What the label lists and what reports show
Insulin human side effects
Insulin human's FDA label lists its adverse reactions in its own words. FAERS holds 46,071 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is blood glucose increased (10,876 reports).
- No generic listed
Check it at the source: the insulin human FDA label on DailyMed (effective March 7, 2025, Baxter Healthcare Corporation); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of AFREZZA?AFREZZA may cause serious side effects that can lead to death, including: See “What is the most important information I should know about AFREZZA?” Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include: Dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, hunger. Decreased lung function. Your healthcare provider should check how your lungs are working before you start using AFREZZA, 6 months after you start using it and yearly after that. Lung cancer. In studies of AFREZZA in people with diabetes, lung cancer occurred in a few more people who were taking AFREZZA than in people who were taking other diabetes medications. There were too few cases to know if lung cancer was related to AFREZZA. […]
Source: FDA drug label (AFREZZA), Mannkind Corporation, effective May 30, 2026 (SPL set 29f4637b-e204-425b-b89c-7238008d8c10), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following adverse reactions are also discussed elsewhere in the labeling: • Hypoglycemia [see Warnings and Precautions (5.2) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] • Hypokalemia [see Warnings and Precautions (5.4) ] Adverse Reactions from Clinical Studies or Postmarketing Reports The following additional adverse reactions have been identified during clinical studies or from postmarketing reports with use of insulin human injection. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure. …
Table 2. Common Adverse Reactions That Occurred in ≥ 2% in Adult Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with AFREZZA
This table is printed in the AFREZZA label published by Mannkind Corporation of May 30, 2026; the label quoted above does not print one.
| Adverse Reaction | AFREZZA (n = 1,991) % | Placebo a (n = 290) % | Non-placebo comparators (n=1,363) % |
|---|---|---|---|
| Cough | 26 | 20 | 5 |
| Throat pain or irritation | 4 | 4 | 1 |
| Headache | 3 | 3 | 2 |
| Diarrhea | 3 | 1 | 2 |
| Productive cough | 2 | 1 | 1 |
| Fatigue | 2 | 1 | 1 |
| Nausea | 2 | 0.3 | 1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Baxter Healthcare Corporation, effective March 7, 2025 (SPL set afca6e80-a802-49fb-a978-5fe28a173001), via openFDA; the full label on DailyMed
What do FAERS reports show?
46,071 reports list insulin human among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3,681 are coded as a death and 15,618 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Insulin human: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions