Isordil Titradose Side Effects

Generic Name: isosorbide dinitrate

Note: This page contains information about the side effects of isosorbide dinitrate. Some of the dosage forms included on this document may not apply to the brand name Isordil Titradose.

Not all side effects for Isordil Titradose may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to isosorbide dinitrate: capsule extended release, tablet, tablet chewable, tablet extended release

In addition to its needed effects, some unwanted effects may be caused by isosorbide dinitrate (the active ingredient contained in Isordil Titradose). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking isosorbide dinitrate:

Rare
  • Bluish-colored lips, fingernails, or palms
  • dark urine
  • difficulty with breathing
  • dizziness or lightheadedness
  • fever
  • headache
  • pale skin
  • rapid heart rate
  • shortness of breath
  • sore throat
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Incidence not known
  • Arm, back, or jaw pain
  • blurred vision
  • chest pain or discomfort
  • chest tightness or heaviness
  • confusion
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • fainting
  • fast or irregular heartbeat
  • sweating

If any of the following symptoms of overdose occur while taking isosorbide dinitrate, get emergency help immediately:

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
  • convulsions
  • disturbed color perception
  • double vision
  • fast, irregular, pounding, or racing heartbeat or pulse
  • feeling of constant movement of self or surroundings
  • halos around lights
  • headache, severe and throbbing
  • increased sweating
  • loss of appetite
  • loss of consciousness
  • nausea
  • night blindness
  • overbright appearance of lights
  • paralysis
  • sensation of spinning
  • slow heartbeat
  • tunnel vision
  • vomiting
  • wheezing

For Healthcare Professionals

Applies to isosorbide dinitrate: oral capsule extended release, oral tablet, oral tablet chewable, oral tablet extended release, sublingual tablet

Nervous system

Headache is probably due to vasodilation and may respond to acetaminophen analgesia.

A case of isosorbide dinitrate-associated transient ischemic attack has been reported, supposedly due to an arterial "steal phenomenon" secondary to drug-induced vasodilation.

A case of visual hallucinations, suicidal ideation, and depression associated with isosorbide dinitrate (the active ingredient contained in Isordil Titradose) has been reported, even upon blind rechallenge of the drug.

Nervous system side effects have included headache and dizziness.

Cardiovascular

Organic nitrates may induce a sudden drop in systemic blood pressure and enhanced vagal tone, resulting in possible inhibition of reflex tachycardia and syncope.

Cardiovascular side effects include flushing, hypotension, diaphoresis, weakness, sinus bradycardia, and unusual case reports of AV heart block. Unusual cases of edema have also been reported. Frequent dosing, high dosages, and long-acting preparations giving constant 24-hour nitroglycerin levels can result in tolerance to the drug. The risk of tolerance is significantly decreased by withholding the drug, so called "nitrate-free" intervals. Rebound symptoms may occur during this time.

Gastrointestinal

Gastrointestinal side effects include mild nausea and constipation.

Hypersensitivity

Hypersensitivity reactions including rare cases of pruritus and drug rash have been reported.

Hematologic

In vitro data show decreased platelet aggregation when exposed to isosorbide dinitrate (the active ingredient contained in Isordil Titradose)

Nitrates, after conversion to nitrites, may accelerate the oxidation of hemoglobin, resulting in abnormally high plasma concentrations of methemoglobin. While most cases of methemoglobinemia are asymptomatic, methemoglobin levels greater than 60% usually induce symptoms (dyspnea, chest pain), particularly in the presence of underlying coronary artery disease. Treatment in symptomatic persons is methylene blue 1% solution 2 mg/kg intravenously over 10 minutes. It is recommended that affected patients be screened for NADP-methemoglobin reductase deficiency.

Hematologic side effects are rare and include methemoglobinemia and a case of isosorbide dinitrate-induced hemolytic anemia in a patient with underlying glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Renal

Renal side effects of isosorbide dinitrate (the active ingredient contained in Isordil Titradose) (ISDN) are described in nonazotemic patients with liver cirrhosis. ISDN can cause a reduction of glomerular filtration rate and free water clearance associated with significant increases in plasma renin and aldosterone in patients with liver cirrhosis. The changes are most remarkable in patients with ascites.

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