August 2025
Note: Not approved in the United States.
Note: May require a dose reduction of insulin secretagogues (sulfonylureas, meglitinides) to avoid hypoglycemia; consider stopping insulin or reducing insulin dose (Ref).
Diabetes mellitus, type 2, treatment:
Note: May be used as an adjunctive agent or alternative monotherapy for select patients, including those in whom initial therapy with lifestyle intervention and metformin failed, or cannot take metformin, particularly when avoidance of hypoglycemia is desirable. Pioglitazone may have a more favorable cardiovascular profile compared to rosiglitazone; use of any thiazolidinedione has been associated with an increased risk of heart failure, and risk is increased with concomitant insulin use (Ref).
Oral: Initial: 4 mg/day as a single dose or in 2 divided doses. If response is inadequate after 8 to 12 weeks, may increase to 8 mg/day as a single dose or in 2 divided doses daily (maximum dose: 8 mg/day); do not exceed 4 mg/day in patients taking sulfonylureas. Discontinue use if any deterioration in cardiac status occurs (eg, congestive heart failure).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (limited data); use with caution.
Hepatic impairment prior to initiation: There are no dosage adjustments provided in the manufacturer's labeling; use with caution. Clearance is significantly lower in hepatic impairment; therapy should not be initiated if the patient exhibits active liver disease or increased transaminases (ALT >2.5 times the upper limit of normal) at baseline.
Hepatic impairment during therapy: Discontinue therapy if ALT is persistently >3 times ULN or jaundice occurs.
Refer to adult dosing.
(For additional information see "Rosiglitazone (United States: Not available): Pediatric drug information")
Note: Avandia has been discontinued in the United States for >1 year.
Diabetes mellitus, type 2: Limited data available: Note: Rosiglitazone is not recommended for the management of type 2 diabetes mellitus (T2DM) in children and adolescents; if thiazolidinedione therapy is required, other agents are preferred (Ref).
Children ≥10 years and Adolescents: Oral: Initial: 2 mg twice daily; then increase to 4 mg twice daily after 8 weeks. Dosing presented was used in 233 pediatric patients as part of a larger multicenter comparative trial of treatments (n=699) in which rosiglitazone in combination with metformin was more effective than metformin alone or metformin and lifestyle changes at maintaining glycemic control (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Based on experience in adults, no dosage adjustment necessary.
Children ≥10 years and Adolescents:
Hepatic impairment prior to initiation: There are no dosage adjustments provided in the manufacturer's labeling. Clearance is significantly lower in hepatic impairment; based on recommendations in adults, therapy should not be initiated if the patient exhibits active liver disease or increased transaminases (ALT >2.5 times ULN) at baseline.
Hepatic impairment during therapy: Based on recommendations in adults, discontinue therapy if ALT is persistently >3 times ULN or jaundice occurs.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults administered monotherapy.
1% to 10%:
Cardiovascular: Edema (5%), ischemic heart disease (1%)
Hematologic & oncologic: Anemia (2%)
Nervous system: Headache (6%)
Respiratory: Upper respiratory tract infection (10%)
Frequency not defined:
Cardiovascular: Heart failure (including worsening of heart failure), increased plasma volume
Endocrine & metabolic: Fluid retention, hypercholesterolemia, increased LDL cholesterol, weight gain
Gastrointestinal: Constipation, increased appetite
Hematologic & oncologic: Decreased hematocrit, decreased hemoglobin
Hepatic: Decreased serum alkaline phosphatase, decreased serum bilirubin
Neuromuscular & skeletal: Bone fracture
Postmarketing:
Cardiovascular: Acute myocardial infarction, hypertension
Dermatologic: Pruritus, skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis
Endocrine & metabolic: Decreased HDL cholesterol (Gutschi 2006), SIADH (Berker 2008)
Gastrointestinal: Parotid gland enlargement
Hepatic: Hepatic failure (Su 2006), hepatitis (including cholestatic hepatitis, granulomatous hepatitis) (Dhawan 2002, Menees 2005), hepatotoxicity (Al-Salman 2000), increased liver enzymes, increased serum alkaline phosphatase (Hachey 2000)
Hypersensitivity: Anaphylaxis, angioedema
Neuromuscular & skeletal: Decreased bone mineral density (hip, spine), increased creatine phosphokinase in blood specimen (Kennie 2007), myalgia, rhabdomyolysis
Ophthalmic: Macular edema (Colucciello 2005)
Renal: Interstitial nephritis (Castledine 2006)
Respiratory: Pulmonary edema (Cekmen 2006)
Hypersensitivity to rosiglitazone or any component of the formulation; any stage of heart failure (eg, NYHA Class I, II, III, IV); serious hepatic impairment; pregnancy.
