Astelin Side Effects

Please note - some side effects for Astelin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Astelin - for the consumer

Astelin Spray

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Astelin Spray:

Bitter taste; brief burning or stinging sensation; cough; dizziness; drowsiness; dry mouth; headache; mild nosebleed; nasal burning; nausea; sore throat; sudden sneezing attack.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); repeated or persistent nosebleeds; severe nasal irritation.

For the professional

Astelin

Seasonal Allergic Rhinitis

Adverse experience information for Astelin® Nasal Spray is derived from six well-controlled, 2-day to 8-week clinical studies which included 391 patients who received Astelin® Nasal Spray at a dose of 2 sprays per nostril twice daily. In placebo-controlled efficacy trials, the incidence of discontinuation due to adverse reactions in patients receiving Astelin® Nasal Spray was not significantly different from vehicle placebo (2.2% vs 2.8%, respectively).

In these clinical studies, adverse events that occurred statistically significantly more often in patients treated with Astelin® Nasal Spray versus vehicle placebo included bitter taste (19.7% vs 0.6%), somnolence (11.5% vs 5.4%), weight increase (2.0% vs 0%), and myalgia (1.5% vs 0%).

The following adverse events were reported with frequencies ≥2% in the Astelin® Nasal Spray treatment group and more frequently than placebo in short-term (≤2 days) and long-term (2-8 weeks) clinical trials.

A total of 176 patients 5 to 12 years of age were exposed to Astelin® Nasal Spray at a dose of 1 spray each nostril twice daily in 3 placebo-controlled studies. In these studies, adverse events that occurred more frequently in patients treated with Astelin® Nasal Spray than with placebo, and that were not represented in the adult adverse event table above include rhinitis/cold symptoms (17.0% vs 9.5%), cough (11.4% vs 8.3%), conjunctivitis (5.1% vs 1.8%), and asthma (4.5% vs 4.1%).

The following events were observed infrequently (<2% and exceeding placebo incidence) in patients who received Astelin® Nasal Spray (2 sprays/nostril twice daily) in U.S. clinical trials.

Cardiovascular: flushing, hypertension, tachycardia.

Dermatological: contact dermatitis, eczema, hair and follicle infection, furunculosis.

Digestive: constipation, gastroenteritis, glossitis, ulcerative stomatitis, vomiting, increased SGPT, aphthous stomatitis.

Metabolic and Nutritional: increased appetite.

Musculoskeletal: myalgia, temporomandibular dislocation.

Neurological: hyperkinesia, hypoesthesia, vertigo.

Psychological: anxiety, depersonalization, depression, nervousness, sleep disorder, thinking abnormal.

Respiratory: bronchospasm, coughing, throat burning, laryngitis.

Special Senses: conjunctivitis, eye abnormality, eye pain, watery eyes, taste loss.

Urogenital: albuminuria, amenorrhea, breast pain, hematuria, increased urinary frequency.

Whole Body: allergic reaction, back pain, herpes simplex, viral infection, malaise, pain in extremities, abdominal pain.

Vasomotor Rhinitis

Adverse experience information for Astelin® Nasal Spray is derived from two placebo-controlled clinical studies which included 216 patients who received Astelin® Nasal Spray at a dose of 2 sprays per nostril twice daily for up to 28 days. The incidence of discontinuation due to adverse reactions in patients receiving Astelin® Nasal Spray was not different from vehicle placebo (2.8% vs 2.9%, respectively).

The following adverse events were reported with frequencies ≥2% in the Astelin® Nasal Spray treatment group and more frequently than placebo.

Events observed infrequently (<2% and exceeding placebo incidence) in patients who received Astelin® Nasal Spray (2 sprays/nostril twice daily) in U.S. clinical trials in vasomotor rhinitis were similar to those observed in U.S. clinical trials in seasonal allergic rhinitis.

In controlled trials involving nasal and oral azelastine hydrochloride formulations, there were infrequent occurrences of hepatic transaminase elevations. The clinical relevance of these reports has not been established.

In addition, the following spontaneous adverse events have been reported during the marketing of Astelin® Nasal Spray and causal relationship with the drug is unknown: anaphylactoid reaction, application site irritation, chest pain, nasal congestion, confusion, diarrhea, dyspnea, facial edema, involuntary muscle contractions, paresthesia, parosmia, pruritus, rash, tolerance, urinary retention, vision abnormal, and xerophthalmia.

More resources:

Astelin

Astelin

Astelin Spray

Astelin Nasal - Includes detailed dosage instructions.

Astelin

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