metformin/pioglitazone
Brand names: Actoplus Met
Actoplus Met is a drug that combines two medicines to help control blood sugar in adults with type 2 diabetes. It should be used with diet and exercise.
What it does
Actoplus Met helps lower blood sugar in adults who have type 2 diabetes.
Common side effects
Upper respiratory infection, Swelling, Diarrhea
Key warnings
Actoplus Met can cause or worsen heart failure in some people.
How It Works
Actoplus Met contains pioglitazone and metformin. Pioglitazone makes your body more sensitive to insulin. Metformin reduces the amount of sugar your liver releases into your blood.
How to Take It
Take Actoplus Met by mouth with meals to help prevent stomach problems. Your doctor will decide the right dose for you, depending on your current diabetes medicines. Do not take more than 3 tablets per day. If you miss a dose, do not double the next dose.
Pregnancy & Breastfeeding
Talk to your doctor if you are pregnant or plan to become pregnant. It is not known if Actoplus Met will harm your unborn baby. Talk to your doctor if you are breastfeeding or plan to breastfeed.
Missed Dose
If you miss a dose of Actoplus Met, do not double your next dose. Take your next dose at the regular time.
Storage
Store Actoplus Met at room temperature, away from moisture and humidity. Keep the container tightly closed.
Side Effects (from patient reports)
Based on 171,728 FDA adverse event reports.
Serious Warnings
Actoplus Met can cause or worsen heart failure in some people. Watch for signs like rapid weight gain, shortness of breath, and swelling. This medicine can also cause a rare but serious condition called lactic acidosis. Get medical help right away if you have symptoms like feeling very weak, muscle pain, trouble breathing, or stomach pain.
Known Drug Interactions
( 7.3 ) Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine), may increase the accumulation of metformin. 7.4 Drugs that Reduce Metformin Clearance Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2]/multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacol...
Mechanism: Dolutegravir interferes with how your kidneys remove metformin from your body, causing the drug to stay in your system longer. This can lead to a dangerous buildup of acid in your blood.
What to do: Your doctor may need to adjust your metformin dose or monitor you more frequently. Watch for signs of a problem, such as feeling very weak, tired, or having trouble breathing.
( 7.3 ) Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine), may increase the accumulation of metformin. 7.4 Drugs that Reduce Metformin Clearance Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2]/multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacol...
Mechanism: Ranolazine blocks the pathways your kidneys use to get rid of metformin, which can cause metformin levels to rise too high. High levels of this drug increase the risk of a life-threatening acid imbalance.
What to do: Your healthcare provider should monitor you closely and may need to lower your metformin dose. Report any unusual muscle pain or stomach distress to your doctor immediately.
( 7.3 ) Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine), may increase the accumulation of metformin. 7.4 Drugs that Reduce Metformin Clearance Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2]/multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacol...
Mechanism: Cimetidine makes it harder for your kidneys to clear metformin out of your blood. This causes the medicine to accumulate in your body, which can lead to a serious side effect called lactic acidosis.
What to do: Talk to your doctor about adjusting your metformin dose if you need to take cimetidine. Be alert for symptoms like a fast heartbeat or feeling cold and dizzy.
( 7.3 ) Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine), may increase the accumulation of metformin. Therefore, the maximum recommended dosage of ACTOPLUS MET is 15 mg of pioglitazone and 850 mg of metformin HCl once daily if used in combination with gemfibrozil or other strong CYP2C8 inhibitors [see Dosage and Administration (2.3) , Clinical Pharmacology (12.3) ] . Therefore, if an inducer of CYP2C8 is started or stopped during treatment with ACTOPLUS MET, changes in diabetes treatment may be needed based on clinical response without exc...
Mechanism: Taking two medicines that both contain metformin can cause too much of the drug to build up in your body.
What to do: Make sure your doctor knows all the medicines you are taking to avoid accidentally taking a double dose of metformin.
( 7.6 ) Topiramate may decrease pioglitazone concentrations. 7.3 Carbonic Anhydrase Inhibitors Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. 7.8 Topiramate A decrease in the exposure of pioglitazone and its active metabolites were noted with concomitant administration of pioglitazone and topiramate [see Clinical Pharmacology (12.3) ] .
Mechanism: Topiramate can lower the levels of pioglitazone in your body, which might make it work less effectively. It can also cause a change in your blood's acid levels.
What to do: Your doctor may need to check your blood sugar and blood chemistry more often to ensure the medicine is still working safely.
Common Questions
What should I do if I experience swelling in my legs or ankles?
Can I drink alcohol while taking Actoplus Met?
Will Actoplus Met cause me to gain weight?
How often will I need blood tests while taking Actoplus Met?
Can Actoplus Met be used for type 1 diabetes?
What if I take too much Actoplus Met?
Does Actoplus Met interact with other medications?
Can Actoplus Met cause low blood sugar?
What are the symptoms of lactic acidosis?
I have heart failure. Can I take Actoplus Met?
What are the common side effects of metformin/pioglitazone?
Does metformin/pioglitazone interact with other medications?
What drug class is metformin/pioglitazone?
Is metformin/pioglitazone safe during pregnancy?
Related Medications in Biguanide / TZD Combination
Other drugs grouped near metformin/pioglitazone — same-class peers and common alternatives.
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bromocriptine
Cycloset
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canagliflozin
Invokana
Invokana is a medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes.
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colesevelam
Welchol
Colesevelam is a medicine that helps lower bad cholesterol (LDL-C) and control blood sugar in adults.
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What the FDA Data Shows for metformin/pioglitazone
The FDA label for metformin/pioglitazone (sold under brand names such as Actoplus Met) classifies it as a prescription-only medication in the Biguanide / TZD Combination class. Actoplus Met helps lower blood sugar in adults who have type 2 diabetes. Official labeling lists 5 commonly reported side effects, including Upper respiratory infection, Swelling, Diarrhea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 171,728 voluntary reports. The database also lists 10 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: March 27, 2025
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages