Lantus Solostarinsulin glargine
According to the FDA label: LANTUS is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. LANTUS is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 ) Limitations of Use Not recommended for the treatment of diabetic ketoacidosis. ( 1 ) Limitations of Use LANTUS is not recommended for the treatment of diabetic ketoacidosis.
71,538 adverse event reports submitted to the FDA (2003–2026)
Top Reported Adverse Events
The most frequently reported events in association with Lantus Solostar 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
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Blood Glucose Increased 9,138 reports
A blood test result showing a higher than normal blood sugar level.
Full definition in the glossary →Off Label Use 6,861 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 →Inappropriate Schedule of Product Administration 6,418 reports
A report that the medication was taken on the wrong schedule, such as too often, not often enough, or at the wrong time. This is a usage category, not a sign of a problem with the drug.
Full definition in the glossary →Product Storage Error 5,402 reports
A report that a medication was stored incorrectly, for example at the wrong temperature. This is a handling category, not a sign of a problem with the drug.
Full definition in the glossary →Visual Impairment 3,761 reports
Reduced ability to see.
Full definition in the glossary →Drug Ineffective 2,293 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 →Hypoglycaemia 2,224 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 →Device Issue 2,130 reports
A general report of a problem with a medical device, used when no more specific issue is named.
Full definition in the glossary →Blood Glucose Decreased 2,086 reports
A blood test result showing a lower than normal blood sugar level. The opposite of blood glucose increased.
Full definition in the glossary →Injection Site Pain 2,078 reports
Pain at the spot on the body where a medication was injected.
Full definition in the glossary →Product Use Issue 1,871 reports
A general report that there was some problem in how the medication was used.
Full definition in the glossary →Malaise 1,740 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Dyspnoea 1,543 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Hyperglycaemia 1,491 reports
A high level of sugar in the blood. Also spelled hyperglycemia in American English.
Full definition in the glossary →Nausea 1,477 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →
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 | 36,511 |
| Male | 29,055 |
| Unknown | 102 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 705 |
| 18-34 | 1,530 |
| 35-49 | 4,560 |
| 50-64 | 17,306 |
| 65-74 | 17,483 |
| 75+ | 14,151 |
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 Solostar. 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 |
|---|---|
| Non-Serious | 39,018 |
| Other Serious | 20,643 |
| Hospitalization | 16,090 |
| Death | 3,237 |
| Life-Threatening | 2,201 |
| Disability | 1,470 |
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 Solostar. 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 |
|---|---|
| 2003 | 1 |
| 2004 | 99 |
| 2005 | 108 |
| 2006 | 89 |
| 2007 | 109 |
| 2008 | 169 |
| 2009 | 191 |
| 2010 | 322 |
| 2011 | 372 |
| 2012 | 576 |
| 2013 | 2,570 |
| 2014 | 4,134 |
| 2015 | 4,545 |
| 2016 | 3,198 |
| 2017 | 3,003 |
| 2018 | 6,692 |
| 2019 | 5,910 |
| 2020 | 4,433 |
| 2021 | 5,454 |
| 2022 | 5,810 |
| 2023 | 5,726 |
| 2024 | 7,449 |
| 2025 | 8,750 |
| 2026 (partial) | 1,828 |
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 Solostar
In FDA adverse event reports that mention Lantus Solostar, these medications appeared most often in the same report.
- Insulin Glargine-yfgn (20,794 reports)
- Metformin (7,986 reports)
- Insulin Lispro (6,766 reports)
- Insulin Aspart (5,859 reports)
- Aspirin (4,416 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