Duetact Side Effects

Generic name: glimepiride / pioglitazone

Medically reviewed by Drugs.com. Last updated on Aug 12, 2024.

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

Applies to glimepiride / pioglitazone: 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.

This medicine may cause some women who do not have regular monthly periods to ovulate. This can increase your chance of becoming pregnant. If you are a woman of childbearing potential, you should discuss birth control options with your doctor.

If you are rapidly gaining weight, having shortness of breath, 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 immediately. These may be symptoms of a serious heart problem.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these side effects occur, get emergency help at once.

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, decreased vision, 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).

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.

This medicine may increase your risk for bladder cancer if you take it for more than 12 months. Tell your doctor right away if you have blood in the urine, a frequent, strong, or increased urge to urinate, painful urination, or pain in the back, lower abdomen, or stomach.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

This medicine can cause hypoglycemia (low blood sugar). Low blood sugar can also occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms with low blood sugar. It is important that you learn which symptoms of low blood sugar you have in order to 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.

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 you have diabetes with a list of all your medicines.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Duetact

Along with its needed effects, glimepiride / pioglitazone 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 glimepiride / pioglitazone:

Other side effects of Duetact

Some side effects of glimepiride / pioglitazone 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 glimepiride / pioglitazone: oral tablet.

General adverse events

The most common adverse reactions included upper respiratory tract infections, accidental injury, and combined edema/peripheral edema.^[Ref]

Cardiovascular

• Very common (10% or more): Lower leg edema (up to 12.3%)

Pioglitazone:

• Very common (10% or more): Edema (up to 26.7%)
• Common (1% to 10%): Cardiac failure, chest pain^[Ref]

Pioglitazone is associated with edema (peripheral, generalized, and pitting edema and fluid retention) when used alone or when used in combination therapy. In pioglitazone monotherapy trials, edema occurred in 2.5% (n=81), 4.7% (n=275), and 6.5% (n=169) of patients receiving 15 mg, 30 mg, and 45 mg of pioglitazone daily for 16 to 26 weeks. Pioglitazone in combination with a sulfonylurea for 16 to 24 weeks resulted in edema in 1.6% (n=184), 11.3% (n=540), and 23.1% (n=351) of patients receiving 15 mg, 30 mg, and 45 mg of pioglitazone daily, respectively. In a study in patients with NYHA class II or III heart failure the percentage of patients experiencing CHF progression during the study was 13.4% and 8.2% in patients receiving pioglitazone (n=262) and glyburide (n=256), respectively.

In the PROactive trial, a study in 5238 patients with type 2 diabetes and a history of macrovascular disease who were force-uptitrated to pioglitazone 45 mg once a day or received placebo in addition to standard of care, edema occurred in 27.3% of patients treated with pioglitazone (n=2605) compared with 15.9% of placebo (n=2633) patients. Treatment-emergent adverse events leading to at least 1 hospitalized congestive heart failure event occurred in 5.7% of patients receiving pioglitazone and 4.1% of patients receiving placebo.

The primary objective of the 3-year PROactive trial was to examine the effect of pioglitazone on mortality and macrovascular morbidity in high-risk patients. No statistically significant difference between pioglitazone and placebo/standard care were observed for time to the first occurrence of their first event (all-cause mortality, nonfatal myocardial infarction (MI) including silent MI, stroke, acute coronary syndrome, cardiac intervention including coronary artery bypass grafting or percutaneous intervention, major leg amputation above the ankle, and bypass surgery or revascularization in the leg). A total of 514 patients receiving pioglitazone experienced at least 1 event compared with 572 patients receiving placebo/standard care.

Postmarketing reports of congestive heart failure have been received in patients treated with pioglitazone. Reports have been received from patients both with and without a history of a known history of heart disease and both with and without concomitant insulin use.^[Ref]

Pioglitazone-Sulfonylurea

Hepatic

Pioglitazone:

• Uncommon (0.1% to 1%): ALT values greater than 3 times upper limit of normal (3 x ULN)
• Postmarketing reports: Hepatic failure

Glimepiride:

• Common (1% to 10%): Elevated ALT to greater than 2 x ULN
• Postmarketing reports: Liver function impairment (e.g. with cholestasis and jaundice), as well as hepatitis, which may progress to liver failure, hepatic porphyria reactions and disulfiram-like reactions^[Ref]

Hypersensitivity

Glimepiride:

• Uncommon (0.1% to 1%): Allergic reactions
• Postmarketing reports: Serious allergic reactions

There have been postmarketing reports of serious allergic reactions in patients receiving glimepiride such as anaphylaxis, angioedema, Stevens-Johnson syndrome, dyspnea, hypotension, and shock. In clinical trials allergic reactions such as pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, occurred in less than 1% of patients receiving glimepiride, and some resolved despite continued treatment.

