Rhinocort (Budesonide) - 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.

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

Possible Rhinocort side effects / adverse reactions in 29 year old female

Reported by a health professional (non-physician/pharmacist) from Mexico on 2007-01-23

Patient: 29 year old female weighing 50.0 kg (110.0 pounds)

Reactions: Photophobia, Vision Blurred, Lacrimation Increased, Headache

Suspect drug(s):
Rhinocort

Other drugs received by patient: Amoxicillin; Nimesulide; Primalan

Possible Rhinocort side effects / adverse reactions in female

Reported by a health professional (non-physician/pharmacist) from Finland on 2007-03-13

Patient: female

Reactions: Skin Atrophy

Adverse event resulted in: disablity

Suspect drug(s):
Beclomethasone Dipropionate
    Dosage: 2 doses + 1-2 doses per day
    Indication: Asthma
    Start date: 1989-01-01

Prednisolone
    Dosage: a couple of times a year
    Administration route: Oral
    Indication: Asthma
    Start date: 1989-01-01

Rhinocort
    Dosage: 1 dose 1-2 times per day
    Indication: Rhinitis Allergic
    Start date: 1989-01-01

Other drugs received by patient: Norvasc; Emconcor; Emconcor; Cozaar; Cozaar; Triptyl; Primaspan

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

Reported by a individual with unspecified qualification from United States on 2007-03-22

Patient: 60 year old male weighing 78.9 kg (173.6 pounds)

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

Suspect drug(s):
Accuretic

Aleve
    Dosage: 220 mg, hs, oral
    Administration route: Oral
    Indication: Myalgia
    Start date: 2007-01-03

Clarinex

Rhinocort
    Dosage: nasal

Other drugs received by patient: Multi-Vitamin