Concerns related to adverse effects:
• Edema: Dose-related edema may occur. Use with caution in patients with edema; may increase plasma volume and/or cause fluid retention.
• Fluid retention/heart failure: [Canadian Boxed Warning]: Rosiglitazone, like other thiazolidinediones, can cause or exacerbate fluid retention and congestive heart failure. May present as rapid and excessive weight gain. Older patients and patients concurrently receiving metformin or a sulfonylurea may be at increased risk.
• Fractures: Increased incidence of bone fractures in females treated with rosiglitazone was observed during analysis of long-term trial; majority of fractures occurred in the upper arm, hand and foot (differing from the hip or spine fractures usually associated with postmenopausal osteoporosis). Decreases in spine and hip bone mineral density have also been reported. Consider risk of fracture prior to initiation and during use.
• Hepatic effects: Hepatocellular injury has rarely been reported with thiazolidinediones. Hepatitis and increased liver enzymes ≥3 times ULN have occurred with rosiglitazone use; rarely has led to hepatic failure (sometimes fatal).
• Hematologic effects: May decrease hemoglobin and/or hematocrit; effects may be related to increased plasma volume and/or dose related. Changes in hemoglobin and hematocrit generally occurred during the first 3 months after initiation of therapy and after dose increases.
• Hypoglycemia: The risk of hypoglycemia is increased when rosiglitazone is combined with other hypoglycemic agents; dosage adjustment of concomitant hypoglycemic agents may be necessary.
• Macular edema: New onset and/or worsening of macular edema with decreased visual acuity has been reported with rosiglitazone; visual events resolved or improved in some patients following discontinuation of therapy. Consider the possibility of macular edema in patients with disturbances in visual acuity.
• Muscle effects: Elevated creatinine kinase, myalgia, and rhabdomyolysis have rarely occurred with use.
• Weight gain: Dose-related weight gain observed with use; reevaluate treatment in patients with excessive weight gain.
Disease-related concerns:
• Bariatric surgery:
– Presurgical assessment of the indication for use, symptoms, and goals of therapy should be documented to enable postsurgical assessment. Immediate postoperative use may cause hypoglycemia especially as insulin secretion and sensitivity improve postoperatively (AACE/ASMBS/OMA/ASA [Mechanick 2020]; Korner 2009; Peterli 2012).
– Dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 agonists, insulin, and metformin are preferred for outpatient glucose management following bariatric surgery. Consider alternatives to thiazolidinediones for glucose management due to the risk of hypoglycemia and weight gain associated with therapy (AACE/ASMBS/OMA/ASA [Mechanick 2020]; Apovian 2015). Monitor for continued efficacy and tolerability after bariatric surgery and consider switching to alternative medication if condition worsens.
• Ischemic heart disease: [Canadian Boxed Warning]: Rosiglitazone may be associated with an increased risk of cardiac ischemia. Rosiglitazone is not recommended in patients with a history of ischemic heart disease, particularly those with myocardial ischemic symptoms.
• Stress-related states: It may be necessary to discontinue therapy and administer insulin if the patient is exposed to stress (fever, trauma, infection, surgery).
Other warnings/precautions:
• Appropriate use: [Canadian Boxed Warning]: Rosiglitazone should be used only when all other oral antidiabetic agents, in monotherapy or in combination, do not result in adequate glycemic control or are inappropriate due to contraindications or intolerance. Not indicated for use in patients with type 1 diabetes mellitus or with diabetic ketoacidosis (DKA).
• Patient education: Diabetes self-management education (DSME) is essential to maximize the effectiveness of therapy.
May be product dependent
Tablets (Avandia Oral)
2 mg (per each): $4.57
4 mg (per each): $6.78
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Generic: 2 mg, 4 mg, 8 mg
Health Canada requires written informed consent for new and current patients receiving rosiglitazone.
Oral: May be administered without regard to meals.
Oral: May be taken without regard to meals.
Note: Not approved in the United States.
Diabetes mellitus, type 2, treatment: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Avandia [Canada and multiple international markets] may be confused with Avanza brand name for mirtazapine [Australia] and Prandin brand name for deflazacort [South Korea] and repaglinide [multiple international markets].
ALERT: Canadian Boxed Warning: Health Canada-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling.
