EZALLOR SIDE EFFECTS
- Generic Name: rosuvastatin calcium tablets
- Brand Name: Ezallor
- Drug Class: HMG-CoA Reductase Inhibitors
SIDE EFFECTS
The following serious adverse reactions are discussed in greater detail in other sections of the label:
- Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis)
- Liver enzyme abnormalities
Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
In the rosuvastatin controlled clinical trials database (placebo or active-controlled) of 5,394 patients with a mean treatment duration of 15 weeks, 1.4% of patients discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were:
- myalgia
- abdominal pain
- nausea
The most commonly reported adverse reactions (incidence ≥ 2%) in the rosuvastatin controlled clinical
- trial database of 5,394 patients were:
- headache
- myalgia
- abdominal pain
- asthenia
- nausea
Adverse reactions reported in ≥ 2% of patients in placebo-controlled clinical studies and at a rate greater than placebo are shown in Table 1. These studies had a treatment duration of up to 12 weeks.
Table 1: Adverse Reactions1 Reported in ≥ 2% of Patients Treated with Rosuvastatin and > Placebo in Placebo-Controlled Trials (% of Patients)
| Adverse Reactions | Rosuvastatin 5 mg N=291 |
Rosuvastatin 10 mg N=283 |
Rosuvastatin 20 mg N=64 |
Rosuvastatin 40 mg N=106 |
Total Rosuvastatin 5 mg to 40 mg N=744 |
Placebo N=382 |
| Headache | 5.5 | 4.9 | 3.1 | 8.5 | 5.5 | 5 |
| Nausea | 3.8 | 3.5 | 6.3 | 0 | 3.4 | 3.1 |
| Myalgia | 3.1 | 2.1 | 6.3 | 1.9 | 2.8 | 1.3 |
| Asthenia | 2.4 | 3.2 | 4.7 | 0.9 | 2.7 | 2.6 |
| Constipation | 2.1 | 2.1 | 4.7 | 2.8 | 2.4 | 2.4 |
| 1 Adverse reactions by COSTART preferred term. | ||||||
Other adverse reactions reported in clinical studies were abdominal pain, dizziness, hypersensitivity (including rash, pruritus, urticaria, and angioedema) and pancreatitis. The following laboratory abnormalities have also been reported: dipstick-positive proteinuria and microscopic hematuria. elevated creatine phosphokinase, transaminases, glucose, glutamyl transpeptidase, alkaline phosphatase, and bilirubin; and thyroid function abnormalities.
In a clinical trial, involving 981 participants treated with rosuvastatin 40 mg (n=700) or placebo (n=281) with a mean treatment duration of 1.7 years, 5.6% of subjects treated with rosuvastatin versus 2.8% of placebo-treated subjects discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were: myalgia, hepatic enzyme increased, headache, and nausea.
Adverse reactions reported in ≥2% of patients and at a rate greater than placebo are shown in Table 2.
Table 2: Adverse Reactions1 Reported in ≥2% of Patients Treated with Rosuvastatin and > Placebo in a Trial (% of Patients)
| Adverse Reactions | Rosuvastatin 40 mg N=700 |
Placebo N=281 |
| Myalgia | 12.7 | 12.1 |
| Arthralgia | 10.1 | 7.1 |
| Headache | 6.4 | 5.3 |
| Dizziness | 4.0 | 2.8 |
| Increased CPK | 2.6 | 0.7 |
| Abdominal pain | 2.4 | 1.8 |
| ALT >3x ULN2 | 2.2 | 0.7 |
| 1 Adverse reactions by MedDRA preferred term. 2 Frequency recorded as abnormal laboratory value. |
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In a clinical trial, 17,802 participants were treated with rosuvastatin 20 mg (n=8,901) or placebo (n=8,901) for a mean duration of 2 years. A higher percentage of rosuvastatin-treated patients versus placebo-treated patients, 6.6% and 6.2%, respectively, discontinued study medication due to an adverse event, irrespective of treatment causality. Myalgia was the most common adverse reaction that led to treatment discontinuation.
There was a significantly higher frequency of diabetes mellitus reported in patients taking rosuvastatin (2.8%) versus patients taking placebo (2.3%). Mean HbA1c was significantly increased by 0.1% in rosuvastatin-treated patients compared to placebo-treated patients. The number of patients with a HbA1c >6.5% at the end of the trial was significantly higher in rosuvastatin-treated versus placebo-treated patients.
Adverse reactions reported in ≥2% of patients and at a rate greater than placebo are shown in Table 3.
Table 3: Adverse Reactions1 Reported in ≥2% of Patients Treated with Rosuvastatin and > Placebo in a Trial (% of Patients)
| Adverse Reactions | Rosuvastatin 20 mg N=8,901 |
Placebo N=8,901 |
| Myalgia | 7.6 | 6.6 |
| Arthralgia | 3.8 | 3.2 |
| Constipation | 3.3 | 3.0 |
| Diabetes mellitus | 2.8 | 2.3 |
| Nausea | 2.4 | 2.3 |
| 1 Treatment-emergent adverse reactions by MedDRA preferred term. | ||
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of rosuvastatin: arthralgia, fatal and non-fatal hepatic failure, hepatitis, jaundice, thrombocytopenia, depression, sleep disorders (including insomnia and nightmares), peripheral neuropathy, interstitial lung disease and gynecomastia. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
There have been rare reports of immune-mediated necrotizing myopathy associated with statin use.
There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, and confusion) 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).
SRC: NLM .