drug used principally in the treatment of angina pectoris and acts by dilating the blood vessels so as to reduce the blood pressure. It is sold by AstraZeneca under the trade name Imdur.

    Isosorbide mononitrate is used to for the the prophylactic treatment of angina pectoris; that is, it is taken in order to prevent or at least reduce the occurrence of angina. Research on Isosorbide mononitrate as a cervical ripener to reduce time at hospital to birth is supportive.

    Isosorbide mononitrate is an active metabolite of isosorbide dinitrate and exerts qualitatively similar effects. Isosorbide mononitrate reduces the workload of the heart by producing venous and arterial dilation. By reducing the end diastolic pressure and volume, isosorbide mononitrate lowers intramural pressure, hence leading to an improvement in the subendocardial blood flow. The net effect when administering isosorbide mononitrate is therefore a reduced workload for the heart and an improvement in the oxygen supply/demand balance of the myocardium.

    The adverse reactions which follow have been reported in studies with isosorbide mononitrate: Very common. Up to 30% of patients experience headaches and 2-3 % of patients withdraw treatment for this reason, but the incidence reduces rapidly as treatment continues . Common. 6% of patients experience tiredness, sleep disturbances, and gastrointestinal disturbances. 4-5% of patients experience hypotension, 2.5% experience poor appetite, and 1% experience nausea. Patients experience similar adverse effects as they would for all nitrate treatments and their incidence is most common early in treatment. These symptoms generally disappear during long-term treatment. Other reactions that have been reported with isosorbide mononitrate modified release tablets include tachycardia, vomiting, diarrhoea, vertigo and heartburn

    Structure 3D Download Similar Structures

    Structure for Isosorbide mononitrate (DB01020)

    × Close Synonyms

    • IS 5-MN
    • IS-5-MN
    • IS-5MN
    • ISMN
    • Iso-5-mononitrate
    • Isosorbide 5-mononitrate
    • Isosorbide 5-nitrate
    • Isosorbide mononitrate
    • Isosorbide-5-mononitrate
    • Isosorbidi mononitras
    • Mononitrate d’isosorbide
    • Mononitrato de isosorbida
    • Monosorbitrate

    External IDs AHR-4698 / BM 22.145 / BM-22.145 / BM-22145 Active Moieties

    Name Kind UNII CAS InChI Key
    Isosorbide unknown WXR179L51S 652-67-5 KLDXJTOLSGUMSJ-JGWLITMVSA-N

    Product Images Prescription Products

    Name Dosage Strength Route Labeller Marketing Start Marketing End
    Unlock Additional Data
    Imdur Tablet 120 mg/1 Oral Schering Corporation 2003-09-01 2006-11-30 US
    Imdur Tablet, extended release 60 mg Oral Mda Inc. 1994-12-31 Not applicable Canada
    Imdur Tablet 60 mg/1 Oral Schering Corporation 2003-09-01 2006-10-31 US
    Imdur Tablet 30 mg/1 Oral Schering Corporation 2003-09-01 2006-10-31 US
    Ismn Tablet, extended release Oral Sivem Pharmaceuticals Ulc 2015-10-08 2017-06-27 Canada
    Ismo Tablet, film coated 20 mg/1 Oral Reddy Pharmaceuticals, LLC 2007-03-31 Not applicable US
    Ismo Tab 20mg Tablet Oral Wyeth Ayerst Canada Inc. 1994-12-31 2002-06-10 Canada
    Monoket Tablet 20 mg/1 Oral Lannett Company, Inc. 1993-06-30 Not applicable US
    Monoket Tablet 20 mg/1 Oral Ucb Inc 1993-06-30 2012-07-30 US
    Monoket Tablet 10 mg/1 Oral Lannett Company, Inc. 1993-06-30 Not applicable US

