Avandaryl (Rosiglitazone and Glimepiride): Is It Still Available, What Happened, and the Alternative

Avandaryl was a once-daily tablet that combined two type 2 diabetes drugs: rosiglitazone (the drug in Avandia) and glimepiride (the drug in Amaryl). It was approved in the US in 2005 and made by GlaxoSmithKline. Today it is listed as discontinued by the FDA, along with Avandia, Avandamet and the only approved generic version of Avandaryl, and its European twin, Avaglim, was suspended in 2010.

People still search for the Avandaryl price, usually because they or a relative once took it, or because an old prescription or price list names it. This guide explains what happened to it, what the heart safety trials actually found, what the label warned about, and what the nearest available option looks like: pioglitazone with glimepiride, either as the Duetact combination tablet or as two separate generics. We sell pioglitazone and glimepiride tablets, so we have a commercial interest; every figure comes from the FDA labels, the trials or the price data listed at the end. This is not advice to start or switch treatment without your doctor.

The short answer

You cannot currently buy Avandaryl in the US: every approved version is listed as discontinued in the FDA's Drugs@FDA database, and the FDA recorded that the brand was not withdrawn for safety or effectiveness reasons. Rosiglitazone's history is mixed. A 2007 meta-analysis suggested more heart attacks, the long-term RECORD trial did not confirm that, and the FDA lifted its restrictions in 2013. But one risk was never in doubt: rosiglitazone, like pioglitazone, can cause or worsen heart failure, and both carry a boxed warning. In a large study of older Americans, rosiglitazone was linked with more strokes, heart failure and deaths than pioglitazone. The nearest available combination is pioglitazone with glimepiride. In the US the two separate generics cost pharmacies about $4 for 30 days, while the combination tablet costs over $300.

What Avandaryl was

Detail	Avandaryl
Ingredients	Rosiglitazone maleate (a thiazolidinedione, or "glitazone") plus glimepiride (a sulfonylurea)
US approval	2005 (NDA 021700, GlaxoSmithKline)
Strengths (rosiglitazone/glimepiride)	4 mg/1 mg, 4 mg/2 mg, 8 mg/2 mg, 4 mg/4 mg, 8 mg/4 mg
Maximum daily dose in the label	8 mg rosiglitazone and 4 mg glimepiride
Use	Adults with type 2 diabetes, with diet and exercise; not for type 1 diabetes; use with insulin not recommended
Status in the US	Discontinued (brand and the one approved generic)
Status in the EU	Sold as Avaglim; suspended in 2010

The two drugs work in different ways. Rosiglitazone makes the body's tissues more sensitive to insulin. Glimepiride makes the pancreas release more insulin, which is why it can cause low blood sugar (hypoglycaemia). Combining them in one tablet was a convenience, not a new treatment.

Is Avandaryl still available?

Not in the US. In the FDA's Drugs@FDA database (checked October 2026):

• Avandaryl (NDA 021700), all five strengths: discontinued.
• Avandia (rosiglitazone alone, NDA 021071) and Avandamet (rosiglitazone with metformin, NDA 021410): discontinued.
• The only approved generic rosiglitazone and glimepiride tablet (Teva, ANDA 078709): discontinued.
• For Avandaryl, Avandia and Avandamet, the FDA entry carries a Federal Register determination that the product was not discontinued or withdrawn for safety or effectiveness reasons.

In the European Union, the European Medicines Agency recommended in September 2010 that the marketing authorisations for Avandia, Avandamet and Avaglim be suspended, concluding that the benefits of rosiglitazone no longer outweighed its risks.

Why there is no current Avandaryl price

The usual US price benchmark is NADAC, the survey of what pharmacies pay for medicines, published weekly by the Centers for Medicare and Medicaid Services. The 2026 NADAC file (as of 14 October 2026) has no rows for rosiglitazone in any form, alone or combined, which fits a product that is no longer sold. Any website quoting an Avandaryl price today is either out of date or selling a product that is not the US-approved tablet. If you have old Avandaryl tablets, check the expiry date and ask a pharmacist before taking them.

