FEXOFENADINE: 21,453 Adverse Event Reports & Safety Profile
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Active Ingredient: FEXOFENADINE HYDROCHLORIDE · Drug Class: Histamine H1 Receptor Antagonists [MoA] · Route: ORAL · Manufacturer: Rite Aid · FDA Application: 020625 · HUMAN OTC DRUG · FDA Label: Available
Patent Expires: Aug 2, 2030 · First Report: 19590530 · Latest Report: 20250923
What Are the Most Common FEXOFENADINE Side Effects?
All FEXOFENADINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 7,188 | 33.5% | 0 | 31 |
| Extra dose administered | 1,413 | 6.6% | 1 | 0 |
| No adverse event | 1,187 | 5.5% | 0 | 0 |
| Somnolence | 961 | 4.5% | 2 | 21 |
| Therapeutic response decreased | 742 | 3.5% | 1 | 8 |
| Headache | 704 | 3.3% | 1 | 30 |
| Insomnia | 642 | 3.0% | 0 | 13 |
| Feeling abnormal | 617 | 2.9% | 2 | 30 |
| Dizziness | 613 | 2.9% | 1 | 45 |
| Product quality issue | 488 | 2.3% | 0 | 1 |
| Pruritus | 475 | 2.2% | 2 | 34 |
| Hypersensitivity | 450 | 2.1% | 4 | 22 |
| Wrong technique in product usage process | 437 | 2.0% | 1 | 3 |
| Rhinorrhoea | 394 | 1.8% | 1 | 6 |
| Urticaria | 388 | 1.8% | 0 | 23 |
| Fatigue | 383 | 1.8% | 3 | 30 |
| Expired product administered | 379 | 1.8% | 0 | 3 |
| Condition aggravated | 375 | 1.8% | 2 | 36 |
| Nausea | 373 | 1.7% | 1 | 38 |
| Dyspnoea | 347 | 1.6% | 3 | 41 |
Who Reports FEXOFENADINE Side Effects? Age & Gender Data
Gender: 68.4% female, 31.6% male. Average age: 55.9 years. Most reports from: US. View detailed demographics →
Is FEXOFENADINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 2 | 0 | 0 |
| 2003 | 1 | 0 | 0 |
| 2005 | 2 | 0 | 2 |
| 2006 | 8 | 1 | 3 |
| 2007 | 2 | 1 | 0 |
| 2008 | 17 | 1 | 4 |
| 2009 | 4 | 0 | 0 |
| 2010 | 5 | 1 | 1 |
| 2011 | 25 | 1 | 3 |
| 2012 | 22 | 3 | 3 |
| 2013 | 48 | 0 | 11 |
| 2014 | 284 | 2 | 18 |
| 2015 | 259 | 4 | 19 |
| 2016 | 196 | 2 | 23 |
| 2017 | 194 | 4 | 15 |
| 2018 | 186 | 0 | 23 |
| 2019 | 284 | 5 | 46 |
| 2020 | 320 | 2 | 37 |
| 2021 | 350 | 0 | 24 |
| 2022 | 199 | 8 | 19 |
| 2023 | 256 | 3 | 23 |
| 2024 | 225 | 1 | 18 |
| 2025 | 199 | 0 | 18 |
What Is FEXOFENADINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 3,863 |
| Hypersensitivity | 3,348 |
| Multiple allergies | 1,601 |
| Seasonal allergy | 913 |
| Urticaria | 604 |
| Rhinorrhoea | 589 |
| Pruritus | 415 |
| Sneezing | 326 |
| Nasal congestion | 196 |
| Eye pruritus | 164 |
FEXOFENADINE vs Alternatives: Which Is Safer?
Other Drugs in Same Class: Histamine H1 Receptor Antagonists [MoA]
Official FDA Label for FEXOFENADINE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- reduces swelling of nasal passages
- temporarily relieves sinus congestion and pressure
- temporarily restores freer breathing through the nose
Dosage & Administration
Directions (for 60mg) adults and children 12 years of age and over take one 60mg tablet with water every 12 hours; do not take more than 2 tablets 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
Directions (for 180mg) adults and children 12 years of age and over take one 180mg tablet with water 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
Directions (for 60mg) adults and children 12 years of age and over take one 60mg tablet with water every 12 hours; do not take more than 2 tablets 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
Directions (for 180mg) adults and children 12 years of age and over take one 180mg tablet with water 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
Warnings Severe 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 drooling wheezing or problems breathing These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health profession immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times. Do not use to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.
- If you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have kidney disease.Your doctor should determine if you need a different dose. hives that are an unusual color, look bruised or blistered hives that do not itch When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve after 3 days of treatment the hives have lasted more than 6 weeks 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.
Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. 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.
Active Ingredient
HIVES Active ingredient (in each film-coated tablet) Fexofenadine HCl USP 60 mg Fexofenadine HCl USP 180 mg
ALLERGY Active ingredient (in each film-coated tablet) Fexofenadine HCl USP 60 mg Fexofenadine HCl USP 180 mg
Inactive Ingredients
Inactive ingredients cellulose acetate, colloidal silicon dioxide, copovidone, croscarmellose sodium, dibutyl sebacate, ferrosoferric oxide, glyceryl mono- and di-caprylocaprate, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, propylene glycol, shellac, sodium lauryl sulfate, stearic acid, talc and titanium dioxide Questions or Comments? call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) Manufactured for: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/22/2009