Biofed-PE Side Effects
Generic Name: pseudoephedrine / triprolidine
Note: This page contains information about the side effects of pseudoephedrine / triprolidine. Some of the dosage forms included on this document may not apply to the brand name Biofed-PE.
For the Consumer
Applies to pseudoephedrine / triprolidine: capsules, liquid, syrup, tablets
Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur while taking pseudoephedrine / triprolidine:
Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability (especially in children); headache; loss of appetite; nausea; nervousness; restlessness; trouble sleeping; vomiting.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; chest pain; decreased coordination; difficulty urinating; fast or irregular heartbeat; fever; hallucinations; seizure; severe dizziness and drowsiness; severe nervousness, anxiety, or restlessness; tremors; unusual weakness.
For Healthcare Professionals
Applies to pseudoephedrine / triprolidine: oral liquid, oral suspension extended release, oral syrup, oral tablet, oral tablet extended release
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.[Ref]
Cardiovascular side effects of pseudoephedrine have included tachycardia. Some patients have developed hypertension and/or arrhythmias.[Ref]
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.[Ref]
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.[Ref]
Hypersensitivity side effects with the use of pseudoephedrine have included fixed drug eruptions.[Ref]
1. Taylor DM, O'Toole KS, Auble TE, Ryan CM, Sherman DR "The psychometric and cardiac effects of pseudoephedrine in the hyperbaric environment." Pharmacotherapy 20 (2000): 1045-50
2. Lyon CC, Turney JH "Pseudoephedrine toxicity in renal failure." Br J Clin Pract 50 (1996): 396-7
3. Mores N, Campia U, Navarra P, Cardillo C, Preziosi P "No cardiovascular effects of single-dose pseudoephedrine in patients with essential hypertension treated with beta-blockers." Eur J Clin Pharmacol 55 (1999): 251-4
4. Gill ND, Shield A, Blazevich AJ, Zhou S, Weatherby RP "Muscular and cardiorespiratory effects of pseudoephedrine in human athletes." Br J Clin Pharmacol 50 (2000): 205-13
5. Dowd J, Bailey D, Moussa K, Nair S, Doyle R, CulpepperMorgan JA "Ischemic colitis associated with pseudoephedrine: Four cases." Am J Gastroenterol 94 (1999): 2430-4
6. Vidal C, Prieto A, PerezCarral C, Armisen M "Nonpigmenting fixed drug eruption due to pseudoephedrine." Ann Allergy Asthma Immunol 80 (1998): 309-10
Not all side effects for Biofed-PE may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
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