Livalo Side Effects

Generic name: pitavastatin

Note: This document contains side effect information about pitavastatin. Some of the dosage forms listed on this page may not apply to the brand name Livalo.

Some side effects of Livalo may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to pitavastatin: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking pitavastatin (the active ingredient contained in Livalo) 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 of pitavastatin 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.

For Healthcare Professionals

Applies to pitavastatin: oral tablet

Hypersensitivity

Hypersensitivity side effects have included rash, pruritus, and urticaria.

Musculoskeletal

Musculoskeletal side effects have included back pain (1.4% to 3.9%), myalgia (1.9% to 3.1%), pain in extremity (0.6% to 2.3%), and arthralgia.

Gastrointestinal

Gastrointestinal side effects have included constipation (1.5% to 3.6%) and diarrhea (1.5% to 2.6%).

Nervous system

Nervous system side effects have included headache.

Psychiatric

Psychiatric side effects of HMG-CoA reductase inhibitors have included decreased libido, anxiety, insomnia, depression, suicidal thoughts, delusions, paranoia, agitation, and nightmares. Psychiatric side effects reported postmarketing have included 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).

Other

Other side effects reported postmarketing have included abdominal discomfort, abdominal pain, dyspepsia, nausea, asthenia, fatigue, malaise, hepatitis, jaundice, fatal and nonfatal hepatic failure, dizziness, hypoesthesia, insomnia, depression, interstitial lung disease, erectile dysfunction and muscle spasms.

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