Pharmacologic class (EPC) · 9 drug pages

Insulin: adverse event reports filed with FDA

36,121 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

36,121
reports across the class: 0.2% of all reports; 1,133
reports, 12 months to June 2026: 1,406 in the 12 months before; 56.4%
marked serious by the reporter: 57.4% across all reports; 9
drugs with a page: brand and generic names counted separately

Insulin is a pharmacologic class (an FDA Established Pharmacologic Class) with 9 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 36,121 adverse event reports received by FDA, 0.2% of the database, from January 2004 to June 2026.

1,133 reports arrived in the 12 months to June 2026, down 19% from 1,406 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 56.4% of the class's reports are marked serious, 3.5% record death among the outcomes and 29.1% record hospitalisation, as reported.

Across the class the reactions recorded most often are blood glucose increased (32.8%), blood glucose decreased (11.4%) and drug ineffective (9.1%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Humulin NInsulin human	brand	10,914	152	52.1%	Blood glucose increased
Humulin RInsulin human	brand	8,362	215	60.2%	Blood glucose increased
Humulin 70/30Insulin human	brand	6,870	132	49.7%	Blood glucose increased
Insulin human	generic	3,418	186	70.9%	Blood glucose increased
Novolin NHuman insulin	brand	1,680	106	71.7%	Blood glucose increased
Novolin RHuman insulin	brand	1,637	164	76.8%	Blood glucose increased
Novolin 70/30Human insulin	brand	1,388	109	60%	Blood glucose increased
AfrezzaInsulin human	brand	1,216	69	7.2%	Blood glucose increased
Human insulin	generic	636	0	68.2%	Blood glucose increased

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Blood glucose increasedraised blood sugar reading32.8%11,862
Blood glucose decreasedlow blood sugar reading11.4%4,134
Drug ineffectivethe medicine did not work as expected9.1%3,287
Incorrect dose administeredthe wrong dose was given5.4%1,945
Hypoglycaemialow blood sugar4.8%1,745
Visual impairmentreduced vision4.5%1,623
Wrong technique in product usage processthe product was used in the wrong way3.3%1,207
Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure3.3%1,178
Malaisegeneral feeling of being unwell3.2%1,168
Falla fall3.1%1,128
Cataractclouding of the eye lens3%1,083
Blood glucose fluctuation2.9%1,052
Blood glucose abnormal2.9%1,030
Cerebrovascular accidentstroke2.8%1,019
Pharmaceutical product complaint2.7%969
Visual acuity reducedreduced sharpness of vision2.7%962
Weight decreasedweight loss2.6%951
Diabetes mellitus inadequate controldiabetes not well controlled2.6%936
Maternal exposure during pregnancythe mother took the medicine during pregnancy2.6%923
Weight increasedweight gain2.5%896
Blindnessloss of sight2.4%860
Drug dose omissiona dose was missed2.4%857
Dizzinesslight-headedness or unsteadiness2.4%855
Feeling abnormalfeeling odd or not right2.3%839
Myocardial infarctionheart attack2.3%834

Solid bar: share of all class reports. Hollow bar: the median share across the 9 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death3.5%1,282

Life-threatening2.2%810

Hospitalisation (initial or prolonged)29.1%10,514

Disability3.6%1,285

Congenital anomaly0.3%114

Other serious35.3%12,760

Not serious43.6%15,742

Patient age

Under 20.4%134

2 to 110.3%118

12 to 170.4%148

18 to 446.2%2,257

45 to 6416.7%6,043

65 to 7412.1%4,358

75 and over9%3,268

Age not given54.8%19,795

Who reported

Physician6.7%2,426

Pharmacist3.2%1,152

Other health professional5%1,816

Lawyer0%8

Consumer or non-health professional79.1%28,578

Not given5.9%2,141

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Insulin reports

Which drugs are in the Insulin class on this site?

Humulin N, Humulin R, Humulin 70/30, Insulin human, Novolin N and Novolin R and 3 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

36,121 reports through June 2026, 1,133 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

blood glucose increased (32.8%), blood glucose decreased (11.4%), drug ineffective (9.1%), incorrect dose administered (5.4%) and hypoglycaemia (4.8%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.