Basaglar Side Effects: FDA Label Numbers | Dose Track
[Side effects · Basaglar]

Basaglar side effects

insulin glargine 100 units/mL · once-daily injection under the skin, U-100 KwikPen or Tempo Pen · Label checked

Short answer: Low blood sugar (hypoglycemia) is the most common Basaglar side effect, as with all insulin. In the label's Basaglar trials, infection affected 24% and nasopharyngitis 16% of adults with type 1 diabetes, and 17% and 6% with type 2. Severe low blood sugar affected 4% in type 1 at 52 weeks and 1% in type 2 at 24 weeks. Basaglar has no boxed warning.

What Basaglar is approved for: Basaglar is a long-acting insulin approved to improve blood sugar control in adults and children with type 1 diabetes and in adults with type 2 diabetes (section 1). It is not recommended for treating diabetic ketoacidosis.

Source
BASAGLAR (insulin glargine) injection, for subcutaneous use, 100 units/mL, prescribing information, Patient Information and Instructions for Use. Eli Lilly and Company. DailyMed, version published August 10, 2026. DailyMed setid 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae

Does Basaglar have a boxed warning?

No. The current Basaglar label has no boxed warning.

What are the most common Basaglar side effects?

These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Basaglar.

Table 1: Adverse reactions occurring in ≥5% of adult patients with type 1 diabetes treated with BASAGLAR in a 52-week trial [Section 6.1]
Adverse reactionBASAGLAR + insulin lispro, % (n=268)
Infection24
Nasopharyngitis16
Upper respiratory tract infection8

Basaglar with insulin lispro; the table has no comparator column. "Infection" means infections other than nasopharyngitis or upper respiratory tract infection. Mean exposure was 49 weeks.

Table 2: Adverse reactions occurring in ≥5% of adult patients with type 2 diabetes treated with BASAGLAR in a 24-week trial [Section 6.1]
Adverse reactionBASAGLAR + oral antidiabetic medication, % (n=376)
Infection17
Nasopharyngitis6
Upper respiratory tract infection5

Basaglar with oral diabetes medicines; no comparator column. Mean exposure was 22 weeks.

Table 3: Common adverse reactions in 5-year trial of adult patients with type 2 diabetes (incidence ≥10% and higher with another insulin glargine product, 100 units/mL, than comparator) [Section 6.1]
Adverse reactionAnother insulin glargine product, % (n=514)NPH, % (n=503)
Hypertension2019
Sinusitis1918
Cataract1816
Bronchitis1514
Back pain1312
Cough127
Urinary tract infection1110
Diarrhea1110
Depression1110
Headache109

This trial used another insulin glargine 100 units/mL product, not Basaglar itself, against NPH insulin.

Table 5: Severe Symptomatic Hypoglycemia in the ORIGIN Trial [Section 6.1]
MeasureAnother insulin glargine product (N=6231)Standard care (N=6273)
Percent of patients62

Another insulin glargine 100 units/mL product against standard care, median follow-up 6.2 years.

Other numbers in the Adverse Reactions section

  • Section 6.1

    Severe symptomatic low blood sugar on Basaglar: 4% of people with type 1 diabetes at 52 weeks and 1% with type 2 diabetes at 24 weeks. In a trial of another insulin glargine 100 units/mL product in children aged 6 to 15 with type 1 diabetes, it was 23% at 26 weeks.

  • Section 6.1

    Table 4: in a 28-week trial of another insulin glargine product in children with type 1 diabetes, rhinitis occurred in 5% on glargine (n=174) and 5% on NPH (n=175).

  • Section 6.1

    Redness, local swelling and itching at the injection site have occurred and were usually self-limiting. Severe whole-body allergy (anaphylaxis) has been reported. Swelling from sodium retention, skin pits or thickening (lipodystrophy) and weight gain can also occur.

  • Section 6.2

    In a 52-week type 1 study, 42% on Basaglar tested positive for anti-drug antibodies at least once (17% at baseline, 25% developed them). In a 24-week type 2 study, 17% did (5% at baseline, 12% developed them). The label says there was no evidence the antibodies affected efficacy or safety.

  • Section 6.3

    Reported after approval: other insulins, especially rapid-acting ones, given by mistake instead of insulin glargine; and localized cutaneous amyloidosis (lumps under the skin) at injection sites, which has affected blood sugar control.

What serious risks does the Basaglar label warn about?

The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.

  • Section 4

    Who should not use it. Basaglar is not used during an episode of low blood sugar, or by people allergic to insulin glargine or its ingredients.

  • Section 5.1

    Never share a pen. A Basaglar pen is never shared between people, even if the needle is changed, because of the risk of passing on blood-borne infections.

  • Section 5.2

    Changes in insulin regimen. Changing insulin strength, maker, type, injection site or method can cause high or low blood sugar, so changes are made under close medical supervision with more glucose checks.

  • Section 5.3

    Low blood sugar. Hypoglycemia is the most common reaction to insulin, and severe episodes can cause seizures or death. Basaglar's long action may delay recovery from a low. Awareness of lows may be reduced with long diabetes, nerve damage, beta-blockers or repeated lows.

  • Section 5.4

    Medication mix-ups. Mix-ups between insulin products have been reported, so the insulin label is checked before each injection.

  • Section 5.5

    Serious allergic reactions. Severe, life-threatening whole-body allergy, including anaphylaxis, can occur; Basaglar is stopped if it does.

  • Section 5.6

    Low potassium. All insulins shift potassium into cells and can cause low potassium, which untreated can cause breathing paralysis, heart rhythm problems and death.

  • Section 5.7

    Heart failure with TZDs. Thiazolidinediones (such as pioglitazone) with insulin can cause fluid retention that may lead to or worsen heart failure.

When does the label say to call your doctor?

From the Patient Information that comes with Basaglar:

  • Trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue or throat, sweating, extreme drowsiness, dizziness or confusion: get emergency medical help.
  • New or worse heart failure while taking a TZD with Basaglar: treatment may need to be changed or stopped by your healthcare provider.
  • Side effects in general: call your doctor for medical advice about side effects.

How do I keep track of side effects in Dose Track?

Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.

This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.

Side effects for similar medicines

Frequently asked questions

What is the most common side effect of Basaglar?+
Low blood sugar (hypoglycemia), as with all insulins (sections 5.3 and 6.1). Leaving that aside, infection (24%) and nasopharyngitis (16%) were most common in adults with type 1 diabetes (section 6.1, Table 1).
How often did severe low blood sugar happen on Basaglar?+
4% of adults with type 1 diabetes over 52 weeks and 1% of adults with type 2 diabetes over 24 weeks (section 6.1).
Does Basaglar have a boxed warning?+
No. The Basaglar label has no boxed warning. Its warnings cover pen sharing, regimen changes, low blood sugar, mix-ups, allergic reactions, low potassium and heart failure with TZDs (section 5).
Does Basaglar cause weight gain?+
It can. The label says weight gain has occurred with insulins including Basaglar, attributed to insulin's anabolic effects and less sugar lost in the urine (section 6.1).
Why does the Basaglar label show trials of another insulin glargine?+
Tables 3 to 5 of the Basaglar label come from trials of "another insulin glargine product, 100 units/mL", including a 5-year type 2 trial and the ORIGIN trial. Tables 1 and 2 are Basaglar's own trials (section 6.1).