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Azelastine / fluticasone nasal Side Effects

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
  • 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 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, or skin rash
  • 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
  • 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 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

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

The most commonly reported side effects were headache, pyrexia, cough, nasal congestion, and rhinitis.[Ref]

Hypersensitivity

Fluticasone:

Postmarketing reports: Hypersensitivity reactions (including angioedema, skin rash, edema of the face and tongue, pruritus, urticaria, bronchospasm, wheezing, dyspnea, and anaphylaxis/anaphylactoid reactions)[Ref]

Endocrine

Fluticasone:

Frequency not reported: Hypothalamic-pituitary-adrenal (HPA) axis effects[Ref]

Immunologic

Common (1% to 10%): Viral infection

Fluticasone:

Frequency not reported: Immunosuppression, Candida albicans infection[Ref]

Respiratory

Common (1% to 10%): Epistaxis, cough, nasal congestion, rhinitis, upper respiratory tract infection, pharyngitis

Azelastine:

Postmarketing reports: Nasal sores

Fluticasone:

Rare (0.01% than 0.1%): Nasal septal perforation, nasal ulcer, sore throat, throat irritation and dryness, cough, hoarseness, voice changes[Ref]

Nervous system

Common (1% to 10%) Dysgeusia, headache

Uncommon (0.1% to 1%): Somnolence

Azelastine:

Postmarketing reports: Confusion, involuntary muscle contractions, paraesthesia, parosmia, disturbance or loss of sense of smell and/or taste[Ref]

Ocular

Azelastine:

Postmarketing reports: Abnormal vision, xerophthalmia

Fluticasone:

Postmarketing reports: Dryness, irritation, conjunctivitis, blurred vision, glaucoma, increased intraocular pressure, cataracts[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea

Rare (0.01% than 0.1%): Dry mouth

Very rare (less than 0.01%): Nausea[Ref]

Other

Common (1% to 10%): Pyrexia, pain

Very rare (less than 0.01%): Fatigue

Fluticasone:

Frequency not reported: Impaired wound healing[Ref]

Cardiovascular

Azelastine:

Postmarketing reports: Atrial fibrillation, chest pain, palpitations[Ref]

Local

Azelastine:

Postmarketing reports: Application site irritation[Ref]

Genitourinary

Azelastine:

Postmarketing reports: Urinary retention[Ref]

Musculoskeletal

Fluticasone:

Postmarketing reports: Growth suppression[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Dymista (azelastine-fluticasone nasal)." Meda Pharmaceuticals, Somerset, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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