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Dymista

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Dymista

Dymista Side Effects Center

Medical Editor: John Cunha, DO, FACOEP

Dymista (azelastine hydrochloride and fluticasone propionate) is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 12 years of age and older who require treatment with both azelastine hydrochloride and fluticasone propionate for symptomatic relief. Side effects may include sleepiness or drowsiness, nasal problems, slow wound healing, thrush, eye problems and immune system problems.

For intranasal use only, the recommended dose is 1 spray per nostril twice daily in adults and adolescents 12 years of age and older. Dymista may interact with ritonavir or ketoconazole. Tell your doctor all medications you use. There are no adequate and well-controlled clinical trials of Dymista, azelastine hydrochloride only, or fluticasone propionate only in pregnant women. Animal studies of azelastine hydrochloride and fluticasone propionate revealed evidence of teratogenicity and other developmental toxic effects. Because animal reproduction studies are not always predictive of human response, Dymista should be used during pregnancy only if prescribed. It is unknown if Dymista passes into breast milk. Consult your doctor before breastfeeding.

Our Dymista 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.

Dymista 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:

  • drowsiness;
  • minor nosebleed;
  • altered sense of taste;
  • headache; or
  • sinus pain, cough, sore throat.

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.

Read the entire detailed patient monograph for Dymista (Azelastine Hydrochloride and Fluticasone Propionate) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Dymista FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Systemic and local corticosteroid use may result in the following:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice.

The safety data described below reflect exposure to Dymista Nasal Spray in 853 patients (12 years of age and older; 36% male and 64% female) with seasonal allergic rhinitis in 3 double-blind, placebo-controlled clinical trials of 2-week duration. The racial distribution for the 3 clinical trials was 80% white, 16% black, 2% Asian, and 1% other. In the 12-month open-label, active-controlled clinical trial, 404 Asian patients (240 males and 164 females) with perennial allergic rhinitis or vasomotor rhinitis were treated with Dymista Nasal Spray, 1 spray per nostril twice daily.

Adults and Adolescents 12 Years of Age and Older

In the 3 placebo controlled clinical trials of 2-week duration, 3411 patients with seasonal allergic rhinitis were treated with 1 spray per nostril of Dymista Nasal Spray, azelastine hydrochloride nasal spray, fluticasone propionate nasal spray, or placebo, twice daily. The azelastine hydrochloride and fluticasone propionate comparators use the same vehicle and device as Dymista Nasal Spray and are not commercially marketed. Overall, adverse reactions were 16% in the Dymista Nasal Spray treatment groups, 15% in the azelastine hydrochloride nasal spray groups, 13% in the fluticasone propionate nasal spray groups, and 12% in the placebo groups. Overall, 1% of patients in both the Dymista Nasal Spray and placebo groups discontinued due to adverse reactions.

Table 1 contains adverse reactions reported with frequencies greater than or equal to 2% and more frequently than placebo in patients treated with Dymista Nasal Spray in the seasonal allergic rhinitis controlled clinical trials.

Table 1: Adverse Reactions with ≥ 2% Incidence and More Frequently than Placebo in Placebo-Controlled Trials of 2 Weeks Duration with Dymista Nasal Spray in Adult and Adolescent Patients With Seasonal Allergic Rhinitis

  1 spray per nostril twice daily
Dymista Nasal Spray
(N=853)*
Azelastine Hydrochloride Nasal Spray†
(N=851)
Fluticasone Propionate Nasal Spray†
(N=846)
Vehicle Placebo
(N=861)
Dysgeusia 30 (4%) 44 (5%) 4 (1%) 2 ( < 1%)
Headache 18 (2%) 20 (2%) 20 (2%) 10 (1%)
Epistaxis 16 (2%) 14 (2%) 14 (2%) 15 (2%)
*Safety population N=853, intent-to-treat population N=848
† Not commercially marketed

In the above trials, somnolence was reported in < 1% of patients treated with Dymista Nasal Spray (6 of 853) or vehicle placebo (1 of 861) [see WARNINGS AND PRECAUTIONS].

Long-Term (12-Month) Safety Trial:

In the 12-month, open-label, active-controlled, long-term safety trial, 404 patients (12 years of age and older) with perennial allergic rhinitis or vasomotor rhinitis were treated with Dymista Nasal Spray 1 spray per nostril twice daily and 207 patients were treated with fluticasone propionate nasal spray, 2 sprays per nostril once daily. Overall, adverse reactions were 47% in the Dymista Nasal Spray treatment group and 44% in the fluticasone propionate nasal spray group. The most frequently reported adverse reactions ( ≥ 2%) with Dymista Nasal Spray were headache, pyrexia, cough, nasal congestion, rhinitis, dysgeusia, viral infection, upper respiratory tract infection, pharyngitis, pain, diarrhea, and epistaxis. In the Dymista Nasal Spray treatment group, 7 patients (2%) had mild epistaxis and 1 patient ( < 1%) had moderate epistaxis. In the fluticasone propionate nasal spray treatment group 1 patient ( < 1%) had mild epistaxis. No patients had reports of severe epistaxis. Focused nasal examinations were performed and no nasal ulcerations or septal perforations were observed. Eleven of 404 patients (3%) treated with Dymista Nasal Spray and 6 of 207 patients (3%) treated with fluticasone propionate nasal spray discontinued from the trial due to adverse events.

Postmarketing Experience

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.

The following spontaneous adverse events have been reported during the marketing of azelastine hydrochloride nasal spray and causal relationship with the drug is unknown: anaphylactoid reaction, application site irritation, atrial fibrillation, chest pain, confusion, dyspnea, facial edema, involuntary muscle contractions, nasal sores, palpitations, paresthesia, parosmia, pruritus, rash, disturbance or loss of sense of smell and/or taste, tolerance, urinary retention, vision abnormal and xerophthalmia.

In addition, the following events have been identified during post-approval use of fluticasone propionate nasal spray. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to fluticasone propionate or a combination of these factors.

General: Hypersensitivity reactions, including angioedema, skin rash, edema of the face and tongue, pruritus, urticaria, bronchospasm, wheezing, dyspnea, and anaphylaxis/anaphylactoid reactions, which in rare instances were severe.

Ear, Nose, and Throat: Alteration or loss of sense of taste and/or smell and, rarely, nasal septal perforation, nasal ulcer, sore throat, throat irritation and dryness, cough, hoarseness, and voice changes.

Eye: Dryness and irritation, conjunctivitis, blurred vision, glaucoma, increased intraocular pressure, and cataracts.

Cases of growth suppression have been reported for intranasal corticosteroids, including fluticasone propionate [see Use in Specific Populations].

Read the entire FDA prescribing information for Dymista (Azelastine Hydrochloride and Fluticasone Propionate) »

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