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    HomeMedication GuidePseudoephedrine safety
    Decongestant

    Pseudoephedrine: What to Know Before You Take It

    Also known as Sudafed

    A patient-focused safety profile with information from public regulatory sources.

    Reviewed by the OmniRx Health clinical team•Last reviewed Jul 4, 2026

    In plain language

    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

    Read before you decide

    Risks and precautions

    Risks and 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)

    FDA safety data

    Most-reported side effects

    Based on 25,333 FAERS reports. Reports do not prove the drug caused the effect.

    drug ineffective 7,800pain 5,724systemic lupus erythematosus 5,295abdominal discomfort 5,237rheumatoid arthritis 5,213fatigue 5,195pemphigus 5,172alopecia 5,081rash 4,830glossodynia 4,773swelling 4,636wound 4,582
    Explore full FDA safety data

    Regulatory record

    FDA recalls (9)

    Class IIITerminated · Jan 4, 2022

    Failed Dissolution Specifications

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

    Class IIITerminated · Jan 4, 2022

    Failed Dissolution Specifications

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

    Class IIITerminated · Nov 12, 2021

    Failed dissolution specifications

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

    Class IIITerminated · Nov 12, 2021

    Failed dissolution specifications

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

    Class IIITerminated · Nov 12, 2021

    Failed dissolution specifications

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

    Class IIITerminated · Oct 12, 2021

    Failed Moisture Limits

    Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC

    Class IIITerminated · Oct 12, 2021

    Failed Moisture Limits

    Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC

    Class IITerminated · Mar 15, 2021

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    Recalling firm: Cardinal Health Inc.

    Class IITerminated · Feb 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.

    Common questions

    Patient questions

    What is Pseudoephedrine prescribed for?

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

    What are the key warnings and safety precautions for Pseudoephedrine?

    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)

    Does Pseudoephedrine interact with other medications or foods?

    Pseudoephedrine has 0 documented drug interaction(s) and 0 food interaction(s) in clinical databases. Always provide your complete medication list to your clinician.

    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.

    Have medication questions?

    A licensed OmniRx provider can review your health history and medication list. Availability and treatment options are determined individually.