Rosiglitazone

Rosiglitazone is a prescription medication used to treat the symptoms of Type 2 Diabetes Mellitus.

• Rosiglitazone is available under the following different brand names: Avandia

Common side effects of Rosiglitazone include:

• headache, and
• cold symptoms (stuffy nose, sinus pain, sneezing, sore throat)

Serious side effects of Rosiglitazone include:

• shortness of breath,
• unusual tiredness,
• swelling,
• rapid weight gain,
• chest pain or pressure,
• pain spreading to the jaw or shoulder,
• nausea,
• sweating,
• pale skin,
• light-headedness,
• cold hands or feet,
• loss of appetite,
• stomach pain,
• dark urine,
• yellowing of the skin or eyes (jaundice),
• changes in the vision, and
• sudden unusual pain in your hand, arm, or foot

Rare side effects of Rosiglitazone include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 2 mg
• 4 mg

Type 2 Diabetes Mellitus

Adult dosage

• Initial 4 mg orally once a day or divided every 12 hours
• If inadequate response after 8-12 weeks, may increase the dose to 8 mg orally once a day or divided every 12 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Rosiglitazone has no noted severe interactions with any other drugs.
• Rosiglitazone has serious interactions with the following drugs:
  • eluxadoline
  • ethanol
  • gemfibrozil
  • tucatinib
• Rosiglitazone has moderate interactions with at least 75 other drugs.
• Rosiglitazone has minor interactions with at least 69 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to rosiglitazone
• Diabetic ketoacidosis
• Heart failure NYHA class III-IV
• Active liver disease: do not start rosiglitazone if ALT is above 2.5 x ULN

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Rosiglitazone?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Rosiglitazone?”

Cautions

• Fluid retention, which may exacerbate or lead to heart failure, may occur; combination use with insulin and use in congestive heart failure NYHA Class I and II may increase the risk of other cardiovascular effects
• If ALT above 3 into ULN stop treatment; if 1.5-3 in to normal, retest every Week until normal or 3 in to normal and need to discontinue
• Not for use in diabetes mellitus type 1; mechanism requires the presence of endogenous insulin; use with insulin may increase risk of heart failure; not recommended
• Thiazolidinediones, which are peroxisome proliferator-activated receptor (PPAR) gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin; dose-related edema and weight gain may occur
• When used in combination with other hypoglycemic agents, a dose reduction of the concomitant agent may be necessary to reduce the risk of hypoglycemia
• associated with rare cases of new onset or worsening of macular edema
• May result in ovulation in some premenopausal anovulatory women; ensure adequate contraception
• Increased risk of fractures of the upper arm, hand, or foot in female patients
• Dose-related decreases in hemoglobin and hematocrit reported

Pregnancy and Lactation

• Limited data in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy
• Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications; poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity
• Reproductive potential of patients
  • Discuss the potential for unintended pregnancy with premenopausal women as therapy may result in ovulation in some anovulatory women
• Lactation
  • There are no data on the presence of rosiglitazone in human milk, effects on the breastfed infant, or milk production; the drug is present in rat milk; however, due to species-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk; developmental and health benefits of breastfeeding should be considered along with mother's clinical need for therapy and any potential adverse effects on the breastfed infant or the underlying maternal condition