Note: This document contains side effect information about pseudoephedrine. Some dosage forms listed on this page may not apply to the brand name Silfedrine.
Applies to pseudoephedrine: oral solution, oral tablets.
Side effects include:
Nervous system effects (e.g., CNS stimulation, nervousness, excitability, restlessness, dizziness, weakness, insomnia, headache, drowsiness) and cardiovascular effects (e.g., increased irritability of heart muscle, altered rhythmic function of ventricles, tachycardia, palpitation).
For Healthcare Professionals
Applies to pseudoephedrine: compounding powder, oral capsule, oral liquid, oral suspension extended release, oral tablet, oral tablet chewable, oral tablet extended release.
General
The most commonly reported adverse effects have included cardiovascular and (e.g. elevated blood pressure, tachycardia, or arrhythmias), CNS stimulation (e.g. restlessness, insomnia, anxiety, tremors, and rarely hallucinations), skin rashes, and urinary retention.[Ref]
Cardiovascular
Frequency not reported: Tachycardia, palpitations, arrhythmia, hypertension, impaired circulation to the extremities[Ref]
Nervous system
Frequency not reported: Headache, tremor
Gastrointestinal
Frequency not reported: Dry mouth, nausea, vomiting
Hypersensitivity
Frequency not reported: Hypersensitivity reactions including cross-sensitivity with other sympathomimetic[Ref]
Psychiatric
Rare (less than 0.1%): Hallucinations
Frequency not reported: Restlessness, insomnia, sleep disturbances, anxiety, excitability[Ref]
Genitourinary
Frequency not reported: Urinary retention, especially in men with prostatic enlargement
Ocular
Frequency not reported: Angle-closure glaucoma
Dermatologic
Frequency not reported: Skin rashes, fixed drug eruption in the form of erythematous nodular patches[Ref]
Other
Post marketing reports: False-positive amphetamine immunoassay[Ref]
False-positives can occur far below the published threshold indicating that cross-reactivity in human specimens is sometimes greater than the limits reported.[Ref]
