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Liptruzet

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Liptruzet

Liptruzet Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Liptruzet (ezetimibe/atorvastatin) is a combination of a cholesterol blocker and a statin used to reduce cholesterol. Common side effects of Liptruzet include muscle pain, tenderness, or weakness, increased fatigue, or elevation of your liver enzymes.

Liptruzet is dosed as 10/10 (ezetimibe/atorvastatin) mg per day through 10/80 mg per day, with the recommended starting dose of 10/10 mg per day or 10/20 mg per day. Liptruzet may interact with antibiotics, medications prescribed for HIV/AIDS, other statins, and some oral contraceptives. Patients who are allergic or sensitive to ezetimibe and/or atorvastatin should not take Liptruzet. Liptruzet should not be used by women who are pregnant or may become pregnant as it may cause fetal harm. It is not known whether atorvastatin (a component of Liptruzet) is excreted into human milk. Another drug in this class passes into breast milk. Because statins have the potential for serious adverse reactions in nursing infants, breastfeeding is not recommended.

Liptruzet (ezetimibe and atorvastatin) 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 Prescribing information?

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

Liptruzet 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:

Clinical Trials Experience

LIPTRUZET

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 a LIPTRUZET (ezetimibe and atorvastatin) placebo-controlled clinical trial, 628 patients (age range 18-86 years, 59% women, 85% Caucasians, 6% Blacks, 5% Hispanics, 3% Asians) with a median treatment duration of 12 weeks, 6% of patients on LIPTRUZET and 5% of patients on placebo discontinued due to adverse reactions.

The most common adverse reactions in the group treated with LIPTRUZET that led to treatment discontinuation and occurred at a rate greater than placebo were:

  • Myalgia (0.8%)
  • Abdominal pain (0.8%)
  • Increased hepatic enzymes (0.8%)

The most commonly reported adverse reactions (incidence ≥ 2% and greater than placebo) in this trial were: increased ALT (5%), increased AST (4%), and musculoskeletal pain (4%).

LIPTRUZET has been evaluated for safety in 2403 patients in 7 clinical trials (one placebo-controlled trial and six active-controlled trials).

Table 2 summarizes the frequency of clinical adverse reactions reported in ≥ 2% of patients treated with LIPTRUZET (n=255) and at an incidence greater than placebo, regardless of causality assessment, from the placebo-controlled trial.

Table 2*: Clinical and Selected Laboratory Adverse Reactions Occurring in ≥ 2% of Patients Treated with LIPTRUZET and at an Incidence Greater than Placebo, Regardless of Causality

Body System/Organ Class
Adverse Reaction
Placebo (%)
n=60
Ezetimibe 10 mg (%)
n=65
Atorvastatin† (%)
n=248
LIPTRUZET†(%)
n=255
Nervous system disorders
  Dizziness 0 6 < 1 2
Respiratory, thoracic, and mediastinal disorders
  Coughing 0 3 < 1 2
Gastrointestinal disorders
  Abdominal pain 2 2 4 3
  Nausea 0 2 5 3
Musculoskeletal and connective tissue disorders
  Arthralgia 0 5 6 3
  Muscle weakness 0 2 0 2
  Musculoskeletal pain 3 8 5 4
Metabolism and nutrition disorders
  Hyperkalemia 0 0 < 1 2
Infections and infestations
  Bronchitis 0 2 2 2
  Sinusitis 0 3 2 2
Vascular disorders
  Hot flushes 0 0 < 1 2
Investigations
  ALT increased 0 0 2 5
  AST increased 0 0 < 1 4
* Placebo-controlled combination study in which the active ingredients equivalent to LIPTRUZET were coadministered.
† All doses.

After completing the 12-week study, eligible patients were assigned to coadministered ezetimibe and atorvastatin equivalent to LIPTRUZET (10/10-10/80) or atorvastatin (10-80 mg/day) for an additional 48 weeks. The long-term coadministration of ezetimibe plus atorvastatin had an overall safety profile similar to that of atorvastatin alone.