    Additional Data Available

    • Application Number Application Number

      A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

      Learn more

    • Product Code Product Code

      A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

      Learn more

    Generic Prescription Products

    Name Dosage Strength Route Labeller Marketing Start Marketing End
    Unlock Additional Data
    Apo-ismn Tablet, extended release Oral Apotex Corporation 2006-03-03 Not applicable Canada
    Dom-ismn Tablet, extended release Oral Dominion Pharmacal Not applicable Not applicable Canada
    Imdur Tablet, extended release 120 mg/1 Oral Schering Corporation 2006-01-05 2017-04-06 US
    Imdur Tablet, extended release 60 mg/1 Oral Physicians Total Care, Inc. 1997-01-03 2012-06-30 US
    Imdur Tablet, extended release 60 mg/1 Oral Schering Corporation 2006-01-05 2017-04-06 US
    Imdur Tablet, extended release 30 mg/1 Oral Physicians Total Care, Inc. 2009-12-02 2012-06-30 US
    Imdur Tablet, extended release 30 mg/1 Oral Schering Corporation 2006-01-05 2017-04-06 US
    Isorsorbide Mononitrate Tablet, film coated, extended release 60 mg/1 Oral Actavis Pharma Company 2005-05-04 2006-07-30 US
    Isorsorbide Mononitrate Tablet, film coated, extended release 30 mg/1 Oral Actavis Pharma Company 2005-05-04 2006-07-30 US
    Isosorbide Tablet, film coated, extended release 60 mg/1 Oral Hikma Pharmaceuticals USA Inc. 2006-03-30 2020-09-30 US

    Additional Data Available

    • Application Number Application Number

      A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

      Learn more

    • Product Code Product Code

      A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

      Learn more

    International/Other Brands Chemydur / Corangin / Dilatrate / Duride / Elantan / Etimonis / Imodur / Imtrate / Ismexin / Ismox / Isomon / Isomonit / Isonorm / Medocor / Monicor / Monit / Mono Corax / Mono Mack / Monocedocard / Monoclair / Monocord / Monodur Durules / Monolong / Monomax / Mononit / Monopront / Monosorb / Monosordil / Monotrate / Nitramin / Olicard / Olicardin / Orasorbil / Pertil / Plodin / Promocard / Sigacora / Solotrate / Sorbimon / Turimonit / Uniket / Vasdilat Categories UNII LX1OH63030 CAS number 16051-77-7 Weight Average: 191.1388
    Monoisotopic: 191.042987025 Chemical Formula C6H9NO6 InChI Key YWXYYJSYQOXTPL-SLPGGIOYSA-N InChI InChI=1S/C6H9NO6/c8-3-1-11-6-4(13-7(9)10)2-12-5(3)6/h3-6,8H,1-2H2/t3-,4+,5+,6+/m0/s1 IUPAC Name (3R,3aS,6S,6aR)-6-hydroxy-hexahydrofurofuran-3-yl nitrate SMILES 12OC(O()=O)1()OC2O



    For the prevention of angina pectoris due to coronary artery disease and the treatment of acute and chronic angina pectoris, hypertension, and myocardial infarction.

    Associated Conditions

    • Angina Pectoris


    Isosorbide-5-mononitrate, the long-acting metabolite of isosorbide dinitrate, is used as a vasodilatory agent in the management of angina pectoris. By dilating the vessels, it lowers the blood pressure and reduces the left ventricular preload and afterload, therefore, leads to a reduction of myocardial oxygen requirement.

    Mechanism of action

    Similar to other nitrites and organic nitrates, Isosorbide Mononitrate is converted to nitric oxide (NO), an active intermediate compound which activates the enzyme guanylate cyclase (Atrial natriuretic peptide receptor A). This stimulates the synthesis of cyclic guanosine 3′,5′-monophosphate (cGMP) which then activates a series of protein kinase-dependent phosphorylations in the smooth muscle cells, eventually resulting in the dephosphorylation of the myosin light chain of the smooth muscle fiber. The subsequent release of calcium ions results in the relaxation of the smooth muscle cells and vasodilation.

    Target Actions Organism
    AGuanylate cyclase soluble subunit alpha-2 inducer Humans

    Unlock Additional Data Additional Data Available Adverse Effects

    Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.

    Learn more Additional Data Available Contraindications

    Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

    Learn more Additional Data Available Blackbox Warnings

    Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.

