Insulin Human Inhalation
Inhaled human insulin used to improve blood sugar control in adults and children 6 and older with diabetes mellitus.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Afrezza can cause sudden, severe airway tightening (bronchospasm) in people with chronic lung disease, and this can be life-threatening. Because of this risk, Afrezza is completely contraindicated (must not be used) in anyone with asthma or COPD. Before starting Afrezza, every patient must have a lung function test (called spirometry or FEV1) to rule out hidden lung disease. If you have asthma or COPD, do not use Afrezza — ask your doctor about other insulin options.
📖 Insulin Human Inhalation: Patient Information Guide
A plain-language walkthrough of Insulin Human Inhalation — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Insulin human inhalation (Afrezza) is a rapid-acting inhaled insulin approved to improve blood sugar control in people with diabetes mellitus.
- Afrezza is approved for adults and children aged 6 years and older with type 1 diabetes mellitus — always used together with a long-acting (basal) insulin in type 1
- Afrezza is approved for adults and children aged 6 years and older with type 2 diabetes mellitus
- Afrezza is NOT recommended for treating diabetic ketoacidosis (DKA)
- Afrezza is NOT recommended for people who currently smoke or have recently stopped smoking
⚙️How it works▾
Insulin is the body's key for unlocking cells so they can absorb glucose (sugar) from the blood. Afrezza delivers human insulin directly to the lungs through inhalation, where it rapidly enters the bloodstream. Once in the blood, it signals muscle and fat cells to take up glucose, tells the liver to reduce its own glucose output, and helps the body store energy by limiting fat and protein breakdown. Because it reaches peak effect in roughly 35–55 minutes and its action fades within 90 minutes to about 4–5 hours (depending on dose), it is designed to handle the blood sugar rise that happens after a meal.
💊How it's taken▾
Afrezza is inhaled through the mouth at the start of every meal using the Afrezza inhaler. Your prescriber will set your starting dose based on your current insulin regimen or your diabetes type, then adjust it based on your blood sugar readings and goals. If you have type 1 diabetes, you will also need a separate long-acting (basal) insulin — Afrezza alone is not enough.
- Inhale at the beginning of each meal — not before or after
- If you miss a dose at a meal, skip it and resume at your next meal — do not double up
- Monitor your blood sugar more frequently when starting Afrezza or changing your dose
- Dosage may need adjustment if your activity level, meal patterns, kidney function, or liver function changes
🤒Side effects — in detail▾
The most common side effects of Afrezza are low blood sugar, cough, and throat irritation — but there are a few others worth knowing about.
- Low blood sugar (hypoglycemia) — the most common; can range from mild shakiness to severe confusion or unconsciousness
- Cough — reported in about 27% of adults; the most common reason people stop Afrezza
- Throat pain or irritation
- Headache
- Diarrhea and nausea
- Fatigue
- Decline in lung function (measured as FEV1) — a small but real decrease seen in clinical trials
- Weight gain — as with other insulins, due to the anabolic (building) effects of insulin
Seek emergency care for severe low blood sugar, sudden wheezing or difficulty breathing, or signs of a serious allergic reaction (throat swelling, hives, rapid heartbeat).
⚠️Warnings & precautions▾
- Acute bronchospasm (sudden airway tightening): Afrezza is completely contraindicated in asthma or COPD. This is a boxed warning — the most serious level of FDA caution. It can be life-threatening.
- Decline in lung function: Even in people without lung disease, Afrezza causes a measurable drop in lung function that starts within 3 months and persists. Lung function testing is required before starting and every 6–12 months during treatment.
- Severe low blood sugar (hypoglycemia): Can cause seizures, loss of consciousness, or death. Risk is highest at the peak of Afrezza's effect (roughly 35–55 minutes after inhalation).
- Lung cancer signal: A small number of lung cancer cases were observed in Afrezza-treated patients in clinical trials. The data are not conclusive, but people with a history of lung cancer or heavy smoking should discuss this risk with their doctor.
- Diabetic ketoacidosis (DKA): More common in type 1 diabetes patients on Afrezza than on comparator insulins — especially during illness. Afrezza is not recommended for treating DKA.
- Low potassium (hypokalemia): All insulins shift potassium into cells, which can drop blood potassium to dangerous levels. People on potassium-lowering medications are at highest risk.
- Heart failure risk with TZD diabetes pills: Combining any insulin with thiazolidinediones (like pioglitazone) can cause fluid retention and worsen or trigger heart failure.
