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Zetia

Zetia (Ezetimibe Tablets) side effects drug center

 

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CONSUMER

SIDE EFFECTS

 

Zetia Side Effects Center

What Is Zetia?

Zetia (ezetimibe) is a lipid-lowering compound used to treat high cholesterol. Zetia works by decreasing the absorption of cholesterol from the intestine.

What Are Side Effects of Zetia?

Side effects of Zetia include:

Dosage for Zetia

The recommended dose of Zetia is 10 mg once daily.

What Drugs, Substances, or Supplements Interact with Zetia?

Zetia may interact with cholestyramine, colestipol, colesevelam, gemfibrozil, cyclosporine, or blood thinners. Tell your doctor all medications and supplements you use.

Zetia During Pregnancy and Breastfeeding

Before taking Zetia, tell your doctor if you are pregnant or plan to become pregnant during treatment; it is unknown if it would harm a fetus. It is unknown if Zetia passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

Our Zetia Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Zetia 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.

Some cholesterol medications can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Side effects may be more likely in older adults.

Common side effects may include:

  • muscle or joint pain;
  • stuffy nose, sinus pain, sore throat;
  • diarrhea; or
  • pain in an arm or leg.

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 Zetia (Ezetimibe Tablets)

 

Zetia Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the label:

Monotherapy Studies

In the ZETIA controlled clinical trials database (placebo-controlled) of 2396 patients with a median treatment duration of 12 weeks (range 0 to 39 weeks), 3.3% of patients on ZETIA and 2.9% of patients on placebo discontinued due to adverse reactions. The most common adverse reactions in the group of patients treated with ZETIA that led to treatment discontinuation and occurred at a rate greater than placebo were:

  • Arthralgia (0.3%)
  • Dizziness (0.2%)
  • Gamma-glutamyltransferase increased (0.2%)

The most commonly reported adverse reactions (incidence ≥2% and greater than placebo) in the ZETIA monotherapy controlled clinical trial database of 2396 patients were: upper respiratory tract infection (4.3%), diarrhea (4.1%), arthralgia (3.0%), sinusitis (2.8%), and pain in extremity (2.7%).

Statin Coadministration Studies

In the ZETIA + statin controlled clinical trials database of 11,308 patients with a median treatment duration of 8 weeks (range 0 to 112 weeks), 4.0% of patients on ZETIA + statin and 3.3% of patients on statin alone discontinued due to adverse reactions. The most common adverse reactions in the group of patients treated with ZETIA + statin that led to treatment discontinuation and occurred at a rate greater than statin alone were:

The most commonly reported adverse reactions (incidence ≥2% and greater than statin alone) in the ZETIA + statin controlled clinical trial database of 11,308 patients were: nasopharyngitis (3.7%), myalgia (3.2%), upper respiratory tract infection (2.9%), arthralgia (2.6%) and diarrhea (2.5%).

Clinical Trials 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.

Monotherapy

In 10 double-blind, placebo-controlled clinical trials, 2396 patients with primary hyperlipidemia (age range 9-86 years, 50% women, 90% Caucasians, 5% Blacks, 3% Hispanics, 2% Asians) and elevated LDL-C were treated with ZETIA 10 mg/day for a median treatment duration of 12 weeks (range 0 to 39 weeks).

Adverse reactions reported in ≥2% of patients treated with ZETIA and at an incidence greater than placebo in placebo-controlled studies of ZETIA, regardless of causality assessment, are shown in Table 1.

TABLE 1: Clinical Adverse Reactions Occurring in ≥2% of Patients Treated with ZETIA and at an Incidence Greater than Placebo, Regardless of Causality

Body System/Organ Class
Adverse Reaction		 ZETIA 10 mg (%)
n = 2396		 Placebo (%)
n = 1159
Gastrointestinal disorders
  Diarrhea 4.1 3.7
General disorders and administration site conditions
  Fatigue 2.4 1.5
Infections and infestations
  Influenza 2.0 1.5
  Sinusitis 2.8 2.2
  Upper respiratory tract infection 4.3 2.5
Musculoskeletal and connective tissue disorders
  Arthralgia 3.0 2.2
  Pain in extremity 2.7 2.5

The frequency of less common adverse reactions was comparable between ZETIA and placebo.

Combination with a Statin

In 28 double-blind, controlled (placebo or active-controlled) clinical trials, 11,308 patients with primary hyperlipidemia (age range 10-93 years, 48% women, 85% Caucasians, 7% Blacks, 4% Hispanics, 3% Asians) and elevated LDL-C were treated with ZETIA 10 mg/day concurrently with or added to on-going statin therapy for a median treatment duration of 8 weeks (range 0 to 112 weeks).

The incidence of consecutive increased transaminases (≥3 × ULN) was higher in patients receiving ZETIA administered with statins (1.3%) than in patients treated with statins alone (0.4%). [See WARNINGS AND PRECAUTIONS]

Clinical adverse reactions reported in ≥2% of patients treated with ZETIA + statin and at an incidence greater than statin, regardless of causality assessment, are shown in Table 2.

TABLE 2: Clinical Adverse Reactions Occurring in ≥2% of Patients Treated with ZETIA Coadministered with a Statin and at an Incidence Greater than Statin, Regardless of Causality

Body System/Organ Class Adverse Reaction All Statins* (%)
n=9361		 ZETIA + All Statins* (%)
n = 11,308
Gastrointestinal disorders
  Diarrhea 2.2 2.5
General disorders and administration site conditions 
  Fatigue 1.6 2.0
Infections and infestations
  Influenza 2.1 2.2
  Nasopharyngitis 3.3 3.7
  Upper respiratory tract infection 2.8 2.9
Musculoskeletal and connective tissue disorders
  Arthralgia 2.4 2.6
  Back pain   2.3 2.4
  Myalgia 2.7 3.2
  Pain in extremity 1.9 2.1
* All Statins = all doses of all statins

Combination with Fenofibrate

This clinical study involving 625 patients with mixed dyslipidemia (age range 20-76 years, 44% women, 79% Caucasians, 0.1% Blacks, 11% Hispanics, 5% Asians) treated for up to 12 weeks and 576 patients treated for up to an additional 48 weeks evaluated coadministration of ZETIA and fenofibrate. This study was not designed to compare treatment groups for infrequent events. Incidence rates (95% CI) for clinically important elevations (≥3 — ULN, consecutive) in hepatic transaminase levels were 4.5% (1.9, 8.8) and 2.7% (1.2, 5.4) for fenofibrate monotherapy (n=188) and ZETIA coadministered with fenofibrate (n=183), respectively, adjusted for treatment exposure. Corresponding incidence rates for cholecystectomy were 0.6% (95% CI: 0.0%, 3.1%) and 1.7% (95% CI: 0.6%, 4.0%) for fenofibrate monotherapy and ZETIA coadministered with fenofibrate, respectively [see DRUG INTERACTIONS]. The numbers of patients exposed to coadministration therapy as well as fenofibrate and ezetimibe monotherapy were inadequate to assess gallbladder disease risk. There were no CPK elevations > 10 — ULN in any of the treatment groups.

Post-Marketing Experience

Because the reactions below are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following additional adverse reactions have been identified during post-approval use of ZETIA:

Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria; erythema multiforme; arthralgia; myalgia; elevated creatine phosphokinase; myopathy/rhabdomyolysis [see WARNINGS AND PRECAUTIONS]; elevations in liver transaminases; hepatitis; abdominal pain; thrombocytopenia; pancreatitis; nausea; dizziness; paresthesia; depression; headache; cholelithiasis; cholecystitis.

Read the entire FDA prescribing information for Zetia (Ezetimibe Tablets)

&Copy; Zetia Patient Information is supplied by Cerner Multum, Inc. and Zetia Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.