Lantusinsulin glargine
According to the FDA label: BASAGLAR ® is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. BASAGLAR ® is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use : Not recommended for treating diabetic ketoacidosis.
145,088 adverse event reports submitted to the FDA (2001–2026)
Top Reported Adverse Events
The most frequently reported events in association with Lantus in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Blood Glucose Increased 21,397 reports
A blood test result showing a higher than normal blood sugar level.
Full definition in the glossary →Nausea 7,908 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 6,753 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Blood Glucose Decreased 6,584 reports
A blood test result showing a lower than normal blood sugar level. The opposite of blood glucose increased.
Full definition in the glossary →Hypoglycaemia 6,339 reports
A low level of sugar in the blood, which can cause shakiness, sweating, and confusion. Also spelled hypoglycemia in American English.
Full definition in the glossary →Diarrhoea 5,419 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Fatigue 5,264 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Vomiting 5,022 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Weight Decreased 4,977 reports
Dyspnoea 4,948 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 4,805 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Fall 4,575 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Malaise 4,406 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Dizziness 4,304 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Asthenia 4,160 reports
Physical weakness or lack of strength.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 71,519 |
| Male | 63,240 |
| Unknown | 642 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 2,014 |
| 18-34 | 3,637 |
| 35-49 | 9,776 |
| 50-64 | 31,533 |
| 65-74 | 26,917 |
| 75+ | 19,625 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Lantus. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 56,959 |
| Hospitalization | 52,168 |
| Non-Serious | 48,280 |
| Death | 11,486 |
| Life-Threatening | 6,321 |
| Disability | 3,875 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Lantus. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2001 | 1 |
| 2003 | 2 |
| 2004 | 1,035 |
| 2005 | 1,806 |
| 2006 | 3,269 |
| 2007 | 3,325 |
| 2008 | 2,950 |
| 2009 | 3,915 |
| 2010 | 5,376 |
| 2011 | 6,259 |
| 2012 | 5,294 |
| 2013 | 6,074 |
| 2014 | 8,490 |
| 2015 | 15,061 |
| 2016 | 10,086 |
| 2017 | 9,218 |
| 2018 | 12,578 |
| 2019 | 10,526 |
| 2020 | 8,908 |
| 2021 | 6,807 |
| 2022 | 6,147 |
| 2023 | 4,961 |
| 2024 | 5,381 |
| 2025 | 6,136 |
| 2026 (partial) | 1,483 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Lantus
In FDA adverse event reports that mention Lantus, these medications appeared most often in the same report.
- Insulin Lispro (39,735 reports)
- Metformin (24,107 reports)
- Insulin Glargine-yfgn (20,802 reports)
- Insulin Aspart (18,320 reports)
- Furosemide (17,358 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026