Afrezza Side Effects

Generic name: insulin inhalation, rapid acting

Medically reviewed by Drugs.com. Last updated on Mar 11, 2024.

Note: This document provides detailed information about Afrezza Side Effects associated with insulin inhalation, rapid acting. Some dosage forms listed on this page may not apply specifically to the brand name Afrezza.

Applies to insulin inhalation, rapid acting: inhalation aerosol powder.

Precautions

Your doctor will want to check your progress at regular visits, especially during the first few weeks you take this medicine. Blood and lung function tests may be needed to check for unwanted effects.

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol (including beer and wine) may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines during the time you are taking this medicine unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

• Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
• Keep an extra supply of insulin on hand in case high blood sugar occurs.
• Keep some kind of quick-acting sugar handy to treat low blood sugar.
• Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

Tell your doctor if you are smoking or have recently stopped smoking while using this medicine.

Too much insulin human inhaled can cause hypoglycemia (low blood sugar). Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, depression, difficulty in thinking, dizziness or lightheadedness, drowsiness, excessive hunger, fast heartbeat, headache, irritability or abnormal behavior, nervousness, nightmares, restless sleep, shakiness, slurred speech, and tingling in the hands, feet, lips, or tongue.

If symptoms of low blood sugar occur, eat glucose tablets or gel to relieve the symptoms. Also, check your blood for low blood sugar. Get to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination, ketones in the urine, loss of appetite, stomachache, nausea, or vomiting, tiredness, troubled breathing (rapid and deep), unconsciousness, or unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor right away if you have a cough that keeps coming back or does not go away, shortness of breath, or trouble breathing.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you receive the medicine.

Using this medicine together with other diabetes medicine (such as pioglitazone, rosiglitazone, Actos®, Actoplus Met®, Avandia®) may cause serious heart problem or edema (fluid retention). Check with your doctor immediately if you are rapidly gaining weight, having shortness of breath, chest pain or discomfort, extreme tiredness or weakness, trouble breathing, uneven heartbeat, or excessive swelling of the hands, wrist, ankles, or feet.

Serious side effects of Afrezza

Along with its needed effects, insulin inhalation, rapid acting (the active ingredient contained in Afrezza) 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:

Other side effects of Afrezza

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:

For healthcare professionals

Applies to insulin inhalation, rapid acting: inhalation powder.

General adverse events

The most common adverse reactions reported included hypoglycemia, cough, throat pain or irritation.

The most common reason for drug discontinuation was cough.^[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]

Respiratory

• Very common (10% or more): Cough (25.6% to 29.4%)
• Common (1% to 10%): Bronchitis, productive cough, decreased pulmonary function test^[Ref]

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]

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]

See also:

Further information

Afrezza side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer