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Last reviewed on RxList: 8/17/2017
Livalo Side Effects Center

Last reviewed on RxList 8/17/2017

Livalo (pitavastatin) is a statin drug used to improve blood cholesterol levels in persons with elevated or abnormal blood cholesterol levels. Common side effects of Livalo include:

  • muscle pain,
  • back pain,
  • joint pain,
  • pain in your arms and legs,
  • diarrhea,
  • constipation,
  • skin rash,
  • headache,
  • sore throat,
  • stuffy or runny nose, and
  • flu symptoms.

The dose range for Livalo is 1 to 4 mg orally once daily. The recommended starting dose is 2 mg and the maximum dose is 4 mg. Livalo may interact with cyclosporine, erythromycin, rifampin, gemfibrozil, other fibrates, niacin, or warfarin. Tell your doctor all medications you are taking. Livalo is not recommended for use during pregnancy, as it may cause fetal harm. It is not known whether Livalo passes into breast milk, however, it has been shown that a small amount of another drug in this class passes into breast milk and that drug has the potential to cause serious adverse reactions in nursing infants. Breastfeeding is not recommended while taking this medication.

Our Livalo (pitavastatin) 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.

Livalo Consumer Information

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.

Stop taking pitavastatin and call your doctor at once if you have any of these serious side effects:

  • unexplained muscle pain, tenderness, or weakness;
  • confusion, memory problems;
  • fever, unusual tiredness, and dark colored urine;
  • increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss); or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild muscle pain;
  • back pain, pain in your arms or legs;
  • diarrhea, constipation; or
  • mild skin rash.

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 Livalo (Pitavastatin)

Livalo Professional Information


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].

Of 4,798 patients enrolled in 10 controlled clinical studies and 4 subsequent open-label extension studies, 3,291 patients were administered pitavastatin 1 mg to 4 mg daily. The mean continuous exposure of pitavastatin (1 mg to 4 mg) was 36.7 weeks (median 51.1 weeks). The mean age of the patients was 60.9 years (range; 18 years – 89 years) and the gender distribution was 48% males and 52% females. Approximately 93% of the patients were Caucasian, 7% were Asian/Indian, 0.2% were African American and 0.3% were Hispanic and other.

Clinical Studies Experience

Because clinical studies on LIVALO are conducted in varying study populations and study designs, the frequency of adverse reactions observed in the clinical studies of LIVALO cannot be directly compared with that in the clinical studies of other HMG-CoA reductase inhibitors and may not reflect the frequency of adverse reactions observed in clinical practice.

Adverse reactions reported in ≥ 2% of patients in controlled clinical studies and at a rate greater than or equal to placebo are shown in Table 1. These studies had treatment duration of up to 12 weeks.

Table 1. Adverse Reactions* Reported by ≥2.0% of Patients Treated with LIVALO and >Placebo in Short-Term Controlled Studies

Adverse Reactions* Placebo
N= 208
1 mg
2 mg
4 mg
Back Pain 2.9% 3.9% 1.8% 1.4%
Constipation 1.9% 3.6% 1.5% 2.2%
Diarrhea 1.9% 2.6% 1.5% 1.9%
Myalgia 1.4% 1.9% 2.8% 3.1%
Pain in extremity 1.9% 2.3% 0.6% 0.9%
* Adverse reactions by MedDRA preferred term.

Other adverse reactions reported from clinical studies were arthralgia, headache, influenza, and nasopharyngitis.

The following laboratory abnormalities have also been reported: elevated creatine phosphokinase, transaminases, alkaline phosphatase, bilirubin, and glucose.

In controlled clinical studies and their open-label extensions, 3.9% (1 mg), 3.3% (2 mg), and 3.7% (4 mg) of pitavastatin-treated patients were discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were: elevated creatine phosphokinase (0.6% on 4 mg) and myalgia (0.5% on 4 mg).

Hypersensitivity reactions including rash, pruritus, and urticaria have been reported with LIVALO.

In a double-blind, randomized, controlled, 52-week trial, 252 HIV-infected patients with dyslipidemia were treated with either LIVALO 4mg once daily (n=126) or another statin (n=126). All patients were taking antiretroviral therapy (excluding darunavir) and had HIV-1 RNA less than 200 copies/mL and CD4 count greater than 200 cell/μL for at least 3 months prior to randomization. The safety profile of LIVALO was generally consistent with that observed in the clinical trials described above. One patient (0.8%) treated with LIVALO had a peak creatine phosphokinase value exceeding 10 times the upper limit of normal (10x ULN), which resolved spontaneously. Four patients (3%) treated with LIVALO had at least one ALT value exceeding 3x but less than 5x ULN, none of which led to drug discontinuation. Virologic failure was reported for four patients (3%) treated with LIVALO, defined as a confirmed measurement of HIV-1 RNA exceeding 200 copies/mL that was also more than a 2-fold increase from baseline.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of LIVALO. 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.

Adverse reactions associated with LIVALO therapy reported since market introduction, regardless of causality assessment, include the following: abdominal discomfort, abdominal pain, dyspepsia, nausea, asthenia, fatigue, malaise, hepatitis, jaundice, fatal and non-fatal hepatic failure, dizziness, hypoesthesia, insomnia, depression, interstitial lung disease, erectile dysfunction, muscle spasms and 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).

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

Read the entire FDA prescribing information for Livalo (Pitavastatin)

Related Resources for Livalo

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

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