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pitavastatin

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Brand names: Livalo

HMG-CoA Reductase Inhibitor (Statin) Rx

Pitavastatin (Livalo) is a drug that helps lower bad cholesterol (LDL-C) in your blood. It is used along with a healthy diet.

Drug Pricing (NADAC)

Brand Price

$10.23/unit

Generic Price

$1.65/unit

Generic Savings

84%

Generic Available

Yes (7 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

Pitavastatin is used to lower LDL-C (bad cholesterol) in adults.

Common side effects

Muscle pain, Constipation, Back pain

Key warnings

Pitavastatin can cause muscle problems, including myopathy and rhabdomyolysis.

How It Works

Pitavastatin belongs to a class of drugs called statins. It works by blocking a substance your body needs to make cholesterol. This helps to lower the amount of cholesterol in your blood.

How to Take It

Take pitavastatin once a day, with or without food. Try to take it at the same time each day. The usual dose is between 2 mg and 4 mg daily. Your doctor may adjust your dose based on your cholesterol levels.

Pregnancy & Breastfeeding

Do not take pitavastatin if you are pregnant. It can harm your unborn baby. Breastfeeding is also not recommended while taking this medicine.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store pitavastatin at room temperature, away from light.

Side Effects (from patient reports)

Based on 2,955 FDA adverse event reports.

Muscle pain
408
Diarrhea
335
Feeling dizzy
285
Difficulty breathing
281
Loss of appetite
280
Fever
278
Feeling sick to your stomach
274
Feeling tired
273
Itching
272
Headache
269

FDA Adverse Event Report Analysis

Detailed analysis of 3,148 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

3,148

Death-Related Reports

561

Hospitalization Reports

1,405

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 1,221 (48%)
Male 1,308 (52%)

Age Distribution

0–17 66
18–44 106
45–64 662
65–74 772
75+ 733

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 MYALGIA 408
2 DIARRHOEA 335
3 DIZZINESS 285
4 DYSPNOEA 281
5 DECREASED APPETITE 280
6 PYREXIA 278
7 NAUSEA 274
8 FATIGUE 273
9 PRURITUS 272
10 HEADACHE 269
11 MALAISE 265
12 FALL 264
13 ARTHRALGIA 261
14 ASTHENIA 255
15 ALTERED STATE OF CONSCIOUSNESS 250

Reactions in Death Reports

HAEMORRHAGIC STROKE 233
CARDIO-RESPIRATORY ARREST 229
TACHYCARDIA 229
DIARRHOEA 227
ALTERED STATE OF CONSCIOUSNESS 223
DYSPNOEA 221
SEPSIS 221
FALL 219
OCULAR DISCOMFORT 217
PRURITUS 216

Reactions in Hospitalization Reports

PYREXIA 92
PNEUMONIA 73
DIARRHOEA 67
INTERSTITIAL LUNG DISEASE 59
DECREASED APPETITE 58
MALAISE 55
ANAEMIA 54
HEPATIC FUNCTION ABNORMAL 53
OFF LABEL USE 51
NAUSEA 44

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Pitavastatin can cause muscle problems, including myopathy and rhabdomyolysis. Tell your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or feel sick. Pitavastatin can also cause liver problems. Your doctor may do blood tests to check your liver before and during treatment.

Known Drug Interactions

Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with pitavastatin tablets Cyclosporine Clinical Impact: Cyclosporine significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. Intervention: Concomitant use of cyclosporine with pitavastatin tablets is contraindicated [see Contraindications ( 4 )].

Mechanism: Cyclosporine stops the body from clearing pitavastatin, causing the medicine to build up to unsafe levels in the blood. This significantly increases the risk of serious muscle damage and kidney problems.

What to do: Do not take these two medications together. This combination is contraindicated because it is considered too dangerous.

Erythromycin Clinical Impact: Erythromycin significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. Intervention: In patients taking erythromycin, do not exceed pitavastatin tablets 1 mg once daily [see Dosage and Administration ( 2.4 )].

Mechanism: Erythromycin slows down how the body processes pitavastatin, which leads to higher amounts of the drug in your system. Having too much pitavastatin in the blood can cause severe muscle breakdown.

What to do: If you must take both drugs, your doctor should limit your pitavastatin dose to no more than 1 mg once daily.