    Learn more Absorption


    Volume of distribution

    • 0.6 to 0.7 L/kg

    Protein binding




    Route of elimination

    Isosorbide mononitrate is primarily metabolized by the liver, but unlike oral isosorbide dinitrate, it is not subject to first-pass metabolism. Isosorbide mononitrate is cleared by denitration to isosorbide and glucuronidation as the mononitrate, with 96% of the administered dose excreted in the urine within 5 days and only about 1% eliminated in the feces. At least six different compounds have been detected in urine, with about 2% of the dose excreted as the unchanged drug and at least five metabolites.

    Half life

    5 hours


    • 120–122 mL/min
    • 151–187 mL/min
    • 132-151 mL/min
    • 119-140 mL/min


    Symptoms of overdose include vasodilatation, venous pooling, reduced cardiac output, and hypotension. There are no data suggesting what dose of isosorbide mononitrate is likely to be life-threatening in humans. In rats and mice, there is significant lethality at doses of 2000 mg/kg and 3000 mg/kg, respectively.

    Affected organisms

    • Humans and other mammals

    Pathways Not Available Pharmacogenomic Effects/ADRs Not Available


    Drug Interactions This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.

    • All Drugs
    • Approved
    • Vet approved
    • Nutraceutical
    • Illicit
    • Withdrawn
    • Investigational
    • Experimental
    Drug Interaction
    Unlock Additional Data
    7,8-Dichloro-1,2,3,4-tetrahydroisoquinoline 7,8-Dichloro-1,2,3,4-tetrahydroisoquinoline may increase the orthostatic hypotensive activities of Isosorbide mononitrate.
    Abacavir Isosorbide mononitrate may decrease the excretion rate of Abacavir which could result in a higher serum level.
    Acarbose Acarbose may decrease the excretion rate of Isosorbide mononitrate which could result in a higher serum level.
    Acebutolol The therapeutic efficacy of Acebutolol can be increased when used in combination with Isosorbide mononitrate.
    Aceclofenac Aceclofenac may decrease the excretion rate of Isosorbide mononitrate which could result in a higher serum level.
    Acemetacin Acemetacin may decrease the excretion rate of Isosorbide mononitrate which could result in a higher serum level.
    Acetaminophen The risk or severity of methemoglobinemia can be increased when Acetaminophen is combined with Isosorbide mononitrate.
    Acetazolamide Acetazolamide may increase the excretion rate of Isosorbide mononitrate which could result in a lower serum level and potentially a reduction in efficacy.
    Acetylsalicylic acid Acetylsalicylic acid may decrease the excretion rate of Isosorbide mononitrate which could result in a higher serum level.
    Aclidinium Isosorbide mononitrate may decrease the excretion rate of Aclidinium which could result in a higher serum level.

    Additional Data Available

    • Extended Description Extended Description

      Extended description of the mechanism of action and particular properties of each drug interaction.

      Learn more

    • Severity Severity

      A severity rating for each drug interaction, from minor to major.

      Learn more

    • Evidence Level Evidence Level

      A rating for the strength of the evidence supporting each drug interaction.

      Learn more

    • Action Action

      An effect category for each drug interaction. Know how this interaction affects the subject drug.

      Learn more

    Food Interactions

    • Take without regard to meals.

    General References Not Available External Links Human Metabolome Database HMDB0015155 KEGG Drug D00630 KEGG Compound C07714 PubChem Compound 27661 PubChem Substance 46506594 ChemSpider 25736 ChEBI 6062 ChEMBL CHEMBL1311 Therapeutic Targets Database DAP001058 PharmGKB PA450126 RxList RxList Drug Page Drug Page Wikipedia Isosorbide_mononitrate ATC Codes C01DA14 — Isosorbide mononitrate

    • C01DA — Organic nitrates

    AHFS Codes

    • 24:12.08 — Nitrates and Nitrites

    FDA label (217 KB) MSDS (66.5 KB)

