Note: This document contains side effect information about insulin inhalation, rapid acting. Some dosage forms listed on this page may not apply to the brand name Exubera.
Applies to insulin inhalation, rapid acting: inhalation aerosol powder.
Warning
Inhalation route (Aerosol Powder)
Acute bronchospasm has been observed in patients with asthma and COPD using insulin, human inhaled. Insulin, human inhaled, is contraindicated in patients with chronic lung disease such as asthma or COPD. Before initiating insulin, human inhaled, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients.
Serious side effects of Exubera
Along with its needed effects, insulin inhalation, rapid acting (the active ingredient contained in Exubera) 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 insulin inhalation, rapid acting:
More common
- Anxiety
- blurred vision
- chills
- cold sweats
- coma
- confusion
- cool, pale skin
- cough
- depression
- dizziness
- fast heartbeat
- headache
- increased hunger
- nausea
- nightmares
- seizures
- shakiness
- slurred speech
- unusual tiredness or weakness
Incidence not known
- Difficulty breathing
- difficulty swallowing
- hives, itching, or skin rash
- noisy breathing
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- tightness in the chest
Other side effects of Exubera
Some side effects of insulin inhalation, rapid acting 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
- Diarrhea
- sore throat
Incidence not known
- Weight gain
For Healthcare Professionals
Applies to insulin inhalation, rapid acting: inhalation powder.
Respiratory
In clinical trials of up to 2 years duration, a 15% or greater reduction in forced expiratory volume (FEV1) occurred in 6% of patients treated with inhaled insulin compared with a 3% decline in patients receiving comparator anti-diabetes treatment. Patients with chronic lung disease were not included in these studies. The FEV1 decline occurred during the first 3 months and persisted; it did not appear to worsen with increased duration of use. The changes in FEV1 were similar in patients with type 1 and type 2 diabetes mellitus.[Ref]
Very common (10% or more): Cough (25.6% to 29.4%)
Common (1% to 10%): Bronchitis, productive cough, decreased pulmonary function test[Ref]
Metabolic
Diabetic ketoacidosis:
In patients with type 1 diabetes, diabetic ketoacidosis occurred in 0.43% (n= 13) of patients who received inhaled insulin compared with 0.14% (n=3) of patients receiving subcutaneous insulin.
Hypoglycemia:
The incidence of non-severe hypoglycemia in patients with type 2 diabetes was 67%. The incidence of severe hypoglycemia was reported at 5.1%. A severe episode was defined as a hypoglycemic event requiring assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery following treatment. A non-severe episode was defined as symptoms of hypoglycemia with or without a low blood glucose value. The incidence of hypoglycemia was not reported for patients with type 1 diabetes.
Weight gain:
In patients with type 2 diabetes mellitus who received inhaled insulin therapy, a mean weight gain of 0.49 kg occurred compared with a mean weight loss of 1.13 kg in placebo-treated patients.[Ref]
Very common (10% or more): Hypoglycemia, non-severe (67%)
Common (1% to 10%): Hypoglycemia, severe
Uncommon (0.1% to 1%): Diabetic ketoacidosis
Frequency not reported: Weight gain[Ref]
Gastrointestinal
Common (1% to 10%): Diarrhea, nausea[Ref]
General
The most common adverse reactions reported included hypoglycemia, cough, throat pain or irritation.
The most common reason for drug discontinuation was cough.[Ref]
Local
Common (1% to 10%): Throat pain or irritation[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infection[Ref]
Oncologic
Frequency not reported: Lung cancer[Ref]
During clinical trials, 2 cases of lung cancer were reported; in both cases, heavy tobacco use was reported. Following completion of clinical trials, 2 cases of squamous cell lung cancer were reported in non-smokers.[Ref]
Other
Common (1% to 10%): Fatigue[Ref]
Psychiatric
Common (1% to 10%): Headache[Ref]