How rosiglitazone's story unfolded

Year	Event
2005	Avandaryl approved in the US
2007	Nissen and Wolski meta-analysis of 42 trials reports more heart attacks with rosiglitazone
2009	RECORD outcome trial published: no overall increase in cardiovascular death or hospital admission; more heart failure
2010	FDA restricts prescribing and dispensing of rosiglitazone medicines; EMA recommends suspension in the EU
2013	After a re-evaluation of RECORD, the FDA requires removal of the 2010 prescribing and dispensing restrictions (25 November 2013)
2014	Avandaryl label updated: patient population restrictions and the restricted access programme removed
2015	FDA announces the rosiglitazone REMS safety programme is no longer required (December 2015)

What the 2007 meta-analysis found

The study that set off the controversy pooled 42 randomised trials lasting more than 24 weeks. Compared with control groups, rosiglitazone was associated with an odds ratio for heart attack of 1.43 (95% confidence interval 1.03 to 1.98) and for death from cardiovascular causes of 1.64 (0.98 to 2.74), the second just short of statistical significance (Nissen and Wolski 2007). The authors noted that they did not have the original patient data.

The Avandaryl label later described a similar analysis of 52 mostly short trials (average 6 months): heart attack was more common with rosiglitazone than with pooled comparators, 0.4% vs 0.3% (odds ratio 1.8, 95% CI 1.03 to 3.25), and in the placebo-controlled trials 0.4% vs 0.2% (odds ratio 2.23). In the trials that compared rosiglitazone with other active diabetes drugs, there was no increase.

What the long-term RECORD trial found

RECORD randomised 4,447 people whose diabetes was not controlled on metformin or a sulfonylurea to add rosiglitazone, or to take metformin plus a sulfonylurea, and followed them for a mean of 5.5 years. It was open-label, meaning patients and doctors knew which treatment was used.

Outcome	Rosiglitazone (n = 2,220)	Control (n = 2,227)	Hazard ratio (95% CI)
Cardiovascular death or cardiovascular hospital admission	321	323	0.99 (0.85 to 1.16)
Death from any cause	136	157	0.86 (0.68 to 1.08)
Cardiovascular death	60	71	0.84 (0.59 to 1.18)
Heart attack	64	56	1.14 (0.80 to 1.63)
Stroke	46	63	0.72 (0.49 to 1.06)
Heart failure	61	29	2.10 (1.35 to 3.27)

RECORD showed rosiglitazone was not worse than standard treatment on the main heart outcome, and the heart attack result was not statistically significant either way. Heart failure, though, was about twice as common. This is the finding the FDA relied on when it lifted the restrictions in 2013, and it is why the heart failure warning stayed.

Heart failure: the warning that never went away

Both glitazones, rosiglitazone and pioglitazone, carry a boxed warning, the FDA's strongest. The Avandaryl and Duetact labels say:

• Thiazolidinediones cause or worsen congestive heart failure in some patients.
• After starting treatment and after any dose increase, patients should be watched for signs of heart failure: rapid weight gain, breathlessness or swelling.
• If heart failure develops, stopping the drug or lowering the dose must be considered.
• The drug is not recommended in people with symptomatic heart failure, and starting it in people with established NYHA class III or IV heart failure is contraindicated.

The mechanism is fluid retention. Oedema (swelling) was reported in 3.2% of people on Avandaryl in its main trial, and more often when rosiglitazone was combined with insulin. Rapid weight gain, swelling or new breathlessness on a glitazone is a reason to contact a doctor promptly.

