Rosiglitazone
AVANDIA
Pronunciation: roe-si-GLI-ta-zoen (a-VAN-dee-a)
“A van of Rosey glitter zone”
What it isPPAR-gamma insulin sensitizer; type 2 diabetes.
Why this oneIts legacy is the myocardial-infarction safety signal that sharply curtailed use even after restrictions were eased.
What limits itAvoid in symptomatic heart failure; edema, weight gain, and fractures limit use, and pioglitazone is usually preferred.
Rosiglitazone prescription history
Animated chart of estimated U.S. prescriptions per year, Diabetes meds (1923–2026). Rosiglitazone enters in 1999 (estimated).
FDA-approved for
- type 2 diabetes (1999)
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilityFluid retention, heart failure and weight gain
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Type 2 diabetes mellitus (monotherapy or with metformin, sulfonylurea, or both) | adult | 4 mg QD or 2 mg BID | 4-8 mg/day (QD or divided BID); 4 mg BID gave greatest FPG/HbA1c reduction | 8 mg/day |
Titration May increase to 8 mg/day after 8-12 weeks if inadequate FPG response
Renal No adjustment as monotherapy; combination with metformin contraindicated in renal impairment
Hepatic Do not initiate with clinical evidence of active liver disease or ALT >2.5x ULN; check LFTs before starting and periodically
Pediatric data insufficient to recommend use
Instructions
- May take with or without food
- Start at lowest recommended dose; monitor for fluid retention with any dose increase
- If hypoglycemia on combination therapy, reduce the sulfonylurea dose
Available strengths
- tab 2, 4, 8 mg
Contraindications
- Initiation in established NYHA Class III or IV heart failure
Cautions
- Fluid retention and CHF (boxed) — observe for weight gain, dyspnea, edema; not recommended with symptomatic heart failure
- Increased cardiovascular events in NYHA I/II CHF patients
- Myocardial ischemia (boxed) — risk greater when added to insulin or with nitrates; initiation not recommended during acute coronary events
- Hepatic: measure liver enzymes before initiation and periodically; do not start if ALT >2.5x ULN
- Dose-related edema and anemia
- Hypoglycemia when combined with sulfonylurea or insulin
- Increased fractures in women (upper arm, hand, foot; ADOPT trial)
Adverse reactions
- Upper respiratory tract infection
- Headache
- Back pain
- Hyperglycemia
- Fatigue
- Sinusitis
- Edema
- Anemia
- Hypoglycemia (combination therapy)
- Fractures in women
Pregnancy Category C; crosses human placenta; should not be used during pregnancy — most experts recommend insulin monotherapy
Lactation Unknown if excreted in human milk (detected in rat milk); should not be administered to a nursing woman
Cost
| Strength | #/mo | generic $/mo | CostPlus | |
|---|---|---|---|---|
| 2 mg | tab | 30 qd | not offered | |
| 4 mg | tab | 30 qd | not offered | |
| 8 mg | tab | 30 qd | not offered |
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Memory aids: interaction avatars
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Self-check
- Rosiglitazone: Which heart-failure state warrants avoidance?
Symptomatic heart failure. - Rosiglitazone: Which alternative is usually preferred?
Pioglitazone.