🔀What it interacts with▾
Afrezza interacts with many common medications that can either push blood sugar too low or block Afrezza from working properly.
- Drugs that increase low-blood-sugar risk (may need a lower Afrezza dose): other diabetes medicines, ACE inhibitors, angiotensin II receptor blockers, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs, and certain antibiotics (sulfonamides)
- Drugs that reduce Afrezza's effect (may need a higher dose): corticosteroids, diuretics, estrogens, oral contraceptives, progestogens, antipsychotics (e.g., olanzapine, clozapine), niacin, danazol, isoniazid, phenothiazines, protease inhibitors, somatropin, thyroid hormones, and sympathomimetic agents (e.g., albuterol, epinephrine)
- Alcohol, beta-blockers, clonidine, lithium — can either raise or lower blood sugar unpredictably; monitor closely
- Beta-blockers, clonidine, guanethidine, reserpine — can hide the warning signs of low blood sugar (like a racing heart), making it harder to recognize hypoglycemia
- Pentamidine — can first cause low blood sugar, then rebound high blood sugar
- Albuterol (a bronchodilator) — increases the amount of insulin absorbed from Afrezza by about 25%; note that Afrezza is contraindicated in asthma patients who would typically use albuterol
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Asthma or COPD: Do not use Afrezza — it is contraindicated due to the risk of sudden life-threatening airway tightening
- Any chronic lung disease: A lung function test (spirometry/FEV1) is required before starting Afrezza
- Severe allergy to human insulin or Afrezza ingredients: Do not use — anaphylaxis can occur
- Smokers or recent ex-smokers: Afrezza is not recommended — safety and effectiveness have not been established in this group
- Pregnancy: Data on Afrezza specifically in pregnancy are very limited; poorly controlled diabetes in pregnancy carries serious risks for mother and baby — discuss with your doctor
- Breastfeeding: It is likely that insulin and the carrier particles in Afrezza are excreted in breast milk; discuss risks and benefits with your doctor
- Children under 6 years: Safety and effectiveness have not been established
- Kidney impairment: May need more frequent blood sugar monitoring and a lower dose
- Liver impairment: May need more frequent blood sugar monitoring and a lower dose
- History of or risk factors for lung cancer: Discuss potential risks with your doctor before starting
🚑If you take too much▾
Taking too much Afrezza can cause dangerously low blood sugar (hypoglycemia) and low potassium (hypokalemia). Mild low blood sugar can usually be treated by eating or drinking something with fast-acting sugar (such as glucose tablets or juice); severe cases — especially with seizures, confusion, or loss of consciousness — may require glucagon by injection or intravenous glucose given in a medical setting. If you think too much Afrezza has been used, call the Poison Help line at 1-800-222-1222 or seek emergency care.
📡Pharmacodynamics — effects in the body▾
Afrezza starts lowering blood sugar within about 12 minutes of inhalation. The peak blood-sugar-lowering effect occurs at roughly 35 minutes for lower doses and about 55 minutes for higher doses. The effect then returns to baseline within approximately 90 minutes to 4.5 hours, depending on the dose — meaning it works hard and fast around mealtime but does not linger as long as some other insulin types. The strength of the effect increases in proportion to the dose up to 48 units.
🔬Pharmacokinetics — how your body processes it▾
After inhalation, Afrezza is absorbed through the lungs into the bloodstream, with peak insulin levels reached in just 10–20 minutes — faster than most injected mealtime insulins. The apparent half-life (the time it takes for half the insulin to clear the body) ranges from about 2 to 3.5 hours, and insulin levels return to baseline within roughly 1 to 4 hours after inhalation. About 39% of the inhaled dose reaches the lungs; a small fraction (about 7%) is swallowed but is not absorbed from the gut and is excreted in the stool unchanged. The carrier particles used to deliver the insulin are not metabolized — they are eliminated unchanged in the urine after being absorbed through the lungs. The metabolism of Afrezza is otherwise comparable to regular human insulin.
📦How to store it▾
Not in Use: Refrigerated Storage 2ºC to 8ºC (36ºF to 46ºF) * If a foil package, blister card or strip is not refrigerated, the contents must be used within 10 days. refrigerator after being stored at room temperature.
📄 Written from Insulin Human Inhalation’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Insulin Human Inhalation — the kind of thing our pharmacy team would talk through with you at the counter.