Substrate of CYP2C8 (Major), CYP2C9 (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Abiraterone Acetate: May increase hypoglycemic effects of Thiazolidinediones. Risk C: Monitor
Alpha-Lipoic Acid: May increase hypoglycemic effects of Antidiabetic Agents. Risk C: Monitor
Androgens: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Risk C: Monitor
Beta-Blockers (Beta1 Selective): May increase adverse/toxic effects of Antidiabetic Agents. Specifically, beta-blockers may mask the hypoglycemic symptoms of antidiabetic agents. Risk C: Monitor
Beta-Blockers (Nonselective): May increase hypoglycemic effects of Antidiabetic Agents. Beta-Blockers (Nonselective) may increase adverse/toxic effects of Antidiabetic Agents. Specifically, beta-blockers may mask the hypoglycemic symptoms of antidiabetic agents. Risk C: Monitor
Bortezomib: May increase therapeutic effects of Antidiabetic Agents. Bortezomib may decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor
Cannabidiol: May increase serum concentration of CYP2C8 Substrates (High risk with Inhibitors). Risk C: Monitor
Clarithromycin: May increase hypoglycemic effects of Thiazolidinediones. Risk C: Monitor
CYP2C8 Inducers (Moderate): May decrease serum concentration of Rosiglitazone. Risk C: Monitor
CYP2C8 Inhibitors (Strong): May increase serum concentration of Rosiglitazone. Risk C: Monitor
Direct Acting Antiviral Agents (HCV): May increase hypoglycemic effects of Antidiabetic Agents. Risk C: Monitor
Etilefrine: May decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor
Guanethidine: May increase hypoglycemic effects of Antidiabetic Agents. Risk C: Monitor
Hyperglycemia-Associated Agents: May decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor
Hypoglycemia-Associated Agents: Antidiabetic Agents may increase hypoglycemic effects of Hypoglycemia-Associated Agents. Risk C: Monitor
Inhibitors of the Proton Pump (PPIs and PCABs): May increase adverse/toxic effects of Thiazolidinediones. Specifically, the risk of osteoporosis or fracture may be increased. Risk C: Monitor
Insulin: May increase adverse/toxic effects of Rosiglitazone. Specifically, the risk of fluid retention, heart failure, and hypoglycemia may be increased with this combination. Risk X: Avoid
Letermovir: May increase serum concentration of Rosiglitazone. Risk C: Monitor
Lumacaftor and Ivacaftor: May decrease serum concentration of CYP2C8 Substrates (High Risk with Inhibitors or Inducers). Lumacaftor and Ivacaftor may increase serum concentration of CYP2C8 Substrates (High Risk with Inhibitors or Inducers). Risk C: Monitor
Maitake: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Risk C: Monitor
Monoamine Oxidase Inhibitors: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Risk C: Monitor
Pegvisomant: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Risk C: Monitor
Pregabalin: May increase fluid-retaining effects of Thiazolidinediones. Risk C: Monitor
Prothionamide: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Risk C: Monitor
Quinolones: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Quinolones may decrease therapeutic effects of Agents with Blood Glucose Lowering Effects. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Risk C: Monitor
Reproterol: May decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor
Ritodrine: May decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor
Salicylates: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Risk C: Monitor
Selective Serotonin Reuptake Inhibitor: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Risk C: Monitor
Sulfonylureas: Thiazolidinediones may increase hypoglycemic effects of Sulfonylureas. Management: Consider sulfonylurea dose adjustments in patients taking thiazolidinediones and monitor for hypoglycemia. Risk D: Consider Therapy Modification
Thiazide and Thiazide-Like Diuretics: May decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor
Vasodilators (Organic Nitrates): May increase adverse/toxic effects of Rosiglitazone. Specifically, a greater risk of ischemia and other adverse effects has been associated with this combination in some pooled analyses. Risk C: Monitor
Thiazolidinediones may cause ovulation in anovulatory premenopausal patients, increasing the risk of unintended pregnancy.
Thiazolidinediones are not recommended for patients with type 2 diabetes mellitus planning to become pregnant. Patients who could become pregnant should use effective contraception during therapy. Transition to a preferred therapy should be initiated prior to conception and contraception should be continued until glycemic control is achieved (ADA 2023; Alexopoulos 2019; Egan 2020)
Rosiglitazone crosses the placenta (Chan 2005).
Inadvertent use early in pregnancy has been reported, although in the majority of cases, the medication was stopped as soon as pregnancy was detected (Chan 2005; Kalyoncu 2005; Yaris 2004).
Poorly controlled diabetes during pregnancy can be associated with an increased risk of adverse maternal and fetal outcomes, including diabetic ketoacidosis, preeclampsia, spontaneous abortion, preterm delivery, delivery complications, major malformations, stillbirth, and macrosomia. To prevent adverse outcomes, prior to conception and throughout pregnancy, maternal blood glucose and HbA1c should be kept as close to target goals as possible but without causing significant hypoglycemia (ADA 2023).
Agents other than rosiglitazone are currently recommended to treat diabetes mellitus in pregnancy (ADA 2023).
It is not known if rosiglitazone is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother
Individualized medical nutrition therapy (MNT) based on American Diabetes Association recommendations is an integral part of therapy.
Fasting blood glucose (periodically).
