Basaglar Tempo Peninsulin 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.
42,714 adverse event reports submitted to the FDA (2003–2026)
Top Reported Adverse Events
The most frequently reported events in association with Basaglar Tempo Pen 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.
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Blood Glucose Increased 6,993 reports
A blood test result showing a higher than normal blood sugar level.
Full definition in the glossary →Incorrect Dose Administered 2,484 reports
A report that the wrong dose was given or taken. This is a usage category, not a sign of a problem with the drug itself.
Full definition in the glossary →Drug Ineffective 2,029 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 →Visual Impairment 1,925 reports
Reduced ability to see.
Full definition in the glossary →Hypoglycaemia 1,772 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 →Blood Glucose Decreased 1,616 reports
A blood test result showing a lower than normal blood sugar level. The opposite of blood glucose increased.
Full definition in the glossary →Accidental Underdose 1,540 reports
A report that less of a medication was taken than intended, by accident. This is a usage category.
Full definition in the glossary →Nausea 1,433 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Injection Site Pain 1,394 reports
Pain at the spot on the body where a medication was injected.
Full definition in the glossary →Diarrhoea 1,297 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 →Inappropriate Schedule of Product Administration 1,254 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 →Fatigue 1,217 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Dyspnoea 1,191 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Glycosylated Haemoglobin Increased 1,152 reports
A higher than normal result on the HbA1c blood test, which reflects average blood sugar over the past few months. Also spelled hemoglobin in American English.
Full definition in the glossary →Vomiting 1,116 reports
Throwing up the contents of the stomach.
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 | 21,141 |
| Male | 18,772 |
| Unknown | 36 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 576 |
| 18-34 | 1,038 |
| 35-49 | 2,594 |
| 50-64 | 8,506 |
| 65-74 | 7,509 |
| 75+ | 5,858 |
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 Basaglar Tempo Pen. 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 | 18,157 |
| Other Serious | 14,653 |
| Hospitalization | 13,826 |
| Death | 2,838 |
| Life-Threatening | 2,073 |
| Disability | 917 |
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 Basaglar Tempo Pen. 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 | 299 |
| 2011 | 360 |
| 2012 | 264 |
| 2013 | 403 |
| 2014 | 423 |
| 2015 | 618 |
| 2016 | 740 |
| 2017 | 2,296 |
| 2018 | 4,876 |
| 2019 | 5,639 |
| 2020 | 4,715 |
| 2021 | 4,422 |
| 2022 | 4,523 |
| 2023 | 3,801 |
| 2024 | 3,925 |
| 2025 | 3,818 |
| 2026 (partial) | 826 |
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 Basaglar Tempo Pen
In FDA adverse event reports that mention Basaglar Tempo Pen, these medications appeared most often in the same report.
- Insulin Glargine-yfgn (20,794 reports)
- Metformin (8,129 reports)
- Insulin Lispro (7,306 reports)
- Insulin Aspart (5,295 reports)
- Furosemide (3,520 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