Azelastine / Fluticasone Nasal Side Effects
Medically reviewed by Drugs.com. Last updated on Nov 18, 2023.
Applies to azelastine/fluticasone nasal: nasal spray.
Precautions
It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to use it.
If your or your child's symptoms do not improve within a few days or if they become worse, check with your doctor.
This medicine may increase your risk of having some unwanted effects in the nose. Check with your doctor right away if you or your child have bloody mucus, sores inside the nose, unexplained nosebleeds, or a whistling sound when you breathe while you are using this medicine.
You may get infections more easily while you are using this medicine. Avoid being around people who are sick or have infections such as chickenpox or measles or if you have never had these infections. This is especially important for children. Tell your doctor right away if you think you have been exposed to chickenpox or measles.
This medicine may cause thrush (a type of fungus infection) in the nose or throat. Tell your doctor right away if you or your child have white patches in the throat, or pain when you eat or swallow.
Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes checked by an eye doctor.
This medicine may cause dizziness or drowsiness. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert.
This medicine may increase your risk of having an adrenal gland that is less active than normal. The adrenal gland makes steroids for your body. This is more likely for people who use steroids for a long time or use high doses. Check with your doctor right away if you or your child have any of the following symptoms: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
This medicine may cause children to grow more slowly than normal. This would cause a child not to gain weight or get taller. Talk with your doctor if you think your child is not growing properly or if you have any questions about this.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates muscle relaxants, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Serious side effects
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 side effects
- 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
Other side effects
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 side effects
- 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 adverse events
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
- 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]
Common (1% to 10%) Dysgeusia, headache
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]
See also:
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Loratadine
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. (2012) "Product Information. Dymista (azelastine-fluticasone nasal)." Meda Pharmaceuticals
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Further information
Azelastine/fluticasone nasal side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.