Rosiglitazone compared with pioglitazone

There is no large randomised trial comparing the two glitazones head to head on heart outcomes. The largest comparison is observational: 227,571 Medicare patients aged 65 or older who started one or the other between 2006 and 2009 (Graham 2010). After adjusting for differences between the groups, those who started rosiglitazone had:

Outcome	Adjusted hazard ratio, rosiglitazone vs pioglitazone (95% CI)
Heart attack	1.06 (0.96 to 1.18)
Stroke	1.27 (1.12 to 1.45)
Heart failure	1.25 (1.16 to 1.34)
Death from any cause	1.14 (1.05 to 1.24)
Any of the four	1.18 (1.12 to 1.23)

The authors estimated 1.68 extra events per 100 person-years on rosiglitazone, or one extra event for every 60 people treated for a year. Because this was not a randomised trial, some of the difference could reflect who was prescribed which drug. The Avandaryl label itself records that three observational studies in patients aged 65 or older found higher all-cause mortality with rosiglitazone than with pioglitazone, while one study in patients with a mean age of 54 found no difference, and a small prospective study found no statistically significant differences.

How well Avandaryl lowered blood sugar

In the 28-week trial behind the label, 901 people with type 2 diabetes not controlled by diet and exercise (average starting HbA1c about 9%) took glimepiride, rosiglitazone or Avandaryl, with doses raised every 4 weeks towards a glucose target.

Group	Fall in HbA1c (points)	Reached HbA1c below 7%	Hypoglycaemia
Glimepiride alone	1.7	49%	4.1%
Rosiglitazone alone	1.8	46%	0.4%
Avandaryl, up to 4 mg/4 mg	2.4	75%	3.6%
Avandaryl, up to 8 mg/4 mg	2.5	72%	5.5%

Hypoglycaemia here means symptoms with a fingerstick glucose below 50 mg/dL; three people on Avandaryl (0.7%) needed intravenous glucose or glucagon. The label added that for people starting their first treatment, the benefits and risks of one drug or two should be weighed, especially the extra low blood sugar and weight gain with two.

Other warnings on the label

• Fractures. In RECORD, fractures occurred in 8.3% of people on rosiglitazone vs 5.3% on control, with the gap larger in women (11.5% vs 6.3%) than men (5.3% vs 4.3%). In women, most fractures were in the upper arm, hand and foot.
• Weight gain and swelling, related to dose, probably from fluid and fat.
• Macular oedema (swelling at the back of the eye) was reported after marketing; the label says anyone reporting any visual symptom should be promptly referred to an ophthalmologist.
• Anaemia, usually mild.
• Liver. Treatment should not be started in people with active liver disease or raised liver enzymes.
• Hypoglycaemia from glimepiride, especially in older, frail or underweight people and those with kidney, liver, adrenal or pituitary problems.
• G6PD deficiency. Sulfonylureas can cause haemolytic anaemia; the label advises considering a non-sulfonylurea in people with G6PD deficiency.
• Sulfonylureas and heart deaths. Both the Avandaryl and Duetact labels carry the class warning that sulfonylureas have been linked with increased cardiovascular death, based on the older UGDP study, in which tolbutamide was associated with about 2.5 times the cardiovascular death rate of diet alone.
• Ovulation. Glitazones may cause ovulation in some premenopausal women who were not ovulating, which can raise the chance of pregnancy; the label says adequate contraception should be recommended.
• Allergy to sulfonamide drugs is a contraindication, and serious skin and allergic reactions have been reported with glimepiride.

The nearest available option: pioglitazone with glimepiride

Pioglitazone is the other glitazone and is still widely available. Combined with glimepiride it is Duetact (Takeda), still listed as a prescription product in Drugs@FDA. An authorized generic of Duetact (Prasco) is the version priced in the 2026 NADAC file, and a Chartwell generic (ANDA 201049) is also approved. The tablets come in two strengths, 30 mg/2 mg and 30 mg/4 mg, taken once daily with the first main meal. The same two drugs are also available as separate generic tablets, which allows any dose of either drug, including lower starting doses than the combination offers.

