Insulin Glargine vs Insulin Aspart: side effects in FDA adverse event reports
At a glance
| Insulin Glargine | Insulin Aspart | |
|---|---|---|
| Drug class | Insulin Analog | Insulin Analog |
| Brand names | Toujeo | Novolog |
| FAERS reports | 245,215 | 62,953 |
| Serious | 52% | 63% |
| Death outcome | 13,511 | 4,460 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Insulin Glargine | Insulin Aspart | Label screen (A / B) |
|---|---|---|---|
| Diabetes mellitus inadequate control | 3,604 · PRR 21.7 | 1,047 · PRR 20.0 | Labeled (related wording) / Labeled (related wording) |
| Diabetic retinopathy | 823 · PRR 27.1 | 320 · PRR 33.1 | Labeled adverse reaction / Labeled adverse reaction |
| Hypoglycaemic unconsciousness | 568 · PRR 34.0 | 400 · PRR 80.4 | Not in label — unassessed / Labeled (related wording) |
| Hypoglycaemic seizure | 230 · PRR 28.5 | 139 · PRR 57.2 | Not in label — unassessed / Labeled (related wording) |
| Hypoglycaemic coma | 611 · PRR 22.7 | 197 · PRR 23.3 | Not in label — unassessed / Not in label — unassessed |
| Pulmonary vasculitis | 189 · PRR 47.3 | 146 · PRR 121.9 | Not in label — unassessed / Not in label — unassessed |
| Neuritis | 198 · PRR 12.5 | 132 · PRR 29.9 | Not in label — unassessed / Not in label — unassessed |
| Chronic kidney disease-mineral and bone disorder | 135 · PRR 12.1 | 96 · PRR 31.2 | Not in label — unassessed / Not in label — unassessed |
| Total lung capacity abnormal | 112 · PRR 35.4 | 102 · PRR 116.8 | Not in label — unassessed / Not in label — unassessed |
| Dust allergy | 109 · PRR 10.8 | 70 · PRR 24.9 | Not in label — unassessed / Not in label — unassessed |
| Mycotic allergy | 111 · PRR 12.8 | 68 · PRR 27.9 | Not in label — unassessed / Not in label — unassessed |
| Mite allergy | 107 · PRR 17.1 | 68 · PRR 38.0 | Not in label — unassessed / Not in label — unassessed |
| Shock hypoglycaemic | 116 · PRR 27.3 | 39 · PRR 28.4 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Insulin Glargine
- Hypoglycaemia — n=7,973, PRR 16.6 Labeled adverse reaction
- Hyperglycaemia — n=4,714, PRR 12.6 Labeled adverse reaction
- Diabetic neuropathy — n=639, PRR 12.5 Labeled adverse reaction
- Diabetic coma — n=347, PRR 11.8 Labeled (related wording)
- Diabetic metabolic decompensation — n=300, PRR 23.4 Labeled (related wording)
- Adjustment disorder — n=183, PRR 13.8 Labeled (related wording)
- Hypoglycaemia unawareness — n=123, PRR 44.2 Labeled adverse reaction
Labeled signals distinctive to Insulin Aspart
- Respiratory symptom — n=172, PRR 20.8 Labeled (related wording)
Common questions
Which has more reported side effects, Insulin Glargine or Insulin Aspart?
Insulin Glargine has 245,215 FAERS reports and Insulin Aspart 62,953. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (52% vs 63%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Insulin Glargine and Insulin Aspart share?
Both drugs carry disproportionality signals for diabetes mellitus inadequate control, diabetic retinopathy, hypoglycaemic unconsciousness, hypoglycaemic seizure, hypoglycaemic coma. Shared signals often reflect a shared drug class or the condition both are used for.
Is Insulin Glargine or Insulin Aspart safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.