ActoPlus Met Side Effects

Generic name: metformin / pioglitazone

Medically reviewed by Drugs.com. Last updated on May 5, 2024.

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

Applies to metformin / 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 and to decide if you should continue to use it. Blood and urine tests may be needed to check for unwanted effects.

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 right away. These may be symptoms of heart problems or fluid retention (too much water in the body).

Let your doctor or dentist know you are taking this medicine. Your doctor may advise you to Stop taking metformin / pioglitazone 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.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could 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 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 or take certain medicines. 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 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.

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

Limit how much alcohol you drink while using this medicine. Heavy alcohol use can increase your risk for lactic acidosis.

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 ActoPlus Met

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

Other side effects of ActoPlus Met

Some side effects of metformin / 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 metformin / pioglitazone: oral tablet, oral tablet extended release.

General adverse events

The most commonly reported adverse events included upper respiratory tract infection, edema, diarrhea, headache, and weight gain.^[Ref]

Gastrointestinal

Metformin-pioglitazone:

• Very common (10% or more): Abdominal pain, diarrhea, loss of appetite, nausea, vomiting
• Uncommon (0.1% to 1%): Flatulence

Metformin:

• Very common (10% or more): Abdominal pain, diarrhea, loss of appetite, nausea, vomiting^[Ref]

Gastrointestinal events occur most frequently during initiation of therapy and resolve spontaneously in most cases.^[Ref]

Hematologic

• Common (1% to 10%): Anemia
• Very rare (less than 0.01%): Vitamin B12 absorption decreased, lactic acidosis

Metformin:

• Very rare (less than 0.01%): Vitamin B12 absorption decreased, lactic acidosis^[Ref]

Metformin-pioglitazone

Metabolic

Metformin-pioglitazone:

• Common (1% to 10%): Weight increased

Pioglitazone:

• Very common (10% or more): Hypoglycemia (27.3%)
• Common (1% to 10%): Weight gain^[Ref]

Mean weight increase in patients receiving pioglitazone monotherapy for 1 year was 2 to 3 kg. In combination with metformin, mean weight increase over 1 year was 1.5 kg. The mechanism of weight gain is unclear, but probably involves a combination of fluid retention and fat accumulation.^[Ref]

Respiratory

• Common (1% to 10%): Upper respiratory infection
• Uncommon (0.1% to 1%): Sinusitis

Pioglitazone:

• Common (1% to 10%): Upper respiratory infection, pharyngitis
• Uncommon (0.1% to 1%): Sinusitis^[Ref]

Metformin-pioglitazone

Nervous system

Metformin-pioglitazone:

• Common (1% to 10%): Hypoesthesia, headache, taste disturbance
• Uncommon (0.1% to 1%): Insomnia

Metformin:

• Common (1% to 10%): Taste disturbance

Pioglitazone:

• Common (1% to 10%): Hypoesthesia, headache^[Ref]

Ocular

Metformin-pioglitazone:

• Common (1% to 10%): Visual disturbances
• Postmarketing reports: Macular edema

Pioglitazone:

• Common (1% to 10%): Visual disturbances
• Frequency not reported: Macular edema^[Ref]

Visual disturbances have been reported early in treatment and may be related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens. Macular edema has been reported postmarketing in patients taking pioglitazone or another thiazolidinedione. Some patients presented with blurred vision or decreased visual acuity, although some were diagnosed on routine ophthalmologic examination. Most patients had peripheral edema at time of diagnosis. Some patients improved with drug discontinuation.^[Ref]

Dermatologic

Metformin-pioglitazone:

• Very rare (less than 0.01%): Erythema, pruritus, urticaria

Metformin:

• Very rare (less than 0.01%): Erythema, pruritus, urticaria^[Ref]

Endocrine

• Common (1% to 10%): Erectile dysfunction^[Ref]

Cardiovascular

Metformin-pioglitazone:

• Common (1% to 10%): Edema

Pioglitazone:

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

Thiazolidinediones, including pioglitazone can cause dose-related fluid retention which can cause or exacerbate congestive heart failure in some patients. Combination with insulin and use in patients with NYHA Class I and II congestive heart failure may increase risk.^[Ref]

Hepatic

Metformin-pioglitazone:

• Frequency not reported: Hepatitis, alanine aminotransferase increased, abnormal liver function tests

Metformin:

• Frequency not reported: Hepatitis, abnormal liver function tests

Pioglitazone:

• Frequency not reported: Alanine aminotransferase increased
• Postmarketing reports: Hepatic failure^[Ref]

There have been postmarketing reports of hepatic failure, including fatalities, in patients taking pioglitazone. The reports contain insufficient information to establish causality.^[Ref]

Musculoskeletal

Metformin-pioglitazone:

• Common (1% to 10%): Bone fracture, arthralgia

Pioglitazone:

• Common (1% to 10%): Bone fracture, myalgia, extremity pain, back pain
• Uncommon (0.1% to 1%): Serum creatine phosphokinase elevations^[Ref]

In pooled analysis of bone fractures in 8100 patients receiving pioglitazone and 7400 receiving comparator treatment; a higher rate of fractures was observed in women receiving pioglitazone (2.6% versus 1.7%). Some epidemiologic studies have suggested a similarly increased risk of fracture in men.^[Ref]

Oncologic

• Uncommon (0.1% to 1%): Bladder cancer

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]

Metformin-pioglitazone

Renal

• Common (1% to 10%): Hematuria^[Ref]

Hypersensitivity

Metformin-pioglitazone:

• Postmarketing reports: Hypersensitivity and allergic reactions (anaphylaxis, angioedema, and urticaria)

Pioglitazone:

• Postmarketing reports: Hypersensitivity and allergic reactions (anaphylaxis, angioedema, and urticaria)^[Ref]

See also:

Further information

ActoPlus Met 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.

Medical Disclaimer