Why do I have to get a lung test before I can use Afrezza? ▾
I keep coughing every time I use Afrezza — is that normal, and will it go away? ▾
How is low blood sugar from Afrezza different from low blood sugar with injected insulin? ▾
I have type 1 diabetes. Can I use Afrezza as my only insulin? ▾
Can I use Afrezza if I smoke or if I just quit smoking? ▾
Are there medicines I take every day that could interfere with Afrezza? ▾
Is Insulin Human Inhalation available over the counter? ▾
When was Insulin Human Inhalation first available? ▾
💬 Answers drafted from Insulin Human Inhalation’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Insulin Human Inhalation comes
Insulin Human Inhalation is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Inhalation powder
How this form is used
- Afrezza is used to improve blood sugar control in adults and children aged 6 and older with type 1 or type 2 diabetes mellitus
- Afrezza is a rapid-acting mealtime insulin — it is not intended for use as a basal (long-acting) insulin
- Afrezza is not recommended for treating diabetic ketoacidosis (DKA)
- Afrezza is not recommended for people who smoke or have recently stopped smoking
- Afrezza is only administered by oral inhalation using the Afrezza inhaler — never by injection or by mouth
- Afrezza should be inhaled at the beginning of each meal, using the number of cartridges your prescriber has directed
- Afrezza inhaler: hold level with mouthpiece on top after inserting the cartridge; exhale fully away from the inhaler, then place the mouthpiece in your mouth, seal your lips, tilt the inhaler down toward your chin, and inhale deeply; hold your breath as long as comfortable, then breathe normally
- The Afrezza inhaler should be replaced with a new one after 15 days of use
📊 Insulin Human Inhalation across the U.S. market
How Insulin Human Inhalation appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Kit (12) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
📈 How widely Insulin Human Inhalation is used
A general measure of how commonly Insulin Human Inhalation is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Insulin Human Inhalation is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Insulin Human Inhalation prescribed? Of the 1,596 medications we measure, Insulin Human Inhalation ranks #1,219 by Medicaid prescriptions — more than 24% of them.
Utilization by Insulin Human Inhalation product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
insulin, regular, human 4 UNT Inhalation Powder Most dispensed
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1543202
insulin, regular, human 12 UNT Inhalation Powder
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1654910
insulin, regular, human 8 UNT Inhalation Powder
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1544488
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Insulin Human Inhalation, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 6 listed Insulin Human Inhalation NDCs with Medicaid activity.
🔍 Compare Insulin Human Inhalation products
A representative set of FDA-listed product records for Insulin Human Inhalation — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Inhalation powder | ||||
| 4 1 | Respiratory (inhalation) | Mannkind Corporation | BLA | View NDC → |
| 4 [arb'U] | Respiratory (inhalation) | Mannkind Corporation × 3 listings | BLA | View NDC → |
| 8 1 | Respiratory (inhalation) | Mannkind Corporation | BLA | View NDC → |
| 8 [arb'U] | Respiratory (inhalation) | Mannkind Corporation × 3 listings | BLA | View NDC → |
| 12 1 | Respiratory (inhalation) | Mannkind Corporation | BLA | View NDC → |
| 12 [arb'U] | Respiratory (inhalation) | Mannkind Corporation × 3 listings | BLA | View NDC → |
| 💊Kits | ||||
| — | Respiratory (inhalation) | Mannkind Corporation × 12 listings | BLA | View NDC → |
Showing 24 of 24 products — FDA National Drug Code Directory. See every product, package size and price: browse all 24 Insulin Human Inhalation NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Insulin Human Inhalation — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Insulin Human Inhalation in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Insulin Human Inhalation went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 253182 4 dose forms · 8 strengths
-
Dose form (SCDF) Inhalation Powder RxCUI 2108525In current FDA listings -
Dose form (SCDF) Injectable Solution RxCUI 376915No current FDA listing -
Dose form (SCDF) Injection RxCUI 2179743No current FDA listingClinical drug / strength (SCD) 100 ML insulin, regular, human 1 UNT/MLRxCUI 2179744 -
Dose form (SCDF) Pen Injector RxCUI 1731314No current FDA listingClinical drug / strength (SCD) 3 ML insulin, regular, human 100 UNT/MLRxCUI 22060903 ML insulin, regular, human 500 UNT/MLRxCUI 1731315
Look up RxCUI 253182 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Insulin Human Inhalation is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Insulin Human Inhalation belongs to the Insulin class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Mannkind Corporation is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.