pseudoephedrine
Brand names: Sudafed
Pseudoephedrine (Sudafed) helps clear up a stuffy nose. It is a decongestant medicine.
Drug Pricing (NADAC)
Generic Price
$0.05/unit
Generic Available
Yes (4 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine can help with a stuffy nose caused by a cold.
Common side effects
No common side effects listed.
Key warnings
Do not use if the blister packs are torn or show signs of tampering.
How It Works
Pseudoephedrine works by narrowing the blood vessels in your nose and sinuses. This helps to decrease swelling and congestion. That makes it easier to breathe.
How to Take It
Adults and children 12 and over: Take 1 tablet every 12 hours. Do not take more than 2 tablets in 24 hours. Children under 12 years old should not use this medicine.
Pregnancy & Breastfeeding
Ask your doctor if it is safe to take this medicine while pregnant or breastfeeding.
Missed Dose
Take the missed dose as soon as you remember. Do not take more than 1 tablet every 12 hours.
Storage
Store at 59° to 77° F in a dry place, away from light.
Side Effects (from patient reports)
Based on 47,975 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 9,450 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
9,450
Death-Related Reports
3,156
Hospitalization Reports
3,766
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | SYSTEMIC LUPUS ERYTHEMATOSUS | 5,062 |
| 2 | PAIN | 5,007 |
| 3 | DRUG INEFFECTIVE | 4,987 |
| 4 | PEMPHIGUS | 4,947 |
| 5 | RHEUMATOID ARTHRITIS | 4,930 |
| 6 | ABDOMINAL DISCOMFORT | 4,840 |
| 7 | ALOPECIA | 4,782 |
| 8 | GLOSSODYNIA | 4,574 |
| 9 | FATIGUE | 4,429 |
| 10 | SWELLING | 4,417 |
| 11 | WOUND | 4,407 |
| 12 | RASH | 4,324 |
| 13 | HAND DEFORMITY | 4,321 |
| 14 | ARTHROPATHY | 4,081 |
| 15 | SYNOVITIS | 4,059 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Do not use if the blister packs are torn or show signs of tampering.
Known Drug Interactions
Excessive reduction of blood glucose (additive effect) [See Warnings and Precautions (5.14)] ; CNS depressant agents (including opioids, alcohol, sedatives, hypnotics) Use with caution Increased CNS depression Dietary supplements containing sympathomimetics Contraindicated Antidepressants including but not limited to: • Other MAOIs (e.g., linezolid, intravenous methylene blue, selective MAOIs) • Selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) • Tricyclic antidepressants • Amoxapine, bupropion, maprotiline, nefazodone, trazodone, v...
Mechanism: Taking these together can cause a massive release of chemicals that raise blood pressure because the body cannot break them down properly.
What to do: This combination is contraindicated and must be strictly avoided. Talk to your doctor about safer alternatives for treating nasal congestion.
Terazosin has been used concomitantly in at least 50 patients on the following drugs or drug classes: analgesic/anti-inflammatory (e.g., acetaminophen, aspirin, codeine, ibuprofen, indomethacin); antibiotics (e.g., erythromycin, trimethoprim and sulfamethoxazole); anticholinergic/sympathomimetics (e.g., phenylephrine hydrochloride, phenylpropanolamine hydrochloride, pseudoephedrine hydrochloride); antigout (e.g., allopurinol); antihistamines (e.g., chlorpheniramine); cardiovascular agents (e.g., atenolol, hydrochlorothiazide, methyclothiazide, propranolol); corticosteroids; gastrointestinal...
Mechanism: Pseudoephedrine can narrow blood vessels and raise blood pressure, which works against the way terazosin relaxes blood vessels.
What to do: Talk to your doctor before using these together, as your blood pressure may need to be monitored more closely.
Common Questions
What is pseudoephedrine used for?
How often can I take this medicine?
Can children take this medicine?
What should I do if I miss a dose?
How should I store this medicine?
Can I take this if I am pregnant?
Can I take this if I have allergies?
What if the packaging is damaged?
Can I take this with other medicines?
Will this medicine make me sleepy?
Does pseudoephedrine interact with other medications?
What drug class is pseudoephedrine?
Is pseudoephedrine safe during pregnancy?
Related Medications in Decongestant
Other drugs grouped near pseudoephedrine — same-class peers and common alternatives.
aclidinium
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albuterol
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albuterol/ipratropium
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Combivent Respimat is a combination medicine that helps open your airways.
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beclomethasone
Qvar
Qvar Redihaler is an inhaled medicine that helps control asthma symptoms.
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benralizumab
Fasenra
Fasenra is a medicine that can help treat severe asthma and EGPA.
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What the FDA Data Shows for pseudoephedrine
The FDA label for pseudoephedrine (sold under brand names such as Sudafed) classifies it as an over-the-counter product in the Decongestant class. This medicine can help with a stuffy nose caused by a cold. Labeling covers dosing, contraindications, and monitoring requirements derived from clinical trials.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 47,975 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.05.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: April 13, 2021
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages