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.
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
- Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
5,062 reports
- Pain
Pain
5,007 reports
- Pemphigus
Pemphigus
4,947 reports
- Rheumatoid Arthritis
Rheumatoid Arthritis
4,930 reports
- Abdominal Discomfort
Abdominal Discomfort
4,840 reports
- Alopecia
Alopecia
4,782 reports
- Glossodynia
Glossodynia
4,574 reports
- Fatigue
Fatigue
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) 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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for pseudoephedrine?
Related Medications in Decongestant
Other drugs grouped near pseudoephedrine - same-class peers and common alternatives.
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albuterol
Ventolin, ProAir
Albuterol is a drug that helps you breathe easier.
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albuterol/ipratropium
Combivent Respimat, DuoNeb
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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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for pseudoephedrine: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 9,450.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 33.40%.
- dopamine Δ 0.18 pts · 2,938 reports · Inotropic / Vasopressor 33.22%death share
- methadone Δ 1.16 pts · 41,632 reports · Opioid Agonist 32.23%death share
- norepinephrine Δ 1.26 pts · 10,232 reports · Vasopressor (Alpha-1 Agonist) 32.13%death share
- micafungin Δ 2.43 pts · 4,779 reports · Echinocandin Antifungal 35.82%death share
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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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: April 13, 2021
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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