Roszet adverse experiences are expected to be similar to those with co-administered rosuvastatin and ezetimibe taken separately.
In double-blind, controlled (placebo- or active-controlled) clinical trials of rosuvastatin, 5394 patients with primary hyperlipidemia were treated for a duration of up to 12 weeks. Adverse reactions reported in ≥2% of patients in placebo-controlled clinical studies and at a rate greater than placebo were:
|Adverse Reaction||Placebo N=382||Total Rosuvastatin 5 mg-40 mg N=744|
Other adverse reactions reported in clinical studies were abdominal pain, dizziness, hypersensitivity (including rash, pruritus, urticaria, and angioedema), and pancreatitis.
Ezetimibe Combination with Statins
In 28 double-blind, controlled (placebo- or active-controlled) clinical trials, 11,308 patients with primary hyperlipidemia (48% women, 85% Caucasians, 7% Blacks, 4% Hispanics, 3% Asians) and elevated LDL-C were treated with ezetimibe concurrently with or added to ongoing statin therapy for a median treatment duration of 8 weeks. Clinical adverse reactions reported in ≥2% of patients treated with ezetimibe + statin and at an incidence greater than statin were:
|Adverse Reaction||All Statins (%), n=9361||Ezetimibe + statins (%) N=11,308|
|Upper respiratory tract infection||2.8%||2.9%|
|Pain in extremity||1.9%||2.1%|
The incidence of consecutive increased transaminases (≥3x ULN) was higher in patients receiving ezetimibe administered with statins (1.3%) than in patients treated with statins alone (0.4%). These elevations in transaminases were generally asymptomatic, not associated with cholestasis, and returned to baseline after discontinuation of therapy or with continued treatment.
Important Safety Information