Dymista Side Effects

Generic Name: azelastine / fluticasone nasal

Note: This page contains information about the side effects of azelastine / fluticasone nasal. Some of the dosage forms included on this document may not apply to the brand name Dymista.

Not all side effects for Dymista may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to azelastine / fluticasone nasal: nasal spray

In addition to its needed effects, some unwanted effects may be caused by azelastine / fluticasone nasal. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking azelastine / fluticasone nasal:

Less common
  • Bloody nose
  • body aches or pain
  • chills
  • cold or flu-like symptoms
  • congestion
  • cough or hoarseness
  • difficulty with breathing
  • dryness or soreness of the throat
  • ear congestion
  • fever
  • headache
  • loss of voice
  • nasal congestion
  • runny nose
  • sneezing
  • tender, swollen glands in the neck
  • trouble with swallowing
  • unusual tiredness or weakness
  • voice changes
Incidence not known
  • Blindness
  • bloody mucus or unexplained nosebleeds
  • blurred vision
  • chest pain
  • darkening of the skin
  • decreased vision
  • delayed wound healing
  • diarrhea
  • difficult or labored breathing
  • dizziness
  • eye pain
  • fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • hives
  • itching
  • lack or slowing of normal growth in children
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • mental depression
  • nausea or vomiting
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • shortness of breath
  • skin rash
  • sleepiness or unusual drowsiness
  • sore mouth or tongue
  • sores inside the nose
  • tearing
  • tightness in the chest
  • white patches in the mouth or on the tongue

Some of the side effects that can occur with azelastine / fluticasone nasal may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Change in taste
  • loss of taste
Incidence not known
  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • burning, dry, or itching eyes
  • change in sense of smell
  • changes in vision
  • discharge or excessive tearing
  • hives or welts
  • irritation at the application site
  • loss of smell
  • mental or mood changes
  • redness of the skin
  • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

For Healthcare Professionals

Applies to azelastine / fluticasone nasal: nasal spray

General

During clinical trials of 2-week duration, side effects were 16% in the azelastine-fluticasone nasal spray treatment groups, 15% in the azelastine nasal spray groups, 13% in the fluticasone nasal spray groups, and 12% in the placebo groups. Overall, 1% of patients in both the azelastine-fluticasone nasal spray and placebo groups discontinued due to side effects.

In the long-term (12-month) safety trial, side effects were 47% in the azelastine-fluticasone nasal spray treatment group and 44% in the fluticasone nasal spray group. Three percent of patients treated with azelastine-fluticasone nasal spray and 3% of patients treated with fluticasone nasal spray discontinued treatment due to side effects.

Nervous system

Nervous system side effects have included dysgeusia (up to 4%), headache (2% or greater), and somnolence (less than 1%). Confusion, paresthesia, parosmia, involuntary muscle contractions, and disturbance or loss of sense of smell and/or taste have been reported with azelastine nasal spray during postmarketing experience. Alteration or loss of sense of taste and/or smell has been reported with fluticasone nasal spray during postmarketing experience.

Respiratory

In the azelastine-fluticasone nasal spray treatment group, epistaxis was reported as mild in 2% of patients and as moderate in less than 1% of patients.

Respiratory side effects have included cough, nasal congestion, rhinitis, upper respiratory tract infection, pharyngitis, and epistaxis in greater than or equal to 2% of patients. Dyspnea has been reported with azelastine nasal spray during postmarketing experience. Sore throat, throat irritation and dryness, cough, hoarseness, and voice changes have been reported with fluticasone nasal spray during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (2% or greater).

Other

Other side effects have included pyrexia and pain in greater than or equal to 2% of patients. Chest pain, facial edema, and tolerance have been reported with azelastine nasal spray during postmarketing experience.

Immunologic

Immunologic side effects have included viral infection (2% or greater).

Ocular

Ocular side effects have included increased intraocular pressure and posterior subcapsular cataract. Abnormal vision and xerophthalmia have been reported with azelastine nasal spray during postmarketing experience. Dryness and irritation, conjunctivitis, blurred vision, glaucoma, increased intraocular pressure, and cataracts have been reported with fluticasone nasal spray during postmarketing experience.

Cardiovascular

Cardiovascular side effects associated with azelastine nasal spray have included atrial fibrillation and palpitations during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects associated with azelastine nasal spray have included anaphylactoid reaction during postmarketing experience. Hypersensitivity reactions, including angioedema, skin rash, edema of the face and tongue, pruritus, urticaria, bronchospasm, wheezing, dyspnea, and anaphylaxis/anaphylactoid reactions (which in rare cases were severe), have been reported with fluticasone nasal spray during postmarketing experience.

Local

Local side effects associated with intranasal fluticasone have included localized infections of the nose and pharynx with Candida albicans. Application site irritation and nasal sores have been reported with azelastine nasal spray during postmarketing experience. Nasal septal perforation and nasal ulcer have been reported with fluticasone nasal spray during postmarketing experience.

Dermatologic

Dermatologic side effects associated with azelastine nasal spray have included pruritus and rash during postmarketing experience.

Genitourinary

Genitourinary side effects associated with azelastine nasal spray have included urinary retention during postmarketing experience.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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