    Clinical Trials

    Clinical Trials

    Phase Status Purpose Conditions Count
    1 Completed Not Available Healthy Volunteers 2
    1 Completed Diagnostic High Blood Pressure (Hypertension) 1
    1 Completed Treatment Bioequivalence 1
    1 Completed Treatment Healthy Volunteers 1
    1 Completed Treatment High Blood Pressure (Hypertension) 1
    1 Not Yet Recruiting Treatment Anal Fissures 1
    1, 2 Active Not Recruiting Supportive Care Induction of Labour 1
    2 Completed Prevention Cerebral Small Vessels Disease / Cognitive Impairments / Stroke 1
    2 Completed Treatment Heart Failure / Preserved Ejection Fraction 1
    2 Recruiting Treatment Cervical Ripening 1
    2 Recruiting Treatment High Blood Pressure (Hypertension) / Kidney Injury / Proteinuria 1
    2 Recruiting Treatment Induction of Labour 1
    2 Recruiting Treatment Missed Abortion 1
    2 Withdrawn Treatment High Blood Pressure (Hypertension) 1
    2, 3 Completed Treatment Isolated (Idiopathic) Oligohydramnios 1
    2, 3 Recruiting Prevention Cerebral Small Vessels Disease / Stroke, Lacunar 1
    3 Recruiting Supportive Care Induction of Labor Affected Fetus / Newborn 1
    3 Recruiting Supportive Care Induction of Labor Affected Fetus / Newborn / Rupture of Membranes Prior to Onset of Labor 1
    3 Unknown Status Treatment Stable Angina (SA) 1
    4 Completed Prevention Gastrointestinal Hemorrhage / Liver Cirrhosis / Portal Hypertension 1
    4 Completed Prevention Variceal Rebleeding 1
    4 Completed Treatment Acute Heart Failure (AHF) 1
    4 Completed Treatment Second Trimester Abortions 1
    4 Not Yet Recruiting Treatment Coronary Artery Disease 2
    Not Available Completed Treatment Migraine 1
    Not Available Completed Treatment Type 2 Diabetes Mellitus 1
    Not Available Not Yet Recruiting Treatment IUD Insertion Complication 1
    Not Available Recruiting Other Headache / Healthy Volunteers 2
    Not Available Recruiting Prevention Preeclampsia / Premature Labour 1
    Not Available Withdrawn Not Available Coronary Heart Disease (CHD) 1



    • Schering plough corp
    • Actavis elizabeth llc
    • Brightstone pharma inc
    • Dexcel ltd
    • Elan pharmaceutical research corp
    • Ivax pharmaceuticals inc sub teva pharmaceuticals usa
    • Kremers urban co
    • Kv pharmaceutical co
    • Vintage pharmaceuticals inc
    • West ward pharmaceutical corp
    • Promius pharma llc
    • Teva pharmaceuticals usa inc
    • Schwarz gmbh


    • Actavis Group
    • Advanced Pharmaceutical Services Inc.
    • Alvogen Inc.
    • Apothecon
    • A-S Medication Solutions LLC
    • AstraZeneca Inc.
    • Atlantic Biologicals Corporation
    • Bryant Ranch Prepack
    • Cardinal Health
    • Comprehensive Consultant Services Inc.
    • Dexcel Ltd.
    • Dispensing Solutions
    • Diversified Healthcare Services Inc.
    • Elan Pharmaceuticals Inc.
    • Ethex Corp.
    • Heartland Repack Services LLC
    • Ivax Pharmaceuticals
    • Kaiser Foundation Hospital
    • Lake Erie Medical and Surgical Supply
    • Mckesson Corp.
    • Murfreesboro Pharmaceutical Nursing Supply
    • Neuman Distributors Inc.
    • Nucare Pharmaceuticals Inc.
    • Palmetto Pharmaceuticals Inc.
    • Pharmaceutical Utilization Management Program VA Inc.
    • Physicians Total Care Inc.
    • Prepak Systems Inc.
    • Promius Pharma
    • Remedy Repack
    • Resource Optimization and Innovation LLC
    • Schering Corp.
    • Schwarz Pharma Inc.
    • Southwood Pharmaceuticals
    • Stat Rx Usa
    • Teva Pharmaceutical Industries Ltd.
    • Vangard Labs Inc.
    • West-Ward Pharmaceuticals

