Does Monoket (isosorbide mononitrate) cause side effects?

Monoket (isosorbide mononitrate) is a nitrate used to treat and prevent angina pectoris or "heart pain." 

Nitrates are vasodilators (dilators of blood vessels). Blood returning from the body in the veins must be pumped by the heart through the lungs and into the body's arteries against the high pressure in the arteries. 

In order to accomplish this, the heart's muscle must produce and use energy which requires oxygen brought to the heart by the blood. Angina is due to an inadequate flow of blood (and oxygen) to the muscle of the heart. 

Nitrates correct the imbalance between the flow of blood and oxygen to the heart and the work that the heart must do by dilating the arteries and veins in the body. Dilation of the veins reduces the amount of blood that returns to the heart that must be pumped. Dilation of the arteries lowers the pressure in the arteries against which the heart must pump. 

As a consequence of both effects, the heart works less and requires less blood and oxygen.

Common side effects of Monoket include

Serious side effects of Monoket include methemoglobinemia (rare). 

Drug interactions of Monoket include sildenafil, tadalafil, avanafil, and vardenafil, which increase the blood pressure lowering effects of Monoket and may cause excessive reductions in blood pressure. 

Severe reductions in blood pressure, especially when changing posture (orthostatic hypotension), may occur when Monoket is combined with calcium channel blockers, which also reduce blood pressure. 

There are no adequate studies of Monoket in pregnant women. 

It is unknown if Monoket is excreted in breast milk. Consult your doctor before breastfeeding.

What are the important side effects of Monoket (isosorbide mononitrate)?

Headaches are the most common side effect of isosorbide mononitrate and usually are dose related (increase with higher doses). Flushing may occur because isosorbide mononitrate dilates (enlarges) blood vessels. Isosorbide mononitrate may cause a severe drop in blood pressure when rising from a sitting position, causing: 

To reduce the risk of low blood pressure, patients should rise slowly from a sitting position.

Monoket (isosorbide mononitrate) side effects list for healthcare professionals

Headache is the most frequent side effect and was the cause of 2% of all dropouts from controlled-clinical trials. Headache decreased in incidence after the first few days of therapy.

The following table shows the frequency of adverse reactions observed in 1% or more of subjects in 6 placebo-controlled trials, conducted in the United States and abroad. The same table shows the frequency of withdrawal for these adverse reactions. In many cases the adverse reactions were of uncertain relation to drug treatment.

Frequency Of Adverse Reactions (Discontinuations)*

Dose 6 Placebo-Controlled Studies
Placebo 5 mg 10 mg 20 mg
Patients 160 54 52 159
Headache 6% (0%) 17% (0%) 13% (0%) 35% (5%)
Fatigue Upper Respiratory 2% (0%) 0% (0%) 4% (0%) 1% (0%)
Infection < 1% (0%) 0% (0%) 4% (0%) 1% (0%)
Pain < 1% (0%) 4% (0%) 0% (0%) < 1% (0%)
Dizziness 1% (0%) 0% (0%) 0% (0%) 4% (0%)
Nausea Increased < 1% (0%) 0% (0%) 0% (0%) 3% (2%)
Cough < 1% (0%) 0% (0%) 2% (0%) < 1% (0%)
Rash Abdominal 0% (0%) 2% (2%) 0% (0%) < 1% (0%)
Pain Allergic < 1% (0%) 0% (0%) 2% (0%) 0% (0%)
Reaction Cardiovascular 0% (0%) 0% (0%) 2% (0%) 0% (0%)
Disorder 0% (0%) 2% (0%) 0% (0%) 0% (0%)
Chest Pain < 1% (0%) 0% (0%) 2% (0%) < 1% (0%)
Diarrhea 0% (0%) 0% (0%) 2% (0%) 0% (0%)
Flushing Emotional 0% (0%) 0% (0%) 2% (0%) 0% (0%)
Lability 0% (0%) 2% (0%) 0% (0%) 0% (0%)
Pruritus 1% (0%) 2% (2%) 0% (0%) 0% (0%)
*Some individuals discontinued for multiple reasons.

Other adverse reactions, each reported by fewer than 1% of exposed patients, and in many cases of uncertain relation to drug treatment, were:

Cardiovascular: acute myocardial infarction, apoplexy, arrhythmias, bradycardia, edema, hypertension, hypotension, pallor, palpitations, tachycardia.

Dermatologic: sweating.

Gastrointestinal: anorexia, dry mouth, dyspepsia, thirst, vomiting, decreased weight.

Genitourinary: prostatic disorder.

Miscellaneous: amblyopia, back pain, bitter taste, muscle cramps, neck pain, pares thesia, susurrus aurium.

Neurologic: anxiety, impaired concentration, depression, insomnia, nervousness, nightmares, restlessness, tremor, vertigo.

Respiratory: asthma, dyspnea, sinusitis.

Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients; for further discussion of its diagnosis and treatment see the prescribing information.

What drugs interact with Monoket (isosorbide mononitrate)?

Concomitant use of Monoket with phosphodiesterase inhibitors in any form is contraindicated.

Concomitant use of Monoket with riociguat, a soluble guanylate cyclase stimulator, is contraindicated.

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.

Summary

Monoket (isosorbide mononitrate) is a nitrate used to treat and prevent angina pectoris or "heart pain." Common side effects of Monoket include headaches, flushing, and a severe drop in blood pressure when rising from a sitting position, causing dizziness, palpitations, and weakness. There are no adequate studies of Monoket in pregnant women. It is unknown if Monoket is excreted in breast milk.

Treatment & Diagnosis

Medications & Supplements

FDA Logo

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Medically Reviewed on 9/29/2020
References
FDA Prescribing Information

Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.
CONTINUE SCROLLING FOR RELATED SLIDESHOW