The Duetact label carries the same heart failure boxed warning and the same contraindication for NYHA class III or IV heart failure. Some points differ from Avandaryl:

• With gemfibrozil or another strong CYP2C8 inhibitor, the maximum pioglitazone dose is 15 mg a day, below the 30 mg in every Duetact tablet, so the label says such patients should switch to the separate drugs.
• In people with systolic heart dysfunction, the label says the lowest Duetact dose should be prescribed only after a 15 mg to 30 mg pioglitazone titration has been tolerated.
• Duetact should be taken at least 4 hours before colesevelam.

Switching from one glitazone to another, or from a combination tablet to two separate tablets, is a decision for your doctor, who can match the doses to your blood sugar, kidney function and heart history.

What PROactive showed for pioglitazone

Pioglitazone was tested in PROactive, a randomised trial of 5,238 people with type 2 diabetes and a history of disease of the large arteries (macrovascular disease), followed for an average of 34.5 months.

Outcome	Pioglitazone (n = 2,605)	Placebo (n = 2,633)	Result
Main composite (death, heart attack, stroke, acute coronary syndrome, heart or leg artery procedures, amputation)	514 (19.7%)	572 (21.7%)	Hazard ratio 0.90 (0.80 to 1.02); not significant
Death, non-fatal heart attack or stroke (main secondary outcome)	301	358	Hazard ratio 0.84 (0.72 to 0.98)
At least one hospital admission for heart failure	149 (5.7%)	108 (4.1%)	More common on pioglitazone

So the main outcome was not significantly reduced, a narrower secondary outcome was, and heart failure admissions were higher on pioglitazone. The Duetact label states that no clinical study has established conclusive evidence of reduced large-vessel risk with Duetact itself.

The bladder cancer question with pioglitazone

The pioglitazone labels carry a warning about bladder tumours. In PROactive, 14 of 2,605 people on pioglitazone (0.54%) and 5 of 2,633 on placebo (0.19%) were diagnosed with bladder cancer. Over 13 years of trial and follow-up, the rates did not differ (hazard ratio 1.00, 95% CI 0.59 to 1.72). A 10-year US cohort found no significant increase (hazard ratio 1.06), while a UK study did find one (hazard ratio 1.63). The label concludes that the data are inconsistent, that pioglitazone may be associated with an increased risk, and that it should not be used in people with active bladder cancer. The Duetact patient information says to tell your doctor right away about blood or a red colour in the urine, an increased need to urinate, or pain while urinating.

What the combination costs vs two separate generics

In the US, the combination tablet is far more expensive for pharmacies to buy than the same two drugs as separate generic tablets. NADAC figures as of 14 October 2026:

Product	NADAC per tablet	30 days, one a day
Pioglitazone-glimepiride 30 mg/2 mg (combination)	$10.75973	$322.79
Pioglitazone-glimepiride 30 mg/4 mg (combination)	$10.51761	$315.53
Pioglitazone 30 mg (generic)	$0.09301	$2.79
Glimepiride 2 mg (generic)	$0.03752	$1.13
Glimepiride 4 mg (generic)	$0.05069	$1.52
Pioglitazone 30 mg plus glimepiride 2 mg, separate	$0.13053	$3.92
Pioglitazone 30 mg plus glimepiride 4 mg, separate	$0.14370	$4.31

That is about 82 times (30 mg/2 mg) and 73 times (30 mg/4 mg) the cost of the separate generics. The combination figures come from a single NDC row in the file, while pioglitazone and glimepiride each have 17 to 22 rows from many makers. NADAC is what pharmacies pay wholesalers, not what a patient pays at the counter, which adds dispensing fees and depends on insurance. Our brand vs generic prices guide explains how NADAC works.

Who should not take a glitazone with a sulfonylurea

• People with established NYHA class III or IV heart failure (starting treatment is contraindicated), and people with symptomatic heart failure (not recommended).
• People with type 1 diabetes or diabetic ketoacidosis.
• People allergic to either drug or to sulfonamide medicines.
• People with active bladder cancer (pioglitazone).
• People with active liver disease or raised liver enzymes before treatment.
• Pregnant or breastfeeding women should discuss alternatives with their doctor; the Avandaryl label advised stopping either the drug or breastfeeding.