Oncologic

Pioglitazone:

• Uncommon (0.1% to 1%): Bladder cancer^[Ref]

The US FDA has released results of its review of pioglitazone and bladder cancer and concluded that the data suggests use of this drug may be linked to an increase risk of bladder cancer. A 10-year prospective cohort study in diabetic patients performed by the manufacturer (n=158,918 never users; n=34,181 ever users) identified 1075 newly diagnosed cases of bladder cancer in never users and 186 cases in ever users. The fully adjusted hazard ratio (HR) showed pioglitazone use was not associated with an increased risk (HR 1.06 (95% confidence interval 0.89 to 1.26). And while a modest trend towards higher risk with increasing duration was observed, this trend was not statistically significant. Compared to the interim 5-year results, the 10-year results found weaker associations that were not statistically significant. However, there are studies that have shown a statistically significant association between exposure to this drug and bladder cancer and an association between cumulative dose or cumulative duration of exposure and bladder cancer. Overall, this drug may be associated with an increase in the risk of urinary bladder tumors, however there is insufficient data to determine whether this drug is a tumor promoter for urinary bladder tumors.^[Ref]

Endocrine

Pioglitazone:

• Frequency not reported: Resumption of ovulation in premenopausal, anovulatory women, hormonal imbalance

Glimepiride:

• Postmarketing reports: Hyponatremia, syndrome of inappropriate antidiuretic hormone secretion (SIADH)^[Ref]

SIADH has been reported postmarketing in patients receiving glimepiride, most often in patients who are on other medications or who have medical conditions known to cause hyponatremia or increase release of antidiuretic hormone.^[Ref]

Ocular

Pioglitazone:

• Postmarketing reports: New or worsening diabetic macular edema with decreased visual acuity^[Ref]

Macular edema has been reported in postmarketing experience in diabetic patients who were taking pioglitazone or another thiazolidinedione. Some patients presented with blurred vision or decreased visual acuity, but some patients appear to have been diagnosed on routine ophthalmologic examination. Some patients had peripheral edema at the time macular edema was diagnosed. Some patients had improvement in their macular edema after discontinuation of their thiazolidinedione. It is unknown whether or not there is a causal relationship between pioglitazone and macular edema.^[Ref]

Metabolic

• Very common (10% or more): Hypoglycemia (up to 15.7%), weight increase (up to 13.4%)^[Ref]

Pioglitazone is associated with dose-related weight gain when used alone or when used in combination therapy. The mechanism of weight gain is unclear, but probably involves a combination of fluid retention and fat accumulation. In pioglitazone monotherapy trials, weight increases of 0.9 kg, 1 kg, and 2.6 kg occurred in patients receiving 15 mg, 30 mg, and 45 mg of pioglitazone daily for 16 to 26 weeks. Pioglitazone in combination with a sulfonylurea for 16 to 24 weeks resulted in weight increases of 2 kg, 3.1 kg, and 4.1 kg, for patients receiving 15 mg, 30 mg, and 45 mg of pioglitazone daily respectively. In the PROactive (Prospective Pioglitazone Clinical Trial in Macrovascular Events) trial, the median change in body weight in patients treated with pioglitazone (n=2560) compared with placebo (n=2581) was -0.5 kg compared to +3.6 kg. The median exposure to drug was 2.7 years.^[Ref]

Pioglitazone-Sulfonylurea

Respiratory

• Very common (10% or more): Upper respiratory tract infection (up to 14.8%)
• Common (1% to 10%): Sinusitis, pharyngitis

Pioglitazone:

• Very common (10% or more): Upper respiratory tract infection (up to 13.2%)^[Ref]

Pioglitazone-Sulfonylurea

Hematologic

• Frequency not reported: Anemia

Pioglitazone:

• Frequency not reported: Decreases in hemoglobin and hematocrit

Glimepiride:

• Postmarketing reports: Hemolytic Anemia, leukopenia, agranulocytosis, aplastic anemia, pancytopenia, thrombocytopenia, thrombocytopenia purpura^[Ref]

Laboratory findings have shown decreases in hemoglobin and hematocrit with pioglitazone therapy; mean hemoglobin values declined by 2% to 4% in pioglitazone treated patients compared to -1% to 1% in placebo-treated patients. These changes primarily occurred during the first 3 months. Changes may be related to increased plasma volume and not likely to be associated with any clinically significant hematologic effects.^[Ref]

Pioglitazone-Sulfonylurea

Gastrointestinal

• Common (1% to 10%): Diarrhea, nausea^[Ref]

Pioglitazone-Sulfonylurea

Nervous system

• Common (1% to 10%): Headache, dizziness^[Ref]

Pioglitazone-Sulfonylurea

Musculoskeletal

• Common (1% to 10%): Limb pain

Pioglitazone:

• Common (1% to 10%): Myalgia, pain in extremity, back pain
• Frequency not reported: Elevated creatine phosphokinase (CPK)^[Ref]

Elevations in CPK were observed during protocol-specified measurement of CPK in pioglitazone clinical trials. Isolated elevation to 10 times the upper limit of normal was observed in 9 patients (0.2%). Elevations resolved without any clinical sequelae and the relationship to drug therapy is unknown.^[Ref]

Pioglitazone-Sulfonylurea

Dermatologic

Glimepiride:

• Postmarketing reports: Porphyria cutanea tarda, photosensitivity reactions and allergic vasculitis^[Ref]

Genitourinary

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

Pioglitazone-Sulfonylurea

See also:

Further information

Duetact 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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