    Dosage forms

    Form Route Strength
    Tablet, extended release Oral
    Tablet Oral 120 mg/1
    Tablet Oral 30 mg/1
    Tablet Oral 60 mg/1
    Tablet, extended release Oral 60 mg
    Tablet, film coated Oral 20 mg/1
    Tablet Oral
    Tablet Oral 10 mg/1
    Tablet Oral 20 mg/1
    Tablet, coated Oral 20 mg/1
    Tablet, extended release Oral 120 mg/1
    Tablet, extended release Oral 30 mg/1
    Tablet, extended release Oral 60 mg/1
    Tablet, film coated, extended release Oral 120 mg/1
    Tablet, film coated, extended release Oral 30 mg/1
    Tablet, film coated, extended release Oral 60 mg/1


    Unit description Cost Unit
    Imdur er 120 mg tablet 4.19USD tablet
    Imdur 120 mg 24 Hour tablet 3.15USD tablet
    Imdur 60 mg 24 Hour tablet 3.11USD tablet
    Imdur er 60 mg tablet 2.99USD tablet
    Imdur 30 mg 24 Hour tablet 2.87USD tablet
    Imdur er 30 mg tablet 2.85USD tablet
    Monoket 20 mg tablet 2.65USD tablet
    Ismo 20 mg tablet 2.1USD tablet
    Monoket 10 mg tablet 1.75USD tablet
    Isosorbide Mononitrate CR 60 mg 24 Hour tablet 1.48USD tablet
    Isosorbide Mononitrate CR 30 mg 24 Hour tablet 1.16USD tablet
    Isosorbide Mononitrate 20 mg tablet 0.78USD tablet
    Isosorbide Mononitrate 10 mg tablet 0.74USD tablet
    Imdur 60 mg Extended-Release Tablet 0.74USD tablet
    Isosorbide mn 20 mg tablet 0.72USD tablet
    Isosorbide mn 10 mg tablet 0.71USD tablet
    Apo-Ismn 60 mg Extended-Release Tablet 0.42USD tablet
    Pms-Ismn 60 mg Extended-Release Tablet 0.42USD tablet

    DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only. Patents Not Available


    State Solid Experimental Properties

    Property Value Source
    melting point (°C) 88-91 °C Not Available
    water solubility 1.07E+005 mg/L Not Available
    logP -0.15 SANGSTER (1993)

    Predicted Properties

    Property Value Source
    Water Solubility 57.0 mg/mL ALOGPS
    logP -0.74 ALOGPS
    logP -0.48 ChemAxon
    logS -0.53 ALOGPS
    pKa (Strongest Acidic) 13.34 ChemAxon
    pKa (Strongest Basic) -3.5 ChemAxon
    Physiological Charge 0 ChemAxon
    Hydrogen Acceptor Count 6 ChemAxon
    Hydrogen Donor Count 1 ChemAxon
    Polar Surface Area 93.74 Å2 ChemAxon
    Rotatable Bond Count 2 ChemAxon
    Refractivity 38.08 m3·mol-1 ChemAxon
    Polarizability 15.85 Å3 ChemAxon
    Number of Rings 2 ChemAxon
    Bioavailability 1 ChemAxon
    Rule of Five Yes ChemAxon
    Ghose Filter No ChemAxon
    Veber’s Rule No ChemAxon
    MDDR-like Rule No ChemAxon

