Pseudoephedrine
/api/v1/drug/pseudoephedrineMechanism of action
Sourced from openFDAMechanism-of-action classes: Adrenergic alpha-Agonists; Adrenergic beta-Agonists; Monoamine Oxidase Inhibitors.
Indications
Sourced from openFDA- Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressureICD-10: J00
Dosage & administration
Sourced from openFDADirections adults and children 12 years and over take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours children under 12 years do not use this product in children under 12 years of age
Warnings & precautions
Sourced from openFDADo 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)
Approval history
Sourced from openFDA- Sep 19, 1989NDANDA019771Haleon Us Holdings
- Nov 14, 1994NDANDA019670Bayer Healthcare Llc
- Aug 23, 1996NDANDA020470Bayer Healthcare Llc
- Dec 24, 1997NDANDA020786Chattem Sanofi
- Aug 10, 2001NDANDA021150Kenvue Brands
- May 30, 2002NDANDA021374Haleon Us Holdings
- Dec 19, 2002NDANDA021441Haleon Us Holdings
- Jun 22, 2004NDANDA021585Rb Hlth
FAERS reports
- 1Drug Ineffective7,80031%
- 2Pain5,72423%
- 3Systemic Lupus Erythematosus5,29421%
- 4Abdominal Discomfort5,23721%
- 5Rheumatoid Arthritis5,21321%
- 6Fatigue5,19421%
- 7Pemphigus5,17220%
- 8Alopecia5,08120%
- 9Rash4,82919%
- 10Glossodynia4,77319%
- 11Swelling4,63618%
- 12Wound4,58218%
- 13Hand Deformity4,47618%
- 14Arthropathy4,26517%
- 15Pericarditis4,20717%
Literature
Recent PubMed references pinned to Pseudoephedrine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- A Fatal Case Involving Chronic Intravenous Use of Homemade Methcathinone Derived from Pseudoephedrine Tablets: Post-Mortem Concentrations, Health Risk, and Medicolegal Aspect.International journal of molecular sciences · 2025 · Nowak K, Szpot P, Zawadzki M, et al.PMID 41465401DOI 10.3390/ijms262411974
- Effect of pre- and postprandial administration of Maoto extract granules on the pharmacokinetics of ephedrine and pseudoephedrine in healthy adults.Journal of natural medicines · 2026 · Atsumi T, Nakakubo T, Takakura M, et al.PMID 41276775DOI 10.1007/s11418-025-01980-w
- Pseudoephedrine prophylaxis does not prevent middle ear barotrauma in hyperbaric oxygen therapy.Undersea & hyperbaric medicine : journal of the Undersea and Hyperbaric Medical Society, Inc · 2025 · Moayedi S, Gizaw A, Sweet S, et al.PMID 40819351
- Open Digital Reference Materials Unchain Controlled Substance Analysis.Analytical chemistry · 2025 · Tang Y, Wang S, Fang C, et al.PMID 40601392DOI 10.1021/acs.analchem.5c00109
- Exposure to pseudoephedrine during pregnancy and major congenital malformations: Findings from a large population-based cohort of pregnancies.British journal of clinical pharmacology · 2025 · Dor S, Michael T, Levi Y, et al.PMID 40441686DOI 10.1111/bcp.70001
- Exposure to pseudoephedrine during pregnancy and major congenital malformations: Findings from a large population-based cohort of pregnancies.British journal of clinical pharmacology · 2025 · Dor S, Michael T, Levi Y, et al.PMID 39957013DOI 10.1002/bcp.70001
- Pharmacology of chlorphenamine and pseudoephedrine use in the common cold: a narrative review.Current medical research and opinion · 2024 · Douhard R, Humbert P, Milon JY, et al.PMID 39484821DOI 10.1080/03007995.2024.2424422
- Novel Green Chromatographic Approaches for Estimation of a Triple Common Cold Pharmaceutical Combination.Journal of chromatographic science · 2025 · Soliman RM, Rostom Y, Fayez YM, et al.PMID 39324644DOI 10.1093/chromsci/bmae050
Clinical trials
The 10 most recently updated of 310 ClinicalTrials.gov registrations naming Pseudoephedrine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Blocking Sphenopalatine Ganglion by Intranasal Lidocaine Spray in Partial Turbinectomy SurgeriesRecruiting · Phase 3 · Interventional · 50 enrolled · Ain Shams UniversityNCT07299630updated 2026-06-09
- Electric Cardiometry-Guided Standard Versus Restricted Fluid Therapy In Robotic ProstaectomyRecruiting · Interventional · 90 enrolled · Nazmy Edward SeifNCT07626151updated 2026-06-08
- Minimal Flow Anesthesia and Infection RiskCompleted · Interventional · 140 enrolled · Ankara City Hospital BilkentNCT07092046updated 2026-06-05
- Laser Acupuncture for Otitis Media With Effusion in ChildrenCompleted · Interventional · 32 enrolled · Indonesia UniversityNCT07242001updated 2026-06-04
- Oxymetazoline Bridge Therapy With Intranasal Corticosteroids in Pediatric Allergic RhinitisCompleted · Phase 4 · Interventional · 76 enrolled · Dr. Behcet Uz Children's HospitalNCT07593898updated 2026-05-18
- Hemodynamic Effects of Lithotomy Position in Surgical Patients (PH-LITHO)Completed · Interventional · 60 enrolled · Trabzon Karadeniz Teknik UniversitesiNCT07549152updated 2026-05-14
- Influence of Nociception Level Monitor (NOL) Guided Analgesic Delivery on Robot-assisted Colorectal SurgeryRecruiting · Interventional · 60 enrolled · University of Southern DenmarkNCT05662371updated 2026-05-14
- Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After CSERecruiting · Phase 4 · Interventional · 100 enrolled · Icahn School of Medicine at Mount SinaiNCT05873218updated 2026-05-06
- Norepinephrine With Ephedrine Versus Norepinephrine Alone During Spinal Anesthesia for Cesarean DeliveryNot yet recruiting · Phase 4 · Interventional · 260 enrolled · Cairo UniversityNCT07379710updated 2026-04-28
- Management of Postspinal Anesthesia Hypotension During Elective Cesarean Section: Baby Norepinephrine Versus EphedrineCompleted · Interventional · 196 enrolled · Hopital Charles NicolleNCT06498076updated 2026-04-23
Frequently asked questions
- How does Pseudoephedrine work?
- Mechanism-of-action classes: Adrenergic alpha-Agonists; Adrenergic beta-Agonists; Monoamine Oxidase Inhibitors.
- What is Pseudoephedrine used for?
- According to FDA labeling, Pseudoephedrine carries indications including: Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Pseudoephedrine?
- Pseudoephedrine is classified as Sympathomimetics, alpha-Adrenergic Agonist, Adrenergic alpha-Agonists, Adrenergic beta-Agonists, Monoamine Oxidase Inhibitors, Bronchodilation, Vasoconstriction.
- What are the brand names for Pseudoephedrine?
- Pseudoephedrine is marketed under brand names including A-Phedrin, Alavert D, Allegra-D, Aller-Tec D, Allerclear, Ambifed CD, Ambifed-G CD, Aphedrid.
pseudoephedrine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.