Rifampin Clinical Impact: Rifampin significantly increases peak pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. Intervention: In patients taking rifampin, do not exceed pitavastatin tablets 2 mg once daily [see Dosage and Administration ( 2.4 )].

Mechanism: Rifampin causes the levels of pitavastatin in the blood to spike higher than they should. These high levels increase the chance of experiencing dangerous muscle injury.

What to do: If you are taking rifampin, your daily dose of pitavastatin should not exceed 2 mg.

moderate colchicine

Colchicine Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with statins, including pitavastatin tablets. Intervention: Consider the risk/benefit of concomitant use of colchicine with pitavastatin tablets.

Mechanism: Taking these two drugs together can increase the risk of serious muscle damage.

What to do: Your doctor should carefully consider if the benefits of taking both drugs are worth the risks.

moderate gemfibrozil

Gemfibrozil Clinical Impact: Gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of gemfibrozil with statins, including pitavastatin tablets. Intervention: Avoid concomitant use of gemfibrozil with pitavastatin tablets.

Mechanism: Gemfibrozil can cause muscle problems on its own, and the risk becomes even higher when it is mixed with a statin.

What to do: You should not take these two medications together.

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Common Questions

Can I take pitavastatin with other medications?
Some medicines can interact with pitavastatin. Tell your doctor about all the medicines you take, including over-the-counter drugs and supplements.
How long will I need to take pitavastatin?
You will likely need to take pitavastatin long-term to manage your cholesterol.
Will I still need to follow a diet while taking pitavastatin?
Yes, pitavastatin works best when combined with a healthy, low-cholesterol diet.
What should I do if I experience muscle pain?
Tell your doctor right away if you have unexplained muscle pain, tenderness, or weakness.
Can pitavastatin affect my liver?
Yes, pitavastatin can sometimes affect your liver. Your doctor will monitor your liver function with blood tests.
Are there any foods I should avoid while taking pitavastatin?
Follow your doctor's or dietitian's recommendations for a low-cholesterol diet.
What is the maximum dose of pitavastatin?
The maximum recommended dose is 4 mg once daily.
What should I do if I have kidney problems?
Tell your doctor if you have kidney problems. Your doctor may need to adjust your dose.
Can I drink alcohol while taking pitavastatin?
Talk to your doctor about whether it is safe for you to drink alcohol while taking pitavastatin.
What are the symptoms of an allergic reaction to pitavastatin?
Symptoms of an allergic reaction can include rash, itching, swelling, or trouble breathing. Get medical help right away if you have any of these symptoms.
What are the common side effects of pitavastatin?
The most commonly reported side effects of pitavastatin include Muscle pain, Constipation, Back pain, Diarrhea, Pain in your arms or legs. Based on 2,955 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does pitavastatin interact with other medications?
Yes, pitavastatin has 9 known drug interactions. Notable interactions include cyclosporine, erythromycin, rifampin. Always inform your doctor about all medications you are taking.
What drug class is pitavastatin?
pitavastatin belongs to the HMG-CoA Reductase Inhibitor (Statin) drug class. It requires a prescription (Rx). Pitavastatin is used to lower LDL-C (bad cholesterol) in adults.
Is there a generic version of pitavastatin?
Yes, generic pitavastatin is available from 7 manufacturers. The generic costs $1.65 per unit compared to $10.23 for the brand version, saving approximately 84%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
Is pitavastatin safe during pregnancy?
Do not take pitavastatin if you are pregnant. It can harm your unborn baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has pitavastatin been recalled?
There are 2 recalls associated with pitavastatin products. Failed Impurity/Degradation Specifications. Check the recalls section below for full details and affected products.

Active Recalls

Class III June 26, 2025

Failed Impurity/Degradation Specifications

AvKARE

Class III June 11, 2025

Failed Impurities/Degradation Specifications.

Orient Pharma Co., Ltd. Yunlin Plant

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What the FDA Data Shows for pitavastatin

The FDA label for pitavastatin (sold under brand names such as Livalo) classifies it as a prescription-only medication in the HMG-CoA Reductase Inhibitor (Statin) class. Pitavastatin is used to lower LDL-C (bad cholesterol) in adults. Official labeling lists 5 commonly reported side effects, including Muscle pain, Constipation, Back pain.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 2,955 voluntary reports. The database also lists 9 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $1.65 versus $10.23 for the brand — a 84% generic savings.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 2 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: January 16, 2026

All federal data sources used on this page