Rhinocort Aqua (Budesonide Nasal) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

The incidence of common adverse reactions is based upon two U.S. and five non-U.S. controlled clinical trials in 1,526 patients [110 females and 239 males less than 18 years of age, and 635 females and 542 males 18 years of age and older] treated with RHINOCORT AQUA Nasal Spray at doses up to 400 mcg once daily for 3-6 weeks. The table below describes adverse events occurring at an incidence of 2% or greater and more common among RHINOCORT AQUA Nasal Spray-treated patients than in placebo-treated patients in controlled clinical trials. The overall incidence of adverse events was similar between RHINOCORT AQUA and placebo.

Adverse Event	RHINOCORT AQUA	Placebo Vehicle
Epistaxis	8%	5%
Pharyngitis	4%	3%
Bronchospasm	2%	1%
Coughing	2%	<1%
Nasal Irritation	2%	<1%

A similar adverse event profile was observed in the subgroup of pediatric patients 6 to 12 years of age.

Two to three percent (2-3%) of patients in clinical trials discontinued because of adverse events. Systemic corticosteroid side effects were not reported during controlled clinical studies with RHINOCORT AQUA Nasal Spray.

If recommended doses are exceeded, however, or if individuals are particularly sensitive, symptoms of hypercorticism, ie, Cushing’s Syndrome, could occur.

Rare adverse events reported from post-marketing experience include: nasal septum perforation, pharynx disorders (throat irritation, throat pain, swollen throat, burning throat, and itchy throat), angioedema, anosmia, and palpitations.

Cases of growth suppression have been reported for intranasal corticosteroids including RHINOCORT AQUA Nasal Spray (see PRECAUTIONS, Pediatric Use).

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO RHINOCORT AQUA

Possible Rhinocort Aqua side effects / adverse reactions in 59 year old male

Reported by a consumer/non-health professional from Germany on 2007-01-17

Patient: 59 year old male weighing 79.1 kg (174.0 pounds)

Reactions: Burning Sensation, Pruritus, Syncope, Heart Rate Increased, Hypotension, Dizziness, Headache

Suspect drug(s):
Rhinocort Aqua
    Dosage: expired

Aleve
    Dosage: expired
    Administration route: Oral
    Indication: Myalgia
    Start date: 2007-01-03

Other drugs received by patient: Clarinex; Accuretic; Multi-Vitamin

Possible Rhinocort Aqua side effects / adverse reactions in 60 year old male

Reported by a consumer/non-health professional from Germany on 2007-01-25

Patient: 60 year old male weighing 79.1 kg (174.0 pounds)

Reactions: Myalgia, Burning Sensation, Syncope, Pruritus, Heart Rate Increased, Hypotension, Dizziness, Headache

Suspect drug(s):
Rhinocort Aqua
    Dosage: expired

Aleve
    Dosage: expired
    Administration route: Oral
    Indication: Myalgia
    Start date: 2007-01-03

Clarinex

Accuretic

Other drugs received by patient: Multi-Vitamin

Possible Rhinocort Aqua side effects / adverse reactions in 70 year old female

Reported by a physician from United States on 2007-03-08

Patient: 70 year old female

Reactions: Psychotic Disorder, Psychomotor Hyperactivity, Insomnia

Adverse event resulted in: hospitalization

Suspect drug(s):
Rhinocort Aqua