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Amaryl

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Amaryl

Amaryl Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Amaryl (glimepiride) is 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. It is an oral diabetes medicine. This medication is available in generic form. Common side effects include nausea or upset stomach.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Amaryl in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Amaryl Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea and upset stomach may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: yellowing eyes/skin, stomach/abdominal pain, dark urine, unusual tiredness/weakness, easy bleeding/bruising, signs of infection (such as fever, persistent sore throat), mental/mood changes, unusual/sudden weight gain, seizures.

This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor immediately about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your medication dosage may need to be increased.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Amaryl (Glimepiride)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Amaryl FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 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. 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 3.4
Dizziness 5 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 self-treated.

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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Amaryl - User Reviews

Amaryl User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Amaryl sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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