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Amaryl

Last reviewed on RxList: 1/4/2017
Amaryl Side Effects Center

Last reviewed on RxList 9/12/2016

Amaryl (glimepiride) is an oral diabetes medicine used together with diet and exercise to treat type 2 (non-insulin dependent) diabetes. Insulin or other diabetes medicines are sometimes used in combination with Amaryl if needed. Amaryl is available in generic form. Common side effects of Amaryl include:

Amaryl can cause low blood sugar (hypoglycemia). Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet.

The recommended starting dose of Amaryl is 1 mg or 2 mg once daily. The maximum recommended dose is 8 mg once daily. Hyperglycemia (high blood sugar) may result if you take Amaryl with drugs that raise blood sugar, such as: isoniazid, diuretics (water pills), steroids, phenothiazines, thyroid medicine, birth control pills and other hormones, seizure medicines, and diet pills, or medicines to treat asthma, colds or allergies. Hypoglycemia (low blood sugar) may result if you take Amaryl with drugs that lower blood sugar, such as: clarithromycin, disopyramide, fluoxetine, antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, blood thinners, monoamine oxidase inhibitors (MAOIs), or sulfa drugs. It may also interact with albuterol, clonidine, reserpine, or beta-blockers. Tell your doctor all medications you use. Amaryl should be used only when prescribed during pregnancy. Your doctor may substitute insulin for this drug during your pregnancy. Based on information from related drugs, this medication may pass into breast milk. Breast-feeding while using this medication is not recommended.

Our Amaryl (glimepiride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Amaryl Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe skin rash, itching, redness, or irritation;
  • pale skin, easy bruising or bleeding, fever, unusual weakness;
  • numbness or tingly feeling;
  • trouble breathing;
  • feeling like you might pass out;
  • dark urine, clay-colored stools;
  • upper stomach pain, low fever, jaundice (yellowing of the skin or eyes); or
  • nausea, vomiting, loss of appetite, feeling restless or irritable, confusion, hallucinations, muscle pain or weakness, and/or seizure.

Less serious side effects may include:

  • dizziness, headache, tired feeling;
  • mild nausea, vomiting, stomach pain, diarrhea;
  • increased skin sensitivity to sunlight; or
  • mild itching or skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Amaryl (Glimepiride)

Amaryl Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in more detail below and elsewhere in the labeling:

In clinical trials, the most common adverse reactions with AMARYL were hypoglycemia, dizziness, asthenia, headache, and nausea.

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 AMARYL in the controlled clinical trials. In these trials, approximately 1,700 patients were treated with AMARYL for at least 1 year.

Table 1 summarizes adverse events, other than hypoglycemia, that were reported in 11 pooled placebocontrolled trials, whether or not considered to be possibly or probably related to study medication. Treatment duration ranged from 13 weeks to 12 months. Terms that are reported represent those that occurred at an incidence of ≥ 5% among AMARYL-treated patients and more commonly than in patients who received placebo.

Table 1: Eleven Pooled Placebo-Controlled Trials ranging from 13 weeks to 12 months : Adverse Events (Excluding Hypoglycemia) Occurring in ≥ 5% of AMARYL-treated Patients and at a Greater Incidence than with Placebo*

  AMARYL
N=745 %
Placebo
N=294 %
Headache 8.2 7.8
Accidental Injury† 5.8 3.4
Flu Syndrome 5.4 4.4
Nausea 5.0 3.4
Dizziness 5.0 2.4
*AMARYL doses ranged from 1-16 mg administered daily
†Insufficient information to determine whether any of the accidental injury events were associated with hypoglycemia

Hypoglycemia

In a randomized, double-blind, placebo-controlled monotherapy trial of 14 weeks duration, patients already on sulfonylurea therapy underwent a 3-week washout period then were randomized to AMARYL 1 mg, 4 mg, 8 mg or placebo. Patients randomized to AMARYL 4 mg or 8 mg underwent forced-titration from an initial dose of 1 mg to these final doses, as tolerated [see Clinical Studies]. The overall incidence of possible hypoglycemia (defined by the presence of at least one symptom that the investigator believed might be related to hypoglycemia; a concurrent glucose measurement was not required) was 4% for AMARYL 1 mg, 17% for AMARYL 4 mg, 16% for AMARYL 8 mg and 0% for placebo. All of these events were self-treated.

In a randomized, double-blind, placebo-controlled monotherapy trial of 22 weeks duration, patients received a starting dose of either 1 mg AMARYL or placebo daily. The dose of AMARYL was titrated to a target fasting plasma glucose of 90-150 mg/dL. Final daily doses of AMARYL were 1, 2, 3, 4, 6 or 8 mg [see Clinical Studies]. The overall incidence of possible hypoglycemia (as defined above for the 14-week trial) for AMARYL vs. placebo was 19.7% vs. 3.2%. All of these events were selftreated.

Weight gain: AMARYL, like all sulfonylureas, can cause weight gain [see Clinical Studies].

Allergic Reactions: In clinical trials, allergic reactions, such as pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, occurred in less than 1% of AMARYL-treated patients. These may resolve despite continued treatment with AMARYL. There are postmarketing reports of more serious allergic reactions (e.g., dyspnea, hypotension, shock) [see WARNINGS AND PRECAUTIONS].

Laboratory Tests

Elevated Serum Alanine Aminotransferase (ALT): In 11 pooled placebo-controlled trials of AMARYL, 1.9% of AMARYL-treated patients and 0.8% of placebo-treated patients developed serum ALT greater than 2 times the upper limit of the reference range.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of AMARYL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for Amaryl (Glimepiride)

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