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Crestor (Rosuvastatin Calcium) - Side Effects and Adverse Reactions

 


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6ADVERSE REACTIONS

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). [ see Warnings and Precautions (5.1)]

  • Liver Enzyme Abnormalities [ see Warning and Precautions (5.2)]

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 1 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

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 [ 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 1 Reported by ≥ 2% of Patients Treated with CRESTOR and ≥ Placebo in the METEOR Trial (% of Patients)
Adverse ReactionsCRESTOR 40 mg Placebo
N = 700N = 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

1 Adverse reactions by MedDRA preferred term.

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.



REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO CRESTOR

Below is a sample of reports where side effects / adverse reactions may be related to Crestor. The information is not vetted and should not be cosidered as verified clinical evidence.

Possible Crestor side effects / adverse reactions in female

Reported by a physician from France on 2007-01-05

Patient: female weighing 63.0 kg (138.6 pounds)

Reactions: Stomatitis, Gingivitis Ulcerative

Suspect drug(s):
Crestor

Other drugs received by patient: Nexium; Aspirin; Acetaminophen W/ Propoxyphene HCL; Piascledine; Voltarene LP



Possible Crestor side effects / adverse reactions in male

Reported by a health professional (non-physician/pharmacist) from France on 2007-01-08

Patient: male

Reactions: International Normalised Ratio Increased, Drug Interaction, Epistaxis

Adverse event resulted in: hospitalization

Suspect drug(s):
Crestor

Other drugs received by patient possibly interacting with the suspect drug:
Previscan
    Administration route: Oral
    End date: 2006-11-21

Previscan
    Administration route: Oral
    Start date: 2006-11-22

Plavix
    Administration route: Oral
    End date: 2006-11-21

Aspirin
    Administration route: Oral

Cordarone
    Administration route: Oral

Other drugs received by patient: Nexium; Cardensiel; Triatec; Modopar



Possible Crestor side effects / adverse reactions in 51 year old male

Reported by a individual with unspecified qualification from United States on 2007-01-09

Patient: 51 year old male weighing 84.8 kg (186.6 pounds)

Reactions: Back Pain, Pain, Muscular Weakness, Headache, Urine Odour Abnormal, Hepatitis, Epistaxis

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Crestor
    Dosage: 1 tablet daily po
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2006-01-04
    End date: 2006-11-13

Bactrim
    Dosage: 2 tablets daily for 7 days 1 daily afterward po
    Administration route: Oral
    Indication: Urinary Tract Infection
    Start date: 2006-09-23
    End date: 2006-10-20



Possible Crestor side effects / adverse reactions in 658 month old female

Reported by a health professional (non-physician/pharmacist) from France on 2007-01-10

Patient: 658 month old female

Reactions: Cytomegalovirus Antibody Positive, Weight Decreased, Blood Creatine Phosphokinase Increased, Eye Irritation, Fall, Transaminases Increased, Muscle Enzyme Increased, Myalgia, Skin Discolouration, Skeletal Injury, Peripheral Vascular Disorder, Blood Lactate Dehydrogenase Increased, Alanine Aminotransferase Increased, Varicose Vein, Mucosal Erosion, Ocular Hyperaemia, Aspartate Aminotransferase Increased, Herpes Virus Infection

Adverse event resulted in: disablity

Suspect drug(s):
Crestor
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2005-12-21
    End date: 2006-01-31

Zelitrex
    Administration route: Oral
    Indication: Antiviral Prophylaxis
    Start date: 2005-12-01
    End date: 2006-01-31

Other drugs received by patient: Seresta; Mepronizine; Motilium; Lamaline



Possible Crestor side effects / adverse reactions in 71 year old male

Reported by a individual with unspecified qualification from United States on 2007-01-10

Patient: 71 year old male

Reactions: Myasthenia Gravis

Suspect drug(s):
Crestor
    Administration route: Oral

Byetta
    Start date: 2005-12-01

Byetta
    End date: 2006-10-01

Other drugs received by patient: Metformin HCL; Actos



Possible Crestor side effects / adverse reactions in 55 year old male

Reported by a physician from France on 2007-01-11

Patient: 55 year old male

Reactions: Tendon Rupture, Arthralgia

Adverse event resulted in: disablity

Suspect drug(s):
Crestor

Other drugs received by patient: Tildiem



Possible Crestor side effects / adverse reactions in 46 year old male

Reported by a physician from Japan on 2007-01-11

Patient: 46 year old male

Reactions: Acute Promyelocytic Leukaemia

Adverse event resulted in: life threatening event

Suspect drug(s):
Crestor
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2006-10-14
    End date: 2006-12-12

Allopurinol
    Administration route: Oral
    Start date: 2006-10-14
    End date: 2006-12-12

Olmetec
    Administration route: Oral
    Start date: 2006-10-14
    End date: 2006-12-12



Possible Crestor side effects / adverse reactions in 36 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2007-01-12

Patient: 36 year old male

Reactions: Nervous System Disorder, Haemolytic Anaemia, Thrombocytopenia

Adverse event resulted in: life threatening event

Suspect drug(s):
Crestor

Other drugs received by patient: Aspirin; Timoptic; Levothyroxine Sodium; Augmentin '125'



