Applies to beclomethasone: inhalation aerosol liquid.

Serious side effects of Beclomethasone

Along with its needed effects, beclomethasone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking beclomethasone:

More common

• Body aches or pain
• congestion
• cough
• difficulty with breathing
• dryness or soreness of the throat
• fever
• hoarseness
• runny nose
• tender, swollen glands in the neck
• trouble swallowing
• voice changes

Incidence not known

• Attack, assault, or force
• blindness
• blurred vision
• changes in behavior
• chills
• darkening of the skin
• decreased vision
• diarrhea
• dizziness
• eye pain
• fainting
• headache
• loss of appetite
• lower back or side pain
• mental depression
• nausea
• painful or difficult urination
• skin rash
• sore mouth or tongue
• tearing
• thoughts of killing oneself
• unusual tiredness or weakness
• vomiting
• white patches in the mouth or on the tongue

Other side effects of Beclomethasone

Some side effects of beclomethasone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Cramps
• heavy bleeding
• pain
• pain or tenderness around the eyes and cheekbones
• stuffy or runny nose
• tightness of the chest

For Healthcare Professionals

Applies to beclomethasone: compounding powder, inhalation aerosol, inhalation aerosol with adapter.

General

The most commonly reported adverse reactions have included headache, pharyngitis, rhinitis, inhalation site and taste sensation.^[Ref]

Endocrine

Oral therapy:

Following 4 weeks of oral therapy for ulcerative colitis, a reduction of plasma cortisol levels has been observed in up to 25% of patients; HPA-axis function recovery is expected to be transient, however follow up data is lacking.^[Ref]

Common (1% to 10%): Dysmenorrhea

Uncommon (0.1% to 1%): Menorrhagia

Very rare (less than 0.01%): Adrenal suppression, Cushing syndrome, cushingoid features^[Ref]

Respiratory

Very common (10% or more): Pharyngitis (up to 27%)

Common (1% to 10%): Rhinitis, hoarseness, throat irritation, upper respiratory tract infection, dysphonia

Uncommon (0.1% to 1%): Bronchitis, coughing, epistaxis

Rare (0.01% to 0.1%): Acute asthma episode, hemoptysis, respiratory disorder, sinusitis

Very rare (less than 0.01%): Paradoxical bronchospasm with wheezing

Frequency not reported: Eosinophilic pneumonia^[Ref]

Gastrointestinal

Common (1% to 10%): Oral candidiasis of mouth and throat

Uncommon (0.1% to 1%): Abdominal pain, constipation

Rare (0.01% to 0.1%): Dyspepsia, unspecified gastrointestinal disorders, nausea, tongue discoloration, toothache^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reactions including rashes, urticaria, pruritus, erythema

Very rare (less than 0.01%): Hypersensitivity reactions including edema of the eyes, face, lips, and throat (angioedema), anaphylaxis and anaphylactoid reactions^[Ref]

Ocular

Frequency not reported: Glaucoma, cataracts

Postmarketing reports: Blurred vision, central serous chorioretinopathy^[Ref]

Psychiatric

Uncommon (0.1% to 1%): Anxiety

Rare (0.01% to 0.1%): Depression, insomnia, sleep disorders, hyperactivity, aggression, irritability (mostly in children)

Postmarketing reports: Suicidal ideation^[Ref]

Nervous system

Very common (10% or more): Headache (up to 25%)

Uncommon (0.1% to 1%): Dizziness, dysphonia, migraine

Rare (0.01% to 0.1%): Neuropathy, tremor, vertigo^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, purpura

Rare (0.01% to 0.1%): Photosensitivity reaction, skin disorder, urticaria

Frequency not reported: Easy bruising, skin thinning^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Myalgia, muscle cramps, back pain

Very rare (less than 0.01%): Growth retardation, decrease in bone mineral density^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Chest pain, edema

Rare (0.01% to 0.1%): Hypertension, palpitations, angina pectoris^[Ref]

Local

Common (1% to 10%): Inhalation site sensation and taste sensation^[Ref]

Metabolic

Uncommon (0.1% to 1%): Increased weight^[Ref]