What the label lists and what reports show
Glyburide and metformin side effects
Glyburide and metformin's FDA label: “Most common (>5%) adverse reactions to glyburide and metformin hydrochloride diarrhea, headache, nausea/vomiting, abdominal pain, and dizziness.” FAERS holds 216 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 (22 reports).
- Generic listed
- Boxed warning
Check it at the source: the glyburide and metformin FDA label on DailyMed (effective June 30, 2026, Aurobindo Pharma Limited); 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 glyburide and metformin hydrochloride tablets?Glyburide and metformin hydrochloride tablets can cause serious side effects, including: See “What is the most important information I should know about glyburide and metformin hydrochloride tablets?” low blood sugar (hypoglycemia). Low blood sugar is a serious, but common side effect of glyburide and metformin hydrochloride tablets. If you take glyburide and metformin hydrochloride tablets with another medicine that can cause low blood sugar, such as insulin, you have a higher risk of getting low blood sugar. The dose of insulin or other diabetic medicines may need to be lowered while you take glyburide and metformin hydrochloride tablets. […]
Source: FDA drug label, Aurobindo Pharma Limited, effective June 30, 2026 (SPL set 7010b662-8b34-49ce-8e5b-73dee0821a60), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common (>5%) adverse reactions to glyburide and metformin hydrochloride diarrhea, headache, nausea/vomiting, abdominal pain, and dizziness.
Table 1: Adverse Reactions Occurring >5% in Double-Blind Clinical Studies of Glyburide And Metformin Hydrochloride Used as Initial (20 Weeks) or Second-Line (14 Weeks) Therapy
| Reaction | Placebo N=161 | Glyburide N=324 | Metformin HCl N=312 | Glyburide and Metformin Hydrochloride N=642 |
|---|---|---|---|---|
| Diarrhea | 6% | 6% | 21% | 17% |
| Headache | 11% | 11% | 9% | 9% |
| Nausea/vomiting | 6% | 5% | 12% | 8% |
| Abdominal pain | 4% | 3% | 8% | 7% |
| Dizziness | 4% | 6% | 4% | 6% |
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 adverse reactions are also discussed elsewhere in the labeling: Lactic Acidosis [see Boxed Warning and Warnings and Precautions (5.1) ] Hypoglycemia [see Warnings and Precautions (5.2) ] Cardiovascular mortality [see Warnings and Precautions (5.3) ] Hemolytic anemia [see Warnings and Precautions (5.4) ] Vitamin B 12 Deficiency [ see Warnings and Precautions (5.5) ] Most common (>5%) adverse reactions to glyburide and metformin hydrochloride diarrhea, headache, nausea/vomiting, abdominal pain, and dizziness. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In double-blind clinical studies with glyburide and metformin hydrochloride as initial therapy or as second-line therapy of 20 and 14 weeks, respectively (see section 14 ), a total of 642 patients received glyburide and metformin hydrochloride, 312 received metformin HCl, 324 received glyburide, and 161 received placebo. Adverse reactions are listed in Table 1.
Source: FDA drug label, Aurobindo Pharma Limited, effective June 30, 2026 (SPL set 7010b662-8b34-49ce-8e5b-73dee0821a60), via openFDA; the full label on DailyMed
What do FAERS reports show?
216 reports list glyburide and metformin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 16 are coded as a death and 85 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.
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?
- Glyburide and metformin: 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