FDA Approves Afrezza (insulin human) Inhaled Insulin for Adult Diabetes

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FDA Published June 3, 2026 Medically reviewed June 3, 2026 DOI ↗ By Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

Key Takeaway

Consider Afrezza as a non-injectable prandial insulin option for adults with diabetes, but avoid in smokers and those with chronic lung disease.

The FDA has approved Afrezza (insulin human) inhalation powder, a rapid-acting inhaled human insulin, for improving glycemic control in adult patients with diabetes mellitus. The approval provides an alternative to injectable mealtime insulin for patients who may prefer or benefit from a non-invasive route of administration. Afrezza is administered at the beginning of each meal using a dedicated inhaler. Clinicians should note that the drug is not recommended for the treatment of diabetic ketoacidosis (DKA) or in patients who smoke or have recently stopped smoking, as safety and efficacy in these populations have not been established. Before initiating therapy, a medical history, physical exam, and spirometry (FEV1) are required to rule out chronic lung disease, which is a contraindication due to risk of acute bronchospasm.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Not reported in label.

Indication & Patient Population

Afrezza is indicated to improve glycemic control in adult patients with diabetes mellitus. Limitations of use: Not recommended for the treatment of diabetic ketoacidosis (DKA). Not recommended in patients who smoke or who have recently stopped smoking.

Dosing & Administration

Only administer via oral inhalation using the AFREZZA inhaler. Administer at the beginning of each meal. For insulin-naïve patients, the initial dosage is 4 units inhaled at the beginning of each meal. When switching from subcutaneous mealtime insulin, follow conversion table: up to 3 units subcutaneous → 4 units Afrezza; 4-5 units → 8 units; 6-7 units → 12 units; 8 or more units → 16 units. Modify dosage based on metabolic needs, blood glucose monitoring, and glycemic control goal. If control is not achieved with increased dosages, consider discontinuing Afrezza.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Contraindicated in patients with chronic lung disease due to risk of acute bronchospasm. Before initiating, perform medical history, physical exam, and spirometry (FEV1) to identify potential lung disease. Not recommended for DKA or in patients who smoke or have recently stopped smoking. Increased frequency of blood glucose monitoring is needed when switching from other insulins.

Place in Therapy

Afrezza offers a non-injectable option for prandial insulin therapy in adults with diabetes. It may be considered for patients who have difficulty with injections or prefer inhaled delivery. However, it requires pulmonary function assessment prior to use and is not suitable for smokers or those with chronic lung disease. It is not recommended for DKA.

Study Details

Study typeFda approval

PublishedJun 2014

View Original Abstract ↓

1 INDICATIONS AND USAGE AFREZZA ® is indicated to improve glycemic control in adult patients with diabetes mellitus. AFREZZA ® is a rapid acting inhaled human insulin indicated to improve glycemic control in adult patients with diabetes mellitus. ( 1 ) Limitations of Use : Not recommended for the treatment of diabetic ketoacidosis (DKA) ( 1 ) Not recommended in patients who smoke or who have recently stopped smoking ( 1 ) Limitations of Use: AFREZZA is not recommended for the treatment of diabetic ketoacidosis (DKA) [see Warning and Precautions ( 5.6 )] . The safety and effectiveness of AFREZZA in patients who smoke have not been established. The use of AFREZZA is not recommended in patients who smoke or who have recently stopped smoking.