Ismo (Isosorbide Mononitrate) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

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Congestive Heart Failure »

Congestive heart failure facts

Congestive heart failure (CHF) is a condition in which the heart's function as a pump is inadequate to meet the body's needs.

Many disease processes can impair the pumping efficiency of the heart to cause congestive heart failure.

The symptoms of congestive heart failure vary, but can include fatigue, diminished exercise capacity, shortness of breath, and swelling.

The diagnosis of congestive heart failure is based on knowledge of the individual's medical history, a careful physical examination, and selected laboratory tests.

The treatment of congestive heart failure can include lifestyle modifications, addressing potentially reversible factors, medications, heart transplant, and mechanical therapies.

The course of congestive heart failure in any given patient is extremely variable.

What is congestive h...

Read the Congestive Heart Failure article »

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SIDE EFFECTS

The table below shows the frequencies of the adverse reactions observed in more than 1% of the subjects (a) in 6 placebo-controlled domestic studies in which patients in the active-treatment arm received 20 mg of isosorbide mononitrate twice daily, and (b) in all studies in which patients received isosorbide mononitrate in a variety of regimens. In parentheses, the same table shows the frequencies with which these adverse reactions led to discontinuation of treatment. Overall, 11% of the patients who received isosorbide mononitrate in the six controlled U.S. studies discontinued treatment because of adverse reactions. Most of these discontinued because of headache. "Dizziness" and nausea were also frequently associated with withdrawal from these studies.

Frequency of Adverse Reactions (Discontinuations)*
	6 Controlled Studies		92 Clinical Studies
Dose	Placebo	20 mg	(varied)
Patients	204	219	3344
Headache	9% (0%)	38% (9%)	19% (4.3%)
Dizziness	1% (0%)	5% (1%)	3% (0.2%)
Nausea, Vomiting	< 1% (0%)	4% (3%)	2% (0.2%)
*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: angina pectoris, arrhythmias, atrial fibrillation, hypotension, palpitations, postural hypotension, premature ventricular contractions, supraventricular tachycardia, syncope.

Dermatologic: pruritus, rash.

Gastrointestinal: abdominal pain, diarrhea, dyspepsia, tenesmus, tooth disorder, vomiting.

Genitourinary: dysuria, impotence, urinary frequency.

Miscellaneous: asthenia, blurred vision, cold sweat, diplopia, edema, malaise, neck stiffness, rigors.

Musculoskeletal: arthralgia.

Neurological: agitation, anxiey, confusion, dyscoordination, hypoesthesia, hypokinesia, increased appetite, insomnia, nervousness, nightmares.

Respiratory: bronchitis, pneumonia, upper-respiratory tract infection.

Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients; for futher discussion of its diagnosis and treatment see under OVERDOSAGE.

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.

Last reviewed on RxList: 4/13/2009
This monograph has been modified to include the generic and brand name in many instances.