Avandamet Side Effects

Generic name: metformin / rosiglitazone

Medically reviewed by Drugs.com. Last updated on Jul 27, 2024.

Note: This document provides detailed information about Avandamet Side Effects associated with metformin / rosiglitazone. Some dosage forms listed on this page may not apply specifically to the brand name Avandamet.

Applies to metformin / rosiglitazone: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Call your doctor right away if you have chest pain or discomfort, nausea, pain or discomfort in the arms, jaw, back, or neck, shortness of breath, sweating, or vomiting. These may be symptoms of a heart attack.

If you are rapidly gaining weight or having trouble breathing, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor right away. These may be symptoms of a heart problem or edema (fluid retention).

Let your doctor or dentist know you are taking this medicine. Your doctor may advise you to Stop taking metformin / rosiglitazone before you have major surgery or diagnostic tests, especially tests that use a contrast dye.

Under certain conditions, too much metformin can cause a serious condition called lactic acidosis. The symptoms of lactic acidosis are severe and appear quickly. Lactic acidosis usually occurs when other serious health problems are present, such as a heart attack or kidney failure. The symptoms of lactic acidosis include: abdominal or stomach discomfort, decreased appetite, diarrhea, fast or shallow breathing, a general feeling of discomfort, muscle pain or cramping, and unusual sleepiness, tiredness, or weakness. If you have more than one of these symptoms together, you should get immediate emergency medical help.

If you have abdominal or stomach pain, dark urine, a loss of appetite, nausea or vomiting, unusual tiredness or weakness, or yellow eyes or skin, check with your doctor right away. These may be symptoms of a serious liver problem.

Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs while you are taking this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Certain women may be at an increased risk for pregnancy while taking this medicine. If you had problems ovulating and had irregular periods in the past, this medicine may cause you to ovulate. This could increase your chance of becoming pregnant. If you are a woman of childbearing potential, you should discuss birth control options with your doctor.

This medicine may increase the risk for bone fractures in women. Ask your doctor about ways to keep your bones strong to help prevent fractures.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

It is very important to follow carefully any instructions from your doctor about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your doctor.
• Other medicines—Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
• In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
• Symptoms of fluid retention—Know what to do if you start to retain fluid. Fluid retention may worsen or lead to heart problems.

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with certain medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated right away. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.

Serious side effects of Avandamet

Along with its needed effects, metformin / rosiglitazone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking metformin / rosiglitazone:

Other side effects of Avandamet

Some side effects of metformin / rosiglitazone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to metformin / rosiglitazone: oral tablet.

General adverse events

The most commonly reported adverse reports included upper respiratory tract infections, injury, and headache.^[Ref]

Metabolic

Metformin-Rosiglitazone:

• Very common (10% or more): Hypoglycemia (12%)
• Common (1% to 10%): Hypercholesterolemia, hyperlipidemia
• Uncommon (0.1% to 1%): Weight gain

Rosiglitazone:

• Common (1% to 10%): Hypoglycemia (8%), hypercholesterolemia
• Uncommon (0.1% to 1%): Weight gain
• Frequency not reported: Increases in waist and hip circumference

Metformin:

• Common (1% to 10%): Hypoglycemia (9%)
• Very rare (less than 0.01%): Lactic acidosis^[Ref]

The mechanism of weight gain is unclear, although it probably is due to a combination of fluid retention and fat accumulation. In the ADOPT monotherapy trial, the median weight change with rosiglitazone at 4 years was plus 3.5 kg; with metformin it was a weight loss of 2.4 kg. In drug-naive patients, no overall change in median weight was observed in clinical trials.^[Ref]

Cardiovascular

• Common (1% to 10%): Edema, hypertension
• Frequency not reported: Cardiovascular deaths, congestive heart failure (CHF), myocardial infarction, angina, angina pectoris, angina dyspnea, myocardial infarction, coronary thrombosis, myocardial ischemia, coronary artery disease, coronary artery disorder^[Ref]

Major Adverse Cardiovascular Events:

Overall data from rosiglitazone long-term trials including the RECORD, ADOPT, and DREAM trials (rosiglitazone n=6311; control n=7756) showed no difference in overall mortality or major adverse cardiovascular events; however, a meta-analysis of shorter-term trials suggests and increased risk for myocardial infarction with rosiglitazone compared with placebo.

The RECORD trial (Rosiglitazone evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes; mean age 58 years; 52% male) revealed no significant difference in cardiovascular hospitalization or cardiovascular death (primary outcome) among patients with type 2 diabetes receiving rosiglitazone add-on therapy (n=2220) compared with active control (n=2227); however, there was a significant difference in the incidence of CHF (secondary endpoint). In this trial, patients who had failed metformin or sulfonylurea monotherapy were randomized to add-on rosiglitazone or active control (add-on metformin for those inadequately controlled on sulfonylurea or add-on sulfonylurea for those inadequately controlled on metformin). Patients were treated to a target glycosylated hemoglobin (HbA1c) of 7% or less. Heart failure was reported in 61 patients receiving add-on rosiglitazone and 29 patients receiving active control.

In a retrospective analysis of 42 clinical trials (mean duration 6 months), rosiglitazone was associated with an increased risk of myocardial ischemia compared with combined active or placebo control (2% versus 1.53%). These events included angina pectoris, angina dyspnea, myocardial infarction, coronary thrombosis, myocardial ischemia, coronary artery disease, and coronary artery disorder. There was an increased risk with combination insulin therapy and in patients receiving nitrates for known coronary heart disease.

