Insulin adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Insulin
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Insulin analog
Also reported as: Insulin Nos, Insulin Injection, Insulin /00030501/

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

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

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 8,135 adverse event reports that name Insulin. In these reports the drug is a suspect or interacting product.

In the same period, 66,805 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 522 reports in the 12 months to June 2026 and 555 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 522 (under 0.1%) name Insulin. Reports from consumers or other non-health professionals were 20.9% of the reports that name Insulin and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Insulin is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 110 reports that name Insulin.
In January to March 2026, FDA received 138.
In April to June 2025, FDA received 106.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 764 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 8,103 of the 8,135 reports (99.6%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 764 terms.

Reaction terms in the reports that name Insulin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 8,135 reports
Hypoglycaemialow blood sugar	1,019	12.5%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	767	9.4%
Drug ineffectivethe medicine did not work as expected	755	9.3%
Completed suicidedeath by suicide	612	7.5%
Premature babya baby born early	531	6.5%
Toxicity to various agentspoisoning or toxic effect of one or more substances	524	6.4%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	490	6%
Blood glucose increasedraised blood sugar reading	470	5.8%
Off label useused for a purpose or in a way not on the label	403	5%
Exposure during pregnancythe medicine was taken during pregnancy	392	4.8%
Premature delivery	358	4.4%
Blood glucose decreasedlow blood sugar reading	354	4.4%
Drug interactionan interaction between medicines	323	4%
Hypotensionlow blood pressure	301	3.7%
Hyperglycaemiahigh blood sugar	280	3.4%
Overdosea dose above the recommended amount	247	3%
Condition aggravatedthe condition being treated got worse	234	2.9%
Acute kidney injurysudden loss of kidney function	229	2.8%
Diabetic ketoacidosisa serious complication of diabetes with acid build-up	202	2.5%
Intentional overdosea deliberate overdose	189	2.3%
Diabetes mellitus inadequate controldiabetes not well controlled	188	2.3%
Weight decreasedweight loss	186	2.3%
Dyspnoeashortness of breath	185	2.3%
Low birth weight baby	185	2.3%
Cardiac arrestthe heart stopped	180	2.2%
Hyperkalaemiahigh blood potassium	168	2.1%
Falla fall	167	2.1%
Somnolencedrowsiness	165	2%
Nauseafeeling sick	164	2%
Vomitingbeing sick	160	2%
Weight increasedweight gain	160	2%
Dizzinesslight-headedness or unsteadiness	157	1.9%
Fatiguetiredness	157	1.9%
Astheniaweakness or lack of energy	151	1.9%
Diabetes mellitusdiabetes	151	1.9%
Hypertensionhigh blood pressure	151	1.9%
Lactic acidosisa build-up of lactic acid in the blood	150	1.8%
Diarrhoealoose or frequent stools	139	1.7%
Malaisegeneral feeling of being unwell	138	1.7%
Coma	137	1.7%
Loss of consciousnesspassing out	137	1.7%
Pneumonialung infection	137	1.7%
Painpain, site not specified	135	1.7%
Respiratory failurethe lungs could not supply enough oxygen	135	1.7%
Cardiogenic shockshock from the heart failing to pump	130	1.6%
Deaththe patient died; cause not stated by this term	128	1.6%
Metabolic acidosistoo much acid in the body fluids	128	1.6%
Renal failurekidney failure	124	1.5%
Product use in unapproved indicationused for a purpose not on the label	121	1.5%
Bradycardiaslow heart rate	118	1.5%

Download all 764 terms of Insulin (CSV)

The counts add to more than 8,135 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Insulin, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	156	146	28	12	82	15	2	72	10
2005	182	173	25	11	110	20	1	88	9
2006	110	96	18	9	42	4	2	45	14
2007	128	110	16	10	69	1	4	35	18
2008	158	137	25	17	88	1	2	39	21
2009	123	102	17	17	60	2	1	34	21
2010	129	120	35	9	47	1	2	54	9
2011	244	227	56	18	112	5	1	103	17
2012	184	158	29	9	98	2	6	66	26
2013	329	279	79	28	133	1	11	133	50
2014	343	293	83	25	134	3	5	144	50
2015	296	237	56	19	115	5	2	113	59
2016	324	271	43	22	157	11	9	139	53
2017	340	308	113	31	152	6	8	145	32
2018	571	464	91	34	199	5	35	334	107
2019	570	508	90	46	217	5	29	364	62
2020	620	554	105	61	242	3	28	420	66
2021	655	591	96	52	213	3	35	472	64
2022	473	412	66	55	206	6	23	314	61
2023	666	618	166	55	291	7	19	431	48
2024	567	516	74	72	199	4	20	416	51
2025	636	599	126	75	274	8	16	453	37
2026	331	316	83	57	178	5	9	210	15

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Insulin, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Insulin, by the year in which FDA received them
Year	Reports
2004	145
2005	179
2006	115
2007	119
2008	154
2009	140
2010	131
2011	250
2012	226
2013	326
2014	353
2015	309
2016	331
2017	385
2018	655
2019	644
2020	602
2021	647
2022	458
2023	631
2024	547
2025	540
2026	248

Reports that name Insulin, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Insulin
Age	Reports	Share
Under 2	156	1.9%
2 to 11	73	0.9%
12 to 17	177	2.2%
18 to 44	1,450	17.8%
45 to 64	2,091	25.7%
65 to 74	1,053	12.9%
75 and over	685	8.4%
Age not given	2,450	30.1%

Sex of the patient in the reports that name Insulin
Sex	Reports	Share
Female	3,983	49%
Male	3,160	38.8%
Unknown or not given	992	12.2%

Type of reporter in the reports that name Insulin
Reporter	Reports	Share
Physician	2,010	24.7%
Pharmacist	786	9.7%
Other health professional	3,219	39.6%
Lawyer	7	0.1%
Consumer or non-health professional	1,697	20.9%
Not given	416	5.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 46.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Insulin record
Indication as recorded (MedDRA)	Reports	Share
Diabetes mellitus	1,373	16.9%
Type 2 diabetes mellitus	764	9.4%
Type 1 diabetes mellitus	308	3.8%
Gestational diabetes	300	3.7%
Foetal exposure during pregnancy	136	1.7%
Hyperkalaemia	92	1.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 8,135 reports.

Drugs in the same reports

Other drugs that the reports of Insulin name, in any role, in order of name
Drug	Reports that name the two
Amlodipine	580
Aspirin	575
Dextrose	320
Furosemide	632
Gabapentin	289
Metformin	1,543
Metformin hydrochloride	426
Methyldopa	434
Nifedipine	371
Omeprazole	426

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Humalog Mix75/25 same class
Insulin aspart same class
Humalog Kwikpen same class
Insulin degludec same class
Humalog Junior Kwikpen same class
Insulin detemir same class
Inspra next in the A to Z list
Inrebic next in the A to Z list
Inqovi next in the A to Z list
Insulin degludec and liraglutide next in the A to Z list
Inpefa next in the A to Z list
Inovelon next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for InsulinThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

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Reported Reactions. Insulin: adverse event reports that FDA received. https://reportedreactions.com/drug/insulin/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Insulin as a suspect or interacting product. The 66,805 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Insulin was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Insulin?

No. It is a count of what people reported to FDA: 8,135 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (39.6%), physician (24.7%) and consumer or non-health professional (20.9%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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