Rosuzet Adverse Reactions

Clinical Trials Experience: Adults: Ezetimibe + Rosuvastatin (ROSUZET): Ezetimibe + Rosuvastatin (ROSUZET) (as coadministration of ezetimibe and rosuvastatin equivalent to Ezetimibe + Rosuvastatin (ROSUZET)) has been evaluated for safety in a clinical trial with more than 220 patients. Ezetimibe + Rosuvastatin (ROSUZET) was generally well tolerated.
The following uncommon (≥ 1/1000, <1/100) drug-related adverse experiences were reported in patients taking Ezetimibe + Rosuvastatin (ROSUZET): Gastrointestinal disorders: Uncommon: abdominal distension; abdominal pain; constipation; dry mouth; nausea.
Skin and subcutaneous tissue disorders: Uncommon: allergic dermatitis; eczema.
Musculoskeletal and connective tissue disorders: Uncommon: arthralgia; myalgia.
Ezetimibe/Rosuvastatin Fixed Dose Combination: The following common (≥ 1/100, <1/10) or uncommon (≥ 1/1000, <1/100) drug-related adverse experiences were reported in patients taking a fixed dose combination of ezetimibe/rosuvastatin in a clinical trial with more than 200 Korean patients.
Gastrointestinal disorders: Uncommon: nausea.
Skin and subcutaneous tissue disorders: Common: pruritus. Uncommon: rash.
Investigations: Uncommon: ALT increased.
Post-marketing Experience and Other Clinical Trial Experience: The following additional adverse reactions have been reported in clinical studies or post-marketing use with ezetimibe (with or without a statin) or rosuvastatin: Blood and lymphatic system disorders: thrombocytopenia.
Immune system disorders: hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria.
Endocrine disorders: diabetes mellitus [frequency will depend on the presence or absence of risk factors (fasting blood glucose ≥ 5.6 mmol/L, BMI >30 kg/m², raised triglycerides, history of hypertension)].
Metabolism and nutrition disorders: decreased appetite.
Psychiatric disorders: depression, sleep disorders (including insomnia and nightmares).
Nervous system disorders: dizziness; headache; paresthesia; peripheral neuropathy.
There have been rare postmarketing reports of memory loss associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
Vascular disorders: hot flush; hypertension.
Respiratory, thoracic, and mediastinal disorders: cough.
Gastrointestinal disorders: diarrhea; dyspepsia; flatulence; gastritis; gastroesophageal reflux disease; pancreatitis.
Hepatobiliary disorders: jaundice; hepatitis; increased hepatic transaminase; cholelithiasis; cholecystitis.
Skin and subcutaneous tissue disorders: erythema multiforme; urticaria.
Musculoskeletal and connective tissue disorders: back pain; muscle spasms; muscular weakness; myopathy (including myositis) and rhabdomyolysis and [see Skeletal Muscle Effects under PRECAUTIONS]; neck pain; pain in extremity; Immune-mediated necrotizing myopathy.
Reproductive system and breast disorders: gynecomastia.
General disorders and administration site conditions: asthenia; chest pain; fatigue; pain; peripheral edema.
Investigations: AST increased; blood CPK increased; gamma-glutamyl transferase increased; liver function test abnormal.
Skeletal Muscle Effects: Rare cases of rhabdomyolysis, which were occasionally associated with impairment of renal function, have been reported with rosuvastatin and with other marketed statins.
Laboratory Effects: As with other HMG-CoA reductase inhibitors, a dose-related increase in liver transaminases and CK has been observed in a small number of patients taking rosuvastatin. Increases in HbA1c have also been observed in a small number of patients treated with rosuvastatin (see Liver Enzyme Abnormalities under PRECAUTIONS and PHARMACOLOGY under Actions). Abnormal urinalysis testing (dipstick-positive proteinuria) has been seen in a small number of patients taking rosuvastatin and other HMG-CoA reductase inhibitors. The protein detected was mostly tubular in origin. In most cases, proteinuria decreases or disappears spontaneously on continued therapy and is not predictive, of acute or progressive renal disease.
Other effects: In a long-term controlled clinical trial Rosuvastatin was shown to have no harmful effects on the ocular lens. In rosuvastatin treated patients, there was no impairment of adrenocortical function.