Dymista Side Effects – FDA Approved

May 9th, 2012 by Maggie Heart

The U.S. Food and Drug Administration (FDA) has approved Dymista for treatment of seasonal allergic rhinitis (SAR) in patients 12 years of age and older who require treatment with both azelastine hydrochloride and fluticasone proprionate for symptomatic relief. Dymista is administered twice daily in each nostril. The efficacy and safety of Dymista has been documented in several studies involving over 4,000 patients, including a long-term safety study with more than 600 patients.

Dymista Nasal Spray is a prescription medicine used to treat symptoms of seasonal allergic rhinitis in people 12 years of age and older, who need treatment with both azelastine hydrochloride and fluticasone propionate. It helps reduce the symptoms of seasonal allergic rhinitis (inflammation of the lining of the nose), such as stuffy nose, itching, and sneezing.

It is not known if Dymista Nasal Spray is safe or effective in children under 12 years of age.

Before using Dymista Nasal Spray tell your healthcare provider if you:

  • have had recent nasal sores, nasal surgery, or nasal injury
  • have eye or vision problems, such as cataracts or glaucoma (increased pressure in your eye)
  • have tuberculosis or any untreated fungal, bacterial, viral infections or eye infections caused by herpes
  • have been near someone who has chickenpox or measles
  • are not feeling well or have any other symptoms that you do not understand
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if Dymista Nasal Spray will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if Dymista Nasal Spray passes into your breast milk. Talk to your doctor about the best way to feed your baby while using Dymista Nasal Spray.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Dymista Nasal Spray may affect the way other medicines work, and other medicines may affect how Dymista Nasal Spray works.

Especially tell your healthcare provider if you take:

  • ritanovir (Norvir) or medicines that contain ritanovir (commonly used to treat HIV infection or AIDS)
  • ketoconazole, fluconazole, or itraconazole (for fungal infections)

Ask your healthcare provider or pharmacist for a list of these medications, if you are not sure.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

Dymista Nasal Spray may cause serious side effects including:

  • Sleepiness or drowsiness.
  • Nasal Problems.Symptoms of nasal problems may include:
    • crusting in the nose
    • nosebleeds
    • runny nose
    • 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 Dymista 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 doctor if you have any redness or white colored patches in your nose or mouth.
  • Eye problems, such as glaucoma or cataracts. Some people may have eye problems, including glaucoma and cataracts. You should have regular eye exams when using Dymista Nasal Spray.
  • Immune system problems that may increase your risk of infections.Dymista Nasal Spray may cause problems with the way your immune system protects your body against infection and increase your risk of infection. Avoid contact with people who have contagious diseases such as chickenpox or measles while you use Dymista Nasal Spray. Symptoms of infection may include:
    • fever
    • aches or pains
    • chills
    • feeling tired
  • Adrenal Insufficiency.Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency may include:
    • tiredness
    • weakness
    • nausea
    • vomiting
    • low blood pressure
  • Slowed or delayed growth in children. A child’s growth should be checked regularly while using Dymista Nasal Spray.

Call your healthcare provider or get medical help right away if you have symptoms of any of the serious side effects listed above.

The most common side effects of Dymista Nasal Spray include:

  • changes in taste
  • nosebleeds
  • headache

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Dymista Nasal Spray. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.