pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Adrenergic alpha-Agonists; Adrenergic alpha1-Agonists.

Indications

Sourced from openFDA
  • Uses temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergiesICD-10: J00

Dosage & administration

Sourced from openFDA

Directions adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: ask a doctor

Warnings & precautions

Sourced from openFDA

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 diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the 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 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.

Approval history

Sourced from openFDA
  • May 27, 2010NDANDA022565Haleon Us Holdings
  • Dec 21, 2011NDANDA022113Haleon Us Holdings
  • Dec 20, 2012NDANDA203826Hikma
  • Mar 21, 2013NDANDA203510Paragon Bioteck
  • May 30, 2014NDANDA205388Rayner Surgical
  • Jan 15, 2015NDANDA207926Alcon
  • Oct 21, 2019NDANDA212909Dr Reddys Labs Sa
  • May 30, 2025NDANDA216830Dr Reddys Labs Sa

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
217,640 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective23,47311%
  2. 2Fatigue20,2219.3%
  3. 3Headache16,9157.8%
  4. 4Nausea16,5467.6%
  5. 5Pain16,4507.6%
  6. 6Off Label Use15,4847.1%
  7. 7Diarrhoea13,9036.4%
  8. 8Dyspnoea13,4626.2%
  9. 9Arthralgia12,3675.7%
  10. 10Dizziness10,1244.7%
  11. 11Vomiting9,8044.5%
  12. 12Rash9,5204.4%
  13. 13Asthenia9,2504.3%
  14. 14Pyrexia8,9474.1%
  15. 15Pain In Extremity8,1343.7%

Literature

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Recent PubMed references pinned to Phenylephrine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 742 ClinicalTrials.gov registrations naming Phenylephrine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Phenylephrine work?
Mechanism-of-action classes: Adrenergic alpha-Agonists; Adrenergic alpha1-Agonists.
What is Phenylephrine used for?
According to FDA labeling, Phenylephrine carries indications including: Uses temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Phenylephrine?
Phenylephrine is classified as Adrenergic and dopaminergic agents, Other agents for treatment of hemorrhoids and anal fissures for topical use, Sympathomimetics, Sympathomimetics, combinations excl. corticosteroids, Sympathomimetics excl. antiglaucoma preparations, Sympathomimetics, plain, Sympathomimetics used as decongestants, alpha-1 Adrenergic Agonist, Adrenergic alpha-Agonists, Adrenergic alpha1-Agonists, Conjunctival Arterial Vasoconstriction, Decreased Nasal and Sinus Secretions.
What are the brand names for Phenylephrine?
Phenylephrine is marketed under brand names including Alahist D, Benadryl Allergy Plus Congestion, Benadryl-D Allergy and Sinus, Biorphen, Brovex PBC, Cyclomydril, Dallergy Reformulated Nov 2011, Immphentiv.
Note. Data for phenylephrine 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.

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