Biofed-PE Side Effects

Generic name: pseudoephedrine / triprolidine

Note: This document contains side effect information about pseudoephedrine / triprolidine. Some of the dosage forms listed on this page may not apply to the brand name Biofed-PE.

Some side effects of Biofed-PE 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 / triprolidine: oral liquid, oral syrup, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking pseudoephedrine / triprolidine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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

• fast or uneven heart rate;

• mood changes;

• tremor, seizure (convulsions);

• easy bruising or bleeding, unusual weakness;

• urinating less than usual or not at all;

• feeling short of breath; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

Less serious side effects of pseudoephedrine / triprolidine may include:

• dizziness, drowsiness;

• dry mouth, nose, or throat;

• constipation;

• blurred vision; or

• feeling nervous or restless.

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 / triprolidine: oral liquid, oral suspension extended release, oral syrup, oral tablet, 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 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 (stimulated) 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 of pseudoephedrine have included tachycardia. Some patients have developed hypertension and/or arrhythmias.

Nervous system

Nervous system side effects of pseudoephedrine have included insomnia in up to 30% of patients. Tremor, anxiety, nervousness, and headache have also been reported with the use of pseudoephedrine. Antihistamines such as triprolidine have been reported to cause drowsiness.

Gastrointestinal

Gastrointestinal side effects of pseudoephedrine have included anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat have occurred in up to 15% of patients receiving pseudoephedrine. Antihistamines such as triprolidine have also been reported to cause dry mouth. Pseudoephedrine-triprolidine may cause diarrhea.

Hypersensitivity

Hypersensitivity side effects with the use of pseudoephedrine have included fixed drug eruptions.

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