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Veramyst Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Veramyst Nasal Spray (fluticasone furoate) is a corticosteroid prescribed for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older. Veramyst is available in generic form. Side effects of Veramyst may include but are not limited to severe or ongoing nosebleed, sores in the nose that won't heal, headache, throat infection, nasal irritation, sneezing, cough, nausea, and vomiting. Severe allergic reaction (anaphylaxis) may occur.
Each Veramyst spray contains about 27.5 mcg of fluticasone furoate. Administer Veramyst Nasal Spray by the intranasal route only and keep away from the eyes. There are no adequate and well-controlled studies of Veramyst in pregnant women. Veramyst Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Since there are no data from controlled trials on the use of intranasal fluticasone furoate by nursing mothers, caution should be exercised when Veramyst Nasal Spray is administered to a nursing woman. Safety and effectiveness in pediatric patients under age 2 has not been established.
Our Veramyst (fluticasone furoate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Veramyst in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- severe or ongoing nosebleeds;
- noisy breathing, runny nose, or crusting around your nostrils;
- redness, sores, or white patches in your mouth or throat;
- fever, chills, weakness, nausea, vomiting, flu symptoms;
- any wound that will not heal; or
- blurred vision, eye pain, or seeing halos around lights.
Less serious side effects may include:
- headache, back pain;
- minor nosebleed;
- menstrual problems, loss of interest in sex;
- sinus pain, cough, sore throat; or
- sores or white patches inside or around your nose.
Read the entire detailed patient monograph for Veramyst (Fluticasone Furoate) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Veramyst Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: severe/persistent nosebleeds, pain in your nose, eye pain, white patches in your nose/back of your throat, painful swallowing, persistent sore throat.
Rarely, it is possible that corticosteroids given in the nose will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time and in high doses. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Veramyst (Fluticasone Furoate)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Veramyst FDA Prescribing Information: Side Effects
Systemic and local corticosteroid use may result in the following:
- Epistaxis, ulcerations, Candida albicans infection, impaired wound healing, and nasal septal perforation [see WARNINGS AND PRECAUTIONS]
- Cataracts and glaucoma [see WARNINGS AND PRECAUTIONS]
- Immunosuppression [see WARNINGS AND PRECAUTIONS]
- Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction [see WARNINGS AND PRECAUTIONS, Use In Specific Populations]
Clinical Trials Experience
The safety data described below reflect exposure to VERAMYST Nasal Spray in 1,563 patients with seasonal or perennial allergic rhinitis in 9 controlled clinical trials of 2 to 12 weeks' duration. The data from adults and adolescents are based upon 6 clinical trials in which 768 patients with seasonal or perennial allergic rhinitis (473 females and 295 males aged 12 years and older) were treated with VERAMYST Nasal Spray 110 mcg once daily for 2 to 6 weeks. The racial distribution of adult and adolescent patients receiving VERAMYST Nasal Spray was 82% white, 5% black, and 13% other. The data from pediatric patients are based upon 3 clinical trials in which 795 children with seasonal or perennial rhinitis (352 females and 443 males aged 2 to 11 years) were treated with VERAMYST Nasal Spray 55 or 110 mcg once daily for 2 to 12 weeks. The racial distribution of pediatric patients receiving VERAMYST Nasal Spray was 75% white, 11% black, and 14% other.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adults and Adolescents Aged 12 Years and Older
Overall adverse reactions were reported with approximately the same frequency by patients treated with VERAMYST Nasal Spray and those receiving placebo. Less than 3% of patients in clinical trials discontinued treatment because of adverse reactions. The rate of withdrawal among patients receiving VERAMYST Nasal Spray was similar or lower than the rate among patients receiving placebo.
Table 1 displays the common adverse reactions (>1% in any patient group receiving VERAMYST Nasal Spray) that occurred more frequently in patients aged 12 years and older treated with VERAMYST Nasal Spray compared with placebo-treated patients.
Table 1: Adverse Reactions With >1% Incidence in
Controlled Clinical Trials of 2 to 6 Weeks' Duration With VERAMYST Nasal Spray
in Adult and Adolescent Patients With Seasonal or Perennial Allergic Rhinitis
|Adverse Event||Adult and Adolescent Patients Aged 12 Years and Older|
(n = 774)
|VERAMYST Nasal Spray 110 mcg Once Daily
(n = 768)
|Headache||54 (7%)||72 (9%)|
|Epistaxis||32 (4%)||45 (6%)|
|Pharyngolaryngeal pain||8 (1%)||15 (2%)|
|Nasal ulceration||3 (<1%)||11 (1%)|
|Back pain||7 (<1%)||9 (1%)|
There were no differences in the incidence of adverse reactions based on gender or race. Clinical trials did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger subjects.
Pediatric Patients Aged 2 to 11 Years
In the 3 clinical trials in pediatric patients aged 2 to <12 years, overall adverse reactions were reported with approximately the same frequency by patients treated with VERAMYST Nasal Spray and those receiving placebo. Table 2 displays the common adverse reactions (>3% in any patient group receiving VERAMYST Nasal Spray), that occurred more frequently in patients aged 2 to 11 years treated with VERAMYST Nasal Spray compared with placebo-treated patients.
Table 2: Adverse Reactions With
>3% Incidence in Controlled Clinical Trials of 2 to 12 Weeks' Duration With
VERAMYST Nasal Spray in Pediatric Patients With Seasonal or Perennial Allergic
|Adverse Event||Pediatric Patients Aged 2 to <12 Years|
(n = 429)
|VERAMYST Nasal Spray 55 mcg Once Daily
(n = 369)
|VERAMYST Nasal Spray 110 mcg Once Daily
(n = 426)
|Headache||31 (7%)||28 (8%)||33 (8%)|
|Nasopharyngitis||21 (5%)||20 (5%)||21 (5%)|
|Epistaxis||19 (4%)||17 (5%)||17 (4%)|
|Pyrexia||7 (2%)||17 (5%)||19 (4%)|
|Pharyngolaryngeal pain||14 (3%)||16 (4%)||12 (3%)|
|Cough||12 (3%)||12 (3%)||16 (4%)|
There were no differences in the incidence of adverse reactions based on gender or race. Pyrexia occurred more frequently in children aged 2 to <6 years compared with children aged 6 to <12 years.
Long-Term (52-Week) Safety Trial
In a 52-week, placebo-controlled, long-term safety trial, 605 patients (307 females and 298 males aged 12 years and older) with perennial allergic rhinitis were treated with VERAMYST Nasal Spray 110 mcg once daily for 12 months and 201 were treated with placebo nasal spray. While most adverse reactions were similar in type and rate between the treatment groups, epistaxis occurred more frequently in patients who received VERAMYST Nasal Spray (123/605, 20%) than in patients who received placebo (17/201, 8%). Epistaxis tended to be more severe in patients treated with VERAMYST Nasal Spray. All 17 reports of epistaxis that occurred in patients who received placebo were of mild intensity, while 83, 39, and 1 of the total 123 epistaxis events in patients treated with VERAMYST Nasal Spray were of mild, moderate, and severe intensity, respectively. No patient experienced a nasal septal perforation during this trial.
In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postmarketing use of VERAMYST Nasal Spray. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to fluticasone furoate or a combination of these factors.
Immune System Disorders
Respiratory, Thoracic, and Mediastinal Disorders
Rhinalgia, nasal discomfort (including nasal burning, nasal irritation, and nasal soreness), nasal dryness, and nasal septal perforation.
Read the entire FDA prescribing information for Veramyst (Fluticasone Furoate) »
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