Ezallor

Last updated on RxList: 10/8/2020
Ezallor Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Ezallor?

Ezallor (rosuvastatin) is an HMG Co-A reductase inhibitor indicated for adult patients with hypertriglyceridemia as an adjunct to diet; with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet; and with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB.

What Are Side Effects of Ezallor?

Common side effects of Ezallor include:

Dosage for Ezallor

The dose range for Ezallor is 5 mg to 40 mg once daily. Use a 40 mg dose of Ezallor only for patients not reaching LDL-C goal with 20 mg.

What Drugs, Substances, or Supplements Interact with Ezallor?

Ezallor may interact with cyclosporine, gemfibrozil, protease inhibitors, coumarin anticoagulants, fibrates, niacin, or colchicine. Tell your doctor all medications and supplements you use.

Ezallor During Pregnancy and Breastfeeding

Ezallor is not recommended for use during pregnancy; it may harm a fetus. Females of reproductive potential are advised to use effective contraception during treatment with Ezallor. Because of the potential for serious adverse reactions in a breastfed infant, breastfeeding is not recommended during treatment with Ezallor.

Additional Information

Our Ezallor (rosuvastatin) Capsules, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Ezallor Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • unexplained muscle pain, tenderness, or weakness;
  • muscle weakness in your hips, shoulders, neck, and back;
  • trouble lifting your arms, trouble climbing or standing;
  • confusion, memory problems; or
  • liver problems--upper stomach pain, tiredness, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • headache;
  • weakness;
  • muscle aches; or
  • nausea, stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ezallor (Rosuvastatin Calcium Tablets)

SLIDESHOW

How to Lower Your Cholesterol & Save Your Heart See Slideshow
Ezallor Professional Information

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) [see WARNINGS AND PRECAUTIONS]
  • Liver enzyme abnormalities [see WARNINGS AND PRECAUTIONS]

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 ReactionsRosuvastatin 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
Headache5.54.93.18.55.55
Nausea3.83.56.303.43.1
Myalgia3.12.16.31.92.81.3
Asthenia2.43.24.70.92.72.6
Constipation2.12.14.72.82.42.4
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]; 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 ReactionsRosuvastatin 40 mg
N=700
Placebo
N=281
Myalgia12.712.1
Arthralgia10.17.1
Headache6.45.3
Dizziness4.02.8
Increased CPK2.60.7
Abdominal pain2.41.8
ALT >3x ULN22.20.7
1 Adverse reactions by MedDRA preferred term.
2 Frequency recorded as abnormal laboratory value.

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 [see WARNINGS AND PRECAUTIONS].

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 ReactionsRosuvastatin 20 mg
N=8,901
Placebo
N=8,901
Myalgia7.66.6
Arthralgia3.83.2
Constipation3.33.0
Diabetes mellitus2.82.3
Nausea2.42.3
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 [see WARNINGS AND PRECAUTIONS].

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).

Read the entire FDA prescribing information for Ezallor (Rosuvastatin Calcium Tablets)

© Ezallor Patient Information is supplied by Cerner Multum, Inc. and Ezallor Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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