Possible Crestor side effects / adverse reactions in 41 year old male

Reported by a physician from Canada on 2007-01-12

Patient: 41 year old male

Reactions: Blood Creatine Phosphokinase Increased, Fatigue, Pain in Extremity, Pain, Liver Function Test Abnormal, Oedema Peripheral, Drug Interaction, Protein Total Decreased, Cardiac Failure Congestive

Suspect drug(s):
Crestor

Other drugs received by patient possibly interacting with the suspect drug:
Grapefruit Juice
    Indication: Weight Decreased

Other drugs received by patient: Nephril; MS Contin; Prochlorperazine; Clonazepam; Valproic Acid



Possible Crestor side effects / adverse reactions in 76 year old female

Reported by a consumer/non-health professional from Brazil on 2007-01-16

Patient: 76 year old female weighing 80.0 kg (176.0 pounds)

Reactions: Lower Limb Fracture

Adverse event resulted in: disablity

Suspect drug(s):
Crestor

Other drugs received by patient: Verapamil Cloridrate



Possible Crestor side effects / adverse reactions in female

Reported by a pharmacist from Ireland on 2007-01-16

Patient: female weighing 77.0 kg (169.4 pounds)

Reactions: Polyarthritis

Adverse event resulted in: disablity

Suspect drug(s):
Crestor

Other drugs received by patient: Arava



Possible Crestor side effects / adverse reactions in male

Reported by a physician from Japan on 2007-01-16

Patient: male weighing 79.0 kg (173.8 pounds)

Reactions: Gastrointestinal Haemorrhage

Adverse event resulted in: hospitalization

Suspect drug(s):
Crestor
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2006-08-18

Crestor
    Administration route: Oral

Other drugs received by patient: Artist; Artist; Lasix; Panaldine; Gaster D; Coniel; Norvasc; Aspirin; Sigmart; Olmetec; Amaryl; Pravastatin; Basen



Possible Crestor side effects / adverse reactions in 54 year old female

Reported by a individual with unspecified qualification from United States on 2007-01-17

Patient: 54 year old female weighing 68.0 kg (149.7 pounds)

Reactions: Insomnia, Fall, Tremor, Loss of Consciousness

Suspect drug(s):
Crestor

Other drugs received by patient: Etodolac; Femhrt; Vitamin E; Calcium W/vitamin D; .; General Vitamin Supplement



Possible Crestor side effects / adverse reactions in 55 year old female

Reported by a consumer/non-health professional from Canada on 2007-01-17

Patient: 55 year old female

Reactions: Vascular Injury, Death, Haemorrhage, Arterial Occlusive Disease

Adverse event resulted in: death

Suspect drug(s):
Crestor



Possible Crestor side effects / adverse reactions in 82 year old male

Reported by a physician from United States on 2007-01-17

Patient: 82 year old male

Reactions: Intraocular Pressure Increased

Suspect drug(s):
Crestor
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2006-08-01

Flomax

Other drugs received by patient: Diovan; Colestid; Nifedipine



Possible Crestor side effects / adverse reactions in 75 year old male

Reported by a physician from France on 2007-01-18

Patient: 75 year old male weighing 66.0 kg (145.2 pounds)

Reactions: Amyotrophic Lateral Sclerosis

Adverse event resulted in: disablity

Suspect drug(s):
Crestor
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2006-04-01
    End date: 2006-01-01

Crestor
    Administration route: Oral
    Start date: 2006-01-01
    End date: 2006-07-01

Vasten
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2002-01-01
    End date: 2006-04-01

Other drugs received by patient: Cordarone; Amlor; Olmetec; Fosamax; Calcium; Vitamin D3



Possible Crestor side effects / adverse reactions in 58 year old female

Reported by a physician from Netherlands on 2007-01-18

Patient: 58 year old female weighing 89.0 kg (195.8 pounds)

Reactions: Tinnitus, Deafness

Suspect drug(s):
Crestor
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2005-01-01
    End date: 2006-02-01

Metoprolol Succinate

Other drugs received by patient: Lisinopril; Hydrochlorothiazide



Possible Crestor side effects / adverse reactions in 53 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2007-01-18

Patient: 53 year old female weighing 75.0 kg (165.0 pounds)

Reactions: Pulmonary Embolism

Adverse event resulted in: hospitalization

Suspect drug(s):
Crestor
    Administration route: Oral

Avlocardyl
    Administration route: Oral

Aldactazine
    Administration route: Oral

Amlor
    Administration route: Oral

Valsartan and Hydrochlorothiazide
    Administration route: Oral



Possible Crestor side effects / adverse reactions in 72 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2007-01-18

Patient: 72 year old male weighing 72.0 kg (158.4 pounds)

Reactions: Osteoarthritis

Adverse event resulted in: disablity

Suspect drug(s):
Crestor

Other drugs received by patient: Allopurinol Sodium; Ideos; Perindopril Erbumine; Aspirin



Possible Crestor side effects / adverse reactions in 65 year old male

Reported by a consumer/non-health professional from Canada on 2007-01-19

Patient: 65 year old male

Reactions: Movement Disorder, Muscle Disorder

Suspect drug(s):
Crestor



See index of all Crestor side effect reports >>

Drug label data at the top of this Page last updated: 2008-01-08

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