Astelin Side Effects

Generic name: azelastine nasal

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

Some side effects of Astelin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to azelastine nasal: nasal spray

Get emergency medical help if you have any of these signs of an allergic reaction while taking azelastine nasal (the active ingredient contained in Astelin) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using azelastine and call your doctor at once if you have any of these serious side effects:

• bronchospasm (shortness of breath, tightness in chest, wheezing); or

• fast or uneven heartbeats.

Less serious side effects of azelastine nasal may include:

• a bitter taste in your mouth;

• headache;

• drowsiness or dizziness;

• dry mouth, sore throat;

• sores or burning in your nose;

• weight gain;

• nausea;

• nosebleed;

• cough, sneezing, runny nose, sore throat; or

• eye redness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to azelastine nasal: nasal spray

General

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ingredient contained in Astelin) spray has been generally well tolerated with the number of patients in clinical trials withdrawn due to adverse effects similar to placebo.

Gastrointestinal

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

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.

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.

Local

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

Respiratory

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.

Endocrine

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

Cardiovascular

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.

Other

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

Dermatologic

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

Metabolic

Metabolic side effects have included increased appetite.

Musculoskeletal

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

Psychiatric

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

Ocular

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

Genitourinary

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

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