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    HomeMedication GuidePseudoephedrine Safety
    Decongestant

    Pseudoephedrine: What to Know Before You Take It

    Also sold as Sudafed

    What Pseudoephedrine Is Used For

    Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure

    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 heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dosage 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. (1-800-222-1222)

    Most-Reported Side Effects

    Based on 25,333 reports in the FDA Adverse Event Reporting System (FAERS). Reports do not prove the drug caused the effect.

    drug ineffective7,800pain5,724systemic lupus erythematosus5,295abdominal discomfort5,237rheumatoid arthritis5,213fatigue5,195pemphigus5,172alopecia5,081rash4,830glossodynia4,773swelling4,636wound4,582

    Explore full Pseudoephedrine safety data in our free FDA Safety Explorer

    FDA Recalls (9)

    Class IIITerminatedJan 4, 2022

    Failed Dissolution Specifications

    Recalling firm: Dr. Reddy's Laboratories, Inc.

    Class IIITerminatedJan 4, 2022

    Failed Dissolution Specifications

    Recalling firm: Dr. Reddy's Laboratories, Inc.

    Class IIITerminatedNov 12, 2021

    Failed dissolution specifications

    Recalling firm: Dr. Reddy's Laboratories, Inc.

    Class IIITerminatedNov 12, 2021

    Failed dissolution specifications

    Recalling firm: Dr. Reddy's Laboratories, Inc.

    Class IIITerminatedNov 12, 2021

    Failed dissolution specifications

    Recalling firm: Dr. Reddy's Laboratories, Inc.

    Class IIITerminatedOct 12, 2021

    Failed Moisture Limits

    Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC

    Class IIITerminatedOct 12, 2021

    Failed Moisture Limits

    Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC

    Class IITerminatedMar 15, 2021

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    Recalling firm: Cardinal Health Inc.

    Class IITerminatedFeb 7, 2014

    Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.

    Recalling firm: Ohm Laboratories, Inc.

    This information is educational — not medical advice.

    This page is provided for general educational purposes and summarizes publicly available data from sources such as the U.S. Food & Drug Administration. It is not a substitute for the judgment of a licensed clinician and should not be used to start, stop, or change any medication. It may be incomplete or out of date, and individual circumstances vary. Always talk with your prescriber or pharmacist about your specific medications and health conditions. If you think you may have a medical emergency, call 911.

    Considering Pseudoephedrine? Talk to a Provider First

    Our board-certified providers can review whether Pseudoephedrine is right for you, check it against your current medications, and prescribe online when appropriate.