Widely studied in >4000 patients1

Safety Profile of DYMISTA (azelastine HCl/fluticasone propionate) Nasal Spray

In each of the three 2-week pivotal trials in patients 12 years and older, incidence and types of adverse reactions were comparable across all treatment groups (N=3411).1

Dymista: Adverse reactions occurring with ≥2% incidence and more frequently than with placebo were dysgeusia (4%), epistaxis (2%), and headache (2%).1 The overall incidence of adverse reactions with Dymista was 16%.1

The most frequently reported adverse reactions (≥2%) with Dymista were headache, pyrexia, cough, nasal congestion, rhinitis, dysgeusia, viral infection, upper respiratory tract infection, pharyngitis, pain, diarrhea, and epistaxis.1

Take a closer Look
Dymista azelastine HCIa fluticasone propionatea placebo
Overall incidence 16% 15% 13% 12%
Dysgeusia 4% 5% 1% <1%
Epistaxis 2% 2% 2% 2%
Headache 2% 2% 2% 1%

Reference: 1.Dymista [package insert]. Somerset, NJ: Meda Pharmaceuticals Inc., a Mylan Company; 2015.

More IMPORTANT SAFETY INFORMATION

  • Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking DYMISTA.
  • Avoid concurrent use of alcohol or other central nervous system (CNS) depressants with DYMISTA because further decreased alertness and impairment of CNS performance may occur.
  • Epistaxis, nasal ulcerations, nasal septal perforation, impaired wound healing, Candida albicans infection: Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma.
  • Glaucoma or posterior subcapsular cataracts: Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
  • Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections.
  • Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue DYMISTA slowly.
  • Potential reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving DYMISTA.
  • Potent inhibitors of cytochrome P450 (CYP) 3A4: May increase blood levels of fluticasone propionate.
  • Ritonavir: Coadministration is not recommended.
  • Other potent CYP3A4 inhibitors, such as ketoconazole: use caution with coadministration.
  • The most common adverse reaction (≥2% incidence) are dysgeusia, epistaxis, and headache.

INDICATIONS

DYMISTA contains an H1-receptor antagonist and a corticosteroid, and is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 6 years of age and older who require treatment with both azelastine hydrochloride and fluticasone propionate for symptom relief.

Please see the Full Prescribing Information.