Ezetimibe

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 ezetimibe 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 ezetimibe and at an incidence greater than placebo regardless of causality assessment are shown in Table 3.

Table 3: Clinical Adverse Reactions Occurring in ≥ 2% of Patients Treated with Ezetimibe and at an Incidence Greater than Placebo, Regardless of Causality

Body System/Organ Class
Adverse Reaction
Ezetimibe 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

Atorvastatin

In an atorvastatin placebo-controlled clinical trial database of 16,066 patients (8755 atorvastatin vs. 7311 placebo; age range 10-93 years, 39% women, 91% Caucasians, 3% Blacks, 2% Asians, 4% other) with a median treatment duration of 53 weeks, 9.7% of patients on atorvastatin and 9.5% of the patients on placebo discontinued due to adverse reactions regardless of causality.

The most commonly reported adverse reactions (incidence ≥ 2% and greater than placebo) regardless of causality, in patients treated with atorvastatin in placebo controlled trials (n=8755) were: nasopharyngitis (8.3%), arthralgia (6.9%), diarrhea (6.8%), pain in extremity (6.0%), and urinary tract infection (5.7%).

Table 4 summarizes the frequency of clinical adverse reactions, regardless of causality, reported in ≥ 2% and at a rate greater than placebo in patients treated with atorvastatin (n=8755), from seventeen placebo-controlled trials.

Table 4: Clinical Adverse Reactions Occurring in > 2% in Patients Treated with any dose of Atorvastatin and at an Incidence Greater than Placebo Regardless of Causality (% of patients).

Adverse Reaction* Anydose
n=8755
Atorvastatin 10 mg
n=3908
Atorvastatin 20 mg
n=188
Atorvastatin 40 mg
n=604
Atorvastatin 80 mg
n=4055
Placebo
n=7311
Nasopharyngitis 8.3 12.9 5.3 7.0 4.2 8.2
Arthralgia 6.9 8.9 11.7 10.6 4.3 6.5
Diarrhea 6.8 7.3 6.4 14.1 5.2 6.3
Pain in extremity 6.0 8.5 3.7 9.3 3.1 5.9
Urinary tract infection 5.7 6.9 6.4 8.0 4.1 5.6
Dyspepsia 4.7 5.9 3.2 6.0 3.3 4.3
Nausea 4.0 3.7 3.7 7.1 3.8 3.5
Musculoskeletal pain 3.8 5.2 3.2 5.1 2.3 3.6
Muscle spasms 3.6 4.6 4.8 5.1 2.4 3.0
Myalgia 3.5 3.6 5.9 8.4 2.7 3.1
Insomnia 3.0 2.8 1.1 5.3 2.8 2.9
Pharyngolaryngeal pain 2.3 3.9 1.6 2.8 0.7 2.1
*Adverse Reaction > 2% in any dose greater than placebo

Postmarketing 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 additional events described below have been identified during post-approval use of ezetimibe and/or atorvastatin.

Blood and lymphatic system disorders: thrombocytopenia

Nervous system disorders: headache; paresthesia; peripheral neuropathy

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 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).

Gastrointestinal disorders: pancreatitis

Skin and subcutaneous tissue disorders: angioedema; bullous rashes (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis); rash; urticaria myopathy/rhabdomyolysis [see WARNINGS AND PRECAUTIONS]

There have been rare reports of immune-mediated necrotizing myopathy associated with statin use [see WARNINGS AND PRECAUTIONS].

Injury, poisoning and procedural complications: tendon rupture

Immune system disorders: anaphylaxis; hypersensitivity reactions

Hepatobiliary disorders: hepatitis; cholelithiasis; cholecystitis; fatal and nonfatal hepatic failure

Psychiatric disorders: depression

Laboratory abnormalities: elevated creatine phosphokinase

Read the entire FDA prescribing information for Liptruzet (Ezetimibe and Atorvastatin Tablets) »

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