Dymista Side Effects
Generic name: azelastine / fluticasone nasal
Note: This document contains side effect information about azelastine / fluticasone nasal. Some of the dosage forms listed on this page may not apply to the brand name Dymista.
Some side effects of Dymista may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to azelastine / fluticasone nasal: nasal spray
Along with its needed effects, azelastine / fluticasone nasal may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking azelastine / fluticasone nasal:Less common
- Bloody nose
- body aches or pain
- cold or flu-like symptoms
- cough or hoarseness
- difficulty with breathing
- dryness or soreness of the throat
- ear congestion
- loss of voice
- nasal congestion
- runny nose
- tender, swollen glands in the neck
- trouble with swallowing
- unusual tiredness or weakness
- voice changes
- bloody mucus or unexplained nosebleeds
- blurred vision
- chest pain
- darkening of the skin
- decreased vision
- delayed wound healing
- difficult or labored breathing
- eye pain
- fast, irregular, pounding, or racing heartbeat or pulse
- 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
- tightness in the chest
- white patches in the mouth or on the tongue
Some side effects of azelastine / fluticasone nasal may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:Less common
- Change in taste
- loss of taste
- 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
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 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.
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 side effects have included diarrhea (2% or greater).
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 side effects have included viral infection (2% or greater).
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 side effects associated with azelastine nasal spray have included atrial fibrillation and palpitations during postmarketing experience.
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 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 side effects associated with azelastine nasal spray have included pruritus and rash during postmarketing experience.
Genitourinary side effects associated with azelastine nasal spray have included urinary retention during postmarketing experience.
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