wonderful [1%:2.5 times the upper limit of normal (ULN) at baseline; evaluate patients with ALT 2.5 times ULN at baseline or during therapy for cause of enzyme elevation; during therapy, if ALT >3 times ULN, reevaluate levels promptly and discontinue if elevation persists or if jaundice occurs at any time during use. Idiosyncratic hepatotoxicity has been reported with another thiazolidinedione agent (troglitazone); avoid use in patients who previously experienced jaundice during troglitazone therapy. Ischemic heart disease: Do not initiate in patients with stable ischemic heart disease due to an increased risk of cardiovascular complications (Fihn 2012). Stress-related states: It may be necessary to discontinue therapy and administer insulin if the patient is exposed to stress (fever, trauma, infection, surgery). Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations: Premenopausal/anovulatory females: Use with caution in premenopausal, anovulatory women; may result in a resumption of ovulation, increasing the risk of pregnancy. Use of adequate contraception in premenopausal women is recommended. Monitoring Parameters Hemoglobin A 1c (at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; quarterly in patients not meeting treatment goals or with therapy change [ADA 2017a]), fasting serum glucose 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; weight gain; ophthalmic exams Pregnancy Risk Factor C Pregnancy Considerations Adverse effects were observed in initial animal reproduction studies. Rosiglitazone has been found to cross the placenta during the first trimester of pregnancy. Inadvertent use early in pregnancy has not been shown to increase the risk of adverse fetal effects, although in the majority of cases, the medication was stopped as soon as pregnancy was detected (Chan 2005; Kalyoncu 2005; Yaris 2004). Thiazolidinediones may cause ovulation in anovulatory premenopausal women, increasing the risk of pregnancy. Adequate contraception in premenopausal women is recommended. In women with diabetes, maternal hyperglycemia can be associated with congenital malformations as well as adverse effects in the fetus, neonate, and the mother (ACOG 2005; ADA 2017c; Kitzmiller 2008; Metzger 2007). To prevent adverse outcomes, prior to conception and throughout pregnancy maternal blood glucose and HbA 1c should be kept as close to target goals as possible but without causing significant hypoglycemia (ACOG 2013; ADA 2017c; Blumer 2013; Kitzmiller 2008). Agents other than rosiglitazone are currently recommended to treat diabetes in pregnant women (ADA 2017c). Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience headache, common cold symptoms, joint pain, rhinitis, or pharyngitis. Have patient report immediately to prescriber signs of heart problems (cough or shortness of breath that is new or worse, swelling of the ankles or legs, abnormal heartbeat, weight gain of more than five pounds in 24 hours, dizziness, or passing out), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), bone pain, vision changes, severe loss of strength and energy, difficulty swallowing, tachycardia, signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, tachycardia, confusion, increased hunger, or sweating), or signs of a heart attack (angina; pain in arms, back, neck, jaw, or abdomen; shortness of breath; cold sweats; severe dizziness; passing out; or severe nausea or vomiting) (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about rosiglitazone Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group En Español 8 Reviews Add your own review/rating Drug class: thiazolidinediones Consumer resources Rosiglitazone Rosiglitazone (Advanced Reading) Professional resources Rosiglitazone Maleate (AHFS Monograph) Rosiglitazone (FDA) Other brands: Avandia Related treatment guides Diabetes, Type 2 Nonalcoholic Fatty Liver Disease] Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Rosiglitazone Rating 8 User Reviews 5.4 /10 8 User Reviews 5.4 Rate it! 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