Elixsure Decongestant Side Effects

Generic name: pseudoephedrine

Note: This document contains side effect information about pseudoephedrine. Some of the dosage forms listed on this page may not apply to the brand name Elixsure Decongestant.

Some side effects of Elixsure Decongestant may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to pseudoephedrine: oral liquid, oral suspension extended release, oral tablet, oral tablet chewable, oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking pseudoephedrine (the active ingredient contained in Elixsure Decongestant) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using pseudoephedrine and call your doctor at once if you have a serious side effect such as:

• fast, pounding, or uneven heartbeat;

• severe dizziness or anxiety;

• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

• dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, anxiety, confusion, chest pain, trouble breathing, uneven heart rate, seizure).

Less serious side effects of pseudoephedrine may include:

• loss of appetite;

• warmth, tingling, or redness under your skin;

• feeling restless or excited (especially in children);

• sleep problems (insomnia); or

• skin rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to pseudoephedrine: compounding powder, oral liquid, oral suspension extended release, oral tablet, oral tablet chewable, oral tablet extended release

Cardiovascular

Pseudoephedrine causes vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine (the active ingredient contained in Elixsure Decongestant) has been reported to cause coronary artery spasm and chest pain.

One report evaluated the effect with 60 mg of pseudoephedrine on individuals in a hyperbaric chamber at 1 atmosphere (simulated scuba dive to 66 feet of sea water). Pseudoephedrine and depth (simulated) were found to have significant but opposite effects on heart rate, although these effects were unlikely to be clinically significant during diving.

Cardiovascular side effects have included tachycardia. Some patients have developed hypertension and/or arrhythmias.

Nervous system

Nervous system side effects have included insomnia in up to 30% of patients. Tremor, anxiety, nervousness, and headache have also been reported.

Gastrointestinal

Gastrointestinal side effects have included anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat have occurred in up to 15% of patients.

Hypersensitivity

Hypersensitivity side effects have included fixed drug eruptions.

Other

False-positive amphetamine immunoassay have resulted from pseudoephedrine (the active ingredient contained in Elixsure Decongestant) False-positives can occur far below the published pseudoephedrine threshold, indicating that cross-reactivity in human specimens is sometimes greater than the limits reported.

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