Actos Side Effects

Generic name: pioglitazone

Medically reviewed by Drugs.com. Last updated on Jun 11, 2024.

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

Applies to 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.

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.

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.

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 can cause hypoglycemia (low blood sugar). However, low blood sugar can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, 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 of 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.

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 Actos

Along with its needed effects, pioglitazone (the active ingredient contained in Actos) 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 pioglitazone:

Other side effects of Actos

Some side effects of 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 pioglitazone: oral tablet.

General adverse events

The most commonly reported side effects were hypoglycemia, increased weight, edema, and upper respiratory tract infection.^[Ref]

Hypersensitivity

• Frequency not reported: Hypersensitivity and allergic reactions^[Ref]

Metabolic

• Very common (10% or more): Hypoglycemia (up to 27.3%), increased weight (up to 26.2%)^[Ref]

Cardiovascular

• Very common (greater than 10%): Edema
• Common (1% to 10%): Congestive heart failure (including nonfatal and fatal cases), cardiac failure, chest pain^[Ref]

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 given 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.

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.

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]

Hematologic

• Frequency not reported: Small reduction in mean hemoglobin and hematocrit^[Ref]

Ocular

• Common (1% to 10%): Visual disturbance, abnormal vision
• 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 (the active ingredient contained in Actos) 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]

Hepatic

• Uncommon (0.1% to 1%): Increased alanine aminotransferase
• Frequency not reported: Decreased mean values of bilirubin, AST, alkaline phosphatase, and GGT
• Postmarketing reports: Fatal and nonfatal hepatic failure, hepatocellular dysfunction^[Ref]

Postmarketing reports of fatal and nonfatal hepatic failure have been received in patients treated with this drug; these reports have been insufficient to establish causality. During clinical trials, there was no evidence of drug-induced hepatotoxicity.^[Ref]

Other

• Common (1% to 10%): Fatigue, accidental injury, peripheral edema, asthenia, malaise^[Ref]

Gastrointestinal

• Common (1% to 10%): Tooth disorder, tooth abscess, gastroenteritis, diarrhea, upper abdominal pain^[Ref]

Genitourinary

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

Musculoskeletal

• Common (1% to 10%): Fractures, myalgia, pain in extremity, back pain, cramped legs, arthralgia^[Ref]

In the prospective pioglitazone clinical trial in macrovascular events (PROactive), the incidence of bone fractures in female patients with this drug was 5.1% (44/870) compared to 2.5% (23/905) for placebo treated patients. The majority of fractures were nonvertebral including lower limb and distal upper limb. The incidence in men was 1.7% and no different than placebo (2.1%).^[Ref]

Nervous system

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

Psychiatric

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

Respiratory

• Very common (10% or more): Upper respiratory tract infection (up to 13.2%)
• Common (1% to 10%): Sinusitis, pharyngitis, bronchitis, influenza^[Ref]

Oncologic

• 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]

See also:

Further information

Actos 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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