Note: This document contains side effect information about mometasone. Some dosage forms listed on this page may not apply to the brand name Asmanex Twisthaler.

Applies to mometasone: implantation implant. Other dosage forms:

• inhalation aerosol powder, inhalation powder

Serious side effects of Asmanex Twisthaler

Along with its needed effects, mometasone (the active ingredient contained in Asmanex Twisthaler) 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 mometasone:

More common

• Chest tightness
• chills
• cough producing mucus
• earache
• ear congestion
• feeling faint
• fever
• headache
• lightheadedness
• loss of voice
• noisy breathing
• nosebleeds
• pain or tenderness around the eyes and cheekbones
• redness or swelling in the ear
• sneezing
• sore throat
• stuffy or runny nose
• trouble breathing

Less common

• Blurred vision
• body aches or pain
• fast heartbeat
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• muscle weakness
• redness of the skin
• swelling of the eyelids, face, lips, hands, or feet
• trouble swallowing
• unusual tiredness or weakness

Incidence not known

• Burning, redness, swelling, or irritation around or inside your nose
• darkening of the skin
• diarrhea
• dizziness
• eye pain
• loss of appetite
• mental depression
• nausea or vomiting
• sores or white patches inside the nose or mouth

For Healthcare Professionals

Applies to mometasone: inhalation aerosol, inhalation aerosol powder.

Gastrointestinal

In clinical trials, gastroenteritis and vomiting occurred with an incidence of at least 1% but less than 3%.^[Ref]

Very common (10% or more): Oral candidiasis

Uncommon (0.1% to 1%): Dry mouth and throat, dyspepsia^[Ref]

Nervous system

Very common (10% or more): Headache^[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis, allergic rhinitis, upper respiratory infection

Common (1% to 10%): Sinusitis, bronchitis, pharyngitis, dysphonia, epistaxis, nasal irritation, respiratory disorder

Postmarketing reports: Asthma aggravation, which may include cough, dyspnea, wheezing and bronchospasm^[Ref]

Genitourinary

Common (1% to 10%): Dysmenorrhea, urinary tract infection (in pediatrics)^[Ref]

Musculoskeletal

Common (1% to 10%): Musculoskeletal pain, back pain, myalgia^[Ref]

Other

In clinical trials, fatigue, flu-like symptoms, pain, earache, and infection occurred with an incidence of at least 1% but less than 3%.^[Ref]

Common (1% to 10%): Fatigue, flu-like symptoms, pain, earache, infection, fever and bruise (in pediatrics)^[Ref]

Cardiovascular

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

Metabolic

Uncommon (0.1% to 1%): Weight increase^[Ref]

Ocular

Rare (less than 0.1%): Glaucoma, cataracts

Postmarketing reports: Vision blurred^[Ref]

Psychiatric

Frequency not reported: Psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression^[Ref]

Hypersensitivity

Postmarketing reports: Immediate and delayed hypersensitivity reactions including rash, pruritus, angioedema and anaphylactic reaction^[Ref]