Fexofenadine
/api/v1/drug/fexofenadineMechanism of action
Sourced from openFDAMechanism-of-action class: Histamine H1 Receptor Antagonists.
Indications
Sourced from openFDA- Uses reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
Dosage & administration
Sourced from openFDADirections adults and children 12 years of age and over: take one 180 mg tablet with water every once a day; do not take more than 1 tablet in 24 hours children under 12 years of age: do not use adults 65 years of age and older: ask a doctor consumers with kidney disease: ask a doctor
Warnings & precautions
Sourced from openFDASevere Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing dizziness or loss of consciousness swelling of tongue swelling in or around mouth trouble speaking wheezing or problems breathing drooling These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later
Approval history
Sourced from openFDA- Dec 24, 1997NDANDA020786Chattem Sanofi
- Feb 25, 2000NDANDA020872Chattem Sanofi
- Oct 19, 2004NDANDA021704Chattem Sanofi
- Sep 1, 2005ANDAANDA076447Teva
- Apr 11, 2006ANDAANDA076502Dr Reddys Labs Ltd
- Jul 26, 2007NDANDA021909Chattem Sanofi
- Mar 17, 2010ANDAANDA079043Dr Reddys Labs Ltd
- Jan 24, 2011NDANDA201373Chattem Sanofi
FAERS reports
- 1Drug Ineffective4,02817%
- 2Headache1,0224.4%
- 3Fatigue1,0194.4%
- 4Nausea9444.0%
- 5Pruritus8903.8%
- 6Extra Dose Administered8623.7%
- 7No Adverse Event8593.7%
- 8Diarrhoea8273.5%
- 9Dizziness7933.4%
- 10Dyspnoea7203.1%
- 11Rash7063.0%
- 12Somnolence6812.9%
- 13Cough6412.7%
- 14Insomnia6102.6%
- 15Pain5792.5%
Clinical trials
The 10 most recently updated of 109 ClinicalTrials.gov registrations naming Fexofenadine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and DigoxinRecruiting · Phase 1 · Interventional · 60 enrolled · Karuna Therapeutics, Inc., a Bristol Myers Squibb companyNCT07118215updated 2026-06-11
- Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple SclerosisActive not recruiting · Phase 3 · Interventional · 600 enrolled · Rigshospitalet, DenmarkNCT04688788updated 2026-06-10
- Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)Recruiting · Phase 3 · Interventional · 284 enrolled · SanofiNCT05263206updated 2026-06-08
- A Study to Evaluate the Effect of Multiple Doses of JNJ-56021927 on the Pharmacokinetics of Multiple Cytochrome P450 and Transporter Substrates in Participants With Castration-Resistant Prostate CancerActive not recruiting · Phase 1 · Interventional · 23 enrolled · Aragon Pharmaceuticals, Inc.NCT02592317updated 2026-06-05
- Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve IndicationRecruiting · Interventional · 104 enrolled · Fundación EPICNCT06049654updated 2026-06-05
- A Prospective, Single-centre, Observational Cohort Study on the Efficacy and Safety of Bacterial Lysate (OM-85) in Combination With Antihistamines for the Treatment of Chronic Spontaneous Urticaria (CSU)Not yet recruiting · Observational · 132 enrolled · The Fourth Affiliated Hospital of Zhejiang University School of MedicineNCT07557888updated 2026-05-07
- Mast Cell Treatment in Post-tick Bite Illness (PTBI)Not yet recruiting · Phase 2 · Interventional · 50 enrolled · University of North Carolina, Chapel HillNCT07526558updated 2026-04-13
- A Study of SJP-001 in Comparison With Fexofenadine and Naproxen Administered With AlcoholCompleted · Phase 1 · Phase 2 · Interventional · 47 enrolled · Sen-Jam PharmaceuticalNCT07487909updated 2026-03-23
- Investigation of the NVT ALLEGRA Plus THV System in Patients With Severe Aortic Stenosis or Failed Surgical Aortic BioprosthesisSuspended · Interventional · 177 enrolled · NVT GmbHNCT05804903updated 2026-03-09
- Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical BioprosthesisCompleted · Interventional · 137 enrolled · NVT GmbHNCT05478161updated 2026-02-24
Frequently asked questions
- How does Fexofenadine work?
- Mechanism-of-action class: Histamine H1 Receptor Antagonists.
- What is Fexofenadine used for?
- According to FDA labeling, Fexofenadine carries indications including: Uses reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Fexofenadine?
- Fexofenadine is classified as Other antihistamines for systemic use, Histamine-1 Receptor Antagonist, Histamine H1 Receptor Antagonists, Decreased Histamine Activity.
- What are the brand names for Fexofenadine?
- Fexofenadine is marketed under brand names including Allegra, Allegra-D, Wal-Fex, Wal-Fex D.
fexofenadine 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.