Novorapid adverse event reports that FDA received

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

Name type: Product name as reported

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 February 2004 to June 2026, FDA received 6,983 adverse event reports that name Novorapid. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 13,773 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 571 reports in the 12 months to June 2026 and 603 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, 571 (under 0.1%) name Novorapid. Reports for male patients were 41.7% of the reports that name Novorapid and 34.6% 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 Novorapid 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 96 reports that name Novorapid.
In January to March 2026, FDA received 142.
In April to June 2025, FDA received 140.

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 574 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 6,983 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 574 terms.

Reaction terms in the reports that name Novorapid, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 6,983 reports
Hypoglycaemialow blood sugar	1,094	15.7%
Diabetic ketoacidosisa serious complication of diabetes with acid build-up	870	12.5%
Blood glucose increasedraised blood sugar reading	580	8.3%
Hyperglycaemiahigh blood sugar	419	6%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	390	5.6%
Product leakage	345	4.9%
Dyspnoeashortness of breath	314	4.5%
Drug ineffectivethe medicine did not work as expected	295	4.2%
Vomitingbeing sick	282	4%
Pneumonialung infection	263	3.8%
Malaisegeneral feeling of being unwell	249	3.6%
Condition aggravatedthe condition being treated got worse	241	3.5%
Exposure during pregnancythe medicine was taken during pregnancy	237	3.4%
Pruritusitching	205	2.9%
Diabetes mellitus inadequate controldiabetes not well controlled	204	2.9%
Myocardial infarctionheart attack	202	2.9%
Abdominal painstomach or belly pain	195	2.8%
Asthma	190	2.7%
Falla fall	187	2.7%
Nauseafeeling sick	183	2.6%
Loss of consciousnesspassing out	182	2.6%
Fatiguetiredness	181	2.6%
Weight decreasedweight loss	172	2.5%
Premature babya baby born early	169	2.4%
Dizzinesslight-headedness or unsteadiness	166	2.4%
Hyperhidrosisexcessive sweating	166	2.4%
Hospitalisationadmission to hospital	159	2.3%
Hypertensionhigh blood pressure	159	2.3%
Depressionlow mood	157	2.2%
Off label useused for a purpose or in a way not on the label	157	2.2%
Anxiety	152	2.2%
Intentional overdosea deliberate overdose	151	2.2%
Product physical issuea physical defect in the product	151	2.2%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	149	2.1%
Deaththe patient died; cause not stated by this term	148	2.1%
Hypoglycaemic coma	143	2%
Diarrhoealoose or frequent stools	135	1.9%
Obstructive airways disorder	133	1.9%
Upper respiratory tract infectiona cold or similar infection	132	1.9%
Suicide attempta suicide attempt	131	1.9%
Pyrexiafever	128	1.8%
Urticariahives	127	1.8%
Pulmonary embolisma blood clot in the lung	126	1.8%
Sleep apnoea syndromepauses in breathing during sleep	126	1.8%
Stress	126	1.8%
Thrombosis	121	1.7%
Sepsisa severe body-wide response to infection	116	1.7%
Astheniaweakness or lack of energy	115	1.6%
General physical health deteriorationgeneral decline in health	115	1.6%
Somnolencedrowsiness	115	1.6%

Download all 574 terms of Novorapid (CSV)

The counts add to more than 6,983 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 Novorapid, 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	16	16	0	0	5	1	0	10	0
2005	29	28	4	4	7	3	0	17	1
2006	35	35	5	3	21	1	0	12	0
2007	42	42	6	3	25	3	0	14	0
2008	63	63	3	6	36	2	2	33	0
2009	88	88	5	6	48	4	6	53	0
2010	79	79	8	6	48	0	2	34	0
2011	54	54	6	1	34	2	1	22	0
2012	70	68	10	10	35	2	1	34	2
2013	156	155	21	13	104	1	1	56	1
2014	271	265	20	23	168	6	2	97	6
2015	471	466	28	26	316	8	23	171	5
2016	354	349	33	25	211	10	6	161	5
2017	434	434	27	20	282	9	5	201	0
2018	662	652	43	69	433	8	17	291	10
2019	598	596	25	84	382	4	7	285	2
2020	616	616	38	44	350	8	7	311	0
2021	579	572	50	41	293	5	13	313	7
2022	413	409	37	27	199	11	6	260	4
2023	400	398	44	44	215	36	3	268	2
2024	541	537	42	59	303	17	3	370	4
2025	661	655	61	102	376	31	22	498	6
2026	351	348	56	60	210	41	33	242	3

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 Novorapid, 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 Novorapid, by the year in which FDA received them
Year	Reports
2004	13
2005	30
2006	33
2007	45
2008	63
2009	90
2010	81
2011	64
2012	83
2013	172
2014	410
2015	363
2016	349
2017	485
2018	693
2019	585
2020	631
2021	590
2022	407
2023	424
2024	523
2025	611
2026	238

Reports that name Novorapid, 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 Novorapid
Age	Reports	Share
Under 2	63	0.9%
2 to 11	154	2.2%
12 to 17	289	4.1%
18 to 44	1,281	18.3%
45 to 64	1,565	22.4%
65 to 74	969	13.9%
75 and over	950	13.6%
Age not given	1,712	24.5%

Sex of the patient in the reports that name Novorapid
Sex	Reports	Share
Female	3,699	53%
Male	2,913	41.7%
Unknown or not given	371	5.3%

Type of reporter in the reports that name Novorapid
Reporter	Reports	Share
Physician	1,813	26%
Pharmacist	502	7.2%
Other health professional	1,486	21.3%
Lawyer	3	under 0.1%
Consumer or non-health professional	3,133	44.9%
Not given	46	0.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 1.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Novorapid record
Indication as recorded (MedDRA)	Reports	Share
Type 1 diabetes mellitus	1,455	20.8%
Diabetes mellitus	1,398	20%
Type 2 diabetes mellitus	1,335	19.1%
Gestational diabetes	255	3.7%
Diabetes mellitus insulin-dependent	33	0.5%
Suicide attempt	25	0.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 6,983 reports.

Drugs in the same reports

Other drugs that the reports of Novorapid name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	235
Albuterol	263
Aspirin	304
Furosemide	333
Insulin aspart	208
Insulin glargine	464
Lantus	1,382
Levemir	853
Metformin	544
Tresiba	680

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.

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Official pages

DailyMed labels for NovorapidThe 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. Novorapid: adverse event reports that FDA received. https://reportedreactions.com/drug/novorapid/ 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 Novorapid as a suspect or interacting product. The 13,773 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 Novorapid 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 Novorapid?

No. It is a count of what people reported to FDA: 6,983 reports from February 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 (44.9%), physician (26%) and other health professional (21.3%). 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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