Pseudoephedrine: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Pseudoephedrine. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| Headache | 17.4% |
| Insomnia | 13.3% |
| Nausea | 7.4% |
| Dry mouth | 5.5% |
| Dizziness | 3.2% |
| Dyspepsia | 2.8% |
| Throat irritation | 2.3% |
| Agitation | 1.9% |
| Back pain | 1.9% |
| Palpitation | 1.9% |
| Nervousness | 1.8% |
| Anxiety | 1.4% |
| Upper respiratory infection | 1.4% |
| Abdominal pain | 1.4% |
*Highest percentage across placebo-controlled trial tables summarized in current labeling.
Labeled uses
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, itchy nose/palate/ and/or throat, itchy/watery/red eyes, and nasal congestion. Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets should be administered when both the antihistaminic properties of fexofenadine hydrochloride and the nasal decongestant properties of pseudoephedrine hydrochloride are desired (see CLINICAL PHARMACOLOGY ).
Medical disclaimer: Always consult a qualified healthcare professional about any medication.