Azelastine (Azelastine Hydrochloride) - Side Effects and Adverse Reactions

ADVERSE REACTIONS:

To report SUSPECTED ADVERSE REACTIONS, contact Wallace Pharmaceuticals Inc. at 1-800-619-6344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

In controlled multiple-dose studies where patients were treated for up to 56 days, the most frequently reported adverse reactions were transient eye burning/stinging (approximately 30%), headaches (approximately 15%) and bitter taste (approximately 10%). The occurrence of these events was generally mild.

The following events were reported in 1–10% of patients: asthma, conjunctivitis, dyspnea, eye pain, fatigue, influenza-like symptoms, pharyngitis, pruritus, rhinitis and temporary blurring. Some of these events were similar to the underlying disease being studied.

REPORTS OF SUSPECTED AZELASTINE SIDE EFFECTS / ADVERSE REACTIONS

Possible Azelastine side effects / adverse reactions in 46 year old male

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-01-03

Patient: 46 year old male

Reactions: Dysphagia, Oesophageal Injury, Merycism, Oesophageal Ulcer

Adverse event resulted in: hospitalization

Suspect drug(s):
Azelastine
    Indication: Nasopharyngitis

Naproxen
    Indication: Nasopharyngitis

Possible Azelastine side effects / adverse reactions in 46 year old male

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-02-17

Patient: 46 year old male

Reactions: Regurgitation, Dysphagia, Oesophageal Disorder, Oesophageal Injury, Merycism, Oesophageal Ulcer, Odynophagia

Adverse event resulted in: hospitalization

Suspect drug(s):
Azelastine

Naproxen
    Indication: Nasopharyngitis

Possible Azelastine side effects / adverse reactions in 57 year old female

Reported by a individual with unspecified qualification from United States on 2012-04-04

Patient: 57 year old female weighing 58.5 kg (128.7 pounds)

Reactions: Oropharyngeal Pain, Headache, Epistaxis

Suspect drug(s):
Azelastine