Brand name · Insulin human
Afrezza: adverse event reports filed with FDA
1,216 reports list it as a suspect or interacting product, 2015–2026. Class: Insulin.
- 1,216
- reports as suspect product
- 0% of all reports · about 107 a year
- 69
- reports, 12 months to June 2026
- 111 in the 12 months before
- 7.2%
- marked serious by the reporter
- 56.4% across the class
- 0.8%
- record death among outcomes, as reported
- 10 reports · not verified by FDA
1,216 adverse event reports received by FDA list the brand name Afrezza (insulin human) as a suspect or interacting product, from March 2015 to March 2026. A further 84 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 69 reports listed it, down 38% from 111 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 107 reports a year and 0% of the 20,646,523 reports in the database, and 3.4% of the reports for the insulin class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded blood glucose increased (28.5%), cough (27.4%) and drug ineffective (16.6%). A report can list several reactions, so shares add to more than 100%; 111 different terms appear across these reports. Blood glucose increased is recorded in 28.5% of these reports, about the same share as in the median insulin drug (25.6%).
7.2% of the reports are marked serious by the reporter (56.4% across the class); 0.8% record death among the outcomes and 3.1% record hospitalisation, as reported. 77.5% of the reports came from consumers, and the largest patient age group is 45 to 64 (23.8%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Afrezza reports recording the termmedian drug in insulin
- Blood glucose increasedraised blood sugar reading28.5%347
- Coughcough27.4%333
- Drug ineffectivethe medicine did not work as expected16.6%202
- Blood glucose decreasedlow blood sugar reading7.6%92
- Dyspnoeashortness of breath4.9%60
- Throat irritationan irritated throat4.4%53
- Chest discomfortchest discomfort2.1%26
- Dizzinesslight-headedness or unsteadiness2.1%25
- Product physical issuea physical defect in the product2.1%25
- Wrong technique in product usage processthe product was used in the wrong way2%24
- Blood glucose abnormal1.9%23
- Productive cougha cough with phlegm1.9%23
- Wheezingwheezing1.7%21
- Chest painchest pain1.6%20
- Intentional product use issuedeliberate use not as intended1.6%20
- Headachehead pain1.5%18
- Hypoglycaemialow blood sugar1.5%18
- Product storage errorthe product was stored wrongly1.5%18
- Oropharyngeal painsore throat1.4%17
- Hyperglycaemiahigh blood sugar1.2%14
- Product complaint1.1%13
- Off label useused for a purpose or in a way not on the label0.9%11
- Product use issuea problem in how the product was used0.9%11
- Bronchospasmtightening of the airways0.8%10
- Diarrhoealoose or frequent stools0.8%10
- Fatiguetiredness0.8%10
- Feeling abnormalfeeling odd or not right0.8%10
- Incorrect dose administeredthe wrong dose was given0.8%10
- Nauseafeeling sick0.8%10
Top 30 of 111 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 9 drugs in the insulin class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 36,121 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 100% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Type 1 diabetes mellitus | 252 | 20.7% |
| Diabetes mellitus | 240 | 19.7% |
| Type 2 diabetes mellitus | 195 | 16% |
| Blood glucose abnormal | 4 | 0.3% |
| Blood glucose increased | 2 | 0.2% |
| Latent autoimmune diabetes in adults | 2 | 0.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,216 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Afrezza reports |
|---|---|---|
| Tresiba | 102 | 8.4% |
| Humalog | 85 | 7% |
| Lantus | 80 | 6.6% |
| Metformin | 66 | 5.4% |
| Novolog | 57 | 4.7% |
| Toujeo | 52 | 4.3% |
| Atorvastatin | 31 | 2.5% |
| Insulin | 30 | 2.5% |
| Lisinopril | 29 | 2.4% |
| Levothyroxine | 24 | 2% |
Other products listed in reports where Afrezza is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Afrezza | Insulin | All reports |
|---|---|---|---|
| Reports as suspect product | 1,216 | 36,121 | 20,646,523 |
| Share of that pool | — | 3.4% | 0% |
| Reports, latest 12 months | 69 | — | 1,332,454 |
| Marked serious | 7.2% | 56.4% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 8 | 35 | 91 |
| Hospitalisation recorded, per 1,000 reports | 31 | 291 | 213 |
| Consumer-filed share | 77.5% | 79.1% | 45.8% |
| Top term, share of reports | Blood glucose increased 28.5% | median 25.6% | 0.9% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the insulin class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Humulin N | brand | 10,914 | 152 | 52.1% |
| Humulin R | brand | 8,362 | 215 | 60.2% |
| Humulin 70/30 | brand | 6,870 | 132 | 49.7% |
| Insulin human | generic | 3,418 | 186 | 70.9% |
| Novolin N | brand | 1,680 | 106 | 71.7% |
| Novolin R | brand | 1,637 | 164 | 76.8% |
| Novolin 70/30 | brand | 1,388 | 109 | 60% |
| Human insulin | generic | 636 | 0 | 68.2% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Afrezza reports
How many adverse event reports has FDA received for Afrezza?
1,216 reports list Afrezza as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 69 of them arrived in the latest 12 months. Another 84 list it only as a concomitant medication.
What reactions are recorded in Afrezza reports?
blood glucose increased (28.5%), cough (27.4%), drug ineffective (16.6%), blood glucose decreased (7.6%) and dyspnoea (4.9%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Afrezza was responsible.
How serious are the reports?
7.2% are marked serious by the reporter. Among the outcomes recorded, 0.8% of reports include death and 3.1% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (77.5%), physician (12%) and other health professional (8.2%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Afrezza rising?
69 reports in the 12 months to June 2026, down 38% from 111 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Afrezza was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Afrezza?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Afrezza as a suspect or interacting product; reports listing it only as a concomitant medication (84) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.