PSEUDOEPHEDRINE: 13,070 Adverse Event Reports & Safety Profile
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Active Ingredient: PSEUDOEPHEDRINE HYDROCHLORIDE · Drug Class: Adrenergic alpha-Agonists [MoA] · Route: ORAL · Manufacturer: American Sales Company · FDA Application: 017603 · HUMAN OTC DRUG · FDA Label: Available
First Report: 19731014 · Latest Report: 20250824
What Are the Most Common PSEUDOEPHEDRINE Side Effects?
All PSEUDOEPHEDRINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 5,917 | 45.3% | 1,114 | 1,736 |
| Systemic lupus erythematosus | 5,889 | 45.1% | 1,753 | 2,278 |
| Pain | 5,790 | 44.3% | 1,520 | 2,110 |
| Pemphigus | 5,726 | 43.8% | 1,568 | 2,097 |
| Rheumatoid arthritis | 5,712 | 43.7% | 1,696 | 2,279 |
| Abdominal discomfort | 5,654 | 43.3% | 1,450 | 2,129 |
| Alopecia | 5,587 | 42.8% | 1,396 | 2,032 |
| Glossodynia | 5,348 | 40.9% | 1,646 | 2,056 |
| Fatigue | 5,229 | 40.0% | 1,536 | 2,099 |
| Swelling | 5,184 | 39.7% | 1,632 | 2,183 |
| Hand deformity | 5,092 | 39.0% | 1,627 | 2,047 |
| Wound | 5,074 | 38.8% | 1,688 | 2,057 |
| Rash | 5,007 | 38.3% | 1,678 | 2,140 |
| Arthropathy | 4,813 | 36.8% | 1,363 | 1,950 |
| Synovitis | 4,793 | 36.7% | 1,697 | 2,179 |
| Pericarditis | 4,780 | 36.6% | 1,564 | 2,068 |
| Infusion related reaction | 4,665 | 35.7% | 1,654 | 2,061 |
| Joint swelling | 4,576 | 35.0% | 1,621 | 2,059 |
| Hypersensitivity | 4,521 | 34.6% | 1,400 | 1,937 |
| Hepatic enzyme increased | 4,391 | 33.6% | 1,548 | 2,014 |
Who Reports PSEUDOEPHEDRINE Side Effects? Age & Gender Data
Gender: 90.7% female, 9.3% male. Average age: 46.5 years. Most reports from: CA. View detailed demographics →
Is PSEUDOEPHEDRINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 2 | 0 | 2 |
| 2001 | 6 | 1 | 4 |
| 2002 | 4 | 1 | 3 |
| 2003 | 4 | 0 | 0 |
| 2004 | 3 | 0 | 2 |
| 2005 | 5 | 0 | 1 |
| 2006 | 6 | 3 | 0 |
| 2007 | 5 | 3 | 1 |
| 2008 | 3 | 2 | 2 |
| 2009 | 4 | 0 | 2 |
| 2010 | 16 | 1 | 13 |
| 2011 | 24 | 3 | 10 |
| 2012 | 21 | 14 | 2 |
| 2013 | 18 | 7 | 4 |
| 2014 | 62 | 5 | 10 |
| 2015 | 215 | 18 | 33 |
| 2016 | 181 | 6 | 11 |
| 2017 | 225 | 14 | 16 |
| 2018 | 235 | 5 | 25 |
| 2019 | 150 | 2 | 9 |
| 2020 | 76 | 9 | 2 |
| 2021 | 90 | 12 | 19 |
| 2022 | 114 | 7 | 25 |
| 2023 | 85 | 1 | 5 |
| 2024 | 70 | 0 | 7 |
| 2025 | 24 | 0 | 4 |
What Is PSEUDOEPHEDRINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 6,214 |
| Rheumatoid arthritis | 4,951 |
| Sinus congestion | 398 |
| Nasal congestion | 368 |
| Sinusitis | 262 |
| Nasopharyngitis | 232 |
| Off label use | 194 |
| Sinus disorder | 156 |
| Paranasal sinus discomfort | 130 |
| Foetal exposure during pregnancy | 122 |
PSEUDOEPHEDRINE vs Alternatives: Which Is Safer?
Other Drugs in Same Class: Adrenergic alpha-Agonists [MoA]
Official FDA Label for PSEUDOEPHEDRINE
Official prescribing information from the FDA-approved drug label.
Drug Description
Active ingredients (in each tablet) Pseudoephedrine HCl 60 mg Pyrilamine Maleate 30 mg
FDA Approved Uses (Indications)
Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose itchy, watery eyes nasal congestion sneezing itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing nasal congestion
Dosage & Administration
Directions adults and children 12 years and over swallow one whole tablet with water every 24 hours do not exceed one tablet in 24 hours do not divide, crush, chew or dissolve the tablet the tablet does not completely dissolve and may be seen in the stool (this is normal) children under 12 years do not use this product in children under 12 years of age
Warnings
Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have high blood pressure heart disease thyroid disease diabetes glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product do not exceed recommended dosage excitability may occur, especially in children use caution when driving a motor vehicle or operating machinery drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Active Ingredient
Drug Facts Active ingredient (in each tablet)
Pseudoephedrine
Hydrochloride USP 240 mg
Inactive Ingredients
Inactive ingredients black iron oxide, cellulose acetate, colloidal silicon dioxide, dibutyl sebacate, glyceryl mono and dicaprylocaprate, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, propylene glycol, shellac, sodium lauryl sulfate, stearic acid, talc and titanium dioxide. Questions or comments? call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/22/2009