What the label lists and what reports show
Azelastine and fluticasone side effects
Azelastine and fluticasone's FDA label: “The most common adverse reactions (≥ 2% incidence) are: dysgeusia, epistaxis, and headache.” FAERS holds 4,071 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (321 reports).
- Generic listed
Check it at the source: the azelastine and fluticasone FDA label on DailyMed (effective December 15, 2024, Mylan Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of azelastine hydrochloride and fluticasone propionate nasal spray?Azelastine hydrochloride and fluticasone propionate nasal spray may cause serious side effects including: • sleepiness or drowsiness. • nasal problems. Symptoms of nasal problems may include: o crusting in the nose o nosebleeds o runny nose o hole in the cartilage between your nose (nasal septal perforation). A whistling sound when you breathe may be a symptom of nasal septal perforation. • slow wound healing. You should not use azelastine hydrochloride and fluticasone propionate nasal spray until your nose has healed if you have a sore in your nose, if you have had surgery on your nose, or if your nose has been injured. • thrush (candida), a fungal infection in your nose and throat. Tell your healthcare provider if you have any redness or white colored patches in your nose or mouth. • eye problems, such as glaucoma or cataracts. […]
Source: FDA drug label, Mylan Pharmaceuticals Inc., effective December 15, 2024 (SPL set 7b5cc5a0-0d47-46b5-b5fb-eb9cc248ae9e), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥ 2% incidence) are: dysgeusia, epistaxis, and headache.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: • Somnolence [see Warnings and Precautions (5.1) ] • Local nasal effects, including epistaxis, nasal ulceration, nasal septal perforation, impaired wound healing, and Candida albicans infection [see Warnings and Precautions (5.2) ] • Glaucoma and Cataracts [see Warnings and Precautions (5.3) ] • Immunosuppression and Risk of Infections [see Warnings and Precautions (5.4) ] • Hypercorticism and Adrenal Suppression, including growth reduction [see Warnings and Precautions (5.5 and 5.7), Use in Specific Populations (8.4) ] The most common adverse reactions (≥ 2% incidence) are: dysgeusia, epistaxis, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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. …
Source: FDA drug label, Mylan Pharmaceuticals Inc., effective December 15, 2024 (SPL set 7b5cc5a0-0d47-46b5-b5fb-eb9cc248ae9e), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,071 reports list azelastine and fluticasone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 64 are coded as a death and 889 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 15 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Azelastine and fluticasone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions