Veramyst Side Effects

Please note - some side effects for Veramyst may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Veramyst - for the Consumer

Veramyst Spray

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Veramyst Spray:

Back pain; cough; headache; minor nosebleed; sore throat.

Seek medical attention right away if any of these SEVERE side effects occur when using Veramyst Spray:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); crusting in the nose; dizziness; redness or white patches in the mouth or throat; severe or persistent nosebleed; severe or persistent pain in the nose or throat; shortness of breath; slow wound healing; symptoms of infection (eg, fever, chills, persistent cough or sore throat); unexplained runny nose; unusual nausea or vomiting; unusual tiredness or weakness; vision changes; whistling sound when you breathe.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Veramyst Side Effects - for the Professional

Veramyst

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 (5.1)]
• Cataracts and glaucoma [see Warnings and Precautions (5.2)]
• Immunosuppression [see Warnings and Precautions (5.4)]
• Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)]

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
	Vehicle Placebo (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 Rhinitis

Adverse Event	Pediatric Patients Aged 2 to <12 Years
	Vehicle Placebo (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.

Postmarketing Experience

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: Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria.

Respiratory, Thoracic, and Mediastinal Disorders: Rhinalgia, nasal discomfort (including nasal burning, nasal irritation, and nasal soreness), nasal dryness, and nasal septal perforation.

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Side Effects by Body System - for Healthcare Professionals

Endocrine

Endocrine side effects have included suppression of the hypothalamic-pituitary-adrenal axis. The risk of adrenal suppression is less than that associated with systemic corticosteroids and should be of concern only when using higher than recommended doses. Slight suppression of plasma cortisol has been noted following 250 mcg intranasal doses of fluticasone.

Due to extensive first-pass metabolism of fluticasone to an inactive carboxylic acid, significant systemic effects are not expected from any amount of the drug that may be swallowed via intranasal administration of normally recommended dosages. In one study involving 61 patients, no significant difference was demonstrated in the hypothalamic-pituitary-adrenal axis function among patients given intranasal fluticasone 200 mcg/day or placebo for 1 year.

Local

Local side effects have included nasal irritation including burning, dryness, and soreness in 1% to 6% of patients. Nose bleed has been reported in up to 15% of treated patients and sore throat in 2%. Intranasal fluticasone may also cause sneezing. Nasal ulcerations and Candida albicans infections have been reported. Alteration or loss of sense of taste or smell has been reported rarely. Nasal septal perforation and impaired wound healing has also been reported.

Nervous system

Nervous system adverse effects have included headache in 2% to 4% of patients. Some studies have reported headache in as many as 32% of patients. Dizziness has also been reported.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, and dry mouth.

Hypersensitivity

Hypersensitivity side effects have included postmarketing reports of a systemic eosinophilic condition. Clinical features of this condition have included a vasculitis consistent with Churg-Strauss syndrome, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy. These events have usually been associated with a reduction and/or discontinuation of oral corticosteroid therapy following introduction of fluticasone.

Rarely, hypersensitivity reactions have been reported including angioedema, rash, face and tongue edema, pruritus, urticaria, bronchospasm, wheezing, dyspnea and anaphylaxis.

Cases of serious eosinophilic conditions also have been reported with other inhaled corticosteroids in this clinical setting.

Ocular

Ocular side effects have included reports of cataracts and posterior capsular cataracts.

Immunologic

In 1993, the American Academy of Allergy and Immunology (AAAI) requested that the FDA review its decision regarding the labeled risks of the use of inhaled corticosteroids during severe viral infections. The AAAI's request was based on the lack of data linking inhaled corticosteroids to increases in complications of viral infections.

The danger of infections from immune suppression associated with inhaled corticosteroids has been debated. No conclusive evidence is available to support an increase in tuberculosis or viral infections in patients receiving inhaled fluticasone.

Respiratory

Respiratory side effects have included epistaxis, ulcerations, Candida albicans infection, impaired wound healing, and nasal septal perforation.

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