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Ismo

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Ismo

Ismo Side Effects Center

Pharmacy Editor: Charles Patrick Davis, MD, PhD

Ismo (isosorbide mononitrate) is a nitrate vasodilator used to treat angina, but not used to treat acute angina. Ismo is available as a generic with several names, but isosorbide mononitrate is the generic term. Common side effects include headache, skin warmth, nausea, vomiting, constipation, hot flashes, dry mouth and diarrhea.

Ismo (isosorbide mononitrate) is available in strength of 20 mg tablets .Dosage is usually 20mg twice a day, about 7 hours apart. Serious side effects of Ismo include irregular heart rates, syncopy or near-syncopy, chest pain and shortness of breath. Pregnant and breast-feeding women and their doctors should weigh the benefits versus the potential risks to the fetus or infant as the drug has not been studied in this population. In addition, the use of Ismo in the pediatric population has not been studied.

Our Ismo Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Ismo in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fast, slow, pounding, or uneven heart rate;
  • feeling like you might pass out;
  • trouble breathing, blue-colored skin, tired feeling; or
  • worsening angina pain.

Less serious side effects may include:

  • headache, mild dizziness;
  • warmth, redness, or tingling under your skin;
  • nausea, vomiting, constipation, diarrhea;
  • pain or stiffness in joints or muscles;
  • hot flashes; or
  • dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ismo (Isosorbide Mononitrate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Ismo Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, dizziness, lightheadedness, nausea, and flushing may occur as your body adjusts to this medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Headache is often a sign that this medication is working. Your doctor may recommend treating headaches with an over-the-counter pain reliever (such as acetaminophen, aspirin). If headaches continue or become severe, tell your doctor promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fainting, fast/irregular/pounding heartbeat.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Ismo (Isosorbide Mononitrate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Ismo FDA Prescribing Information: Side Effects
(Adverse Reactions)

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.

Read the entire FDA prescribing information for Ismo (Isosorbide Mononitrate) »

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Ismo - User Reviews

Ismo User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Ismo sorted by most helpful. Patient Discussions FAQs

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.


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