Over-the-counter medication · Decongestant
pseudoephedrine
Also sold as Sudafed. This medicine can help with a stuffy nose caused by a cold.
Data updated 2026-05-15
- 9,450
- FDA reportsLightly reported
- 2
- InteractionsFew interactions
- $0.05
- Generic price (NADAC)
What the data shows
pseudoephedrine (Sudafed) is an over-the-counter Decongestant, reported less often than most tracked drugs (9,450 FDA reports), with 2 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
pseudoephedrine (Sudafed) is an over-the-counter Decongestant. This medicine can help with a stuffy nose caused by a cold.
Pseudoephedrine (Sudafed) helps clear up a stuffy nose. It is a decongestant medicine.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from pseudoephedrine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of pseudoephedrine's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Ask your doctor if it is safe to take this medicine while pregnant or breastfeeding.
This is a plain-language summary of pseudoephedrine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
Take the missed dose as soon as you remember. Do not take more than 1 tablet every 12 hours.
This is a plain-language summary of pseudoephedrine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at 59° to 77° F in a dry place, away from light.
Side Effects (from patient reports)
Based on 9,450 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for pseudoephedrine, by number of reports
- Lupus
Lupus
5,062 reports
- Pain
Pain
5,007 reports
- A skin disorder that causes blisters
A skin disorder that causes blisters
4,947 reports
- Rheumatoid arthritis
Rheumatoid arthritis
4,930 reports
- Stomach upset
Stomach upset
4,840 reports
- Hair loss
Hair loss
4,782 reports
- Burning tongue syndrome
Burning tongue syndrome
4,574 reports
- Tiredness
Tiredness
4,429 reports
- Swelling
Swelling
4,417 reports
- Wound
Wound
4,407 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for pseudoephedrine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where pseudoephedrine sits
pseudoephedrine has more FDA adverse-event reports than 38% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is pseudoephedrine; the line is the median (50th percentile).
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
Reports Mentioning Death
3,156
33.4% of reports — not proof of cause
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 |
| 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 |
| 16 | PERICARDITIS | 4,058 |
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,...
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;...
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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?
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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 9,450 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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