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| __NOTOC__
| | #REDIRECT [[Rosuvastatin#Adverse Reactions]] |
| {{Rosuvastatin}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Adverse Reactions==
| | [[Category: Cardiovascular Drugs]] |
| | | [[Category: Drug]] |
| The following serious adverse reactions are discussed in greater detail in other sections of the label:
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| *[[Rhabdomyolysis]] with [[myoglobinuria]] and [[acute renal failure]] and [[myopathy]] (including [[myositis]]) [see Warnings and Precautions(5.1)]
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| *Liver enzyme abnormalities [see Warnings and Precautions(5.2)]
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| In the CRESTOR controlled clinical trials database (placebo or active-controlled) of 5394 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:
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| *myalgia
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| *abdominal pain
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| *nausea
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| The most commonly reported adverse reactions (incidence ≥ 2%) in the CRESTOR controlled clinical trial database of 5394 patients were:
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| *headache
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| *myalgia
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| *abdominal pain
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| *asthenia
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| *nausea
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| ===Clinical Studies Experience===
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| 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.
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| 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.
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| {|
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| |[[File:Rosuvastatin01.jpg|thumb|800px]]
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| 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.
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| 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 subjects treated with CRESTOR 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 (14.7)].
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| Adverse reactions reported in ≥ 2% of patients and at a rate greater than placebo are shown in Table 2.
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| |[[File:Rosuvastatin02.jpg|thumb|800px]]
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| Table 2. Adverse Reactions1 Reported in 2% of Patients Treated with CRESTOR and > Placebo in the METEOR Trial (% of Patients)
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| In the JUPITER study, 17,802 participants were treated with rosuvastatin 20 mg (n=8901) or placebo (n=8901) 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.
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| In JUPITER, 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 [see Warnings and Precautions (5.5) and Clinical Studies (14.8)].
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| Adverse reactions reported in ≥ 2% of patients and at a rate greater than placebo are shown in Table 3.
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| {|
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| |[[File:Rosuvastatin03.jpg|thumb|800px]]
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| ===Pediatric patients 10 to 17 years of age===
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| In a 12-week controlled study in boys and postmenarchal girls, the safety and tolerability profile of CRESTOR 5 to 20 mg daily was generally similar to that of placebo [seeClinical Studies (14.6) and Use in Specific Populations, Pediatric Use (8.4)].
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| However, elevations in serum creatine phosphokinase (CK) > 10 x ULN were observed more frequently in rosuvastatin compared with placebo-treated children. Four of 130 (3%) children treated with rosuvastatin (2 treated with 10 mg and 2 treated with 20 mg) had increased CK >10 x ULN, compared to 0 of 46 children on placebo.
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| ===Postmarketing Experience===
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| The following adverse reactions have been identified during postapproval use of CRESTOR: [[arthralgia]], fatal and non-fatal hepatic failure, [[hepatitis]], [[jaundice]], [[thrombocytopenia]], [[depression]], [[sleep disorder]]s (including [[insomnia]] and nightmares) 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.
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| There have been rare reports of immune-mediated necrotizing [[myopathy]] associated with [[statin]] use [seeWarnings and Precautions (5.1)].
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| There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, [[amnesia]], memory impairment, [[confusion]]) associated with [[statin ]]use. These cognitive issues have been reported for all [[statin]]s. 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).<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=bb0f3b5e-4bc6-41c9-66b9-6257e2513512 | publisher = | date = | accessdate = 17 February 2014 }}</ref>
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| ==References==
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| {{Reflist|2}}
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| {{Statins}}
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| [[Category:Statins]] | |
| [[Category:AstraZeneca]] | |
| [[Category:Carboxylic acids]] | |
| [[Category:Sulfonamides]]
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| [[Category:Pyrimidines]]
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| [[Category:Organofluorides]]
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