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

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]