Pseudoephedrine: Side Effects, Uses & Monitoring
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.
- Data source
- FDA labeling via NIH DailyMed (label cf6676ff…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| 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 reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
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 ).
Conditions associated with Pseudoephedrine in labeling
Frequently Asked Questions
What is Pseudoephedrine used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Pseudoephedrine?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Pseudoephedrine. Individual risk varies.
Does Pseudoephedrine require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Pseudoephedrine.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.