Dymista Risks, Warnings, and Complications

SLEEPINESS: Dymista can cause sleepiness and affect motor coordination. Be careful while driving and doing other potentially hazardous activities that require you to be fully mentally alert while on this medicine. Avoid drinking alcohol or taking other central nervous system depressants as they can have additive effects and cause reduced alertness.

NASAL EFFECTS: People using Dymista can develop nasal dryness and epistaxis (bleeding from the nasal mucosa). There are also reports of nasal ulceration and nasal septal perforation after use of nasal corticosteroids. In addition, corticosteroids can delay wound healing. Tell your doctor if you have experienced recent nasal ulcers, nasal trauma, or nasal surgery. Your doctor may tell you not to use Dymista until your nose has healed.

Clinical trials have found that fluticasone propionate administered nasally can lead to local infections in the nose and throat with a fungus such as Candida albicans. If this happens, you may need to discontinue Dymista and get treatment for the fungal infection. If you are on corticosteroid administration long-term (using Dymista for several months or more), your healthcare provider will examine you periodically to check for fungal infections and other adverse effects in the nose. 

EYE EFFECTS: Nasal and inhaled corticosteroids can lead to the development of cataracts and/or glaucoma (increased intraocular pressure). Tell your doctor if you have a history of these eye conditions before starting treatment with Dymista. Call your doctor without delay if you develop any changes in vision while on Dymista (azelastine and fluticasone propionate nasal spray). 

INCREASED RISK OF INFECTIONS: Corticosteroids suppress the immune system and can make you more susceptible to infections. For example, infections such as chickenpox and measles can have a more severe and even fatal course in children and adults taking corticosteroids. If you have not had these infections or are not properly immunized, you need to be especially careful to avoid exposure. 

It is unclear if the dose, route of administration (nasal or inhaled fluticasone propionate versus oral doses), fluticasone propionate concentrations, or treatment duration affects the risk of developing a severe infection. It is also unclear if previous corticosteroid treatment contributes to the severity of the infection. 

If you are exposed to chickenpox, you may need preventative varicella zoster immune globulin (VZIG). If you are exposed to measles, you may need preventative pooled intramuscular immunoglobulin (IG). If you develop chickenpox, you may need treatment with antiviral drugs. 

Before starting Dymista, tell your doctor if you have any viral, parasitic, fungal, or bacterial infections, especially active or quiescent tuberculous infections or ocular herpes simplex. Corticosteroids can cause worsening of these infections.

ADRENAL SUPPRESSION: Using nasal steroids at higher than recommended dosages (or at recommended doses in certain high-risk individuals) can lead to systemic corticosteroid effects including hypercorticism (too much cortisol in the body) and adrenal suppression. The concomitant use of nasal corticosteroids with other inhaled corticosteroids can increase the risk of this happening. 

If you develop signs and symptoms of hypercorticism and/or suppression of the hypothalamus-pituitary-adrenal (HPA) axis, Dymista will need to be discontinued slowly, similar to the procedure for discontinuing oral corticosteroid therapy. 

Tell your doctor if you have a history of prior corticosteroid treatment (if you have used a systemic corticosteroid or topical corticosteroid before). Call your doctor if you develop symptoms of acute adrenal insufficiency, such as joint and/or muscle pain, lack of energy, or depression. Switching from systemic corticosteroids taken for prolonged periods to topical corticosteroids requires careful monitoring by your healthcare provider.

DRUG INTERACTIONS: Strong CYP3A4 inhibitors, such as the antiviral drug ritonavir, can significantly increase plasma fluticasone propionate exposure and result in significantly low serum cortisol concentrations. There are postmarketing reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir. This led to systemic corticosteroid side effects (Cushing syndrome and adrenal suppression). Give your doctor a full list of all your medications before starting Dymista. 

GROWTH SUPPRESSION IN CHILDREN: Corticosteroids can affect growth in children. Your child’s doctor will monitor height and weight carefully if they prescribe Dymista.