Low blood sugar with glimepiride

Glimepiride is the part of these combinations that can cause hypoglycaemia. The Duetact patient information lists lightheadedness, dizziness, shakiness or hunger, and warns that severe low blood sugar can cause unconsciousness, seizures and death. The Avandaryl label says the risk is higher in older, debilitated or malnourished people, in those with kidney, liver, adrenal or pituitary problems, when food intake is low, after severe or prolonged exercise, with alcohol, and when more than one glucose-lowering drug is used, and it recommended starting such patients on 1 mg of glimepiride. Oral miconazole, an antifungal, can cause severe hypoglycaemia with glimepiride. Our guide to glimepiride dosing and hypoglycaemia risk covers this in more detail.

Questions to ask your doctor

• Is a glitazone still the right choice for me, given my heart, bone and bladder history?
• Would two separate tablets let us use a lower starting dose and cost less?
• Would a different class suit me better, such as an SGLT2 inhibitor or a DPP-4 inhibitor? Our Jardiance vs Farxiga and Januvia vs Tradjenta guides compare common options.
• How often should my weight, ankles, blood sugar and liver tests be checked?

Where SafeRxPills fits

SafeRxPills does not sell Avandaryl or any rosiglitazone product. We sell pioglitazone (Pioz 15 mg and Pioz 30 mg, made by USV in India) and glimepiride (Amaryl 1 mg, Amaryl 2 mg and Glypride 4 mg). These are Indian-market brands, not the US-approved products, and they should be used only on a prescription from a doctor who has reviewed your heart and kidney health. For the wider picture, see our type 2 diabetes page and metformin vs glimepiride.

Sources

1. AVANDARYL (rosiglitazone maleate and glimepiride) US prescribing information, GlaxoSmithKline (revised 03/2015). Boxed warning; sections 1, 2, 4, 5, 6.1 (Tables 3 and 5) and 14.1 (Table 8). Drugs@FDA.
2. U.S. Food and Drug Administration. Drugs@FDA entries for NDA 021700 (Avandaryl), NDA 021071 (Avandia), NDA 021410 (Avandamet), ANDA 078709, NDA 021925 (Duetact), ANDA 201049 and the Prasco authorized generic (NDC 66993-821/822), via openFDA, accessed October 2026.
3. U.S. Food and Drug Administration. Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines, 25 November 2013; REMS removal announced December 2015.
4. European Medicines Agency. European Medicines Agency recommends suspension of Avandia, Avandamet and Avaglim (September 2010) and Avaglim assessment report EMA/831387/2010.
5. DUETACT (pioglitazone and glimepiride) US prescribing information, Takeda (revised March 2025). Boxed warning; sections 2, 4, 5.6, 5.8, 5.11 and 6.1. DailyMed.
6. ACTOS (pioglitazone) US prescribing information, Takeda (2025). Section 2.1. DailyMed.
7. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007;356(24):2457-71. PMID 17517853.
8. Home PD, Pocock SJ, Beck-Nielsen H, et al. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD). Lancet 2009;373(9681):2125-35. PMID 19501900.
9. Graham DJ, Ouellet-Hellstrom R, MaCurdy TE, et al. Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone. JAMA 2010;304(4):411-8. PMID 20584880.
10. Dormandy JA, Charbonnel B, Eckland DJ, et al. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study. Lancet 2005;366(9493):1279-89. PMID 16214598.
11. Centers for Medicare and Medicaid Services. National Average Drug Acquisition Cost (NADAC), weekly file as of 14 October 2026.

This guide is for information and does not replace advice from a doctor or pharmacist who knows your medical history. Do not stop or change diabetes medicines without medical advice.