Rozact Adverse Reactions



Full Prescribing Info
Adverse Reactions
The frequencies of adverse events are ranked according to the following: Common (> 1/100, < 1/10); uncommon (> 1/1000, < 1/100), rare (> 1/10000, < 1/1000), very rare (< 1/10000), not known (cannot be estimated from the available data).
Immune system disorders: Rare: Hypersensitivity reactions including angioedema.
Endocrine disorders: Common: Diabetes mellitus*.
Nervous system disorders: Common: Headache, dizziness.
Gastrointestinal disorders: Common: Constipation, nausea, abdominal pain.
Rare: Pancreatitis.
Skin and subcutaneous tissue disorders: Uncommon: Pruritus, rash and urticaria.
Musculoskeletal, connective tissue and bone disorders: Common: Myalgia.
Rare: Myopathy (including myositis) and rhabdomyolysis.
General disorders: Common: Asthenia.
Note: *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).
As with other HMG-CoA reductase inhibitors, the incidence of adverse drug reactions tends to be dose dependent.
Renal effects: Proteinuria, detected by dipstick testing and mostly tubular in origin, has been observed in patients treated with Rosuvastatin. A minor increase in shift from none or trace to ++ or more were seen in < 1% of patients at some time during treatment with 10 and 20 mg and in approximately 3% of patients treated with 40 mg. A minor increase in shift from none or trace to + was observed with the 20 mg dose. In most cases, proteinuria decreases or disappears spontaneously on continued therapy and is not predictive acute or progressive renal disease.
Skeletal muscle effects: Rare cases of rhabdomyolysis which were occasionally associated with the 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 transaminases and CK have been observed in a small number of patients taking Rosuvastatin; the majority of cases were mild, asymptomatic and transient. If CK levels are elevated (> 5 x ULN), treatment should be discontinued. Increases in HbA1c have also been observed in patients treated with Rosuvastatin.
Post Marketing experience: In addition to above, the following adverse event have been reported with Rosuvastatin and with other marketed Statins.
Haematological disorders: Frequency unknown: Thrombocytopenia.
Hepatobiliary disorders: Very rare: Jaundice, hepatitis.
Rare: Increased hepatic transaminases.
Musculoskeletal disorders: Frequency unknown: Immune-mediated necrotizing myopathy.
Very rare: Arthralgia.
Nervous system disorders: Very rare: Polyneuropathy, memory loss.
Psychiatric disorders: Frequency unknown: Depression, sleep disorders (including insomnia and nightmares).
Reproductive system and breast disorders: Frequency unknown: Gynaecomastia.
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