Actoplus Met Side Effects

Please note - some side effects for Actoplus Met may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Actoplus Met - for the Consumer

Actoplus Met

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Actoplus Met:

Cold-like symptoms; diarrhea; headache; indigestion; mild weight gain; nausea; stomach upset.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; bone pain; chest pain or discomfort; dark urine; difficult or painful urination; dizziness or lightheadedness; fainting; fast or difficult breathing; feeling of being unusually cold; general feeling of being unwell; muscle pain or weakness; pale stools; persistent loss of appetite; severe or persistent headache, nausea, or vomiting; shortness of breath; slow or irregular heartbeat; sudden unexplained weight gain; swelling of the hands, ankles, or feet; unusual stomach pain or discomfort; unusual drowsiness; unusual tiredness or weakness; yellowing of the eyes or skin.

Actoplus Met XR

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Actoplus Met XR:

Cold-like symptoms; diarrhea; headache; indigestion; mild weight gain; nausea; stomach upset.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; bone pain; chest pain or discomfort; dark urine; difficult or painful urination; dizziness or lightheadedness; fainting; fast or difficult breathing; feeling of being unusually cold; general feeling of being unwell; muscle pain or weakness; pale stools; persistent loss of appetite; severe or persistent headache, nausea, or vomiting; shortness of breath; slow or irregular heartbeat; sudden unexplained weight gain; swelling of the hands, ankles, or feet; unusual stomach pain or discomfort; unusual drowsiness; unusual tiredness or weakness; yellowing of the eyes or skin.

Actoplus Met Side Effects - for the Professional

Actoplus Met

Over 8500 patients with type 2 diabetes have been treated with pioglitazone in randomized, double-blind, controlled clinical trials. This includes 2605 high-risk patients with type 2 diabetes treated with pioglitazone from the PROactive clinical trial. Over 6000 patients have been treated for 6 months or longer, and over 4500 patients for one year or longer. Over 3000 patients have received pioglitazone for at least 2 years.

The most common adverse events reported in at least 5% of patients in the controlled 16-week clinical trial between placebo plus metformin and pioglitazone 30 mg plus metformin were upper respiratory tract infection (15.6% and 15.5%), diarrhea (6.3% and 4.8%), combined edema/peripheral edema (2.5% and 6.0%) and headache (1.9% and 6.0%), respectively.

The incidence and type of adverse events reported in at least 5% of patients in any combined treatment group from the 24-week study comparing pioglitazone 30 mg plus metformin and pioglitazone 45 mg plus metformin are shown in Table 4; the rate of adverse events resulting in study discontinuation between the two treatment groups was 7.8% and 7.7%, respectively.  

Most clinical adverse events were similar between groups treated with pioglitazone in combination with metformin and those treated with pioglitazone monotherapy. Other adverse events reported in at least 5% of patients in controlled clinical trials between placebo and pioglitazone monotherapy included myalgia (2.7% and 5.4%), tooth disorder (2.3% and 5.3%), diabetes mellitus aggravated (8.1% and 5.1%) and pharyngitis (0.8% and 5.1%), respectively.

In U.S. double-blind studies, anemia was reported in ≤ 2% of patients treated with pioglitazone plus metformin.

In monotherapy studies, edema was reported for 4.8% (with doses from 7.5 mg to 45 mg) of patients treated with pioglitazone versus 1.2% of placebo-treated patients. Most of these events were considered mild or moderate in intensity.

Side Effects by Body System

Cardiovascular

Cardiovascular side effects have included mild to moderate edema.

Gastrointestinal

Gastrointestinal side effects have included nausea and diarrhea.

Hematologic

Hematologic side effects have included decreases of previously normal levels of serum vitamin B12 to subnormal levels.

Metabolic

Lactic acidosis is a medical emergency requiring immediate evaluation and treatment. The case fatality rate may be as high as 50.3%. Patients taking metformin who present with even vague medical illnesses such as myalgia, malaise, somnolence, abdominal discomfort, and so forth, should be evaluated for a metabolic etiology like lactic acidosis.

Signs and symptoms of severe acidosis may include vomiting, abdominal pain, nausea, dyspnea, hypothermia, hypotension, and bradycardia.

Laboratory evaluation of metformin-induced lactic acidosis generally includes determination of the following: blood glucose concentration, lactic acid concentration, serum electrolytes, blood pH, metformin concentration, and exclusion of ketoacidosis.

If lactic acidosis is present, immediate institution of general supportive care is indicated. Prompt hemodialysis is also generally recommended in order to correct the acidosis and remove metformin. Hemodialysis often results in rapid improvement. Some investigators have suggested that dialysis with a bicarbonate-buffered dialysate may be particularly effective.

Metabolic side effects of metformin have included lactic acidosis, which is a potentially fatal metabolic complication of biguanide therapy. The incidence of lactic acidosis appears to be about 1.5 cases per 10,000 patient years. The incidence may be lower with current recommended doses and less frequent use in the elderly. The risk of lactic acidosis is particularly high in patients with underlying renal insufficiency. Cases of lactic acidosis occurring in patients with normal renal function have been rarely reported. Concomitant cardiovascular or liver disease, sepsis, and hypoxia may also increase the risk of lactic acidosis. Hypoglycemia occurs uncommonly in patients receiving metformin as monotherapy. Strenuous exercise, decreased caloric intake, general debilitation, adrenal insufficiency, pituitary insufficiency, and ethanol use may increase the risk of hypoglycemia. Metabolic side effects of rosiglitazone have included increases in total cholesterol, LDL, and HDL and decreases in free fatty acids. Dose related weight gain has been reported in patients treated with rosiglitazone alone and in combination with other hypoglycemic agents.

Respiratory

Respiratory side effects have included reports of upper respiratory tract infection and sinusitis.

Nervous system

Nervous system side effects have included headache and dizziness.

Genitourinary

Genitourinary side effects have included urinary tract infections.

Ocular

Ocular side effects have included postmarketing reports of new onset or worsening diabetic macular edema with decreased visual acuity.

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