Cardiovascular Events in Patients with NYHA Class I and II Heart Failure:

An increased risk of cardiovascular events was observed in a 52-week trial in patients with NYHA Class I and II Heart Failure receiving rosiglitazone (n=110) compared with placebo (n=114). These events included: cardiovascular deaths (5% vs 4%), worsening CHF (6% vs 4%), new or worsening edema (25% vs 9%), new or worsening dyspnea (26% vs 17%), increases in CHF medication (33% vs 18%), and cardiovascular hospitalization (19% vs 13%).

Edema:

Dose-related edema has been reported in rosiglitazone clinical trials. Healthy volunteers receiving rosiglitazone 8 mg once daily for 8 weeks experienced a statistically significant increase in median plasma volume compared with placebo.

Among patients with inadequate glycemic control on diet and exercise (n=468), edema was reported in 6% of patients starting on combination rosiglitazone/metformin, 7% starting on rosiglitazone alone, and 3% on metformin alone.

Concomitant Administration with Insulin:

Edema was reported with higher frequency in the rosiglitazone plus insulin combination trials (insulin, 5.4%; and rosiglitazone with insulin 14.7%). Reports of new onset or exacerbation of CHF occurred at a rate of 1% for insulin alone, 2% (4 mg) and 3% (8 mg) for insulin in combination with rosiglitazone. The coadministration of rosiglitazone and insulin is not recommended.^[Ref]

Hematologic

Metformin-Rosiglitazone:

• Very common (10% or more): Anemia (up to 16.7%)

Metformin:

• Common (1% to 10%): Anemia
• Very rare (less than 0.01%): Subnormal vitamin B12 levels

Rosiglitazone:

• Common (1% to 10%): Anemia
• Frequency not reported: Decrease in WBC counts^[Ref]

Among patients inadequately controlled on rosiglitazone monotherapy switched to rosiglitazone/metformin combination treatment, anemia was reported in 7.1% (n=338) of patients compared with 1.9% (n=2526) and 2.2% (n=225) of patient receiving rosiglitazone or metformin monotherapy. Lower pretreatment hemoglobin/hematocrit levels in patients receiving combination therapy may have contributed to the higher reporting rate. Laboratory findings have shown dose-related decreases in hemoglobin and hematocrit in patients receiving rosiglitazone; mean decreases of 1 g/dL and up to 3.3% were seen in hemoglobin and hematocrit, respectively. These changes primarily occurred during the first 3 months or following a dose increase. They may be related to increased plasma volume.^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea/vomiting (16%), diarrhea (14%)
• Common (1% to 10%): Dyspepsia, abdominal pain, loose stools, constipation, flatulence, gastritis
• Uncommon (0.1% to 1%): Anorexia

side effects have included nausea, anorexia, metallic taste, diarrhea, dyspepsia, flatulence, and abdominal pain. Diarrhea has been reported by 12.7% of patients in clinical trials.^[Ref]

Respiratory

• Very common (10% or more): Upper respiratory tract infection (16% to 28%)
• Common (1% to 10%): Nasopharyngitis, sinusitis, bronchitis, coughing, pharyngitis

Rosiglitazone:

• Frequency not reported: Dyspnea
• Postmarketing reports: Pulmonary edema, pleural effusions^[Ref]

Hypersensitivity

Rosiglitazone:

• Postmarketing reports: Anaphylactic reaction, urticaria, angioedema^[Ref]

Ocular

Rosiglitazone:

• Postmarketing reports: Diabetic macular edema with decreased visual acuity^[Ref]

Musculoskeletal

• Very common: (10% or more): Arthralgia (10.6%)
• Common (1% to 10%): Back pain, arthritis
• Frequency not reported: Fractures^[Ref]

Large long-term rosiglitazone clinical trials have shown an increased incidence of bone fracture in patients receiving rosiglitazone both alone and in combination with sulfonylureas or metformin. This increased incidence appeared after the first year and persisted. The majority of fractures were observed in women and occurred in the upper arm, hand, and foot.^[Ref]

Dermatologic

Metformin:

• Very rare (less than 0.01%): Mild erythema

Rosiglitazone:

• Postmarketing reports: Rash, pruritus, urticaria, angioedema, Stevens-Johnson syndrome^[Ref]

Endocrine

• Frequency not reported: Resumption of ovulation in premenopausal, anovulatory women, hormonal imbalance^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infection^[Ref]

Hepatic

Rosiglitazone:

• Uncommon (0.1% to 1%): Hyperbilirubinemia, ALT elevations
• Postmarketing reports: Hepatitis, hepatic enzyme elevations greater than 3 times the upper limit of normal, hepatic failure^[Ref]

Immunologic

• Common (1% to 10%): Viral infection^[Ref]

Nervous system

• Very common (10% or more): Headaches (11%)
• Common (1% to 10%): Dizziness

Metformin:

• Common (1% to 10%): Metallic taste

Rosiglitazone:

• Frequency not reported: Stroke^[Ref]

Other

• Very common (10% or more): Injury (16.9%)
• Common (1% to 10%): Fatigue, pain^[Ref]

See also:

Further information

Avandamet side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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