Budesonide nasal Side Effects

Not all side effects for budesonide nasal may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to budesonide nasal: nasal aerosol powder, nasal spray

In addition to its needed effects, some unwanted effects may be caused by budesonide nasal. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking budesonide nasal:

More common
  • Bloody nose
Less common
  • Body aches or pain
  • congestion
  • cough
  • difficulty with breathing
  • dryness or soreness of the throat
  • fever
  • hoarseness
  • noisy breathing
  • runny nose
  • shortness of breath
  • tender, swollen glands in the neck
  • tightness in the chest
  • trouble with swallowing
  • voice changes
  • wheezing
Incidence not known
  • Backache
  • blistering, crusting, irritation, itching, or reddening of the skin
  • bloody mucus
  • blurred vision
  • cracked, dry, or scaly skin
  • darkening of the skin
  • decreased vision
  • diarrhea
  • difficulty with swallowing
  • dizziness
  • eye pain
  • facial hair growth in females
  • fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • full or round face, neck, or trunk
  • headache
  • hives or welts
  • increased thirst or urination
  • irritability
  • itching
  • lack or slowing of normal growth in children
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • loss of sexual desire or ability
  • menstrual irregularities
  • mental depression
  • muscle wasting
  • nausea or vomiting
  • nosebleeds
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash
  • swelling
  • tearing
  • unusual tiredness or weakness

Some of the side effects that can occur with budesonide nasal may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Incidence not known
  • Burning, itching, swollen, or sore throat
  • loss of sense of smell

For Healthcare Professionals

Applies to budesonide nasal: nasal aerosol with adapter, nasal spray

General

Budesonide is generally well tolerated. Due to the nature of its administration, it is not inclined to produce the adverse effects associated with the systemic use of corticosteroids.

Respiratory

Bronchoconstriction has been reported in one patient receiving budesonide inhaled by mouth.

Respiratory side effects have generally been local in nature. Nasal irritation, congestion, bleeding, and sneezing have been most commonly reported. Pharyngitis and coughing are also commonly reported in patients receiving budesonide. Candidiasis has been reported occasionally.

Gastrointestinal

Gastrointestinal side effects have included dry mouth, dyspepsia, or nausea. Budesonide may taste bad to some patients.

Nervous system

Nervous system side effects have included rare reports of behavioral disturbances in pediatric patients. These reactions were characterized by insomnia, hyperactivity, and aggressive behavior. The same reactions have been reported in one adult with a history of psychiatric disturbances.

Hypersensitivity

Hypersensitivity side effects have included contact allergic reactions. These reactions have been characterized by pruritus, burning, worsening of rhinitis, erythematous flares, eczema, and vesicles on the lip, nose, eyelids, and cheeks. Reactions may progress to other sites on the body. Generalized allergic skin eruptions have also been reported.

The reported onset of hypersensitivity reactions has ranged from 2 days to 7 months. Symptoms have resolved upon discontinuation of medication, usually in 7 to 10 days.

Erythema-multiform-like contact dermatitis has been reported with the use of budesonide topical ointment (not available in the U.S.).

Endocrine

Endocrine side effects have included rare suppression of the hypothalamic-pituitary-adrenal axis. The risk of adrenal suppression is less than that associated with systemic corticosteroids and should only be of concern when using higher than recommended doses.

Immunologic

Immunologic side effects have included concern with immune suppression resulting from inhaled corticosteroids. No conclusive evidence is available to support an increased risk of tuberculosis and viral infections in patients receiving inhaled corticosteroids.

In 1993, the American Academy of Allergy and Immunology (AAAI) requested that the FDA review its labeling decision regarding the use of inhaled corticosteroids during severe viral infections. The AAAI's request was based on the lack of data linking inhaled corticosteroids to increases in complications from viral infections.

Dermatologic

In one prospective study, patients receiving at least 800 mcg/day of inhaled budesonide (or 1 mg of beclomethasone) for 3 months or more had a higher incidence of ecchymosis than matched controls. In addition, the severity was more pronounced in the treatment group. Older patients were more likely to be affected. The presence of skin bruising was associated with lower urinary cortisol levels, suggesting systemic absorption of the inhaled drug.

Dermatologic side effects have included acne and thinning of the skin. Easy bruising has been associated with budesonide use in some patients.

Ocular

Ocular side effects have included occasional reports of posterior capsular cataracts, especially with long-term use. In addition, one epidemiologic study suggests that prolonged use of high-dose inhaled corticosteroids (1600 mcg or more of budesonide daily) may be associated with increased risk of ocular hypertension and open-angle glaucoma.

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