    Predicted ADMET features

    Property Value Probability
    Human Intestinal Absorption + 0.9156
    Blood Brain Barrier + 0.9355
    Caco-2 permeable 0.579
    P-glycoprotein substrate Non-substrate 0.7621
    P-glycoprotein inhibitor I Non-inhibitor 0.7159
    P-glycoprotein inhibitor II Non-inhibitor 0.9116
    Renal organic cation transporter Non-inhibitor 0.8563
    CYP450 2C9 substrate Non-substrate 0.8674
    CYP450 2D6 substrate Non-substrate 0.8613
    CYP450 3A4 substrate Substrate 0.5357
    CYP450 1A2 substrate Non-inhibitor 0.8532
    CYP450 2C9 inhibitor Non-inhibitor 0.8769
    CYP450 2D6 inhibitor Non-inhibitor 0.9106
    CYP450 2C19 inhibitor Non-inhibitor 0.8469
    CYP450 3A4 inhibitor Non-inhibitor 0.9471
    CYP450 inhibitory promiscuity Low CYP Inhibitory Promiscuity 0.9596
    Ames test Non AMES toxic 0.9133
    Carcinogenicity Non-carcinogens 0.7696
    Biodegradation Ready biodegradable 0.8359
    Rat acute toxicity 2.0753 LD50, mol/kg Not applicable
    hERG inhibition (predictor I) Weak inhibitor 0.5741
    hERG inhibition (predictor II) Non-inhibitor 0.9304

    ADMET data is predicted using admetSAR, a free tool for evaluating chemical ADMET properties. (23092397)


    Mass Spec (NIST) Not Available Spectra

    Spectrum Spectrum Type Splash Key
    Predicted GC-MS Spectrum – GC-MS Predicted GC-MS Not Available
    Predicted MS/MS Spectrum – 10V, Positive (Annotated) Predicted LC-MS/MS Not Available
    Predicted MS/MS Spectrum – 20V, Positive (Annotated) Predicted LC-MS/MS Not Available
    Predicted MS/MS Spectrum – 40V, Positive (Annotated) Predicted LC-MS/MS Not Available
    Predicted MS/MS Spectrum – 10V, Negative (Annotated) Predicted LC-MS/MS Not Available
    Predicted MS/MS Spectrum – 20V, Negative (Annotated) Predicted LC-MS/MS Not Available
    Predicted MS/MS Spectrum – 40V, Negative (Annotated) Predicted LC-MS/MS Not Available


    Description This compound belongs to the class of organic compounds known as isosorbides. These are organic polycyclic compounds containing an isosorbide(1,4-Dianhydrosorbitol) moiety, which consists of two -oxolan-3-ol rings. Kingdom Organic compounds Super Class Organoheterocyclic compounds Class Furofurans Sub Class Isosorbides Direct Parent Isosorbides Alternative Parents Tetrahydrofurans / Alkyl nitrates / Secondary alcohols / Organic nitro compounds / Organic nitric acids and derivatives / Oxacyclic compounds / Dialkyl ethers / Organic zwitterions / Organic oxides / Organic nitrogen compoundsHydrocarbon derivatives show 1 more Substituents Isosorbide / Organic nitrate / Tetrahydrofuran / Alkyl nitrate / Organic nitric acid or derivatives / Secondary alcohol / Organic nitro compound / Dialkyl ether / Ether / OxacycleAllyl-type 1,3-dipolar organic compound / Organic 1,3-dipolar compound / Organooxygen compound / Organic oxide / Organic oxygen compound / Hydrocarbon derivative / Alcohol / Organic zwitterion / Organic nitrogen compound / Aliphatic heteropolycyclic compound show 10 more Molecular Framework Aliphatic heteropolycyclic compounds External Descriptors nitrate ester, glucitol derivative (CHEBI:6062)


    Kind Protein Organism Humans Pharmacological action Yes Actions Inducer General Function Heme binding Specific Function Has guanylyl cyclase on binding to the beta-1 subunit.Isoform 2 acts as a negative regulator of guanylyl cyclase activity as it forms non-functional heterodimers with the beta subunits. Gene Name GUCY1A2 Uniprot ID P33402 Uniprot Name Guanylate cyclase soluble subunit alpha-2 Molecular Weight 81749.185 Da ×Unlock Data

    There is additional data available for commercial users including Adverse Effects, Contraindications, and Blackbox Warnings. Contact us to learn more about these and other features.

    Learn more

    Drug created on June 13, 2005 07:24 / Updated on February 02, 2020 00:23

    About the author

    Leave a Reply

    Your email address will not be published. Required fields are marked *