6ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in other sections of the label:
In the CRESTOR 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 CRESTOR controlled clinical trial database of 5,394 patients were:
-
headache
-
myalgia
-
abdominal pain
-
asthenia
-
nausea
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.
Adverse reactions reported in ≥ 2% of patients in placebo-controlled clinical studies and at a rate greater than or equal to placebo are shown in Table 1. These studies had a treatment duration of up to 12 weeks.
Table 1. Adverse Reactions
Reported by ≥ 2% of Patients Treated with CRESTOR and ≥ Placebo in Placebo-Controlled Trials (% of Patients) |
Adverse Reactions
|
CRESTOR 5 mg
N=291
|
CRESTOR 10 mg
N=283
|
CRESTOR 20 mg
N=64
|
CRESTOR 40 mg
N=106
|
Total CRESTOR 5 mg – 40 mg
N=744
|
Placebo
N=382
|
|
Headache
|
5.5
|
4.9
|
3.1
|
8.5
|
5.5
|
5.0
|
| 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
|
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 [ see Warnings and Precautions (5.4)]; elevated creatine phosphokinase, transaminases, glucose, glutamyl transpeptidase, alkaline phosphatase, and bilirubin; and thyroid function abnormalities.
In the METEOR study, 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 CRESTOR-treated subjects 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 [ see Clinical Studies (14.5)]
Adverse reactions reported in ≥ 2% of patients and at a rate greater than or equal to placebo are shown in Table 2.
Table 2. Adverse Reactions
Reported by ≥ 2% of Patients Treated with CRESTOR and ≥ Placebo in the METEOR Trial (% of Patients) | Adverse Reactions | CRESTOR 40 mg | Placebo |
|---|
| N = 700 | N = 281 |
|---|
|
Myalgia
|
12.7
|
12.1
|
|
Arthralgia
|
10.1
|
7.1
|
|
Headache
|
6.4
|
5.3
|
|
Dizziness
|
4.0
|
2.8
|
|
Blood CPK
|
2.6
|
0.7
|
|
Abdominal Pain
|
2.4
|
1.8
|
|
ALT > 3x ULN
|
2.2
|
0.7
|
6.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of CRESTOR: arthralgia, hepatitis, jaundice and memory loss. 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.
|
