Pseudoephedrine
- Generic Name
- Pseudoephedrine
- Brand Names
- Advil Cold and Sinus, Alavert D, Aleve-D, Allegra-D, Aller-tec D, Allerclear, Bromfed DM, Cheratussin Dac, Clarinex-D, Claritin-D, Codar D, Covan, Entex T, Lodrane D, Mar-cof BP, Mucinex D, Nexafed, Pseudodine C, Rescon Tablets, Semprex-D, Stahist Ad Liquid, Sudafed, Sudafed Sinus & Pain, Sudogest, Triacin-C, Tusnel C, Wal Zyr D, Wal-act, Wal-itin D, Wal-phed, Zephrex-D, Zyrtec-D
- Drug Type
- Small Molecule
- Chemical Formula
- C10H15NO
- CAS Number
- 90-82-4
- Unique Ingredient Identifier
- 7CUC9DDI9F
- Background
Pseudoephedrine is structurally related to ephedrine but exerts a weaker effect on the sympathetic nervous system. Both drugs naturally occur in in ephedra plant which have a history of use in traditional Eastern medicine and were first researched in the west in 1889. The decongestant effect of pseudoephedrine was described in dogs in 1927.
- Indication
Pseudoephedrine is a sympathomimetic amine used for its decongestant activity.
- Associated Conditions
- Allergic Reaction, Allergic Rhinitis (AR), Common Cold, Common Cold Associated With Cough, Cough, Cough caused by Common Cold, Eye allergy, Fever, Flu caused by Influenza, Headache, Irritative cough, Nasal Allergies, Nasal Congestion, Nasal Congestion caused by Common Cold, Pain, Perennial Allergy, Priapism, Respiratory Allergy, Rhinorrhoea, Seasonal Allergic Rhinitis, Seasonal Allergies, Sinus Congestion, Sinusitis, Sneezing, Sore Throat, Symptoms of Acute Bronchitis Accompanied by Coughing, Throat irritation, Upper Respiratory Tract Infection, Upper respiratory tract congestion, Upper respiratory tract signs and symptoms, Cold or flu syndrome, Dry cough, Minor aches and pains, Sinus pain, Watery itchy eyes
- Associated Therapies
- Airway secretion clearance therapy
Why the FDA wants to pull this common cold medicine ingredient from shelves
The FDA proposes removing phenylephrine from cold medicines like NyQuil, Benadryl, and Sudafed due to its ineffectiveness in pill or syrup form, despite being effective in nasal sprays. Dr. Randy Hatton, a University of Florida professor, has been advocating for this change for two decades, noting that phenylephrine replaced pseudoephedrine when the latter was restricted for methamphetamine production.
FDA to Finally Ban Controversial Ingredient in Popular Decongestants
The FDA proposes removing oral phenylephrine from decongestants due to its ineffectiveness, impacting $1.76 billion market. Popular products like Advil Sinus, Sudafed PE, Vicks DayQuil, and Tylenol Cold & Flu may be affected. Phenylephrine, once deemed effective in 1976, was criticized for lack of efficacy in 2005 and 2007, leading to ongoing debate. The FDA's decision follows recent trials confirming its ineffectiveness at any dose.
What you should know about OTC phenylephrine during cold and flu season
FDA may remove oral phenylephrine from OTC cough and cold products due to ineffectiveness. Walgreens suggests alternatives like nasal sprays, pseudoephedrine products, antihistamines, and non-drug options for congestion relief. FDA's proposal does not affect phenylephrine nasal sprays or pose safety concerns, but consumers can switch to other OTC medicines if desired.
FDA Plans to Ban Ineffective Cold Medicine Ingredient—How It Will Affect You
FDA proposes to ban oral phenylephrine from OTC drugs due to ineffectiveness in treating nasal congestion, despite its common use in cold medications. Public comment period open until May 7, 2025, with no safety concerns cited. Proposal does not affect nasal spray form. Alternatives include nasal sprays, oral pseudoephedrine, and antihistamine nasal sprays.
FDA Suggests Removing Nonprescription Decongestant from Market
The FDA proposes removing nonprescription drugs containing phenylephrine from shelves due to its ineffectiveness as a nasal decongestant, based on recent and historical research. This follows advisory committee votes against its efficacy and a review showing it no better than a placebo.
FDA proposes banning oral phenylephrine in decongestants
FDA seeks to ban oral phenylephrine in OTC nasal decongestants due to ineffectiveness; no safety concerns; found in NyQuil, Benadryl, Sudafed, Mucinex; public comment period open.
After decades, FDA finally moves to pull ineffective decongestant off shelves
The FDA proposed removing oral phenylephrine from OTC products due to its ineffectiveness as a nasal decongestant, based on multiple studies showing no significant difference from placebo. The proposal follows years of reevaluation since its 1976 approval.
Drug Development Updates
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