Insulin aspart adverse event reports that FDA received

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

Name type: Generic name
Class: Insulin analog
Also reported as: Insulin Aspart 30

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 April 2004 to June 2026, FDA received 3,232 adverse event reports that name Insulin aspart. In these reports the drug is a suspect or interacting product.

In the same period, 6,602 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 553 reports in the 12 months to June 2026 and 506 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, 553 (under 0.1%) name Insulin aspart. Reports from other health professionals were 34.4% of the reports that name Insulin aspart and 19.7% 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 aspart 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 158 reports that name Insulin aspart.
In January to March 2026, FDA received 109.
In April to June 2025, FDA received 111.

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 400 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 3,204 of the 3,232 reports (99.1%).

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 400 terms.

Reaction terms in the reports that name Insulin aspart, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,232 reports
Hypoglycaemialow blood sugar	395	12.2%
Blood glucose increasedraised blood sugar reading	356	11%
Vomitingbeing sick	327	10.1%
Dyspnoeashortness of breath	326	10.1%
Condition aggravatedthe condition being treated got worse	317	9.8%
Nauseafeeling sick	293	9.1%
Off label useused for a purpose or in a way not on the label	286	8.8%
Abdominal painstomach or belly pain	285	8.8%
Stress	273	8.4%
Abdominal distensiona bloated abdomen	239	7.4%
General physical health deteriorationgeneral decline in health	233	7.2%
Hyponatraemialow blood sodium	233	7.2%
Multiple organ dysfunction syndromeseveral organs failing	233	7.2%
Sepsisa severe body-wide response to infection	230	7.1%
Ascitesfluid in the abdomen	227	7%
Constipation	223	6.9%
Appendicitis	222	6.9%
Appendicolith	218	6.7%
Cardiogenic shockshock from the heart failing to pump	216	6.7%
Asthma	210	6.5%
Thrombosis	204	6.3%
Anxiety	200	6.2%
Drug ineffectivethe medicine did not work as expected	199	6.2%
Ventricular fibrillationa chaotic rhythm from the lower heart chambers	197	6.1%
Pulmonary embolisma blood clot in the lung	193	6%
Wheezing	182	5.6%
Somnolencedrowsiness	175	5.4%
Sleep disordera sleep problem	167	5.2%
Therapeutic product effect incomplete	162	5%
Dry mouth	157	4.9%
Lung disordera lung problem, type not specified	157	4.9%
Sleep disorder due to a general medical condition	157	4.9%
Deaththe patient died; cause not stated by this term	156	4.8%
Blood phosphorus increased	149	4.6%
Pulmonary fibrosis	149	4.6%
Diabetes mellitusdiabetes	148	4.6%
Respiratory symptom	148	4.6%
Malaisegeneral feeling of being unwell	146	4.5%
Blood glucose decreasedlow blood sugar reading	144	4.5%
Haemoptysiscoughing up blood	143	4.4%
Loss of personal independence in daily activities	140	4.3%
Obstructive airways disorder	140	4.3%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	138	4.3%
Pulmonary vasculitis	138	4.3%
Incorrect route of product administrationthe product was given by the wrong route	137	4.2%
Full blood count abnormal	136	4.2%
Pain in extremitypain in an arm or leg	135	4.2%
Anaemialow red blood cells	132	4.1%
Pneumonialung infection	132	4.1%
Intentional product misusedeliberate use not as intended	131	4.1%

Download all 400 terms of Insulin aspart (CSV)

The counts add to more than 3,232 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.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Insulin aspart with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Insulin aspart (this page)	Generic name	3,232
Fiasp	Brand name	1,569
NovoLog Mix 70/30	Brand name	2,101
Novolog	Brand name	14,477

Sum of the separately reported names: 21,379. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

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.

Outcomes by year

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

Outcomes in the reports that name Insulin aspart, 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	13	13	0	3	6	1	1	8	0
2005	5	5	0	0	3	1	0	2	0
2006	3	3	0	0	2	0	0	1	0
2007	10	9	0	2	7	0	0	1	1
2008	22	16	1	1	11	0	1	2	6
2009	37	19	0	9	11	0	1	4	18
2010	13	12	1	2	5	0	0	10	1
2011	10	10	0	0	3	0	0	7	0
2012	21	20	4	2	13	1	0	5	1
2013	30	27	1	0	14	0	2	14	3
2014	29	17	0	1	12	0	1	5	12
2015	39	22	0	6	19	0	0	7	17
2016	38	26	2	0	14	1	0	14	12
2017	41	35	6	1	22	0	0	18	6
2018	103	98	7	1	44	1	14	69	5
2019	81	75	7	5	43	1	5	42	6
2020	137	116	26	0	77	0	1	72	21
2021	324	268	69	8	97	5	2	185	56
2022	412	364	78	23	169	30	16	265	48
2023	433	406	105	95	215	63	31	316	27
2024	487	454	77	95	251	41	10	316	33
2025	589	524	112	118	274	53	36	422	65
2026	355	323	92	77	208	46	55	256	32

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 aspart, 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 aspart, by the year in which FDA received them
Year	Reports
2004	12
2005	6
2006	3
2007	10
2008	21
2009	39
2010	13
2011	13
2012	23
2013	27
2014	31
2015	41
2016	37
2017	54
2018	133
2019	86
2020	161
2021	424
2022	428
2023	417
2024	478
2025	508
2026	267

Reports that name Insulin aspart, 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 aspart
Age	Reports	Share
Under 2	28	0.9%
2 to 11	28	0.9%
12 to 17	41	1.3%
18 to 44	373	11.5%
45 to 64	793	24.5%
65 to 74	532	16.5%
75 and over	588	18.2%
Age not given	849	26.3%

Sex of the patient in the reports that name Insulin aspart
Sex	Reports	Share
Female	1,346	41.6%
Male	1,539	47.6%
Unknown or not given	347	10.7%

Type of reporter in the reports that name Insulin aspart
Reporter	Reports	Share
Physician	654	20.2%
Pharmacist	265	8.2%
Other health professional	1,111	34.4%
Lawyer	0	0%
Consumer or non-health professional	1,164	36%
Not given	38	1.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 30.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Insulin aspart record
Indication as recorded (MedDRA)	Reports	Share
Type 2 diabetes mellitus	664	20.5%
Diabetes mellitus	615	19%
Type 1 diabetes mellitus	333	10.3%
Hyperglycaemia	54	1.7%
Foetal exposure during pregnancy	33	1%
Gestational diabetes	33	1%

The reporter fills in the indication, and the field is often empty. Each share is of all 3,232 reports.

Drugs in the same reports

Other drugs that the reports of Insulin aspart name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	406
Albuterol	411
Allopurinol	341
Betamethasone	363
Furosemide	370
Gabapentin	375
Insulin glargine	686
Ipratropium bromide	322
Metformin	468
Potassium chloride	302

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

Fiasp same ingredient
NovoLog Mix 70/30 same ingredient
Novolog same ingredient
Insulin same class
Insulin degludec same class
Humalog Mix75/25 same class
Insulin detemir same class
Humalog Kwikpen same class
Insulin glargine same class
Inspra next in the A to Z list
Insulin degludec and liraglutide next in the A to Z list
Inrebic 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 Insulin aspartThe 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.

Cite this page

Reported Reactions. Insulin aspart: adverse event reports that FDA received. https://reportedreactions.com/drug/insulin-aspart/ 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 aspart as a suspect or interacting product. The 6,602 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 aspart 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 aspart?

No. It is a count of what people reported to FDA: 3,232 reports from April 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?

Consumer or non-health professional (36%), other health professional (34.4%) and physician (20.2%). 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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