What the label lists and what reports show
Glimepiride side effects
Glimepiride's FDA label: “In clinical trials, the most common adverse reactions with glimepiride were hypoglycemia, dizziness, asthenia, headache, and nausea.” FAERS holds 38,737 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 (3,006 reports).
- Generic listed
Check it at the source: the glimepiride FDA label on DailyMed (effective May 12, 2025, Micro Labs Limited); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsIn clinical trials, the most common adverse reactions with glimepiride were hypoglycemia, dizziness, asthenia, headache, and nausea.
Table 1: Eleven Pooled Placebo-Controlled Trials ranging from 13 weeks to 12 months:…
| Reaction | Glimepiride N=745 % | Placebo N=294 % |
|---|---|---|
| Headache | 8.2 | 7.8 |
| Accidental Injury | 5.8 | 3.4 |
| Flu Syndrome | 5.4 | 4.4 |
| Nausea | 5 | 3.4 |
| Dizziness | 5 | 2.4 |
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.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed in more detail below and elsewhere in the labeling: Hypoglycemia [see Warnings and Precautions (5.1) ] Hemolytic anemia [see Warnings and Precautions (5.3) ] Common adverse reactions in clinical trials (≥5% and more common than with placebo) include hypoglycemia, headache, nausea, and dizziness ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA, Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Approximately 2,800 patients with type 2 diabetes have been treated with glimepiride in the controlled clinical trials. In these trials, approximately 1,700 patients were treated with glimepiride for at least 1 year. In clinical trials, the most common adverse reactions with glimepiride were hypoglycemia, dizziness, asthenia, headache, and nausea. Table 1 summarizes adverse events, other than hypoglycemia, that were reported in 11 pooled placebo-controlled trials, whether or not considered to be possibly or probably related to study medication. Treatment duration ranged from 13 weeks to 12 months. …
Source: FDA drug label, Micro Labs Limited, effective May 12, 2025 (SPL set 60e9397e-83b9-489e-9683-6f87e458bbaa), via openFDA; the full label on DailyMed
What do FAERS reports show?
38,737 reports list glimepiride among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3,272 are coded as a death and 13,866 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 22 reactions below, 7 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Glimepiride: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions