Applies to amikacin liposome: inhalation suspension.

Serious side effects of Amikacin liposome

Along with its needed effects, amikacin liposome 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 amikacin liposome:

More common

• Chest tightness
• cough
• coughing or spitting up blood
• difficulty breathing
• dizziness
• feeling of fullness in the ears
• fever
• loss of balance
• loss of hearing
• noisy breathing
• ringing or buzzing in the ears
• sore throat
• trouble hearing
• upper airway irritation
• voice changes

Less common

• Balance disorder
• blue lips, fingernails, or skin
• change in sputum
• chest discomfort or pain
• chills
• cough producing mucus
• general feeling of discomfort or illness
• irregular, fast or slow, or shallow breathing
• nosebleed
• severe pain in the chest
• sudden onset of severe breathing difficulty
• thickening of bronchial secretions

Incidence not known

• Difficulty swallowing
• hives, itching, skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• unusual tiredness or weakness

Other side effects of Amikacin liposome

Some side effects of amikacin liposome 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:

More common

• Bone or muscle pain
• decreased weight
• diarrhea
• headache
• lack or loss of strength
• nausea
• rash
• vomiting

Less common

• Anxiety
• change in taste
• dry mouth
• loss of taste

For Healthcare Professionals

Applies to amikacin liposome: inhalation suspension.

General

The most commonly reported side effects included dysphonia, cough, bronchospasm, and hemoptysis.^[Ref]

Respiratory

Very common (10% or more): Dysphonia (up to 47%), cough (up to 39%), bronchospasm (up to 29%), hemoptysis (up to 18%), upper airway irritation (up to 17%), exacerbation of underlying pulmonary disease (up to 15%)

Common (1% to 10%): Bronchitis, change in sputum, epistaxis, hypersensitivity pneumonitis, pneumonia, pneumothorax, respiratory failure

Frequency not reported: Acute respiratory failure, allergic alveolitis, aspiration pneumonia, asthma, atypical pneumonia, bronchial hyperreactivity, chronic obstructive pulmonary disease (COPD) exacerbation, dyspnea, dyspnea exertional, increased sputum, infective exacerbation of bronchiectasis, infective exacerbation of COPD, interstitial lung disease, laryngeal erythema, laryngeal pain, laryngitis, lower respiratory tract infection, lung infection, lung infection pseudomonas, oropharyngeal discomfort, oropharyngeal pain, pharyngeal edema, pharyngeal erythema, pleural effusion infection, productive cough, pneumomediastinum, pneumonia pseudomonas, pneumonitis, prolonged expiration, respiratory tract infection, spontaneous pneumothorax, sputum discolored, throat irritation, throat tightness, upper airway cough syndrome, upper airway inflammation, vocal cord inflammation, wheezing^[Ref]

Other

Very common (10% or more): Ototoxicity (up to 17%), asthenia (up to 16%), fatigue (up to 16%)

Common (1% to 10%): Chest discomfort, exercise tolerance decreased, pyrexia

Frequency not reported: Body ache, deafness, exacerbation of underlying disease, hypoacusis, neurosensory deafness, pain, tinnitus, unilateral deafness^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 13%), nausea (up to 12%)

Common (1% to 10%): Dry mouth, oral fungal infection, vomiting

Frequency not reported: Oral candidiasis, post-tussive vomiting^[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (up to 17%)

Frequency not reported: Arthralgia, back pain, muscle spasm, muscle weakness, myalgia^[Ref]

Nervous system

Common (1% to 10%): Balance disorder, dysgeusia, headache, neuromuscular disorder

Frequency not reported: Aphonia, dizziness, neuromuscular blockade, peripheral neuropathy, presyncope, vertigo^[Ref]

Dermatologic

Common (1% to 10%): Rash

Frequency not reported: Drug eruption, maculopapular rash, urticaria^[Ref]

Psychiatric

Common (1% to 10%): Anxiety^[Ref]

Metabolic

Common (1% to 10%): Decreased weight^[Ref]

Immunologic

Frequency not reported: Empyema, pseudomonas infection, sputum purulent^[Ref]

Renal

Frequency not reported: Nephrotoxicity^[Ref]