Insulin inhalation, rapid acting Side Effects
For the Consumer
Applies to insulin inhalation, rapid acting: inhalation aerosol powder
In addition to its needed effects, some unwanted effects may be caused by insulin inhalation, rapid acting. 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 insulin inhalation, rapid acting:More common:
- blurred vision
- cold sweats
- cool, pale skin
- fast heartbeat
- increased hunger
- slurred speech
- unusual tiredness or weakness
- 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
Minor Side Effects
Some of the side effects that can occur with insulin inhalation, rapid acting 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:Less common:
- sore throat
- Weight gain
For Healthcare Professionals
Applies to insulin inhalation, rapid acting: inhalation powder
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]
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]
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.
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.
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]
Common (1% to 10%): Diarrhea, nausea[Ref]
The most common adverse reactions reported included hypoglycemia, cough, throat pain or irritation.
The most common reason for drug discontinuation was cough.[Ref]
Common (1% to 10%): Throat pain or irritation[Ref]
Common (1% to 10%): Urinary tract infection[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]
Frequency not reported: Lung cancer[Ref]
Common (1% to 10%): Fatigue[Ref]
Common (1% to 10%): Headache[Ref]
1. "Product Information. Afrezza (insulin inhalation, rapid acting)." MannKind Corporation, Valencia, CA.
Not all side effects for insulin inhalation, rapid acting 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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