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Exubera Side Effects

Generic Name: insulin inhalation, rapid acting

Note: This document contains side effect information about insulin inhalation, rapid acting. Some of the dosage forms listed on this page may not apply to the brand name Exubera.

For the Consumer

Applies to insulin inhalation, rapid acting: inhalation aerosol powder

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

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

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

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

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]

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]

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

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]

Frequency not reported: Lung cancer[Ref]

Other

Common (1% to 10%): Fatigue[Ref]

Psychiatric

Common (1% to 10%): Headache[Ref]

References

1. "Product Information. Afrezza (insulin inhalation, rapid acting)." MannKind Corporation, Valencia, CA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

More about Exubera (insulin inhalation, rapid acting)

Consumer resources

Other brands: Afrezza

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