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.

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; drowsiness; fatigue; headache; mild nasal bleeding, burning, discomfort, or stinging; sudden sneezing attack.

Seek medical attention right away if any of these SEVERE side effects occur when using Astelin Spray:

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Astelin Side Effects - for the Professional

Astelin

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Seasonal Allergic Rhinitis

Astelin® Nasal Spray Two Sprays Per Nostril Twice Daily

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 different from vehicle placebo (2.2% vs 2.8%, respectively). In these clinical studies, adverse events that occurred 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 table contains adverse events that were reported with frequencies ≥2% in the Astelin® Nasal Spray 2 sprays per nostril twice daily treatment group and more frequently than placebo in short-term (≤2 days) and long-term (2-8 weeks) clinical trials.

ADVERSE EVENT	Astelin® Nasal Spray n = 391	Vehicle Placebo n = 353
Bitter Taste	19.7	0.6
Headache	14.8	12.7
Somnolence	11.5	5.4
Nasal Burning	4.1	1.7
Pharyngitis	3.8	2.8
Dry Mouth	2.8	1.7
Paroxysmal Sneezing	3.1	1.1
Nausea	2.8	1.1
Rhinitis	2.3	1.4
Fatigue	2.3	1.4
Dizziness	2.0	1.4
Epistaxis	2.0	1.4
Weight Increase	2.0	0.0

Astelin® Nasal Spray One Spray Per Nostril Twice Daily

Adverse experience information for Astelin® Nasal Spray at a dose of one spray per nostril twice daily is derived from two placebo-controlled 2-week clinical studies which included 276 patients. None of the patients receiving Astelin® Nasal Spray were discontinued from these studies due to adverse reactions. Three patients receiving vehicle placebo were discontinued due to adverse reactions. Bitter taste was reported in 8.3% of patients compared to none in the placebo group. Somnolence was reported in 0.4% of patients compared to none in the placebo group.

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 dosed at 1 or 2 sprays per nostril twice daily in U.S. clinical trials.

Cardiovascular: flushing, hypertension, tachycardia.

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

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

Metabolic and Nutritional: increased appetite.

Musculoskeletal: myalgia, temporomandibular dislocation, rheumatoid arthritis.

Neurological: hyperkinesia, hypoesthesia, vertigo.

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

Respiratory: bronchospasm, coughing, throat burning, laryngitis, bronchitis, dry throat, nocturnal dyspnea, nasopharyngitis, nasal congestion, pharyngolaryngeal pain, sinusitis, nasal dryness, paranasal sinus hypersecretion, post nasal drip.

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, pyrexia.

ADVERSE REACTIONS

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.

ADVERSE EVENT	Astelin® Nasal Spray n = 216	Vehicle Placebo n = 210
Bitter Taste	19.4	2.4
Headache	7.9	7.6
Dysesthesia	7.9	3.3
Rhinitis	5.6	2.4
Epistaxis	3.2	2.4
Sinusitis	3.2	1.9
Somnolence	3.2	1.0

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, atrial fibrillation, chest pain, confusion, dyspnea, facial edema, involuntary muscle contractions, nasal sores, palpitations, paresthesia, parosmia, pruritus, rash, disturbance or loss of sense of smell and/or taste, tolerance, urinary retention, vision abnormal and xerophthalmia.

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Side Effects by Body System - for Healthcare Professionals

General

General side effects have included allergic reactions, back pain, herpes simplex, viral infection, malaise, pain in extremities, abdominal pain, and pyrexia. Azelastine nasal 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.

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 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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