Glimepiride Side Effects: FDA Label Numbers vs Placebo
[Side effects · Glimepiride Tablets]

Glimepiride Tablets side effects

glimepiride (generic Amaryl) · once-daily oral tablet, 1 mg, 2 mg or 4 mg · Label checked

Short answer: Low blood sugar (hypoglycemia) is the main glimepiride side effect. In one 22-week trial, possible low blood sugar was reported by 19.7% on glimepiride vs 3.2% on placebo. In pooled trials, other common events were headache (8.2% vs 7.8%), accidental injury, flu syndrome, nausea and dizziness (5% vs 2.4%). It can also cause weight gain. There is no boxed warning.

What Glimepiride Tablets is approved for: Glimepiride is a sulfonylurea approved, along with diet and exercise, to improve blood sugar control in adults with type 2 diabetes. It is not for type 1 diabetes or diabetic ketoacidosis (section 1). Amaryl is the original brand; this page uses a current generic label because Amaryl has no current label on DailyMed.

Source
Glimepiride Tablets, USP 1 mg, 2 mg and 4 mg, prescribing information. Aurobindo Pharma. DailyMed, version published April 13, 2026. DailyMed setid 28eefc95-d92e-4555-b6c5-2933860b0610

Does Glimepiride Tablets have a boxed warning?

No. The current Glimepiride Tablets label has no boxed warning.

What are the most common Glimepiride Tablets side effects?

These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Glimepiride Tablets.

Table 1: Eleven Pooled Placebo-Controlled Trials ranging from 13 weeks to 12 months: Adverse Events (excluding hypoglycemia) Occurring in ≥5% of Glimepiride-treated Patients and at a Greater Incidence than with Placebo [Section 6.1]
Adverse eventGlimepiride (N=745) %Placebo (N=294) %
Headache8.27.8
Accidental Injury5.83.4
Flu Syndrome5.44.4
Nausea53.4
Dizziness52.4

Glimepiride doses ranged from 1 to 16 mg daily. The label notes there was not enough information to tell whether any accidental injuries were linked to low blood sugar.

Possible hypoglycemia in two monotherapy trials, from the text of section 6.1 [Section 6.1]
Trial and doseGlimepiride %Placebo %
14 weeks, 1 mg40
14 weeks, 4 mg170
14 weeks, 8 mg160
22 weeks, titrated 1 to 8 mg19.73.2

Possible hypoglycemia meant at least one symptom the investigator thought might be from low blood sugar; a glucose reading was not required. All events were self-treated.

Other numbers in the Adverse Reactions section

  • Section 6.1

    The label lists the most common reactions in trials as hypoglycemia, dizziness, asthenia (weakness), headache and nausea. About 2,800 people with type 2 diabetes took glimepiride in the controlled trials.

  • Section 6.1

    Allergic skin reactions such as itching, redness, hives and rash occurred in less than 1% and may resolve with continued treatment.

  • Section 6.1

    ALT (a liver enzyme) above 2 times the upper limit of normal: 1.9% on glimepiride vs 0.8% on placebo in 11 pooled trials.

  • Section 14.1

    Weight in the 22-week trial: +1.8 kg on glimepiride vs -0.9 kg on placebo (adjusted mean change from baseline, Table 4).

  • Section 6.2

    Reported after approval: serious allergic reactions including Stevens-Johnson syndrome, hemolytic anemia, liver problems including hepatitis, low blood counts and platelets, low sodium (SIADH), sun sensitivity, taste changes and hair loss.

What serious risks does the Glimepiride Tablets label warn about?

The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.

  • Section 4

    Who should not use it. Glimepiride is not used by people who have had an allergic reaction to glimepiride, its ingredients, or sulfonamide derivatives.

  • Section 5.1

    Low blood sugar. All sulfonylureas, including glimepiride, can cause severe hypoglycemia, which can lead to unconsciousness, seizures, brain impairment or death. Older people, people with kidney, liver, adrenal or pituitary problems, and people who are frail, eat too little, exercise hard or drink alcohol are at higher risk. Warning signs may be weaker with nerve damage or beta-blockers.

  • Section 5.2

    Serious allergic reactions. Anaphylaxis, angioedema and Stevens-Johnson syndrome have been reported. If an allergic reaction is suspected, glimepiride is stopped.

  • Section 5.3

    Hemolytic anemia. Sulfonylureas can break down red blood cells in people with G6PD deficiency, and it has also been reported in people without it. The label says to consider a non-sulfonylurea in G6PD deficiency.

  • Section 5.4

    Heart-related deaths with sulfonylureas. In the older UGDP study, people on the sulfonylurea tolbutamide for 5 to 8 years had heart-related death rates about 2 and a half times those on diet alone. The label says this warning may apply to the whole class, including glimepiride.

When does the label say to call your doctor?

From the Patient Counseling Information (section 17) that comes with Glimepiride Tablets:

  • Signs of an allergic reaction: the label says to seek medical treatment and stop glimepiride.
  • Known or suspected pregnancy: the label says to tell the prescriber.
  • Breastfeeding: the label says to watch the baby for signs of low blood sugar, such as jitters, blue color, pauses in breathing, low body temperature, excessive sleepiness, poor feeding or seizures.

How do I keep track of side effects in Dose Track?

Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.

This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.

Side effects for similar medicines

Frequently asked questions

What is the most common side effect of glimepiride?+
Low blood sugar. In a 22-week trial, possible hypoglycemia was reported by 19.7% on glimepiride vs 3.2% on placebo (section 6.1). The label also lists dizziness, weakness, headache and nausea as common.
Does glimepiride cause weight gain?+
It can. The label says glimepiride, like all sulfonylureas, can cause weight gain. In the 22-week trial, weight changed by +1.8 kg on glimepiride vs -0.9 kg on placebo (sections 6.1 and 14.1).
Does glimepiride have a boxed warning?+
No. Its label has no boxed warning, but section 5.4 carries a class warning about higher heart-related death rates seen with the sulfonylurea tolbutamide in the UGDP study.
Can people with a sulfa allergy take glimepiride?+
The label says glimepiride is not used in people with a history of allergic reaction to sulfonamide derivatives, because they may also react to glimepiride (section 4).
Is glimepiride the same as Amaryl?+
Yes, Amaryl is the original brand of glimepiride. The brand has no current label on DailyMed, so this page is based on a current generic glimepiride label.