Insulin Glargine vs Insulin Glargine-Yfgn: side effects in FDA adverse event reports
At a glance
| Insulin Glargine | Insulin Glargine-Yfgn | |
|---|---|---|
| Drug class | Insulin Analog | Insulin Analog |
| Brand names | Toujeo | Insulin Glargine |
| FAERS reports | 245,215 | 21,736 |
| Serious | 52% | 88% |
| Death outcome | 13,511 | 2,408 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Insulin Glargine | Insulin Glargine-Yfgn | Label screen (A / B) |
|---|---|---|---|
| Hypoglycaemia | 7,973 · PRR 16.6 | 1,654 · PRR 34.0 | Labeled adverse reaction / Labeled adverse reaction |
| Diabetic metabolic decompensation | 300 · PRR 23.4 | 145 · PRR 112.8 | Labeled (related wording) / Labeled (related wording) |
| Hypoglycaemia unawareness | 123 · PRR 44.2 | 14 · PRR 39.0 | Labeled adverse reaction / Labeled adverse reaction |
| Hypoglycaemic coma | 611 · PRR 22.7 | 129 · PRR 45.0 | Not in label — unassessed / Not in label — unassessed |
| Neuritis | 198 · PRR 12.5 | 183 · PRR 130.2 | Not in label — unassessed / Not in label — unassessed |
| Pulmonary vasculitis | 189 · PRR 47.3 | 186 · PRR 526.3 | Not in label — unassessed / Not in label — unassessed |
| Total lung capacity abnormal | 112 · PRR 35.4 | 107 · PRR 378.2 | Not in label — unassessed / Not in label — unassessed |
| Mycotic allergy | 111 · PRR 12.8 | 104 · PRR 135.8 | Not in label — unassessed / Not in label — unassessed |
| Dust allergy | 109 · PRR 10.8 | 104 · PRR 116.6 | Not in label — unassessed / Not in label — unassessed |
| Mite allergy | 107 · PRR 17.1 | 104 · PRR 188.0 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Insulin Glargine
- Hyperglycaemia — n=4,714, PRR 12.6 Labeled adverse reaction
- Diabetes mellitus inadequate control — n=3,604, PRR 21.7 Labeled (related wording)
- Diabetic retinopathy — n=823, PRR 27.1 Labeled adverse reaction
- Diabetic neuropathy — n=639, PRR 12.5 Labeled adverse reaction
- Diabetic coma — n=347, PRR 11.8 Labeled (related wording)
- Adjustment disorder — n=183, PRR 13.8 Labeled (related wording)
Labeled signals distinctive to Insulin Glargine-Yfgn
- Respiratory symptom — n=180, PRR 66.2 Labeled (related wording)
- Systemic infection — n=96, PRR 59.0 Labeled (related wording)
- Therapeutic drug monitoring analysis not performed — n=31, PRR 112.1 Labeled (related wording)
- Therapeutic drug monitoring analysis incorrectly performed — n=22, PRR 286.6 Labeled (related wording)
Common questions
Which has more reported side effects, Insulin Glargine or Insulin Glargine-Yfgn?
Insulin Glargine has 245,215 FAERS reports and Insulin Glargine-Yfgn 21,736. 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 88%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Insulin Glargine and Insulin Glargine-Yfgn share?
Both drugs carry disproportionality signals for hypoglycaemia, diabetic metabolic decompensation, hypoglycaemia unawareness, hypoglycaemic coma, neuritis. Shared signals often reflect a shared drug class or the condition both are used for.
Is Insulin Glargine or Insulin Glargine-Yfgn 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.