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 SUSPECTED RHINOCORT SIDE EFFECTS / ADVERSE REACTIONS

Possible Rhinocort side effects / adverse reactions in 46 year old female

Reported by a individual with unspecified qualification from United States on 2011-10-04

Patient: 46 year old female weighing 115.6 kg (254.3 pounds)

Reactions: Blood Pressure Increased, Cataract, Overdose, Drug Prescribing Error, Sinusitis

Suspect drug(s):
Zyflo
    Dosage: 1200 mg;tid
    Indication: Asthma

Theophylline
    Dosage: 200 mg;qam ; 400 mg;hs
    Indication: Asthma

Rhinocort
    Dosage: 32 ug;qd
    Indication: Seasonal Allergy

Advair HFA
    Dosage: bid
    Indication: Asthma

Medrol
    Indication: Sinusitis

Milnacipran Hydrochloride (Milnacipran Hydrochloride)
    Dosage: 200 mg;bid ; 12.5 mg;qd ; 12.5 mg;bid ; 50 mg;bid ; 50 mg;bid ; 100 mg;bid
    Indication: Fibromyalgia
    Start date: 2010-06-01
    End date: 2010-06-01

Milnacipran Hydrochloride (Milnacipran Hydrochloride)
    Dosage: 200 mg;bid ; 12.5 mg;qd ; 12.5 mg;bid ; 50 mg;bid ; 50 mg;bid ; 100 mg;bid
    Indication: Fibromyalgia
    Start date: 2010-06-01
    End date: 2010-06-01

Milnacipran Hydrochloride (Milnacipran Hydrochloride)
    Dosage: 200 mg;bid ; 12.5 mg;qd ; 12.5 mg;bid ; 50 mg;bid ; 50 mg;bid ; 100 mg;bid
    Indication: Fibromyalgia
    Start date: 2010-08-01
    End date: 2010-09-14

Milnacipran Hydrochloride (Milnacipran Hydrochloride)
    Dosage: 200 mg;bid ; 12.5 mg;qd ; 12.5 mg;bid ; 50 mg;bid ; 50 mg;bid ; 100 mg;bid
    Indication: Fibromyalgia
    Start date: 2010-06-01
    End date: 2010-06-01

Milnacipran Hydrochloride (Milnacipran Hydrochloride)
    Dosage: 200 mg;bid ; 12.5 mg;qd ; 12.5 mg;bid ; 50 mg;bid ; 50 mg;bid ; 100 mg;bid
    Indication: Fibromyalgia
    Start date: 2010-06-01
    End date: 2010-06-01

Milnacipran Hydrochloride (Milnacipran Hydrochloride)
    Dosage: 200 mg;bid ; 12.5 mg;qd ; 12.5 mg;bid ; 50 mg;bid ; 50 mg;bid ; 100 mg;bid
    Indication: Fibromyalgia
    Start date: 2010-07-01
    End date: 2010-08-01

Maxair
    Dosage: bid;inh
    Indication: Asthma

Pulmicort
    Dosage: 180 ug;bid
    Indication: Asthma

Other drugs received by patient: B12 /00056201/; Percocet; Multi-Vitamins; Nexium; Xyzal; Relpax; Topamax; Calcium with Vitamin D /00944201/

Possible Rhinocort side effects / adverse reactions in 77 year old female

Reported by a consumer/non-health professional from United States on 2011-10-11

Patient: 77 year old female

Reactions: Pancreatic Carcinoma

Adverse event resulted in: death

Suspect drug(s):
Toprol-XL
    Administration route: Oral

Rhinocort

Other drugs received by patient: Xeloda; Gemzar

Possible Rhinocort side effects / adverse reactions in 56 year old female

Reported by a consumer/non-health professional from United States on 2011-10-12

Patient: 56 year old female

Reactions: Intervertebral Disc Protrusion, Mastoid Disorder, Tinnitus, Osteoporosis, Pain, Paraesthesia, Weight Increased, Malaise, Activities of Daily Living Impaired

Suspect drug(s):
Symbicort

Rhinocort

Nexium
    Administration route: Oral