Astepro Side Effects

Please note - some side effects for Astepro 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 Astepro - for the Consumer

Astepro 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 Astepro 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.

Astepro Side Effects - for the Professional

Astepro

The most common adverse reactions (≥2% incidence) include bitter taste, epistaxis, headache, fatigue and somnolence (6.1)

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

Side Effects by Body System

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 Azelastine nasal spray has been generally well tolerated with the number of patients in clinical trials withdrawn due to adverse effects similar to placebo.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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