Isosorbide: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 22, 2026🚩 Report this page

Isosorbide

Active ingredient

GB MHRAUS FDA

Drug class: -
Availability: Prescription only
Routes: Oral
Markets covered: 2
Products on record: 35

Overview

Isosorbide is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	28	May 22, 2026
US United States	FDA	7	May 11, 2026

GBUnited Kingdom· MHRA

28 products

Uses

GBOfficial regulatory label· revised December 12, 2025[1]

For the prophylaxis and long term management of angina pectoris. As adjunctive therapy after acute myocardial infarction and chronic congestive heart failure.

How to take

GB

USUnited States· FDA

7 products

Uses

USOfficial regulatory label· revised March 27, 2026[2]

INDICATIONS AND USAGE
Isosorbide Mononitrate Tablets USP are indicated for the prevention and treatment 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.

How to take

Drug interactions

Known interactions involving Isosorbide. Select one for details. This list is informational and not a complete interaction checker.

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PL200750312 · revised December 12, 2025
[2]FDA DailyMed · 06839534-85b8-42… · revised March 27, 2026 [PDF]

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised December 12, 2025[1]

Assessment of the side effects is based on the following frequency categories:
Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) The following undesirable effects may be observed during treatment with isosorbide mononitrate: Nervous system disorders Very common: headache (“nitrate headache”) at the start of treatment, which experience shows usually subsides after a few days of continued treatment.
g. rash), transient reddening of the skin (flushing) Very rare: exfoliative dermatitis Immune system disorders Not known: angioedema General disorders and administration site conditions Common: feeling of weakness Note Severe hypotension, including nausea, vomiting, restlessness, pallor and severe sweating have been reported during treatment with organic nitrates.
Transient hypoxaemia may occur with administration of isosorbide mononitrate due to a relative redistribution of the blood flow in hypoventilated alveolar regions, and may trigger myocardial hypoxia in patients with coronary heart disease.
Increasing the dose or adjusting the interval between doses may result in a reduction in effect or loss of effect. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised December 12, 2025[1]

g. in acute myocardial infarction, impaired left ventricular function (left heart failure). A drop in systolic blood pressure below 90 mmHg should be avoided. - aortic and/or mitral valve stenosis. - susceptibility to orthostatic circulatory dysregulation.
Isosorbide mononitrate is not suitable for treating an acute angina pectoris attack, as onset of effect is not sufficiently rapid. Development of tolerance (reduction in efficacy) and the occurrence of cross-tolerance in relation to other nitrate compounds (reduced effect due to previous treatment with other nitrate compounds) have been described.
In order to avoid weakening of effect or loss of effect, high continuous dosages should be avoided. g. sildenafil, tadalafil, vardenafil) must not be used to treat erectile dysfunction as there is a risk that this might cause a massive drop in blood pressure, which can have serious consequences such as syncope or myocardial infarction.
g. sildenafil, tadalafil, vardenafil). g. 5). Hypoxaemia Caution is advised in patients with hypoxaemia and ventilation/perfusion mismatch due to lung disease or ischaemic heart disease. Isosorbide mononitrate, a potent vasodilator, can cause increased perfusion of regions with a low oxygen supply, hence leading to intensification of the ventilation/perfusion mismatch and a further drop in arterial oxygen partial pressure.
5). Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

USOfficial regulatory label· Adverse reactions· revised March 27, 2026[2]

ADVERSE REACTIONS
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)* 6 Placebo-Controlled Studies Dose Placebo 5 mg 10 mg 20 mg Patients 160 54 52 159 Headache 6% (0%) 17% (0%) 13% (0%) 35% (5%) Fatigue 2% (0%) 0% (0%) 4% (0%) 1% (0%) Upper Respiratory 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 <1% (0%) 0% (0%) 0% (0%) 3% (2%) Increased Cough <1% (0%) 0% (0%) 2% (0%) <1% (0%) Rash 0% (0%) 2% (2%) 0% (0%) <1% (0%) Abdominal Pain <1% (0%) 0% (0%) 2% (0%) 0% (0%) Allergic Reaction 0% (0%) 0% (0%) 2% (0%) 0% (0%) Cardiovascular 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 0% (0%) 0% (0%) 2% (0%) 0% (0%) Emotional 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, paresthesia, 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 OVERDOSAGE .
To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. gov/medwatch.

USOfficial regulatory label· Warnings and precautions· revised March 27, 2026[2]

WARNINGS
Amplification of the vasodilatory effects of isosorbide mononitrate 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 isosorbide mononitrate 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.

This is not medical advice. Consult a qualified healthcare professional.