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Azelastine (Azelastine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Azelastine and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (7)

Reports by Reaction Type

Oesophageal Ulcer (3)Dysphagia (3)Regurgitation (2)Oesophageal Injury (2)Merycism (2)Odynophagia (2)Product Substitution Issue (1)Drug Ineffective (1)Product Packaging Quantity Issue (1)Headache (1)Oropharyngeal Pain (1)Epistaxis (1)

Possible Azelastine side effects in

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient:

Reactions: Product Quality Issue, Product Packaging Quantity Issue

Drug(s) suspected as cause:
Azelastine



Possible Azelastine side effects in 46 year old male

Reported by a physician from Korea, Democratic People's Republic of on 2012-06-13

Patient: 46 year old male

Reactions: Regurgitation, Dysphagia, Oesophageal Mucosal Dissection, Oesophageal Ulcer, Odynophagia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azelastine
    Indication: Nasopharyngitis

Naproxen
    Indication: Nasopharyngitis



Possible Azelastine side effects in 75 year old female

Reported by a individual with unspecified qualification from United States on 2012-05-16

Patient: 75 year old female, weighing 55.8 kg (122.7 pounds)

Reactions: Amnesia

Drug(s) suspected as cause:
Azelastine



Possible Azelastine side effects 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

Drug(s) suspected as cause:
Azelastine



Possible Azelastine side effects 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

Drug(s) suspected as cause:
Azelastine

Naproxen
    Indication: Nasopharyngitis



Possible Azelastine side effects 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

Drug(s) suspected as cause:
Azelastine
    Indication: Nasopharyngitis

Naproxen
    Indication: Nasopharyngitis



Possible Azelastine side effects in female

Reported by a physician from United States on 2011-10-21

Patient: female, weighing 133.0 kg (292.6 pounds)

Reactions: Product Substitution Issue, Drug Ineffective

Drug(s) suspected as cause:
Azelastine

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