Astepro Side Effects

Generic Name: azelastine nasal

Note: This page contains information about the side effects of azelastine nasal. Some of the dosage forms included on this document may not apply to the brand name Astepro.

Not all side effects for Astepro may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to azelastine nasal: nasal spray

In addition to its needed effects, some unwanted effects may be caused by azelastine nasal (the active ingredient contained in Astepro). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking azelastine nasal:

  • Blood in the urine
  • blurred vision or other change in vision
  • cough
  • eye pain
  • eye redness
  • hives
  • itching
  • rapid heartbeat
  • skin rash
  • sores in the mouth or on the lips
  • tightness in the chest
  • troubled breathing

Some of the side effects that can occur with azelastine nasal may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Bitter taste in the mouth
  • drowsiness or sleepiness
Less common
  • Bloody mucus or unexplained nosebleeds
  • burning inside the nose
  • dizziness
  • dryness of the mouth
  • headache
  • muscle aches or pain
  • nausea
  • sore throat
  • sudden outbursts of sneezing
  • unusual tiredness or weakness
  • weight gain

For Healthcare Professionals

Applies to azelastine nasal: nasal spray


General side effects have included allergic reactions, back pain, herpes simplex, viral infection, malaise, pain in extremities, abdominal pain, and pyrexia. Azelastine nasal (the active ingredient contained in Astepro) spray has been generally well tolerated with the number of patients in clinical trials withdrawn due to adverse effects similar to placebo.[Ref]


The bitter or altered taste is thought to be primarily related to the direct effects of azelastine reaching the mouth versus a systemic effect.[Ref]

Gastrointestinal side effects have included constipation, gastroenteritis, glossitis, ulcerative stomatitis, vomiting, increased SGPT levels, aphthous stomatitis, diarrhea, and toothache. A bitter taste occurred in 19.7% of patients. Nausea and dry mouth occurred in 2.8% of patients on azelastine.[Ref]

Nervous system

Nervous system side effects have included headache (14.8%) and somnolence (11.5%). Dizziness has also occurred infrequently. Hyperkinesia and hypokinesia have also been reported.[Ref]


Local side effects have included nasal burning (4.1%), paroxysmal sneezing (3.1%), and epistaxis (2.0%).[Ref]


Respiratory side effects which occurred in clinical trials with a frequency greater than placebo included pharyngitis (3.5%) and rhinitis (2.3%). Bronchospasm, coughing, throat burning, laryngitis, bronchitis, dry throat, nocturnal dyspnea, nasopharyngitis, nasal congestion, pharyngolaryngeal pain, sinusitis, nasal dryness, paranasal sinus hypersecretion, and post nasal drip have also been reported. Postmarketing reports have included nasal sores.[Ref]


Endocrine side effects have included reports of weight increase in 2% of patients treated with azelastine.[Ref]


Cardiovascular side effects have included infrequent reports of flushing, hypertension and tachycardia. Azelastine has not been shown to have significant effects on the QTc interval. Postmarketing reports have included atrial fibrillation and palpitations.[Ref]


Other side effects included the loss of the sense of smell in one patient receiving azelastine nasal (the active ingredient contained in Astepro) spray. The effects lasted three days and resolved during the course of therapy.[Ref]


Dermatologic side effects have included contact dermatitis, eczema, hair and follicle infection, furunculosis, and skin laceration.[Ref]


Metabolic side effects have included increased appetite.[Ref]


Musculoskeletal side effects have included myalgia, temporomandibular dislocation and rheumatoid arthritis.[Ref]


Psychiatric side effects have included anxiety, depersonalization, depression, nervousness, sleep disorder, and abnormal thinking.[Ref]


Ocular side effects have included conjunctivitis, eye abnormality, eye pain, and watery eyes.[Ref]


Genitourinary side effects have included albuminuria, amenorrhea, breast pain, hematuria, and increased urinary frequency.[Ref]


1. Dorow P, Aurich R, Petzold U "Efficacy and tolerability of azelastine nasal spray in patients with allergic rhinitis compared to placebo and budesonide." Arzneimittelforschung 43 (1993): 909-12

2. "Product Information. Astelin (azelastine)." Carter Products, Cranbury, NJ.

3. Ratner PH, Findlay SR, Hampel F Jr, van Bavel J, Widlitz MD, Freitag JJ "A double-blind, controlled trial to assess the safety and efficacy of azelastine nasal spray in seasonal allergic rhinitis." J Allergy Clin Immunol 94 (1994): 818-25

4. LaForce C, Dockhorn RJ, Prenner BM, Chu TJ, Kraemer MJ, Widlitz MD, D'Eletto TA, Freitag JJ "Safety and efficacy of azelastine nasal spray (Astelin NS) for seasonal allergic rhinitis: a 4-week comparative multicenter trial." Ann Allergy Asthma Immunol 76 (1996): 181-8

5. Gastpar H, Aurich R, Petzold U, Dorow P, Enzmann H, Gering R, Kochy HP, Philippe A, Renz W, Wendenburg G "Intranasal treatment of perennial allergic rhinitis. Comparison of azelastine nasal spray and budesonide nasal aerosol." Arzneimittelforschung 43 (1993): 475-9

6. Gastpar H, Dorow P, Aurich R, Petzold U "Investigation of long-term efficacy and tolerability of azelastine nasal spray in the treatment of perennial allergic rhinitis." Arzneimittelforschung 43 (1993): 771-6

7. Gastpar H, Nolte D, Aurich R, Brendt P, Enzmann H, Giesemann G, Kunkel G, Petzold U, Renz W, Schata M, et al "Comparative efficacy of azelastine nasal spray and terfenadine in seasonal and perennial rhinitis." Allergy 49 (1994): 152-8

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