Asmanex Twisthaler Side Effects

Generic Name: mometasone

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

In Summary

Common side effects of Asmanex Twisthaler include: oral candidiasis, upper respiratory tract infection, musculoskeletal pain, pharyngitis, allergic rhinitis, depression, and fatigue. Other side effects include: sinus congestion. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to mometasone: inhalation aerosol powder, inhalation powder

In addition to its needed effects, some unwanted effects may be caused by mometasone (the active ingredient contained in Asmanex Twisthaler). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

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

• Body aches or pain
• cold or flu-like symptoms
• congestion
• cough
• dryness or soreness of the throat

• Abdominal or stomach pain
• diarrhea
• fever or chills
• loss of appetite
• lower back or side pain
• nausea

• White patches inside the nose or mouth

Minor Side Effects

Some of the side effects that can occur with mometasone 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:

• Difficulty with moving
• discouragement
• feeling sad or empty
• headache
• increased abdominal or stomach pain and cramping during menstrual periods
• irritability
• lack of appetite
• loss of interest or pleasure
• muscle or joint pain
• muscle pain or stiffness
• nasal burning and irritation
• stomach discomfort following meals
• stuffy or runny nose
• tiredness
• trouble concentrating
• trouble sleeping
• unexplained runny nose or sneezing
• upset stomach

• Accidental injury
• bladder pain
• bloated
• bloody mucus or unexplained nosebleeds
• bloody or cloudy urine
• chest congestion
• difficult, burning, or painful urination
• excess air or gas in stomach or intestines
• frequent urge to urinate
• full feeling
• general feeling of discomfort or illness
• lower back or side pain
• menstrual changes
• passing gas
• post-procedure pain
• shivering
• sweating
• unusual tiredness or weakness
• vomiting

For Healthcare Professionals

Applies to mometasone: inhalation aerosol, inhalation aerosol powder

Gastrointestinal

Very common (10% or more): Oral candidiasis
Uncommon (0.1% to 1%): Dry mouth and throat, dyspepsia^[Ref]

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

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

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

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

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