Humulin R (insulin human) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Insulin human
Class: Insulin

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.

Reports on file

From January 2004 to June 2026, FDA received 8,362 adverse event reports that name Humulin R. In these reports the drug is a suspect or interacting product.

In the same period, 4,717 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 215 reports in the 12 months to June 2026 and 173 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 Humulin R 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 1 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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 37 reports that name Humulin R.
In January to March 2026, FDA received 75.
In April to June 2025, FDA received 54.

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 531 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 all 8,362 reports.

The site keeps a term for a year only if two or more reports of that year record it.

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 531 terms.

Reaction terms in the reports that name Humulin R, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 8,362 reports
Blood glucose increasedraised blood sugar reading	3,367	40.3%
Blood glucose decreasedlow blood sugar reading	1,213	14.5%
Drug ineffectivethe medicine did not work as expected	997	11.9%
Wrong technique in product usage processthe product was used in the wrong way	623	7.5%
Incorrect dose administeredthe wrong dose was given	504	6%
Hypoglycaemialow blood sugar	459	5.5%
Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure	376	4.5%
Visual impairmentreduced vision	375	4.5%
Blood glucose abnormal	332	4%
Blood glucose fluctuation	304	3.6%
Weight decreasedweight loss	303	3.6%
Malaisegeneral feeling of being unwell	302	3.6%
Pharmaceutical product complaint	291	3.5%
Falla fall	285	3.4%
Neuropathy peripheralnerve damage in hands or feet	281	3.4%
Cataractclouding of the eye lens	273	3.3%
Diabetes mellitus inadequate controldiabetes not well controlled	272	3.3%
Weight increasedweight gain	266	3.2%
Cerebrovascular accidentstroke	262	3.1%
Myocardial infarctionheart attack	258	3.1%
Headachehead pain	240	2.9%
Visual acuity reducedreduced sharpness of vision	238	2.8%
Blindnessloss of sight	232	2.8%
Feeling abnormalfeeling odd or not right	229	2.7%
Drug exposure during pregnancythe medicine was taken during pregnancy	227	2.7%
Loss of consciousnesspassing out	223	2.7%
Diarrhoealoose or frequent stools	222	2.7%
Eye haemorrhage	220	2.6%
Hypertensionhigh blood pressure	207	2.5%
Cardiac failure congestivecongestive heart failure	198	2.4%
Arthritis	197	2.4%
Dizzinesslight-headedness or unsteadiness	180	2.2%
Injection site painpain where the injection was given	177	2.1%
Astheniaweakness or lack of energy	169	2%
Chest pain	165	2%
Drug dose omissiona dose was missed	165	2%
Dyspnoeashortness of breath	163	1.9%
Hyperglycaemiahigh blood sugar	161	1.9%
Memory impairmentmemory problems	159	1.9%
Fatiguetiredness	157	1.9%
Nauseafeeling sick	157	1.9%
Renal failurekidney failure	157	1.9%
Painpain, site not specified	151	1.8%
Tremorshaking	151	1.8%
Abdominal pain upperupper stomach pain	148	1.8%
Cardiac disorder	147	1.8%
Vomitingbeing sick	143	1.7%
Insulin resistancethe body responding less to insulin	142	1.7%
Gait disturbancedifficulty walking	139	1.7%
Medication errora mistake in prescribing, dispensing or taking a medicine	136	1.6%

Download all 531 terms of Humulin R (CSV)

The counts add to more than 8,362 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 human with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Insulin human	Generic name	3,418
Afrezza	Brand name	1,216
Humulin	Brand name	251
Humulin 70/30	Brand name	6,870
Humulin N	Brand name	10,914
Humulin R (this page)	Brand name	8,362

Sum of the separately reported names: 31,031. 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 Humulin R, 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	405	397	15	16	240	44	1	295	8
2005	429	427	31	17	265	58	1	290	2
2006	309	304	21	12	165	27	1	194	5
2007	201	198	21	5	122	14	0	109	3
2008	223	217	19	5	117	5	3	126	6
2009	239	236	17	6	134	4	8	131	3
2010	281	276	37	8	133	10	5	167	5
2011	187	180	9	7	114	20	1	101	7
2012	187	185	13	10	103	21	0	112	2
2013	31	29	0	0	12	4	0	23	2
2014	94	88	4	4	41	9	2	60	6
2015	1,480	234	4	7	109	8	2	152	1,246
2016	530	281	17	7	136	9	0	173	249
2017	649	325	22	7	161	10	0	193	324
2018	533	283	12	11	142	12	1	160	250
2019	553	304	26	10	152	20	0	163	249
2020	504	281	18	5	144	19	0	160	223
2021	464	241	7	6	131	15	0	137	223
2022	313	164	11	4	78	17	0	94	149
2023	235	122	4	0	60	25	0	73	113
2024	177	98	8	2	51	29	0	63	79
2025	216	91	3	0	52	30	0	73	125
2026	122	71	4	1	41	17	0	48	51

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 Humulin R, 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 Humulin R, by the year in which FDA received them
Year	Reports
2004	377
2005	428
2006	324
2007	195
2008	189
2009	285
2010	292
2011	190
2012	199
2013	33
2014	100
2015	1,493
2016	539
2017	662
2018	526
2019	553
2020	507
2021	451
2022	309
2023	240
2024	157
2025	201
2026	112

Reports that name Humulin R, 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 Humulin R
Age	Reports	Share
Under 2	35	0.4%
2 to 11	32	0.4%
12 to 17	24	0.3%
18 to 44	538	6.4%
45 to 64	1,558	18.6%
65 to 74	904	10.8%
75 and over	504	6%
Age not given	4,767	57%

Sex of the patient in the reports that name Humulin R
Sex	Reports	Share
Female	4,338	51.9%
Male	3,606	43.1%
Unknown or not given	418	5%

Type of reporter in the reports that name Humulin R
Reporter	Reports	Share
Physician	568	6.8%
Pharmacist	219	2.6%
Other health professional	375	4.5%
Lawyer	2	under 0.1%
Consumer or non-health professional	6,504	77.8%
Not given	694	8.3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 73.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Humulin R record
Indication as recorded (MedDRA)	Reports	Share
Diabetes mellitus	2,485	29.7%
Type 2 diabetes mellitus	1,038	12.4%
Type 1 diabetes mellitus	516	6.2%
Gestational diabetes	162	1.9%
Diabetes mellitus insulin-dependent	78	0.9%
Diabetes mellitus non-insulin-dependent	53	0.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 8,362 reports.

Drugs in the same reports

Other drugs that the reports of Humulin R name, in any role, in order of name
Drug	Reports that name the two
Aspirin	212
Humalog	1,687
Humulin 70/30	476
Humulin N	2,823
Humulin R U-500	296
Insulin glargine	183
Lantus	1,206
Lipitor	174
Metformin	525
Novolog	245

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

Insulin human same ingredient
Afrezza same ingredient
Humulin same ingredient
Humulin 70/30 same ingredient
Humulin N same ingredient
Novolin 70/30 same class
Novolin N same class
Humulin Nph next in the A to Z list
Humulin R U 500 next in the A to Z list
Humulin R U-500 next in the A to Z list
Humulin L next in the A to Z list
Hyaluronate sodium 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 Humulin RThe 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. Humulin R: adverse event reports that FDA received. https://reportedreactions.com/drug/humulin-r/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Humulin R as a suspect or interacting product. The 4,717 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 Humulin R 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 Humulin R?

No. It is a count of what people reported to FDA: 8,362 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?

Consumer or non-health professional (77.8%), physician (6.8%) and other health professional (4.5%). 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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