HbA1c: Monitor at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; monitor quarterly in patients in whom treatment goals have not been met, or with therapy change. Note: In patients prone to glycemic variability (eg, patients with insulin deficiency), or in patients whose HbA1c is discordant with serum glucose levels or symptoms, consider evaluating HbA1c in combination with blood glucose levels and/or a glucose management indicator (ADA 2023; KDIGO 2020).
Liver enzymes (prior to initiation of therapy, then periodically thereafter); evaluate patients with ALT ≤2.5 times ULN at baseline or during therapy for cause of enzyme elevation. Patients with an elevation in ALT >3 times ULN during therapy should be rechecked as soon as possible. If the ALT levels remain >3 times ULN, therapy with rosiglitazone should be discontinued.
Signs and symptoms of fluid retention or heart failure (periodically and with dose adjustments); weight gain (periodically and with dose adjustments); ophthalmic exams (at least every 1 to 2 years, or more frequently if symptoms dictate) (ADA 2023); fractures/fracture risk.
Recommendations for glycemic control in patients with diabetes:
Nonpregnant adults (AACE [Samson 2023]; ADA 2023):
HbA1c: <7% (a more aggressive [<6.5%] or less aggressive [<8%] HbA1c goal may be targeted based on patient-specific characteristics). Note: In patients using a continuous glucose monitoring system, a goal of time in range >70% with time below range <4% is recommended and is similar to a goal HbA1c <7%.
Preprandial capillary blood glucose: 80 to 130 mg/dL (SI: 4.4 to 7.2 mmol/L) (more or less stringent goals may be appropriate based on patient-specific characteristics).
Peak postprandial capillary blood glucose (~1 to 2 hours after a meal): <180 mg/dL (SI: <10 mmol/L) (more or less stringent goals may be appropriate based on patient-specific characteristics).
Older adults (≥65 years of age) (ADA 2023):
Note: Consider less strict targets in patients who are using insulin and/or insulin secretagogues (sulfonylureas, meglitinides) (ES [LeRoith 2019]).
HbA1c: <7% to 7.5% (healthy); <8% (complex/intermediate health). Note: Individualization may be appropriate based on patient and caregiver preferences and/or presence of cognitive impairment. In patients with very complex or poor health (ie, limited remaining life expectancy), consider making therapy decisions based on avoidance of hypoglycemia and symptomatic hyperglycemia rather than HbA1c level.
Preprandial capillary blood glucose: 80 to 130 mg/dL (SI: 4.4 to 7.2 mmol/L) (healthy); 90 to 150 mg/dL (SI: 5 to 8.3 mmol/L) (complex/intermediate health); 100 to 180 mg/dL (SI: 5.6 to 10 mmol/L) (very complex/poor health).
Bedtime capillary blood glucose: 80 to 180 mg/dL (SI: 4.4 to 10 mmol/L) (healthy); 100 to 180 mg/dL (SI: 5.6 to 10 mmol/L) (complex/intermediate health); 110 to 200 mg/dL (SI: 6.1 to 11.1 mmol/L) (very complex/poor health).
Classification of hypoglycemia (ADA 2023):
Level 1: 54 to 70 mg/dL (SI: 3 to 3.9 mmol/L); hypoglycemia alert value; initiate fast-acting carbohydrate (eg, glucose) treatment.
Level 2: <54 mg/dL (SI: <3 mmol/L); threshold for neuroglycopenic symptoms; requires immediate action.
Level 3: Hypoglycemia associated with a severe event characterized by altered mental and/or physical status requiring assistance.
Thiazolidinedione antidiabetic agent that lowers blood glucose by improving target cell response to insulin, without increasing pancreatic insulin secretion. It has a mechanism of action that is dependent on the presence of insulin for activity. Rosiglitazone is an agonist for peroxisome proliferator-activated receptor-gamma (PPARgamma). Activation of nuclear PPARgamma receptors influences the production of a number of gene products involved in glucose and lipid metabolism. PPARgamma is abundant in the cells within the renal collecting tubules; fluid retention results from stimulation by thiazolidinediones which increases sodium reabsorption.
Onset of action: Delayed; Maximum effect: Up to 12 weeks.
Protein binding: 99.8%; primarily albumin.
Metabolism: Hepatic via CYP2C8 (primarily); minor metabolism via CYP2C9.
Bioavailability: 99%.
Half-life elimination: 3 to 4 hours; prolonged by ~2 hours in patients with moderate-to-severe hepatic impairment.
Time to peak, plasma: 1 hour.
Excretion: Urine (~64%) and feces (~23%) as metabolites.
Hepatic function impairment: In moderate to severe liver disease (Child-Pugh class B or C), unbound oral Cl was significantly lower; Cmax and AUC were increased 2- and 3-fold, respectively.
Sex: Mean oral Cl in females was 15% lower compared to males (primarily related to body weight).
Body weight: Cl and steady-state Vd increase with increased body weight.
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