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What the label lists and what reports show

Insulin glargine side effects

Insulin glargine's FDA label lists its adverse reactions in its own words. FAERS holds 245,619 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is blood glucose increased (39,069 reports).

  • No generic listed
  • A presentation discontinued

Check it at the source: the insulin glargine FDA label on DailyMed (effective June 16, 2026, Eli Lilly and Company); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of BASAGLAR?

BASAGLAR may cause serious side effects that can lead to death, including: low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include: dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, hunger. severe allergic reaction (whole body reaction). Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction: a rash over your whole body, trouble breathing, a fast heartbeat, or sweating. low potassium in your blood (hypokalemia). heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with BASAGLAR may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. […]

Source: FDA drug label, Eli Lilly and Company, effective June 16, 2026 (SPL set 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

The following adverse reactions are discussed elsewhere: Hypoglycemia [see Warnings and Precautions ( 5.3 )]. Hypoglycemia Due to Medication Errors [see Warnings and Precautions ( 5.4 )]. Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )]. Hypokalemia [see Warnings and Precautions ( 5.6 )]. Adverse reactions commonly (≥5%) associated with insulin glargine products are: Hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, rash, edema, and weight gain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

Table 3: Common adverse reactions in 5-year trial of adult patients with type 2 diabetes (adverse reactions with incidence ≥10% and higher with another insulin glargine product, 100 units/mL, than comparator)

ReactionAnother Insulin Glargine Product, % (n=514)NPH, % (n=503)
Hypertension2019
Sinusitis1918
Cataract1816
Bronchitis1514
Back pain1312
Cough127
Urinary tract infection1110
Diarrhea1110
Depression1110
Headache109

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

Source: FDA drug label, Eli Lilly and Company, effective June 16, 2026 (SPL set 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae), via openFDA; the full label on DailyMed

What do FAERS reports show?

245,619 reports list insulin glargine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 13,523 are coded as a death and 64,727 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Blood Glucose Increased39,069
  • Off Label Use (a use or a product term, not a reaction)13,894
  • Drug Ineffective (a use or a product term, not a reaction)10,643
  • Blood Glucose Decreased10,513
  • Inappropriate Schedule Of Product Administration (a use or a product term, not a reaction)10,214
  • Nausea9,931
  • Product Storage Error8,892
  • Visual Impairment8,814
  • Hypoglycaemia (named in the label)7,988
  • Diarrhoea (named in the label)7,243
  • Fatigue7,009
  • Incorrect Dose Administered (a use or a product term, not a reaction)6,825
  • Malaise6,673
  • Injection Site Pain6,424
  • Weight Decreased6,420
  • Dyspnoea6,381
  • Vomiting6,324
  • Fall6,165
  • Dizziness (named in the label)6,064
  • Headache (named in the label)5,507
  • Asthenia5,399
  • Pain5,125
  • Glycosylated Haemoglobin Increased4,904
  • Hyperglycaemia (named in the label)4,717
  • Death (an outcome recorded in the report)4,660

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Insulin glargine: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions