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Zetia

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Zetia

Zetia Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Zetia (ezetimibe) is a drug that is used to treat high cholesterol that works by decreasing the absorption of cholesterol from the intestine. Side effects of Zetia have included diarrhea, back pain, and abdominal pain.

Zetia is available as 10 mg oral tablets. Bile-acid binding drugs such as cholestyramine (Questran) bind to Zetia and reduce its absorption. There have been no adequate studies of Zetia in pregnant women or nursing mothers.

Our Zetia 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Zetia in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have a serious side effect such as:

  • unusual muscle weakness, tenderness, or pain;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • chest pain;
  • pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate); or
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

  • numbness or tingly feeling;
  • mild stomach pain, diarrhea;
  • tired feeling;
  • headache;
  • dizziness;
  • depressed mood;
  • runny or stuffy nose, cold symptoms;
  • joint pain, back pain; or
  • cough.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Zetia Overview - Patient Information: Side Effects

SIDE EFFECTS: Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This drug may increase the risk of liver damage (when taken with a "statin") or muscle damage when taken with a fibrate or "statin". Tell your doctor right away if you experience any of the following symptoms: signs of liver problems (such as severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine), muscle pain/tenderness/weakness (especially with fever or unusual tiredness).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Zetia (Ezetimibe Tablets)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Zetia FDA Prescribing Information: Side Effects
(Adverse Reactions)

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:

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 Co-Administration 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 X 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 Co-Administered 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 tissuedisorders
  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 co-administration 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 X 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 co-administered 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 co-administered with fenofibrate, respectively [see DRUG INTERACTIONS]. The numbers of patients exposed to co-administration therapy as well as fenofibrate and ezetimibe monotherapy were inadequate to assess gallbladder disease risk. There were no CPK elevations > 10 X 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) »

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Zetia - User Reviews

Zetia User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Zetia sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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